FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25958284 Type 1
Serious
CIPROFLOXACIN
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
CH
Occurrence Country
CH
Reporter Country
CH
Reporter Qualification
Other Health Professional
Literature Reference
Raffaele Piazza. Fluoroquinolone-Associated Disability after taking Ciprofloxacin. Praxis (Bern 1994). 2025;114(8-9):326-330
Company Number
CH-THE J. MOLNER COMPANY-202510000060
Authority Number
--
Sender Organization
The J.Molner Company
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
41.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (6)

Tendonitis (v28.1) Unknown
Extrasystoles (v28.1) Unknown
Insomnia (v28.1) Unknown
Pain (v28.1) Unknown
Tinnitus (v28.1) Unknown
Livedo reticularis (v28.1) Unknown

Drugs (1)

CIPROFLOXACIN (CIPROFLOXACIN) Suspect
Route: 065 | Dosage: 500 MILLIGRAM, BID | Form: Unknown | Indication: Chalazion | Action: Withdrawn
Auth#: 076754 | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435a33b3830196fa56ad8", "safetyreportid": "25958284", "authoritynumb": null, "companynumb": "CH-THE J. MOLNER COMPANY-202510000060", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CH", "patient": { "patientonsetage": 41.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Tendonitis", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Extrasystoles", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Insomnia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pain", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Tinnitus", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Livedo reticularis", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "CIPROFLOXACIN", "drugauthorizationnumb": "076754", "drugbatchnumb": null, "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "500 MILLIGRAM, BID", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Chalazion", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "CIPROFLOXACIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CH", "qualification": 3, "literaturereference": "Raffaele Piazza. Fluoroquinolone-Associated Disability after taking Ciprofloxacin. Praxis (Bern 1994). 2025;114(8-9):326-330" }, "primarysourcecountry": "CH", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "The J.Molner Company" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 1, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25958282 Type 1
Serious
HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE (+5 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Other Health Professional
Literature Reference
Rui Zhang. Successful Management of Cerebral Salt-Wasting Syndrome in a Child With Epileptic Encephalopathy: A Case Report. Clinical Case Reports. 2025;13(9):e70866
Company Number
CN-THE J. MOLNER COMPANY-202510000057
Authority Number
--
Sender Organization
The J.Molner Company
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
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 (1)

Hypokalaemia (v28.1) Unknown

Drugs (8)

HYDROCORTISONE BUTYRATE (HYDROCORTISONE BUTYRATE) Suspect
Route: 065 | Dosage: 100 MILLIGRAM, TID | Form: Unknown | Indication: Cerebral salt-wasting syndrome | Action: Unknown
Auth#: 209556 | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
HYDROCORTISONE BUTYRATE (HYDROCORTISONE BUTYRATE) Suspect
Route: 065 | Dosage: 100 MILLIGRAM, BID | Form: Unknown | Indication: -- | Action: Unknown
Auth#: 209556 | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
HYDROCORTISONE BUTYRATE (HYDROCORTISONE BUTYRATE) Suspect
Route: 065 | Dosage: 100 MILLIGRAM, QD | Form: Unknown | Indication: -- | Action: Unknown
Auth#: 209556 | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
FLUDROCORTISONE (FLUDROCORTISONE) Suspect
Route: 065 | Dosage: 0.05 MILLIGRAM, BID | Form: -- | Indication: Cerebral salt-wasting syndrome | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 0.05 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
FLUDROCORTISONE (FLUDROCORTISONE) Suspect
Route: 065 | Dosage: 0.075 MILLIGRAM, BID | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 0.075 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
FLUDROCORTISONE (FLUDROCORTISONE) Suspect
Route: 065 | Dosage: 0.025 MILLIGRAM, BID | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 0.025 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SODIUM (SODIUM) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Mineral supplementation | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
Pituitary hormone, posterior lobe (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Polyuria | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435a33b3830196fa56ad7", "safetyreportid": "25958282", "authoritynumb": null, "companynumb": "CN-THE J. MOLNER COMPANY-202510000057", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 5.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypokalaemia", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "HYDROCORTISONE BUTYRATE", "drugauthorizationnumb": "209556", "drugbatchnumb": null, "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 MILLIGRAM, TID", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Cerebral salt-wasting syndrome", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "HYDROCORTISONE BUTYRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "HYDROCORTISONE BUTYRATE", "drugauthorizationnumb": "209556", "drugbatchnumb": null, "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 MILLIGRAM, BID", "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": "HYDROCORTISONE BUTYRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "HYDROCORTISONE BUTYRATE", "drugauthorizationnumb": "209556", "drugbatchnumb": null, "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 MILLIGRAM, QD", "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": "HYDROCORTISONE BUTYRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUDROCORTISONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 0.05, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "0.05 MILLIGRAM, BID", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Cerebral salt-wasting syndrome", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUDROCORTISONE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUDROCORTISONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 0.075, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "0.075 MILLIGRAM, BID", "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": "FLUDROCORTISONE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUDROCORTISONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 0.025, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "0.025 MILLIGRAM, BID", "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": "FLUDROCORTISONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SODIUM", "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": "Mineral supplementation", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "SODIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "Pituitary hormone, posterior lobe", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Polyuria", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CN", "qualification": 3, "literaturereference": "Rui Zhang. Successful Management of Cerebral Salt-Wasting Syndrome in a Child With Epileptic Encephalopathy: A Case Report. Clinical Case Reports. 2025;13(9):e70866" }, "primarysourcecountry": "CN", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "The J.Molner Company" }, "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" }
25958281 Type 1
Serious
XULTOPHY 100/3.6
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-NOVOPROD-1534315
Authority Number
--
Sender Organization
NOVO NORDISK
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
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Fall (v28.1) Unknown

Drugs (1)

XULTOPHY 100/3.6 (INSULIN DEGLUDEC\LIRAGLUTIDE) Suspect
Route: -- | Dosage: UNK | Form: Solution for injection | Indication: Product used for unknown indication | Action: Unknown
Auth#: 208583 | Batch#: GP52431 | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435a33b3830196fa56ad6", "safetyreportid": "25958281", "authoritynumb": null, "companynumb": "US-NOVOPROD-1534315", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Fall", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "XULTOPHY 100/3.6", "drugauthorizationnumb": "208583", "drugbatchnumb": "GP52431", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Solution for injection", "drugadministrationroute": null, "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": "INSULIN DEGLUDEC\\LIRAGLUTIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "NOVO NORDISK" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25958280 Type 1
Serious
HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE, DOPAMINE (+7 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
GB
Occurrence Country
GB
Reporter Country
GB
Reporter Qualification
Other Health Professional
Literature Reference
Kirti Gupta. Severe transient hypertrophic cardiomyopathy in an extremely preterm infant receiving early low-dose hydrocortisone for bronchopulmonary dysplasia prevention. J Neonatal Perinatal Med. 2025;18(5):491-495
Company Number
GB-THE J. MOLNER COMPANY-202510000064
Authority Number
--
Sender Organization
The J.Molner Company
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
1.0 day
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Hypertrophic cardiomyopathy (v28.1) Recovered

Drugs (10)

HYDROCORTISONE BUTYRATE (HYDROCORTISONE BUTYRATE) Suspect
Route: 065 | Dosage: 0.5 MILLIGRAM/KILOGRAM, BID | Form: Unknown | Indication: Bronchopulmonary dysplasia | Action: Withdrawn
Auth#: 209556 | Batch#: -- | Structured Dosage: 0.5 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 7.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
HYDROCORTISONE BUTYRATE (HYDROCORTISONE BUTYRATE) Suspect
Route: 065 | Dosage: 0.5 MILLIGRAM/KILOGRAM, QD | Form: Unknown | Indication: -- | Action: Withdrawn
Auth#: 209556 | Batch#: -- | Structured Dosage: 0.5 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 3.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
DOPAMINE (DOPAMINE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: MAXIMUM DOSE 15 MCG/KG/MIN | Form: Infusion | Indication: Hypotension | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CAFFEINE CITRATE (CAFFEINE CITRATE) Concomitant
Route: -- | Dosage: 20 MILLIGRAM/KILOGRAM | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CAFFEINE CITRATE (CAFFEINE CITRATE) Concomitant
Route: -- | Dosage: MAINTENANCE DOSE OF 5-10 MG/KG | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
AMIKACIN (AMIKACIN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PENICILLIN G (PENICILLIN G) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PIPERACILLIN SODIUM\TAZOBACTAM SODIUM (PIPERACILLIN SODIUM\TAZOBACTAM SODIUM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
TEICOPLANIN (TEICOPLANIN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FLUCLOXACILLIN (FLUCLOXACILLIN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435a33b3830196fa56ad5", "safetyreportid": "25958280", "authoritynumb": null, "companynumb": "GB-THE J. MOLNER COMPANY-202510000064", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "GB", "patient": { "patientonsetage": 1.0, "patientonsetageunit": 804, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypertrophic cardiomyopathy", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "HYDROCORTISONE BUTYRATE", "drugauthorizationnumb": "209556", "drugbatchnumb": null, "drugstructuredosagenumb": 0.5, "drugstructuredosageunit": "007", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "0.5 MILLIGRAM/KILOGRAM, BID", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Bronchopulmonary dysplasia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 7.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "HYDROCORTISONE BUTYRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "HYDROCORTISONE BUTYRATE", "drugauthorizationnumb": "209556", "drugbatchnumb": null, "drugstructuredosagenumb": 0.5, "drugstructuredosageunit": "007", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "0.5 MILLIGRAM/KILOGRAM, QD", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 3.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "HYDROCORTISONE BUTYRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DOPAMINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "MAXIMUM DOSE 15 MCG/KG/MIN", "drugdosageform": "Infusion", "drugadministrationroute": null, "drugindication": "Hypotension", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DOPAMINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CAFFEINE CITRATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "007", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "20 MILLIGRAM/KILOGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CAFFEINE CITRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CAFFEINE CITRATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "MAINTENANCE DOSE OF 5-10 MG/KG", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CAFFEINE CITRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "AMIKACIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "AMIKACIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PENICILLIN G", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PENICILLIN G" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PIPERACILLIN SODIUM\\TAZOBACTAM SODIUM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PIPERACILLIN SODIUM\\TAZOBACTAM SODIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TEICOPLANIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "TEICOPLANIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FLUCLOXACILLIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "FLUCLOXACILLIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "GB", "qualification": 3, "literaturereference": "Kirti Gupta. Severe transient hypertrophic cardiomyopathy in an extremely preterm infant receiving early low-dose hydrocortisone for bronchopulmonary dysplasia prevention. J Neonatal Perinatal Med. 2025;18(5):491-495" }, "primarysourcecountry": "GB", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "The J.Molner Company" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 1, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25958278 Type 1
Serious
LENALIDOMIDE, BORTEZOMIB, DARATUMUMAB\HYALURONIDASE-FIHJ (+65 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
CA
Occurrence Country
CA
Reporter Country
CA
Reporter Qualification
Physician
Literature Reference
--
Company Number
--
Authority Number
CA-DRL-USA-CAN/2025/10/015723
Sender Organization
DR REDDYS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
78.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
76.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Pneumonia (v28.1) Not Recovered
Pneumonia haemophilus (v28.1) Not Recovered
Asthma (v28.1) Not Recovered
Atrial fibrillation (v28.1) Not Recovered

Drugs (68)

LENALIDOMIDE (LENALIDOMIDE) Suspect
Route: 048 | Dosage: -- | Form: Capsule | Indication: Plasma cell myeloma | Action: Unknown
Auth#: 209348 | Batch#: Unknown | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 2178.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
BORTEZOMIB (BORTEZOMIB) Suspect
Route: 058 | Dosage: -- | Form: -- | Indication: Plasma cell myeloma | Action: Unknown
Auth#: 202963 | Batch#: Unknown | Structured Dosage: 1.0 (unit: 009) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 172.0 day | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
DARATUMUMAB\HYALURONIDASE-FIHJ (DARATUMUMAB\HYALURONIDASE-FIHJ) Suspect
Route: 058 | Dosage: -- | Form: -- | Indication: Plasma cell myeloma | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: 1800.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 2158.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
DEXAMETHASONE (DEXAMETHASONE) Suspect
Route: 058 | Dosage: -- | Form: -- | Indication: Plasma cell myeloma | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 2172.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
ALLOPURINOL (ALLOPURINOL) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 6.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
AMOXICILLIN\CLAVULANATE POTASSIUM (AMOXICILLIN\CLAVULANATE POTASSIUM) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Upper respiratory tract infection | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 5.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
AMOXICILLIN\CLAVULANATE POTASSIUM (AMOXICILLIN\CLAVULANATE POTASSIUM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 675.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.5 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 9.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
TESTOSTERONE UNDECANOATE (TESTOSTERONE UNDECANOATE) Concomitant
Route: 048 | Dosage: -- | Form: Capsule | Indication: Blood testosterone decreased | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TESTOSTERONE UNDECANOATE (TESTOSTERONE UNDECANOATE) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: Blood testosterone decreased | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 477.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
ANDROGEL (TESTOSTERONE) Concomitant
Route: 061 | Dosage: -- | Form: Gel | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 2.5 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 1.0 yr | Rechallenge: -- | Additional: Unknown
Recurrences: --
ATIVAN (LORAZEPAM) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Insomnia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 4.0 hr | Rechallenge: -- | Additional: Unknown
Recurrences: --
BETAMETHASONE VALERATE (BETAMETHASONE VALERATE) Concomitant
Route: 061 | Dosage: -- | Form: -- | Indication: Rash | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 62.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
BRIMONIDINE (BRIMONIDINE TARTRATE) Concomitant
Route: -- | Dosage: 1.0 GTT | Form: Gel | Indication: Cataract | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 4.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
CEFADROXIL (CEFADROXIL) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 6.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
CILGAVIMAB /TIXAGEVIMAB (--) Concomitant
Route: 030 | Dosage: -- | Form: -- | Indication: Prophylaxis | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- day | Rechallenge: -- | Additional: Unknown
Recurrences: --
CLEARLAX (POLYETHYLENE GLYCOL 3350) Concomitant
Route: 048 | Dosage: -- | Form: Powder for oral solution | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 17.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- day | Rechallenge: -- | Additional: Unknown
Recurrences: --
COVID-19 VACCINE (--) Concomitant
Route: 030 | Dosage: -- | Form: -- | Indication: Prophylaxis | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- day | Rechallenge: -- | Additional: Unknown
Recurrences: --
DALTEPARIN SODIUM (DALTEPARIN SODIUM) Concomitant
Route: 058 | Dosage: -- | Form: Injection | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 157.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
DALTEPARIN SODIUM (DALTEPARIN SODIUM) Concomitant
Route: 042 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 33.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
DICLOFENAC (DICLOFENAC) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Osteoarthritis | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 2172.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
DILAUDID (HYDROMORPHONE HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Arthralgia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 3.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 47.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
DILAUDID (HYDROMORPHONE HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: Arthralgia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 3.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 84.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
DILAUDID (HYDROMORPHONE HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 4.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 47.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
DOMPERIDONE (DOMPERIDONE) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: Abdominal pain upper | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.3 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 106.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
DOXYCYCLINE (DOXYCYCLINE) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: Upper respiratory tract infection | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DOXYCYCLINE (DOXYCYCLINE) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Upper respiratory tract infection | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 25.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 6.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
ELIQUIS (APIXABAN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Thrombosis prophylaxis | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 2.5 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
EZETIMIBE (EZETIMIBE) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: Dyslipidaemia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
FLUCONAZOLE (FLUCONAZOLE) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 88.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
FLUTICASONE FUROATE (FLUTICASONE FUROATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Upper respiratory tract infection | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- day | Rechallenge: -- | Additional: Unknown
Recurrences: --
DEXTROSE\SODIUM CHLORIDE (DEXTROSE\SODIUM CHLORIDE) Concomitant
Route: 042 | Dosage: -- | Form: -- | Indication: Polyuria | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 80.0 (unit: 012) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
FILGRASTIM (FILGRASTIM) Concomitant
Route: 058 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- day | Rechallenge: -- | Additional: Unknown
Recurrences: --
HYDROCORTISONE (HYDROCORTISONE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Rash | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 15.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
HYDROCORTISONE (HYDROCORTISONE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 6.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLUENZA VIRUS VACCINE (INFLUENZA VIRUS VACCINE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Rash | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 6.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLUENZA VIRUS VACCINE (INFLUENZA VIRUS VACCINE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Arthralgia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 15.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLUENZA VIRUS VACCINE (INFLUENZA VIRUS VACCINE) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 15.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 57.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLUENZA VIRUS VACCINE (INFLUENZA VIRUS VACCINE) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 4.5 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 17.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
LIPITOR (ATORVASTATIN CALCIUM) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Dyslipidaemia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
LIPITOR (ATORVASTATIN CALCIUM) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
LYRICA (PREGABALIN) Concomitant
Route: 048 | Dosage: -- | Form: Capsule | Indication: Arthralgia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 75.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 374.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
MELATONIN (MELATONIN) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Atrial fibrillation | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 25.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
METHADONE (METHADONE HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Arthralgia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 2.5 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 74.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
METOCLOPRAMIDE (METOCLOPRAMIDE) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.3 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 94.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
METOCLOPRAMIDE (METOCLOPRAMIDE) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 77.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
MOXIFLOXACIN (MOXIFLOXACIN) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: Upper respiratory tract infection | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 6.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
MOXIFLOXACIN (MOXIFLOXACIN) Concomitant
Route: 048 | Dosage: 1.0 GTT | Form: Tablet | Indication: Cataract | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 16.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
MOXIFLOXACIN (MOXIFLOXACIN) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
ELASOMERAN (ELASOMERAN) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Prophylaxis | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
NABILONE (NABILONE) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Insomnia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 0.5 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
NYSTATIN (NYSTATIN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 514.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
FERROUS FUMARATE (FERROUS FUMARATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Prophylaxis | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 285.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PANTALOC (--) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: Hiatus hernia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 285.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PAXLOVID (NIRMATRELVIR\RITONAVIR) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: COVID-19 | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 0.5 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 4.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PIPERACILLIN SODIUM\TAZOBACTAM SODIUM (PIPERACILLIN SODIUM\TAZOBACTAM SODIUM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 405.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: 0.3 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREDNISOLONE (PREDNISOLONE) Concomitant
Route: -- | Dosage: 1.0 GTT | Form: -- | Indication: Cataract | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 16.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREDNISOLONE (PREDNISOLONE) Concomitant
Route: -- | Dosage: 1.0 GTT | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 17.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
IRON (IRON) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: Prophylaxis | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 97.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
ALBUTEROL (ALBUTEROL) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Upper respiratory tract infection | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SILDENAFIL CITRATE (SILDENAFIL CITRATE) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: Blood testosterone decreased | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 876.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
TADALAFIL (TADALAFIL) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: Erectile dysfunction | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TYLENOL 8 HR ARTHRITIS PAIN (ACETAMINOPHEN) Concomitant
Route: 048 | Dosage: TABLET (EXTENDED-RELEASE) | Form: Tablet | Indication: Arthralgia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 850.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 93.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: Prophylaxis | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
VITAMIN D (VITAMIN D NOS) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: Supplementation therapy | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1000.0 (unit: 025) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
XARELTO (RIVAROXABAN) Concomitant
Route: 048 | Dosage: -- | Form: Coated tablet | Indication: Prophylaxis | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 538.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
ZOPICLONE (ZOPICLONE) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: Insomnia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 7.5 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 192.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
HYDROMORPHONE (HYDROMORPHONE) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Arthralgia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 15.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 57.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
HYDROMORPHONE (HYDROMORPHONE) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 4.5 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 17.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

Adverse Reaction Report Number: E2B_08062265

Raw JSON (click to expand)

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"drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Capsule", "drugadministrationroute": "048", "drugindication": "Plasma cell myeloma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 2178.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LENALIDOMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "BORTEZOMIB", "drugauthorizationnumb": "202963", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "058", "drugindication": "Plasma cell myeloma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 172.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "BORTEZOMIB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DARATUMUMAB\\HYALURONIDASE-FIHJ", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 1800.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "058", "drugindication": "Plasma cell myeloma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 2158.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DARATUMUMAB\\HYALURONIDASE-FIHJ" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DEXAMETHASONE", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "058", "drugindication": "Plasma cell myeloma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 2172.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DEXAMETHASONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ALLOPURINOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 6.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ALLOPURINOL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "AMOXICILLIN\\CLAVULANATE POTASSIUM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Upper respiratory tract infection", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 5.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "AMOXICILLIN\\CLAVULANATE POTASSIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "AMOXICILLIN\\CLAVULANATE POTASSIUM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 675.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.5, "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": 9.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "AMOXICILLIN\\CLAVULANATE POTASSIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TESTOSTERONE UNDECANOATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Capsule", "drugadministrationroute": "048", "drugindication": "Blood testosterone decreased", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TESTOSTERONE UNDECANOATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TESTOSTERONE UNDECANOATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Blood testosterone decreased", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 477.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TESTOSTERONE UNDECANOATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ANDROGEL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2.5, "drugstructuredosageunit": "002", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Gel", "drugadministrationroute": "061", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 1.0, 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null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 17.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "HYDROMORPHONE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CA", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "CA", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Adverse Reaction Report Number", "duplicatenumb": "E2B_08062265" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "DR REDDYS" }, "serious": 1, "seriousnesscongenitalanomali": null, "seriousnessdeath": null, "seriousnessdisabling": null, "seriousnesshospitalization": 1, "seriousnesslifethreatening": null, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25958275 Type 1
Serious
ENFORTUMAB VEDOTIN, ENFORTUMAB VEDOTIN, ENFORTUMAB VEDOTIN (+2 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
Gillis, M. Gordon A. Use of dupilumab to manage a grade 3 cutaneous adverse effect from enfortumab vedotin/pembrolizumab treatment in a patient with metastatic urothelial carcinoma. JAAD Case Reports. 2025; 56:40-4
Company Number
US-PFIZER INC-202500004808
Authority Number
--
Sender Organization
ASTELLAS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
69.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Drug eruption (v28.1) Recovering
Intertrigo (v28.1) Recovering

Drugs (5)

ENFORTUMAB VEDOTIN (ENFORTUMAB VEDOTIN) Suspect
Route: 065 | Dosage: FOURTH CYCLE OF EV WAS SUBSEQUENTLY HELD | Form: Unknown | Indication: Transitional cell carcinoma metastatic | Action: Withdrawn
Auth#: -- | Batch#: Asked But Unknown | Structured Dosage: 1.25 (unit: 007) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
ENFORTUMAB VEDOTIN (ENFORTUMAB VEDOTIN) Suspect
Route: 065 | Dosage: RE-CHALLENGED WITH DOSE-REDUCED | Form: Unknown | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: Unknown | Structured Dosage: 1.0 (unit: 007) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
ENFORTUMAB VEDOTIN (ENFORTUMAB VEDOTIN) Suspect
Route: 065 | Dosage: SEVENTH CYCLE (REDUCED DOSE) | Form: Unknown | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: Unknown | Structured Dosage: 0.75 (unit: 007) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
ENFORTUMAB VEDOTIN (ENFORTUMAB VEDOTIN) Suspect
Route: 065 | Dosage: 10TH CYCLE (REDUCED DOSE) | Form: Unknown | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: Unknown | Structured Dosage: 0.5 (unit: 007) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
PEMBROLIZUMAB (PEMBROLIZUMAB) Suspect
Route: 065 | Dosage: -- | Form: Infusion | Indication: Transitional cell carcinoma metastatic | Action: Dose Not Changed
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435a33b3830196fa56ad2", "safetyreportid": "25958275", "authoritynumb": null, "companynumb": "US-PFIZER INC-202500004808", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 69.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug eruption", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Intertrigo", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ENFORTUMAB VEDOTIN", "drugauthorizationnumb": null, "drugbatchnumb": "Asked But Unknown", "drugstructuredosagenumb": 1.25, "drugstructuredosageunit": "007", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FOURTH CYCLE OF EV WAS SUBSEQUENTLY HELD", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Transitional cell carcinoma metastatic", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "ENFORTUMAB VEDOTIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ENFORTUMAB VEDOTIN", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "007", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "RE-CHALLENGED WITH DOSE-REDUCED", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "ENFORTUMAB VEDOTIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ENFORTUMAB VEDOTIN", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 0.75, "drugstructuredosageunit": "007", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "SEVENTH CYCLE (REDUCED DOSE)", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "ENFORTUMAB VEDOTIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ENFORTUMAB VEDOTIN", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 0.5, "drugstructuredosageunit": "007", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10TH CYCLE (REDUCED DOSE)", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "ENFORTUMAB VEDOTIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PEMBROLIZUMAB", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Infusion", "drugadministrationroute": "065", "drugindication": "Transitional cell carcinoma metastatic", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "PEMBROLIZUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": "Gillis, M. Gordon A. Use of dupilumab to manage a grade 3 cutaneous adverse effect from enfortumab vedotin/pembrolizumab treatment in a patient with metastatic urothelial carcinoma. JAAD Case Reports. 2025; 56:40-4" }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ASTELLAS" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25958274 Type 1
Serious
NOVOLOG, BASAGLAR, LANTUS
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-NOVOPROD-1534307
Authority Number
--
Sender Organization
NOVO NORDISK
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
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Death (v28.1) Fatal

Drugs (3)

NOVOLOG (INSULIN ASPART) Suspect
Route: -- | Dosage: UNK | Form: Solution for injection | Indication: Diabetes mellitus | Action: Not Applicable
Auth#: 20986 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
BASAGLAR (INSULIN GLARGINE) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: Diabetes mellitus | Action: --
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LANTUS (INSULIN GLARGINE) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: Diabetes mellitus | Action: --
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20190201

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435a33b3830196fa56acf", "safetyreportid": "25958274", "authoritynumb": null, "companynumb": "US-NOVOPROD-1534307", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Death", "reactionoutcome": 5 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "NOVOLOG", "drugauthorizationnumb": "20986", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Solution for injection", "drugadministrationroute": null, "drugindication": "Diabetes mellitus", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "INSULIN ASPART" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "BASAGLAR", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Diabetes mellitus", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "INSULIN GLARGINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LANTUS", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Diabetes mellitus", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "INSULIN GLARGINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20190201" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "NOVO NORDISK" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25958273 Type 1
Serious
PROVAYBLUE, METARAMINOL, NOREPINEPHRINE BITARTRATE (+2 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
AU
Occurrence Country
AU
Reporter Country
AU
Reporter Qualification
Consumer
Literature Reference
--
Company Number
AU-Provepharm-2187247
Authority Number
--
Sender Organization
PROVEPHARM
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
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Multiple organ dysfunction syndrome (v28.1) Unknown
Drug ineffective for unapproved indication (v28.1) Unknown

Drugs (5)

PROVAYBLUE (METHYLENE BLUE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: 204630 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
METARAMINOL (METARAMINOL) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
NOREPINEPHRINE BITARTRATE (NOREPINEPHRINE BITARTRATE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ARGIPRESSIN\VASOPRESSIN (ARGIPRESSIN\VASOPRESSIN) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
EPINEPHRINE BITARTRATE (EPINEPHRINE BITARTRATE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435a33b3830196fa56acd", "safetyreportid": "25958273", "authoritynumb": null, "companynumb": "AU-Provepharm-2187247", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "AU", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Multiple organ dysfunction syndrome", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug ineffective for unapproved indication", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "PROVAYBLUE", "drugauthorizationnumb": "204630", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "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": "METHYLENE BLUE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METARAMINOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METARAMINOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "NOREPINEPHRINE BITARTRATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "NOREPINEPHRINE BITARTRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ARGIPRESSIN\\VASOPRESSIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ARGIPRESSIN\\VASOPRESSIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "EPINEPHRINE BITARTRATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "EPINEPHRINE BITARTRATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "AU", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "AU", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "PROVEPHARM" }, "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" }
25958271 Type 1
Serious
PALBOCICLIB, ABEMACICLIB, LETROZOLE
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-ELI_LILLY_AND_COMPANY-DE202509030548
Authority Number
--
Sender Organization
PFIZER
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
83.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (7)

Acute kidney injury (v28.1) Recovered
Diarrhoea (v28.1) Recovered
Blood creatine increased (v28.1) Unknown
Dehydration (v28.1) Unknown
Proteinuria (v28.1) Unknown
Oedema peripheral (v28.1) Unknown
Fatigue (v28.1) Unknown

Drugs (3)

PALBOCICLIB (PALBOCICLIB) Suspect
Route: 065 | Dosage: 125 MG, CYCLIC OTHER (Q21D) | Form: Film-coated tablet | Indication: Breast cancer metastatic | Action: Unknown
Auth#: 212436 | Batch#: -- | Structured Dosage: 125.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/17/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ABEMACICLIB (ABEMACICLIB) Suspect
Route: 065 | Dosage: UNK UNK, UNKNOWN | Form: Tablet | Indication: Breast cancer metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/29/2023 | End: 12/16/2023 | Duration: 18.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
LETROZOLE (LETROZOLE) Suspect
Route: 065 | Dosage: 2.5 MG, DAILY | Form: -- | Indication: Breast cancer metastatic | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 2.5 (unit: 003) | Separate Dosage#: -- | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 11/29/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20240201

Report Duplicates (1)

ELI_LILLY_AND_COMPANY: EU-ELI_LILLY_AND_COMPANY-DE202509030548

Raw JSON (click to expand)

{ "_id": "69d435a33b3830196fa56ac6", "safetyreportid": "25958271", "authoritynumb": null, "companynumb": "EU-ELI_LILLY_AND_COMPANY-DE202509030548", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 83.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Acute kidney injury", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blood creatine increased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dehydration", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Proteinuria", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Oedema peripheral", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Fatigue", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "PALBOCICLIB", "drugauthorizationnumb": "212436", "drugbatchnumb": null, "drugstructuredosagenumb": 125.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "125 MG, CYCLIC OTHER (Q21D)", "drugdosageform": "Film-coated tablet", "drugadministrationroute": "065", "drugindication": "Breast cancer metastatic", "drugstartdateformat": "102", "drugstartdate": "2024-01-17T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PALBOCICLIB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ABEMACICLIB", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK UNK, UNKNOWN", "drugdosageform": "Tablet", "drugadministrationroute": "065", "drugindication": "Breast cancer metastatic", "drugstartdateformat": "102", "drugstartdate": "2023-11-29T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-12-16T00:00:00", "drugtreatmentduration": 18.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "ABEMACICLIB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LETROZOLE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2.5 MG, DAILY", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Breast cancer metastatic", "drugstartdateformat": "102", "drugstartdate": "2023-11-29T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LETROZOLE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20240201" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "ELI_LILLY_AND_COMPANY", "duplicatenumb": "EU-ELI_LILLY_AND_COMPANY-DE202509030548" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "PFIZER" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25958269 Type 1
Serious
LEVEMIR
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-NOVOPROD-1534300
Authority Number
--
Sender Organization
NOVO NORDISK
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
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Hospitalisation (v28.1) Unknown

Drugs (1)

LEVEMIR (INSULIN DETEMIR) Suspect
Route: -- | Dosage: UNK | Form: Solution for injection | Indication: Product used for unknown indication | Action: Unknown
Auth#: 21536 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435a33b3830196fa56ac5", "safetyreportid": "25958269", "authoritynumb": null, "companynumb": "US-NOVOPROD-1534300", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hospitalisation", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "LEVEMIR", "drugauthorizationnumb": "21536", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Solution for injection", "drugadministrationroute": null, "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": "INSULIN DETEMIR" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "NOVO NORDISK" }, "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" }