FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25943838 Type 1
Non-Serious
ZEPBOUND, ZEPBOUND, ZEPBOUND (+1 more)
Report Version
1
Receive Date
10/21/2025
Receipt Date
10/21/2025
Transmission Date
01/19/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-ELI_LILLY_AND_COMPANY-US202510012943
Authority Number
--
Sender Organization
ELI LILLY AND COMPANY
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
64.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Extra dose administered (v28.1) Unknown

Drugs (4)

ZEPBOUND (TIRZEPATIDE) Suspect
Route: 058 | Dosage: 2.5 MG, UNKNOWN | Form: Solution for injection in pre-filled pen | Indication: Product used for unknown indication | Action: Unknown
Auth#: 215866 | Batch#: D890245A | Structured Dosage: 2.5 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ZEPBOUND (TIRZEPATIDE) Suspect
Route: 058 | Dosage: 2.5 MG, UNKNOWN | Form: Solution for injection in pre-filled pen | Indication: Product used for unknown indication | Action: Unknown
Auth#: 215866 | Batch#: D890245A | Structured Dosage: 2.5 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ZEPBOUND (TIRZEPATIDE) Suspect
Route: 058 | Dosage: 2.5 MG, UNKNOWN | Form: Solution for injection in pre-filled pen | Indication: Product used for unknown indication | Action: Unknown
Auth#: 215866 | Batch#: D890245A | Structured Dosage: 2.5 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ZEPBOUND (TIRZEPATIDE) Suspect
Route: 058 | Dosage: 2.5 MG, UNKNOWN | Form: Solution for injection in pre-filled pen | Indication: Product used for unknown indication | Action: Unknown
Auth#: 215866 | Batch#: D890245A | Structured Dosage: 2.5 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251007

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4355d3b3830196fa52e8d", "safetyreportid": "25943838", "authoritynumb": null, "companynumb": "US-ELI_LILLY_AND_COMPANY-US202510012943", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 64.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Extra dose administered", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ZEPBOUND", "drugauthorizationnumb": "215866", "drugbatchnumb": "D890245A", "drugstructuredosagenumb": 2.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2.5 MG, UNKNOWN", "drugdosageform": "Solution for injection in pre-filled pen", "drugadministrationroute": "058", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TIRZEPATIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ZEPBOUND", "drugauthorizationnumb": "215866", "drugbatchnumb": "D890245A", "drugstructuredosagenumb": 2.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2.5 MG, UNKNOWN", "drugdosageform": "Solution for injection in pre-filled pen", "drugadministrationroute": "058", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TIRZEPATIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ZEPBOUND", "drugauthorizationnumb": "215866", "drugbatchnumb": "D890245A", "drugstructuredosagenumb": 2.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2.5 MG, UNKNOWN", "drugdosageform": "Solution for injection in pre-filled pen", "drugadministrationroute": "058", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TIRZEPATIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ZEPBOUND", "drugauthorizationnumb": "215866", "drugbatchnumb": "D890245A", "drugstructuredosagenumb": 2.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2.5 MG, UNKNOWN", "drugdosageform": "Solution for injection in pre-filled pen", "drugadministrationroute": "058", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TIRZEPATIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251007" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-21T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-21T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ELI LILLY AND COMPANY" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-19T00:00:00", "transmissiondateformat": "102" }
25943836 Type 2
Serious
CAPIVASERTIB
Report Version
1
Receive Date
10/21/2025
Receipt Date
10/21/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-AstraZeneca-CH-00974190A
Authority Number
--
Sender Organization
ALEXION PHARMACEUTICALS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (7)

Diabetes mellitus (v28.1) Unknown
Diarrhoea (v28.1) Unknown
Decreased appetite (v28.1) Unknown
Weight decreased (v28.1) Unknown
Hepatic lesion (v28.1) Unknown
Emotional distress (v28.1) Unknown
Abdominal pain (v28.1) Unknown

Drugs (1)

CAPIVASERTIB (CAPIVASERTIB) Suspect
Route: -- | Dosage: 200 MILLIGRAM, Q12H | Form: -- | Indication: Neoplasm malignant | Action: Dose Not Changed
Auth#: 218197 | Batch#: YJ0049 | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 12.0 hr | Cumulative: -- (unit: --)
Start: 03/22/2025 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4355d3b3830196fa52e8a", "safetyreportid": "25943836", "authoritynumb": null, "companynumb": "US-AstraZeneca-CH-00974190A", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diabetes mellitus", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Decreased appetite", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Weight decreased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hepatic lesion", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Emotional distress", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal pain", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "CAPIVASERTIB", "drugauthorizationnumb": "218197", "drugbatchnumb": "YJ0049", "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 12.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "200 MILLIGRAM, Q12H", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Neoplasm malignant", "drugstartdateformat": "102", "drugstartdate": "2025-03-22T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "CAPIVASERTIB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-21T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-21T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ALEXION PHARMACEUTICALS" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25943834 Type 1
Non-Serious
ZEPBOUND, ZEPBOUND, ZEPBOUND (+1 more)
Report Version
1
Receive Date
10/21/2025
Receipt Date
10/21/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-ELI_LILLY_AND_COMPANY-US202510012673
Authority Number
--
Sender Organization
ELI LILLY AND COMPANY
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
72.0 yr
Patient Age Group
Elderly
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Extra dose administered (v28.1) Unknown

Drugs (4)

ZEPBOUND (TIRZEPATIDE) Suspect
Route: 065 | Dosage: 2.5 MG, UNKNOWN | Form: Solution for injection in pre-filled pen | Indication: Product used for unknown indication | Action: Unknown
Auth#: 215866 | Batch#: D887666A | Structured Dosage: 2.5 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ZEPBOUND (TIRZEPATIDE) Suspect
Route: 065 | Dosage: 2.5 MG, UNKNOWN | Form: Solution for injection in pre-filled pen | Indication: Product used for unknown indication | Action: Unknown
Auth#: 215866 | Batch#: D887666A | Structured Dosage: 2.5 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ZEPBOUND (TIRZEPATIDE) Suspect
Route: 065 | Dosage: 2.5 MG, UNKNOWN | Form: Solution for injection in pre-filled pen | Indication: Product used for unknown indication | Action: Unknown
Auth#: 215866 | Batch#: D887666A | Structured Dosage: 2.5 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ZEPBOUND (TIRZEPATIDE) Suspect
Route: 065 | Dosage: 2.5 MG, UNKNOWN | Form: Solution for injection in pre-filled pen | Indication: Product used for unknown indication | Action: Unknown
Auth#: 215866 | Batch#: D887666A | Structured Dosage: 2.5 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4355d3b3830196fa52e86", "safetyreportid": "25943834", "authoritynumb": null, "companynumb": "US-ELI_LILLY_AND_COMPANY-US202510012673", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 72.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Extra dose administered", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ZEPBOUND", "drugauthorizationnumb": "215866", "drugbatchnumb": "D887666A", "drugstructuredosagenumb": 2.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2.5 MG, UNKNOWN", "drugdosageform": "Solution for injection in pre-filled pen", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TIRZEPATIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ZEPBOUND", "drugauthorizationnumb": "215866", "drugbatchnumb": "D887666A", "drugstructuredosagenumb": 2.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2.5 MG, UNKNOWN", "drugdosageform": "Solution for injection in pre-filled pen", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TIRZEPATIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ZEPBOUND", "drugauthorizationnumb": "215866", "drugbatchnumb": "D887666A", "drugstructuredosagenumb": 2.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2.5 MG, UNKNOWN", "drugdosageform": "Solution for injection in pre-filled pen", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TIRZEPATIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ZEPBOUND", "drugauthorizationnumb": "215866", "drugbatchnumb": "D887666A", "drugstructuredosagenumb": 2.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2.5 MG, UNKNOWN", "drugdosageform": "Solution for injection in pre-filled pen", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TIRZEPATIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-21T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-21T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ELI LILLY AND COMPANY" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25943837 Type 1
Non-Serious
DALVANCE, ATORVASTATIN CALCIUM, CYANOCOBALAMIN (+9 more)
Report Version
1
Receive Date
10/21/2025
Receipt Date
10/21/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-ABBVIE-6510828
Authority Number
--
Sender Organization
ABBVIE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Feeling hot (v28.1) Recovered
Flushing (v28.1) Recovered
Dysphonia (v28.1) Recovered
Chest discomfort (v28.1) Recovered
Oropharyngeal discomfort (v28.1) Recovered

Drugs (12)

DALVANCE (DALBAVANCIN HYDROCHLORIDE) Suspect
Route: 065 | Dosage: -- | Form: Infusion | Indication: Product used for unknown indication | Action: Withdrawn
Auth#: 021883 | Batch#: MK5636 | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CYANOCOBALAMIN (CYANOCOBALAMIN) Concomitant
Route: -- | Dosage: 1000 MICROGRAM | Form: Injection | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1000.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: 28.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
GABAPENTIN (GABAPENTIN) Concomitant
Route: -- | Dosage: TIME INTERVAL: 0.33333333 DAYS | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 400.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
GUAIFENESIN (GUAIFENESIN) Concomitant
Route: -- | Dosage: TIME INTERVAL: AS NECESSARY: EXTENDED RELEASE | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ESTRADIOL (ESTRADIOL) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
COMBIVENT RESPIMAT (ALBUTEROL SULFATE\IPRATROPIUM BROMIDE) Concomitant
Route: -- | Dosage: TIME INTERVAL: AS NECESSARY: 20TO 100 MICROGRAM INHALER AS NEEDED | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LINZESS (LINACLOTIDE) Concomitant
Route: -- | Dosage: 72 MICROGRAM | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 72.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
METOPROLOL SUCCINATE (METOPROLOL SUCCINATE) Concomitant
Route: -- | Dosage: EXTENDED RELEASE | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OMEPRAZOLE (OMEPRAZOLE) Concomitant
Route: -- | Dosage: DELAYED RELEASE | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Concomitant
Route: -- | Dosage: 800 TO 160 MILLIGRAM FOR TEN DAYS | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 0.25 day | Cumulative: -- (unit: --)
Start: 09/10/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4355d3b3830196fa52e8e", "safetyreportid": "25943837", "authoritynumb": null, "companynumb": "US-ABBVIE-6510828", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Feeling hot", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Flushing", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dysphonia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Chest discomfort", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Oropharyngeal discomfort", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DALVANCE", "drugauthorizationnumb": "021883", "drugbatchnumb": "MK5636", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Infusion", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "DALBAVANCIN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ATORVASTATIN CALCIUM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ATORVASTATIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CYANOCOBALAMIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1000.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 28.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1000 MICROGRAM", "drugdosageform": "Injection", "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CYANOCOBALAMIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "GABAPENTIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "TIME INTERVAL: 0.33333333 DAYS", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "GABAPENTIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "GUAIFENESIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 600.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "TIME INTERVAL: AS NECESSARY: EXTENDED RELEASE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "GUAIFENESIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "HYDROCHLOROTHIAZIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 50.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "HYDROCHLOROTHIAZIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ESTRADIOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ESTRADIOL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "COMBIVENT RESPIMAT", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "TIME INTERVAL: AS NECESSARY: 20TO 100 MICROGRAM INHALER AS NEEDED", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ALBUTEROL SULFATE\\IPRATROPIUM BROMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LINZESS", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 72.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "72 MICROGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LINACLOTIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "METOPROLOL SUCCINATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "EXTENDED RELEASE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "METOPROLOL SUCCINATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OMEPRAZOLE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DELAYED RELEASE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "OMEPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SULFAMETHOXAZOLE\\TRIMETHOPRIM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.25, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "800 TO 160 MILLIGRAM FOR TEN DAYS", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2025-09-10T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "SULFAMETHOXAZOLE\\TRIMETHOPRIM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-21T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-21T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ABBVIE" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25943835 Type 1
Non-Serious
LENALIDOMIDE, LENALIDOMIDE
Report Version
1
Receive Date
10/21/2025
Receipt Date
10/21/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-CIPLA LTD.-2025US12755
Authority Number
--
Sender Organization
CIPLA
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Diarrhoea (v28.1) Not Recovered

Drugs (2)

LENALIDOMIDE (LENALIDOMIDE) Suspect
Route: 048 | Dosage: 15 MILLIGRAM, (FREQUENCY: 14/21) | Form: Capsule | Indication: Plasma cell myeloma | Action: Unknown
Auth#: 210435 | Batch#: -- | Structured Dosage: 15.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
LENALIDOMIDE (LENALIDOMIDE) Suspect
Route: 048 | Dosage: 15 MILLIGRAM, (FREQUENCY: 14/21) | Form: Capsule | Indication: -- | Action: Unknown
Auth#: 210435 | Batch#: -- | Structured Dosage: 15.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/22/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4355d3b3830196fa52e87", "safetyreportid": "25943835", "authoritynumb": null, "companynumb": "US-CIPLA LTD.-2025US12755", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "LENALIDOMIDE", "drugauthorizationnumb": "210435", "drugbatchnumb": null, "drugstructuredosagenumb": 15.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "15 MILLIGRAM, (FREQUENCY: 14/21)", "drugdosageform": "Capsule", "drugadministrationroute": "048", "drugindication": "Plasma cell myeloma", "drugstartdateformat": "602", "drugstartdate": "2021-01-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LENALIDOMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LENALIDOMIDE", "drugauthorizationnumb": "210435", "drugbatchnumb": null, "drugstructuredosagenumb": 15.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "15 MILLIGRAM, (FREQUENCY: 14/21)", "drugdosageform": "Capsule", "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2024-10-22T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LENALIDOMIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-21T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-21T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "CIPLA" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25943839 Type 1
Serious
INFLIXIMAB, INFLIXIMAB, INFLIXIMAB (+52 more)
Report Version
1
Receive Date
10/21/2025
Receipt Date
10/21/2025
Transmission Date
01/17/2026
Primary Source Country
CA
Occurrence Country
CA
Reporter Country
CA
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CA-PFIZER INC-2021887747
Authority Number
--
Sender Organization
CELLTRION
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (15)

Condition aggravated (v28.1) Not Recovered
Symptom recurrence (v28.1) Not Recovered
Inflammation (v28.1) Not Recovered
Constipation (v28.1) Not Recovered
Urinary tract infection (v28.1) Not Recovered
Influenza (v28.1) Not Recovered
Nasopharyngitis (v28.1) Not Recovered
Headache (v28.1) Not Recovered
Drug ineffective (v28.1) Not Recovered
Treatment noncompliance (v28.1) Not Recovered
Off label use (v28.1) Not Recovered
Inappropriate schedule of product administration (v28.1) Not Recovered
Product dose omission issue (v28.1) Not Recovered
Overdose (v28.1) Unknown
Intentional product use issue (v28.1) Unknown

Drugs (55)

INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 1 DOSAGE FORM | Form: Powder for solution for infusion | Indication: Colitis ulcerative | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 1 DOSAGE FORM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 1 DOSAGE FORM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 1 DOSAGE FORM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 1 DOSAGE FORM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 1 DOSAGE FORM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 1 DOSAGE FORM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 1 DOSAGE FORM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 1 DOSAGE FORM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 1 DOSAGE FORM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 1 DOSAGE FORM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 1 DOSAGE FORM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 5 MG/KG | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 5 MG/KG | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 5 MG/KG | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 5 MG/KG | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 5 MG/KG | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 5 MG/KG | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 96.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 10 MG/KG | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 10.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 10 MG/KG | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 10.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 10 MG/KG | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 10.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 335 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 335.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 340 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 340.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 5 MG/KG, INDUCTION DOSES AT WEEK 0, 2 AND 6, THEN EVERY 8 WEEKS | Form: Powder for injection | Indication: Colitis ulcerative | Action: Dose Not Changed
Auth#: 125544 | Batch#: Unknown | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/28/2021 | End: 08/31/2021 | Duration: 96.0 day | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 5 MG/KG, INDUCTION DOSES AT WEEK 0, 2 AND 6, THEN EVERY 8 WEEKS | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: ED3223 | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/11/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 5 MG/KG, INDUCTION DOSES AT WEEK 0, 2 AND 6, THEN EVERY 8 WEEKS | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: EL5950 | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/09/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 5 MG/KG, INDUCTION DOSES AT WEEK 0, 2 AND 6, THEN EVERY 8 WEEKS | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: ET8255 | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/31/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 10 MG/KG, (1 DF) FOR ONE DOSE, THEN 5MG/KG EVERY 4 WEEKS | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: ED3223 | Structured Dosage: 10.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/27/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 10 MG/KG, (1 DF) FOR ONE DOSE, THEN 5MG/KG EVERY 4 WEEKS | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: DY0027 | Structured Dosage: 10.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/27/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 10 MG/KG, (1 DF) FOR ONE DOSE, THEN 5MG/KG EVERY 4 WEEKS | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: CW4747 | Structured Dosage: 10.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/27/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 1 DF, 10MG/KG FOR ONE DOSE, THEN 5MG/KG EVERY 4 WEEKS | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: Unknown | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/28/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 1 DF, 10MG/KG FOR ONE DOSE, THEN 5MG/KG EVERY 4 WEEKS | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: FH4210 | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/29/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 1 DF, 10MG/KG FOR ONE DOSE, THEN 5MG/KG EVERY 4 WEEKS | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: Unknown | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/20/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 1 DF, 10MG/KG FOR ONE DOSE, THEN 5MG/KG EVERY 4 WEEKS | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: FH4211 | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/23/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 1 DF 10MG/KG FOR ONE DOSE, THEN 5MG/KG EVERY 4 WEEKS | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: Unknown | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/18/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 1 DF 10 MG/KG FOR ONE DOSE, THEN 5MG/KG EVERY 4 WEEKS | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: fh4211 | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/14/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 1 DF, AFTER 7 WEEKS AND 3 DAYS (10 MG/KG FOR ONE DOSE, THEN 5MG/KG EVERY 4 WEEKS | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: FK8703 | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 04/07/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 1 DF 10 MG/KG FOR ONE DOSE, THEN 5MG/KG EVERY 4 WEEKS | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: FD1689 | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/01/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 1 DF, AFTE 14 WEEKS AND 1 DAY (10 MG/KG FOR ONE DOSE, THEN 5MG/KG EVERY 4 WEEKS) | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: FK8703 | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/08/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 1 DF, 10 MG/KG FOR ONE DOSE, THEN 5MG/KG EVERY 4 WEEKS | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: FK8701 | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/08/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 1 DF 10MG/KG FOR ONE DOSE, THEN 5MG/KG EVERY 4 WEEKS | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: GH7394 | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/06/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 1 DF, AFTER 6 WEEKS (10MG/KG FOR ONE DOSE, THEN 5MG/KG EVERY 4 WEEKS) | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: GH7393 | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/19/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 5 MG/KG, EVERY 4 WEEKS, WEEK 0,2,6 THEN Q4WEEKS | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: Unknown | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/15/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 5 MG/KG, WEEK0,2,6 THEN Q4WEEKS | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: LG5358 | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/24/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 335 MG, 4 WEEKS (W6) (5 MG/KG, WEEK0,2,6 THEN Q4WEEKS) | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: LL2938 | Structured Dosage: 335.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/25/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 340 MG, AFTER 3 WEEKS AND 6 DAYS (WEEK 0 ,2, 6 THEN Q 4 WEEKS) | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: Unknown | Structured Dosage: 340.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 04/21/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ACETAMINOPHEN (ACETAMINOPHEN) Concomitant
Route: 065 | Dosage: 1 DF, DOSAGE NOT AVAILABLE | Form: Unknown | Indication: -- | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
FOLIC ACID (FOLIC ACID) Concomitant
Route: 065 | Dosage: 5 MG, FREQUENCY NOT AVAILABLE | Form: Unknown | Indication: -- | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
HYDROMORPHONE (HYDROMORPHONE) Concomitant
Route: 065 | Dosage: 1 DF, DOSAGE NOT AVAILABLE | Form: Unknown | Indication: -- | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
LORAZEPAM (LORAZEPAM) Concomitant
Route: 065 | Dosage: 1 DF, DOSAGE NOT AVAILABLE | Form: Unknown | Indication: -- | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
METHOTREXATE (METHOTREXATE) Concomitant
Route: 065 | Dosage: 1 DF, DOSAGE NOT AVAILABLE | Form: Unknown | Indication: -- | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
PANTOPRAZOLE (PANTOPRAZOLE) Concomitant
Route: 065 | Dosage: 40 MG, FREQUENCY NOT AVAILABLE | Form: Unknown | Indication: -- | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREDNISONE (PREDNISONE) Concomitant
Route: 065 | Dosage: 1 DF, DOSAGE NOT AVAILABLE | Form: Unknown | Indication: -- | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/01/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CALCIUM CARBONATE\CHOLECALCIFEROL (CALCIUM CARBONATE\CHOLECALCIFEROL) Concomitant
Route: 065 | Dosage: 1 DF, DOSAGE NOT AVAILABLE | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Concomitant
Route: 065 | Dosage: 1 DF, DOSAGE NOT AVAILABLE | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20210709

Report Duplicates (9)

PFIZER INC: CA-PFIZER INC-2021887747
PFIZER INC: CA-PFIZER INC-2021887747
PFIZER INC: CA-PFIZER INC-2021887747
PFIZER INC: CA-PFIZER INC-2021887747
PFIZER INC: CA-PFIZER INC-2021887747
PFIZER INC: CA-PFIZER INC-2021887747
PFIZER INC: CA-PFIZER INC-2021887747
PFIZER INC: CA-PFIZER INC-2021887747
PFIZER INC: CA-PFIZER INC-2021887747

Raw JSON (click to expand)

{ "_id": "69d4355d3b3830196fa52e8c", "safetyreportid": "25943839", "authoritynumb": null, "companynumb": "CA-PFIZER INC-2021887747", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CA", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Condition aggravated", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Symptom recurrence", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Inflammation", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Constipation", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Urinary tract infection", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Influenza", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nasopharyngitis", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Headache", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Treatment noncompliance", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Off label use", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Inappropriate schedule of product administration", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product dose omission issue", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Overdose", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Intentional product use issue", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "INFLIXIMAB", "drugauthorizationnumb": "115544", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DOSAGE FORM", "drugdosageform": "Powder for solution for infusion", "drugadministrationroute": "042", "drugindication": "Colitis ulcerative", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "INFLIXIMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "INFLIXIMAB", "drugauthorizationnumb": "115544", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DOSAGE FORM", "drugdosageform": "Powder for solution for infusion", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "INFLIXIMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "INFLIXIMAB", "drugauthorizationnumb": "115544", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, 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"drugstartdateformat": "102", "drugstartdate": "2021-12-20T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "INFLIXIMAB-DYYB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "INFLECTRA", "drugauthorizationnumb": "125544", "drugbatchnumb": "FH4211", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DF, 10MG/KG FOR ONE DOSE, THEN 5MG/KG EVERY 4 WEEKS", "drugdosageform": "Powder for injection", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2021-12-23T00:00:00", "drugenddateformat": null, "drugenddate": 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"drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DF, 10 MG/KG FOR ONE DOSE, THEN 5MG/KG EVERY 4 WEEKS", "drugdosageform": "Powder for injection", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2022-09-08T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "INFLIXIMAB-DYYB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "INFLECTRA", "drugauthorizationnumb": "125544", "drugbatchnumb": "GH7394", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DF 10MG/KG FOR ONE DOSE, THEN 5MG/KG EVERY 4 WEEKS", "drugdosageform": "Powder for injection", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2022-12-06T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "INFLIXIMAB-DYYB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "INFLECTRA", "drugauthorizationnumb": "125544", "drugbatchnumb": "GH7393", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DF, AFTER 6 WEEKS (10MG/KG FOR ONE DOSE, THEN 5MG/KG EVERY 4 WEEKS)", "drugdosageform": "Powder for injection", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-01-19T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "INFLIXIMAB-DYYB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "INFLECTRA", "drugauthorizationnumb": "125544", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "007", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG/KG, EVERY 4 WEEKS, WEEK 0,2,6 THEN Q4WEEKS", "drugdosageform": "Powder for injection", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2024-11-15T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "INFLIXIMAB-DYYB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "INFLECTRA", "drugauthorizationnumb": "125544", "drugbatchnumb": "LG5358", "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "007", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG/KG, WEEK0,2,6 THEN Q4WEEKS", "drugdosageform": "Powder for injection", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-02-24T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "INFLIXIMAB-DYYB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "INFLECTRA", "drugauthorizationnumb": "125544", "drugbatchnumb": "LL2938", "drugstructuredosagenumb": 335.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "335 MG, 4 WEEKS (W6) (5 MG/KG, WEEK0,2,6 THEN Q4WEEKS)", "drugdosageform": "Powder for injection", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-03-25T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "INFLIXIMAB-DYYB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "INFLECTRA", "drugauthorizationnumb": "125544", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 340.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "340 MG, AFTER 3 WEEKS AND 6 DAYS (WEEK 0 ,2, 6 THEN Q 4 WEEKS)", "drugdosageform": "Powder for injection", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-04-21T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "INFLIXIMAB-DYYB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ACETAMINOPHEN", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DF, DOSAGE NOT AVAILABLE", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FOLIC ACID", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG, FREQUENCY NOT AVAILABLE", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FOLIC ACID" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "HYDROMORPHONE", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DF, DOSAGE NOT AVAILABLE", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "HYDROMORPHONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LORAZEPAM", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DF, DOSAGE NOT AVAILABLE", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LORAZEPAM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "METHOTREXATE", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DF, DOSAGE NOT AVAILABLE", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "METHOTREXATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PANTOPRAZOLE", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "40 MG, FREQUENCY NOT AVAILABLE", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PANTOPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PREDNISONE", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DF, DOSAGE NOT AVAILABLE", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2021-05-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PREDNISONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CALCIUM CARBONATE\\CHOLECALCIFEROL", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DF, DOSAGE NOT AVAILABLE", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CALCIUM CARBONATE\\CHOLECALCIFEROL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SULFAMETHOXAZOLE\\TRIMETHOPRIM", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DF, DOSAGE NOT AVAILABLE", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "SULFAMETHOXAZOLE\\TRIMETHOPRIM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20210709" }, "primarysource": { "reportercountry": "CA", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CA", "quarter": "2025Q4", "receiptdate": "2025-10-21T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-21T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "PFIZER INC", "duplicatenumb": "CA-PFIZER INC-2021887747" }, { "duplicatesource": "PFIZER INC", "duplicatenumb": "CA-PFIZER INC-2021887747" }, { "duplicatesource": "PFIZER INC", "duplicatenumb": "CA-PFIZER INC-2021887747" }, { "duplicatesource": "PFIZER INC", "duplicatenumb": "CA-PFIZER INC-2021887747" }, { "duplicatesource": "PFIZER INC", "duplicatenumb": "CA-PFIZER INC-2021887747" }, { "duplicatesource": "PFIZER INC", "duplicatenumb": "CA-PFIZER INC-2021887747" }, { "duplicatesource": "PFIZER INC", "duplicatenumb": "CA-PFIZER INC-2021887747" }, { "duplicatesource": "PFIZER INC", "duplicatenumb": "CA-PFIZER INC-2021887747" }, { "duplicatesource": "PFIZER INC", "duplicatenumb": "CA-PFIZER INC-2021887747" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "CELLTRION" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25943833 Type 1
Non-Serious
ZEPBOUND, ZEPBOUND, ZEPBOUND (+1 more)
Report Version
1
Receive Date
10/21/2025
Receipt Date
10/21/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-ELI_LILLY_AND_COMPANY-US202510015054
Authority Number
--
Sender Organization
ELI LILLY AND COMPANY
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
52.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Hunger (v28.1) Unknown
Extra dose administered (v28.1) Unknown
Underdose (v28.1) Unknown
Overdose (v28.1) Unknown
Product storage error (v28.1) Unknown

Drugs (4)

ZEPBOUND (TIRZEPATIDE) Suspect
Route: 065 | Dosage: 2.5 MG, UNKNOWN | Form: Solution for injection | Indication: Product used for unknown indication | Action: Unknown
Auth#: 215866 | Batch#: -- | Structured Dosage: 2.5 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ZEPBOUND (TIRZEPATIDE) Suspect
Route: 065 | Dosage: 7.5 MG, UNKNOWN | Form: Solution for injection | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 7.5 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ZEPBOUND (TIRZEPATIDE) Suspect
Route: 065 | Dosage: 10 MG, UNKNOWN | Form: Solution for injection | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ZEPBOUND (TIRZEPATIDE) Suspect
Route: 065 | Dosage: 15 MG, UNKNOWN | Form: Solution for injection | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: 2178229 | Structured Dosage: 15.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4355d3b3830196fa52e82", "safetyreportid": "25943833", "authoritynumb": null, "companynumb": "US-ELI_LILLY_AND_COMPANY-US202510015054", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 52.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hunger", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Extra dose administered", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Underdose", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Overdose", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product storage error", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ZEPBOUND", "drugauthorizationnumb": "215866", "drugbatchnumb": null, "drugstructuredosagenumb": 2.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2.5 MG, UNKNOWN", "drugdosageform": "Solution for injection", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TIRZEPATIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ZEPBOUND", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 7.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "7.5 MG, UNKNOWN", "drugdosageform": "Solution for injection", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TIRZEPATIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ZEPBOUND", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10 MG, UNKNOWN", "drugdosageform": "Solution for injection", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TIRZEPATIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ZEPBOUND", "drugauthorizationnumb": null, "drugbatchnumb": "2178229", "drugstructuredosagenumb": 15.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "15 MG, UNKNOWN", "drugdosageform": "Solution for injection", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TIRZEPATIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-21T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-21T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ELI LILLY AND COMPANY" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25943832 Type 1
Non-Serious
BLINCYTO
Report Version
1
Receive Date
10/21/2025
Receipt Date
10/21/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Physician
Literature Reference
--
Company Number
US-AMGEN-USASP2025207572
Authority Number
--
Sender Organization
AMGEN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
Adult
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Muscle twitching (v28.1) Recovered

Drugs (1)

BLINCYTO (BLINATUMOMAB) Suspect
Route: 065 | Dosage: UNK, PER LABEL | Form: Powder for solution for injection | Indication: Product used for unknown indication | Action: Withdrawn
Auth#: 125557 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

AMGEN INC: US-AMGEN INC-25-0289428-SR-01

Raw JSON (click to expand)

{ "_id": "69d4355d3b3830196fa52e81", "safetyreportid": "25943832", "authoritynumb": null, "companynumb": "US-AMGEN-USASP2025207572", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 5, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Muscle twitching", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "BLINCYTO", "drugauthorizationnumb": "125557", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK, PER LABEL", "drugdosageform": "Powder for solution for injection", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "BLINATUMOMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-21T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-21T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "AMGEN INC", "duplicatenumb": "US-AMGEN INC-25-0289428-SR-01" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "AMGEN" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25943831 Type 1
Non-Serious
REVLIMID
Report Version
1
Receive Date
10/21/2025
Receipt Date
10/21/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-BRISTOL-MYERS SQUIBB COMPANY-2025-142695
Authority Number
--
Sender Organization
BRISTOL-MYERS SQUIBB COMPANY
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
78.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
81.19 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Feeling abnormal (v28.1) Not Recovered
Abdominal discomfort (v28.1) Not Recovered
Taste disorder (v28.1) Not Recovered

Drugs (1)

REVLIMID (LENALIDOMIDE) Suspect
Route: -- | Dosage: FREQUENCY: EVERY OTHER DAY FOR 21 DAYS, THEN 7 DAYS OFF, EVERY 28 DAYS | Form: Capsule | Indication: Plasma cell myeloma | Action: Dose Not Changed
Auth#: 021880 | Batch#: -- | Structured Dosage: 15.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4355d3b3830196fa52e83", "safetyreportid": "25943831", "authoritynumb": null, "companynumb": "US-BRISTOL-MYERS SQUIBB COMPANY-2025-142695", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 78.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 81.19, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Feeling abnormal", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal discomfort", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Taste disorder", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "REVLIMID", "drugauthorizationnumb": "021880", "drugbatchnumb": null, "drugstructuredosagenumb": 15.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FREQUENCY: EVERY OTHER DAY FOR 21 DAYS, THEN 7 DAYS OFF, EVERY 28 DAYS", "drugdosageform": "Capsule", "drugadministrationroute": null, "drugindication": "Plasma cell myeloma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "LENALIDOMIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-21T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-21T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BRISTOL-MYERS SQUIBB COMPANY" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25943829 Type 1
Serious
AMBISOME, AMBISOME, AMBISOME (+44 more)
Report Version
1
Receive Date
10/21/2025
Receipt Date
10/21/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
EU-PFIZER INC-2017516936
Authority Number
--
Sender Organization
SANDOZ
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
5.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (7)

Drug ineffective (v28.1) Recovered
Pulmonary mucormycosis (v28.1) Recovered
Aspergillus infection (v28.1) Recovering
Hypokalaemia (v28.1) Unknown
Mucormycosis (v28.1) Unknown
Intentional product use issue (v28.1) Unknown
Off label use (v28.1) Unknown

Drugs (47)

AMBISOME (AMPHOTERICIN B) Suspect
Route: 065 | Dosage: 1 MG/KG, QD | Form: -- | Indication: Antifungal treatment | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 007) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 03/01/2015 | End: 01/01/2015 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
AMBISOME (AMPHOTERICIN B) Suspect
Route: 065 | Dosage: 1 MG/KG, QD | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 007) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
AMBISOME (AMPHOTERICIN B) Suspect
Route: 065 | Dosage: 10 MG/KG, QD | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 007) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
AMBISOME (AMPHOTERICIN B) Suspect
Route: 065 | Dosage: 10 MG/KG EVERY 2ND DAY (INCREASED TO 10 MG/KG) | Form: -- | Indication: Aspergillus infection | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 04/01/2015 | End: 05/01/2015 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
AMBISOME (AMPHOTERICIN B) Suspect
Route: 065 | Dosage: 2.5 MG/KG, QD(EVERY 3RD DAY) | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 2.5 (unit: 007) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 05/01/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
AMBISOME (AMPHOTERICIN B) Suspect
Route: 065 | Dosage: 5 MG/KG, QD | Form: -- | Indication: Mucormycosis | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 03/01/2015 | End: 04/01/2015 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
AMBISOME (AMPHOTERICIN B) Suspect
Route: 065 | Dosage: 5 MG/KG, DAILY (INCREASE TO 5 MG/KG/DAY EVERY 3RD DAY) | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 04/01/2016 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
AMBISOME (AMPHOTERICIN B) Suspect
Route: 065 | Dosage: DOSAGES WERE REDUCED | Form: -- | Indication: Pulmonary mucormycosis | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) Suspect
Route: 065 | Dosage: UNK UNK, BLOCK IB | Form: Unknown | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) Suspect
Route: 065 | Dosage: UNK BLOCK IB | Form: Unknown | Indication: B precursor type acute leukaemia | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
CYTARABINE (CYTARABINE) Suspect
Route: 065 | Dosage: UNK | Form: Unknown | Indication: B precursor type acute leukaemia | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
CYTARABINE (CYTARABINE) Suspect
Route: 065 | Dosage: UNKUNK, BLOCK IB | Form: Unknown | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
DEXAMETHASONE (DEXAMETHASONE) Suspect
Route: 065 | Dosage: 10 MG/M2, QD | Form: Unknown | Indication: B precursor type acute leukaemia | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/01/2015 | End: 02/01/2015 | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
DEXAMETHASONE (DEXAMETHASONE) Suspect
Route: 065 | Dosage: UNK BLOCK II A | Form: Unknown | Indication: Acute lymphocytic leukaemia | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2015 | End: 02/01/2015 | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
DOXORUBICIN (DOXORUBICIN) Suspect
Route: 065 | Dosage: UNK | Form: Unknown | Indication: B precursor type acute leukaemia | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
DOXORUBICIN (DOXORUBICIN) Suspect
Route: 065 | Dosage: UNK UNK, BLOCK IIA | Form: Unknown | Indication: Acute lymphocytic leukaemia | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2015 | End: 01/01/2015 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
DAUNORUBICIN (DAUNORUBICIN) Suspect
Route: 065 | Dosage: 4 DOSES BLOCK IA | Form: -- | Indication: B precursor type acute leukaemia | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/01/2014 | End: 01/01/2014 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
DAUNORUBICIN (DAUNORUBICIN) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: Acute lymphocytic leukaemia | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
DAUNORUBICIN (DAUNORUBICIN) Suspect
Route: 065 | Dosage: UNK UNK, BLOCK IIA | Form: -- | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2015 | End: 01/01/2015 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
METHOTREXATE (METHOTREXATE) Suspect
Route: 037 | Dosage: UNK MAINTENANCE: 0.5-0.7 MG/KG ONCE WEEKLY | Form: Unknown | Indication: -- | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/01/2014 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
METHOTREXATE (METHOTREXATE) Suspect
Route: 037 | Dosage: UNK UNK, BLOCK IB | Form: Unknown | Indication: -- | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
METHOTREXATE (METHOTREXATE) Suspect
Route: 037 | Dosage: UNK UNK, BLOCK IIA | Form: Unknown | Indication: B precursor type acute leukaemia | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/01/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
METHOTREXATE SODIUM (METHOTREXATE SODIUM) Suspect
Route: 065 | Dosage: 0.5-0.7 MG/KG, QW | Form: Unknown | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 0.7 (unit: 007) | Separate Dosage#: 1.0 | Interval: 1.0 wk | Cumulative: -- (unit: --)
Start: 04/01/2015 | End: 05/01/2015 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
METHOTREXATE SODIUM (METHOTREXATE SODIUM) Suspect
Route: 037 | Dosage: UNK, BLOCK IA | Form: Unknown | Indication: Acute lymphocytic leukaemia | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/01/2014 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
METHOTREXATE SODIUM (METHOTREXATE SODIUM) Suspect
Route: 037 | Dosage: UNK, BLOCK IB | Form: Unknown | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
MERCAPTOPURINE (MERCAPTOPURINE) Suspect
Route: 065 | Dosage: 1.5 MG/KG 1.5 MG/KG DAILY; MAINTENANCE | Form: -- | Indication: B precursor type acute leukaemia | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 1.5 (unit: 007) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/01/2014 | End: 01/01/2014 | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
MERCAPTOPURINE (MERCAPTOPURINE) Suspect
Route: 065 | Dosage: 1.5 MG/KG, DAILY | Form: -- | Indication: Acute lymphocytic leukaemia | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 1.5 (unit: 007) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/01/2015 | End: 05/01/2015 | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
MERCAPTOPURINE (MERCAPTOPURINE) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
ONCASPAR (PEGASPARGASE) Suspect
Route: 042 | Dosage: 2500 U/M2 DAY 12 AND DAY 8 OF BLOCK IIA | Form: -- | Indication: B precursor type acute leukaemia | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2015 | End: 01/01/2015 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
POSACONAZOLE (POSACONAZOLE) Suspect
Route: 048 | Dosage: 15 MG/KG, QD | Form: Unknown | Indication: Antifungal treatment | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 15.0 (unit: 007) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/01/2015 | End: 05/01/2015 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
POSACONAZOLE (POSACONAZOLE) Suspect
Route: 048 | Dosage: 20 MG/KG, QD | Form: Unknown | Indication: Pulmonary mucormycosis | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 007) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/01/2016 | End: 05/01/2016 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
PREDNISONE (PREDNISONE) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: B precursor type acute leukaemia | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/01/2014 | End: 01/01/2014 | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
PREDNISONE (PREDNISONE) Suspect
Route: 065 | Dosage: UNK BLOCK IA | Form: -- | Indication: Acute lymphocytic leukaemia | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/01/2014 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
THIOGUANINE (THIOGUANINE) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: B precursor type acute leukaemia | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
VORICONAZOLE (VORICONAZOLE) Suspect
Route: 065 | Dosage: 15 MG/KG, QD | Form: Unknown | Indication: Antifungal treatment | Action: Unknown
Auth#: 200265 | Batch#: -- | Structured Dosage: 15.0 (unit: 007) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 03/01/2015 | End: 04/01/2015 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
VORICONAZOLE (VORICONAZOLE) Suspect
Route: 065 | Dosage: 8 MG/KG, QD | Form: Unknown | Indication: Mucormycosis | Action: Unknown
Auth#: 200265 | Batch#: -- | Structured Dosage: 8.0 (unit: 007) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 03/01/2015 | End: 04/01/2015 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
VORICONAZOLE (VORICONAZOLE) Suspect
Route: -- | Dosage: -- | Form: Unknown | Indication: Aspergillus infection | Action: Unknown
Auth#: 200265 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
VINCRISTINE (VINCRISTINE) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: B precursor type acute leukaemia | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
VINCRISTINE (VINCRISTINE) Suspect
Route: 065 | Dosage: UNK BLOCK IA | Form: -- | Indication: Acute lymphocytic leukaemia | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/01/2014 | End: 08/01/2014 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
VINCRISTINE (VINCRISTINE) Suspect
Route: 065 | Dosage: UNK BLOCK IIA | Form: -- | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2015 | End: 01/01/2015 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
AMPHOTERICIN B (AMPHOTERICIN B) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Gastric infection | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/01/2014 | End: 12/01/2016 | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CASPOFUNGIN (CASPOFUNGIN) Concomitant
Route: 065 | Dosage: 1 MG/KG, DAILY | Form: -- | Indication: Antifungal treatment | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 007) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/01/2015 | End: 03/01/2015 | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CASPOFUNGIN (CASPOFUNGIN) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Aspergillus infection | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
Ceftazidim mip (--) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Lung infiltration | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
Linezolid hcs (--) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Lung infiltration | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
POSACONAZOLE (POSACONAZOLE) Concomitant
Route: 065 | Dosage: 15 MG/KG, QD | Form: -- | Indication: Pulmonary mucormycosis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 15.0 (unit: 007) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VORICONAZOLE (VORICONAZOLE) Concomitant
Route: 065 | Dosage: 8 MG/KG, QD | Form: -- | Indication: Pulmonary mucormycosis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 8.0 (unit: 007) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20150401

Report Duplicates (11)

EMA: EU-EMA-DD 20240930-7482661-154002
SERVIER: EU-SERVIER-S20005738
EMA: EU-EMA-DD-20200515-shaik_i-140911
Accord: EU-Accord-066382
GILEAD: EU-GILEAD-2019-0424813
PFIZER INC: EU-PFIZER INC-2017516936
TEVA: EU-TEVA-2020-AT-1239391
STADA: EU-STADA-200593
Adis: NZ-Adis-3474380-220297
SUN PHARMACEUTICAL INDUSTRIES LTD: EU-SUN PHARMACEUTICAL INDUSTRIES LTD-2020R1-247167
009507513: EU-009507513-1908AUT012766

Raw JSON (click to expand)

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"drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "AMPHOTERICIN B" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "AMBISOME", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG/KG, DAILY (INCREASE TO 5 MG/KG/DAY EVERY 3RD DAY)", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2016-04-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "AMPHOTERICIN B" }, "drugrecurrence": [] }, { 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"drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Lung infiltration", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "Linezolid hcs", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Lung infiltration", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "POSACONAZOLE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 15.0, "drugstructuredosageunit": "007", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "15 MG/KG, QD", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Pulmonary mucormycosis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "POSACONAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "VORICONAZOLE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 8.0, "drugstructuredosageunit": "007", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "8 MG/KG, QD", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Pulmonary mucormycosis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "VORICONAZOLE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20150401" }, "primarysource": { "reportercountry": "EU", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-21T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-21T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "EMA", "duplicatenumb": "EU-EMA-DD 20240930-7482661-154002" }, { "duplicatesource": "SERVIER", "duplicatenumb": "EU-SERVIER-S20005738" }, { "duplicatesource": "EMA", "duplicatenumb": "EU-EMA-DD-20200515-shaik_i-140911" }, { "duplicatesource": "Accord", "duplicatenumb": "EU-Accord-066382" }, { "duplicatesource": "GILEAD", "duplicatenumb": "EU-GILEAD-2019-0424813" }, { "duplicatesource": "PFIZER INC", "duplicatenumb": "EU-PFIZER INC-2017516936" }, { "duplicatesource": "TEVA", "duplicatenumb": "EU-TEVA-2020-AT-1239391" }, { "duplicatesource": "STADA", "duplicatenumb": "EU-STADA-200593" }, { "duplicatesource": "Adis", "duplicatenumb": "NZ-Adis-3474380-220297" }, { "duplicatesource": "SUN PHARMACEUTICAL INDUSTRIES LTD", "duplicatenumb": "EU-SUN PHARMACEUTICAL INDUSTRIES LTD-2020R1-247167" }, { "duplicatesource": "009507513", "duplicatenumb": "EU-009507513-1908AUT012766" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANDOZ" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 1, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }