FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25947895 Type 1
Serious
AVASTIN, CARBOPLATIN, DENOSUMAB (+1 more)
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/18/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CN-ROCHE-10000409974
Authority Number
--
Sender Organization
ROCHE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
73.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Granulocytopenia (v28.1) Unknown

Drugs (4)

AVASTIN (BEVACIZUMAB) Suspect
Route: 042 | Dosage: -- | Form: Injection | Indication: Lung neoplasm malignant | Action: Unknown
Auth#: -- | Batch#: H0402B03 | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 08/19/2025 | End: 08/19/2025 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CARBOPLATIN (CARBOPLATIN) Suspect
Route: 042 | Dosage: -- | Form: Injection | Indication: Lung neoplasm malignant | Action: Unknown
Auth#: -- | Batch#: AB1J4031 | Structured Dosage: 550.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 08/19/2025 | End: 08/19/2025 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DENOSUMAB (DENOSUMAB) Suspect
Route: 042 | Dosage: -- | Form: Injection | Indication: Lung neoplasm malignant | Action: Unknown
Auth#: -- | Batch#: 1173500 | Structured Dosage: 120.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 08/19/2025 | End: 08/19/2025 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
PEMETREXED DISODIUM (PEMETREXED DISODIUM) Suspect
Route: 042 | Dosage: -- | Form: Injection, Powder | Indication: Lung neoplasm malignant | Action: Unknown
Auth#: -- | Batch#: 4H0015B34 | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 08/19/2025 | End: 08/19/2025 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250924

Report Duplicates (1)

NMPACDR: 2101021025837202501554

Raw JSON (click to expand)

{ "_id": "69d435733b3830196fa53ec9", "safetyreportid": "25947895", "authoritynumb": null, "companynumb": "CN-ROCHE-10000409974", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 73.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Granulocytopenia", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "AVASTIN", "drugauthorizationnumb": null, "drugbatchnumb": "H0402B03", "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Injection", "drugadministrationroute": "042", "drugindication": "Lung neoplasm malignant", "drugstartdateformat": "102", "drugstartdate": "2025-08-19T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-19T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "BEVACIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CARBOPLATIN", "drugauthorizationnumb": null, "drugbatchnumb": "AB1J4031", "drugstructuredosagenumb": 550.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Injection", "drugadministrationroute": "042", "drugindication": "Lung neoplasm malignant", "drugstartdateformat": "102", "drugstartdate": "2025-08-19T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-19T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CARBOPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DENOSUMAB", "drugauthorizationnumb": null, "drugbatchnumb": "1173500", "drugstructuredosagenumb": 120.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Injection", "drugadministrationroute": "042", "drugindication": "Lung neoplasm malignant", "drugstartdateformat": "102", "drugstartdate": "2025-08-19T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-19T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DENOSUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PEMETREXED DISODIUM", "drugauthorizationnumb": null, "drugbatchnumb": "4H0015B34", "drugstructuredosagenumb": 800.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Injection, Powder", "drugadministrationroute": "042", "drugindication": "Lung neoplasm malignant", "drugstartdateformat": "102", "drugstartdate": "2025-08-19T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-19T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PEMETREXED DISODIUM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250924" }, "primarysource": { "reportercountry": "CN", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CN", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "NMPACDR", "duplicatenumb": "2101021025837202501554" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ROCHE" }, "serious": 1, "seriousnesscongenitalanomali": null, "seriousnessdeath": null, "seriousnessdisabling": null, "seriousnesshospitalization": 1, "seriousnesslifethreatening": null, "seriousnessother": null, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25947889 Type 2
Non-Serious
BUDESONIDE\FORMOTEROL\GLYCOPYRRONIUM
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-AstraZeneca-CH-00970035AP
Authority Number
--
Sender Organization
ALEXION PHARMACEUTICALS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Hypoacusis (v28.1) Unknown
Speech disorder (v28.1) Unknown
Dysphonia (v28.1) Unknown
Product use issue (v28.1) Unknown
Incorrect dose administered (v28.1) Unknown

Drugs (1)

BUDESONIDE\FORMOTEROL\GLYCOPYRRONIUM (BUDESONIDE\FORMOTEROL\GLYCOPYRRONIUM) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: -- | Action: Dose Reduced
Auth#: 212122 | Batch#: 6103714D00 | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435733b3830196fa53ec7", "safetyreportid": "25947889", "authoritynumb": null, "companynumb": "US-AstraZeneca-CH-00970035AP", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypoacusis", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Speech disorder", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dysphonia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product use issue", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Incorrect dose administered", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "BUDESONIDE\\FORMOTEROL\\GLYCOPYRRONIUM", "drugauthorizationnumb": "212122", "drugbatchnumb": "6103714D00", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 2, "activesubstance": { "activesubstancename": "BUDESONIDE\\FORMOTEROL\\GLYCOPYRRONIUM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ALEXION PHARMACEUTICALS" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25947892 Type 1
Non-Serious
MOUNJARO, MOUNJARO, MOUNJARO (+1 more)
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-ELI_LILLY_AND_COMPANY-US202510017963
Authority Number
--
Sender Organization
ELI LILLY AND COMPANY
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
81.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Cough (v28.1) Unknown
Dysphonia (v28.1) Unknown

Drugs (4)

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

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435733b3830196fa53ec8", "safetyreportid": "25947892", "authoritynumb": null, "companynumb": "US-ELI_LILLY_AND_COMPANY-US202510017963", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 81.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Cough", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dysphonia", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "MOUNJARO", "drugauthorizationnumb": "215866", "drugbatchnumb": null, "drugstructuredosagenumb": 2.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2.5 MG, UNKNOWN", "drugdosageform": "Solution for injection in pre-filled pen", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TIRZEPATIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "MOUNJARO", "drugauthorizationnumb": "215866", "drugbatchnumb": null, "drugstructuredosagenumb": 2.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2.5 MG, UNKNOWN", "drugdosageform": "Solution for injection in pre-filled pen", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TIRZEPATIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "MOUNJARO", "drugauthorizationnumb": "215866", "drugbatchnumb": null, "drugstructuredosagenumb": 2.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2.5 MG, UNKNOWN", "drugdosageform": "Solution for injection in pre-filled pen", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TIRZEPATIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "MOUNJARO", "drugauthorizationnumb": "215866", "drugbatchnumb": null, "drugstructuredosagenumb": 2.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2.5 MG, UNKNOWN", "drugdosageform": "Solution for injection in pre-filled pen", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TIRZEPATIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ELI LILLY AND COMPANY" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25947894 Type 1
Non-Serious
REPATHA
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-AMGEN-USASP2025206931
Authority Number
--
Sender Organization
AMGEN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
74.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Abdominal pain (v28.1) Not Recovered
Abdominal distension (v28.1) Recovering
Malaise (v28.1) Not Recovered

Drugs (1)

REPATHA (EVOLOCUMAB) Suspect
Route: 065 | Dosage: 140 MILLIGRAM, Q2WK | Form: Solution for injection | Indication: Blood cholesterol increased | Action: Dose Not Changed
Auth#: 125522 | Batch#: 1187409 | Structured Dosage: 140.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 01/01/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251013

Report Duplicates (1)

AMGEN INC: US-AMGEN INC-25-0288617-SR-01

Raw JSON (click to expand)

{ "_id": "69d435733b3830196fa53eca", "safetyreportid": "25947894", "authoritynumb": null, "companynumb": "US-AMGEN-USASP2025206931", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 74.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal pain", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal distension", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Malaise", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "REPATHA", "drugauthorizationnumb": "125522", "drugbatchnumb": "1187409", "drugstructuredosagenumb": 140.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "140 MILLIGRAM, Q2WK", "drugdosageform": "Solution for injection", "drugadministrationroute": "065", "drugindication": "Blood cholesterol increased", "drugstartdateformat": "602", "drugstartdate": "2025-01-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "EVOLOCUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251013" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "AMGEN INC", "duplicatenumb": "US-AMGEN INC-25-0288617-SR-01" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "AMGEN" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25947887 Type 1
Non-Serious
BOTOX
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-ABBVIE-6504131
Authority Number
--
Sender Organization
ABBVIE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Swelling (v28.1) Unknown
Headache (v28.1) Not Recovered
Nausea (v28.1) Unknown

Drugs (1)

BOTOX (ONABOTULINUMTOXINA) Suspect
Route: 030 | Dosage: TIME INTERVAL: AS NECESSARY | Form: Injection | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 103000 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2025 | End: 01/01/2025 | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435733b3830196fa53ec5", "safetyreportid": "25947887", "authoritynumb": null, "companynumb": "US-ABBVIE-6504131", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Swelling", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Headache", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nausea", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "BOTOX", "drugauthorizationnumb": "103000", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "TIME INTERVAL: AS NECESSARY", "drugdosageform": "Injection", "drugadministrationroute": "030", "drugindication": "Product used for unknown indication", "drugstartdateformat": "602", "drugstartdate": "2025-01-01T00:00:00", "drugenddateformat": "602", "drugenddate": "2025-01-01T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ONABOTULINUMTOXINA" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101" }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ABBVIE" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25947891 Type 1
Non-Serious
WAINUA
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-AstraZeneca-CH-00974541A
Authority Number
--
Sender Organization
ALEXION PHARMACEUTICALS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
67.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Pain (v28.1) Recovered

Drugs (1)

WAINUA (EPLONTERSEN) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Cardiac amyloidosis | Action: Dose Not Changed
Auth#: 217388 | Batch#: Unknown | Structured Dosage: 45.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 mo | Cumulative: -- (unit: --)
Start: 11/26/2024 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251001

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435733b3830196fa53ec6", "safetyreportid": "25947891", "authoritynumb": null, "companynumb": "US-AstraZeneca-CH-00974541A", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 67.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pain", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "WAINUA", "drugauthorizationnumb": "217388", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 45.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 802, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Cardiac amyloidosis", "drugstartdateformat": "102", "drugstartdate": "2024-11-26T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "EPLONTERSEN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251001" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ALEXION PHARMACEUTICALS" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25947880 Type 1
Non-Serious
VERZENIO
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-ELI_LILLY_AND_COMPANY-US202510020272
Authority Number
--
Sender Organization
ELI LILLY AND COMPANY
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
80.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Alopecia (v28.1) Unknown

Drugs (1)

VERZENIO (ABEMACICLIB) Suspect
Route: 048 | Dosage: 50 MG, BID | Form: Tablet | Indication: Breast cancer female | Action: Unknown
Auth#: 208716 | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: 2.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435733b3830196fa53ec3", "safetyreportid": "25947880", "authoritynumb": null, "companynumb": "US-ELI_LILLY_AND_COMPANY-US202510020272", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 80.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Alopecia", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "VERZENIO", "drugauthorizationnumb": "208716", "drugbatchnumb": null, "drugstructuredosagenumb": 50.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 2.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "50 MG, BID", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Breast cancer female", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ABEMACICLIB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ELI LILLY AND COMPANY" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25947881 Type 1
Serious
DAPAGLIFLOZIN
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/17/2026
Primary Source Country
JP
Occurrence Country
JP
Reporter Country
JP
Reporter Qualification
Pharmacist
Literature Reference
--
Company Number
JP-ASTRAZENECA-202510JPN014508JP
Authority Number
--
Sender Organization
ALEXION PHARMACEUTICALS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Hallucination (v28.1) Unknown

Drugs (1)

DAPAGLIFLOZIN (DAPAGLIFLOZIN) Suspect
Route: -- | Dosage: 10 MILLIGRAM | Form: -- | Indication: Cardiac failure chronic | Action: Dose Not Changed
Auth#: 202293 | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435733b3830196fa53ec4", "safetyreportid": "25947881", "authoritynumb": null, "companynumb": "JP-ASTRAZENECA-202510JPN014508JP", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "JP", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hallucination", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DAPAGLIFLOZIN", "drugauthorizationnumb": "202293", "drugbatchnumb": null, "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Cardiac failure chronic", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "DAPAGLIFLOZIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "JP", "qualification": 2, "literaturereference": null }, "primarysourcecountry": "JP", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ALEXION PHARMACEUTICALS" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25947879 Type 1
Serious
ZOLPIDEM TARTRATE
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Pharmacist
Literature Reference
--
Company Number
--
Authority Number
EU-AFSSAPS-AVGR2025000317
Sender Organization
COSETTE PHARMACEUTICALS INC
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
22.0 yr
Patient Age Group
Adult
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Victim of chemical submission (v28.1) Recovered w/ Sequelae

Drugs (1)

ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: 021774 | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/04/2024 | End: 10/04/2024 | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20241004

Report Duplicates (1)

Other: EU-AFSSAPS-2025089937

Raw JSON (click to expand)

{ "_id": "69d435733b3830196fa53ec2", "safetyreportid": "25947879", "authoritynumb": "EU-AFSSAPS-AVGR2025000317", "companynumb": null, "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 22.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Victim of chemical submission", "reactionoutcome": 4 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ZOLPIDEM TARTRATE", "drugauthorizationnumb": "021774", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2024-10-04T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-10-04T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ZOLPIDEM TARTRATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20241004" }, "primarysource": { "reportercountry": "EU", "qualification": 2, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Other", "duplicatenumb": "EU-AFSSAPS-2025089937" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "COSETTE PHARMACEUTICALS INC" }, "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" }
25947871 Type 1
Serious
ACETAMINOPHEN, ACETAMINOPHEN, IBUPROFEN (+78 more)
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
Dolezalova I, Rektor I, Brazdil M... Stevens-Johnson v syndrom - komplikace v r?mci neurointenzivn? p? e (Stevens-Johnson syndrome: complications as part of neurointensive care.. NEUROLOGY FOR PRACTIC. 2017;18(5):336-340; Irena Dole alov?, MD, Ph.D., prof. MD Ivan Rector, CSc., Prof. Milan Br?zdil, MD, Ph.D. Stevens-Johnson syndrome: complications as part of neurointensive care. Neurologia pre prax. 2017;18(5):288-291; Dolezelova I, Rektor I, Brazdil M. Stevens-Johnsonuv syndrom - komplikace ...
Company Number
EU-EMA-DD-20210119-kumarvn_p-140325
Authority Number
--
Sender Organization
Haleon PLC
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
82.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (8)

Depressed level of consciousness (v28.1) Recovering
Skin laceration (v28.1) Recovered w/ Sequelae
Drug ineffective (v28.1) Unknown
Stevens-Johnson syndrome (v28.1) Recovered
Sopor (v28.1) Recovering
Status epilepticus (v28.1) Recovering
Pneumonia (v28.1) Recovering
Rash (v28.1) Unknown

Drugs (81)

ACETAMINOPHEN (ACETAMINOPHEN) Suspect
Route: 048 | Dosage: UNK | Form: Tablet | Indication: Analgesic therapy | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
ACETAMINOPHEN (ACETAMINOPHEN) Suspect
Route: 048 | Dosage: UNK | Form: Tablet | Indication: Pain | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
IBUPROFEN (IBUPROFEN) Suspect
Route: 048 | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
GLIQUIDONE (GLIQUIDONE) Suspect
Route: 016 | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
GLIQUIDONE (GLIQUIDONE) Suspect
Route: 016 | Dosage: UNK | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
GLIQUIDONE (GLIQUIDONE) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
GLIQUIDONE (GLIQUIDONE) Suspect
Route: 016 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
VALPROATE (VALPROIC ACID) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Partial seizures | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
VALPROATE (VALPROIC ACID) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Seizure | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 30.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
VALPROATE (VALPROIC ACID) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Generalised tonic-clonic seizure | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
IBUPROFEN SODIUM (IBUPROFEN SODIUM) Suspect
Route: 048 | Dosage: UNK | Form: Tablet | Indication: Analgesic therapy | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
IBUPROFEN SODIUM (IBUPROFEN SODIUM) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Pain | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
LEVETIRACETAM (LEVETIRACETAM) Suspect
Route: 042 | Dosage: 3000 MG, QD | Form: Tablet | Indication: Product used for unknown indication | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 3000.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
LEVETIRACETAM (LEVETIRACETAM) Suspect
Route: 042 | Dosage: 40 MG/KG | Form: -- | Indication: Generalised tonic-clonic seizure | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 007) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
LEVETIRACETAM (LEVETIRACETAM) Suspect
Route: 042 | Dosage: 40 MG/M2 | Form: -- | Indication: Partial seizures | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
LERCANIDIPINE HYDROCHLORIDE (LERCANIDIPINE HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: UNK | Form: Tablet | Indication: Hypertension | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
LERCANIDIPINE HYDROCHLORIDE (LERCANIDIPINE HYDROCHLORIDE) Concomitant
Route: 016 | Dosage: UNK | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
RAMIPRIL (RAMIPRIL) Concomitant
Route: 048 | Dosage: UNK | Form: -- | Indication: Hypertension | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
RAMIPRIL (RAMIPRIL) Concomitant
Route: 048 | Dosage: UNK | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
RAMIPRIL (RAMIPRIL) Concomitant
Route: 048 | Dosage: UNK | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ASPIRIN\GLYCINE (ASPIRIN\GLYCINE) Concomitant
Route: 048 | Dosage: TABLET | Form: Tablet | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ASPIRIN\GLYCINE (ASPIRIN\GLYCINE) Concomitant
Route: 048 | Dosage: UNK | Form: Tablet | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ASPIRIN\GLYCINE (ASPIRIN\GLYCINE) Concomitant
Route: 048 | Dosage: UNK | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
EUTHYROX (LEVOTHYROXINE SODIUM) Concomitant
Route: -- | Dosage: ROA: ORAL | Form: Tablet | Indication: Hypothyroidism | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
EUTHYROX (LEVOTHYROXINE SODIUM) Concomitant
Route: -- | Dosage: ROA: UNKNOWN | Form: Tablet | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SIMVASTATIN (SIMVASTATIN) Concomitant
Route: 048 | Dosage: UNK | Form: Tablet | Indication: Hypercholesterolaemia | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SIMVASTATIN (SIMVASTATIN) Concomitant
Route: 016 | Dosage: UNK | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
METAMIZOLE SODIUM (METAMIZOLE SODIUM) Suspect
Route: -- | Dosage: UNK | Form: Suppository | Indication: Pain | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
METAMIZOLE SODIUM (METAMIZOLE SODIUM) Suspect
Route: -- | Dosage: UNK | Form: Suppository | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
METAMIZOLE SODIUM (METAMIZOLE SODIUM) Suspect
Route: -- | Dosage: -- | Form: Suppository | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
PROPOFOL (PROPOFOL) Suspect
Route: 016 | Dosage: UNK | Form: -- | Indication: Clonic convulsion | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
PROPOFOL (PROPOFOL) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Epilepsy | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
PROPOFOL (PROPOFOL) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Generalised tonic-clonic seizure | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
SIMVASTATIN (SIMVASTATIN) Concomitant
Route: -- | Dosage: ROA: UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SIMVASTATIN (SIMVASTATIN) Concomitant
Route: -- | Dosage: ROA: INTRACARDIAC | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CEFTRIAXONE SODIUM (CEFTRIAXONE SODIUM) Suspect
Route: 048 | Dosage: TABLET | Form: Tablet | Indication: Pneumonia | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
CEFTRIAXONE SODIUM (CEFTRIAXONE SODIUM) Suspect
Route: 048 | Dosage: UNK | Form: Tablet | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
CEFTRIAXONE SODIUM (CEFTRIAXONE SODIUM) Suspect
Route: 048 | Dosage: UNK | Form: -- | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
BETAXOLOL HYDROCHLORIDE (BETAXOLOL HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: TABLETY | Form: Tablet | Indication: Hypertension | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
BETAXOLOL HYDROCHLORIDE (BETAXOLOL HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: UNK | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
BETAXOLOL HYDROCHLORIDE (BETAXOLOL HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
GLIQUIDONE (GLIQUIDONE) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
GLIQUIDONE (GLIQUIDONE) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
GLIQUIDONE (GLIQUIDONE) Concomitant
Route: 048 | Dosage: UNK | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
GLIQUIDONE (GLIQUIDONE) Concomitant
Route: 048 | Dosage: UNK | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
AZATHIOPRINE (AZATHIOPRINE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Immunosuppressant drug therapy | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
AZATHIOPRINE (AZATHIOPRINE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
ALLOPURINOL (ALLOPURINOL) Suspect
Route: -- | Dosage: ROA: ORAL | Form: Tablet | Indication: Gout | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
ALLOPURINOL (ALLOPURINOL) Suspect
Route: -- | Dosage: ROA: UNKNOWN | Form: Tablet | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
AMOXICILLIN (AMOXICILLIN) Suspect
Route: 048 | Dosage: UNK | Form: Tablet | Indication: Pneumonia | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
GLYCINE (GLYCINE) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
GLYCINE (GLYCINE) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
GLYCINE (GLYCINE) Concomitant
Route: -- | Dosage: ROA: UNKNOWN | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
METAMIZOLE (METAMIZOLE) Suspect
Route: 048 | Dosage: UNK | Form: Suppository | Indication: Pain | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
METAMIZOLE (METAMIZOLE) Suspect
Route: -- | Dosage: UNK | Form: Suppository | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
METAMIZOLE (METAMIZOLE) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
METAMIZOLE (METAMIZOLE) Suspect
Route: 048 | Dosage: UNK | Form: Suppository | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
PHENYTOIN (PHENYTOIN) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Seizure | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
PHENYTOIN (PHENYTOIN) Suspect
Route: -- | Dosage: ROA: INTRAVENOUS (NOT OTHERWISE SPECIFIED), 20 MG/KG, QD | Form: -- | Indication: Generalised tonic-clonic seizure | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 007) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
PHENYTOIN (PHENYTOIN) Suspect
Route: -- | Dosage: ROA: UNKNOWN, DOSE FORM: UNKNOWN | Form: -- | Indication: Partial seizures | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
PHENYTOIN (PHENYTOIN) Suspect
Route: -- | Dosage: DOSE FORM: UNKNOWN, ROA: UNKNOWN | Form: -- | Indication: Status epilepticus | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
PHENYTOIN (PHENYTOIN) Suspect
Route: -- | Dosage: DOSE FORM: UNKNOWN, ROA: UNKNOWN | Form: -- | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
FLUCONAZOLE (FLUCONAZOLE) Suspect
Route: -- | Dosage: ROA: ORAL | Form: Tablet | Indication: Antifungal treatment | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
FLUCONAZOLE (FLUCONAZOLE) Suspect
Route: -- | Dosage: ROA: ORAL | Form: Tablet | Indication: Pneumonia | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
FLUCONAZOLE (FLUCONAZOLE) Suspect
Route: -- | Dosage: ROA: ORAL | Form: Tablet | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
FLUCONAZOLE (FLUCONAZOLE) Suspect
Route: -- | Dosage: ROA: UNKNOWN | Form: Tablet | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
DIAZEPAM (DIAZEPAM) Concomitant
Route: -- | Dosage: ROA: INTRAVENOUS (NOT OTHERWISE SPECIFIED) | Form: -- | Indication: Generalised tonic-clonic seizure | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
DIAZEPAM (DIAZEPAM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Partial seizures | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
DIAZEPAM (DIAZEPAM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Hypertension | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
cynt (--) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: Hypertension | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ALLOPURINOL (ALLOPURINOL) Suspect
Route: -- | Dosage: ROA: ORAL | Form: Tablet | Indication: Gout | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
ALLOPURINOL (ALLOPURINOL) Suspect
Route: -- | Dosage: ROA: ORAL | Form: -- | Indication: Product used for unknown indication | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
ALLOPURINOL (ALLOPURINOL) Suspect
Route: -- | Dosage: ROA: UNKNOWN | Form: -- | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
ASPIRIN (ASPIRIN) Concomitant
Route: -- | Dosage: ROA: UNKNOWN | Form: -- | Indication: Analgesic therapy | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
Lecanidipine (--) Concomitant
Route: -- | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
RAMIPRIL (RAMIPRIL) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
RAMIPRIL (RAMIPRIL) Concomitant
Route: -- | Dosage: DOSE FORM: UNKNOWN | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
BETAXOLOL (BETAXOLOL) Concomitant
Route: -- | Dosage: DOSE FORM: UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
MOXONIDINE (MOXONIDINE) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
MOXONIDINE (MOXONIDINE) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
MOXONIDINE (MOXONIDINE) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (189)

EVDUP#EUEMEAP: RCT301120170193622
EVDUP#Report Duplicate: EVDUP#JOHNSON AND JOHNSON
EMA: EU-EMA-DD-20190522-gangal_s-181329
EVDUP#AUROBINDO: EU-EMA-DD-20180111-shaevhp-171637
EVDUP#Reference number: 10000264422
E2B Re-Transmittable: EU-BOEHRINGERINGELHEIM-2017-BI-064005
GLAXOSMITHKLINE: EU-GLAXOSMITHKLINE-CZ2019095619
EVDUP#GLAXOSMITHKLINE: EU-GLAXOSMITHKLINE-CZ2018032319
EVDUP#EUEMEAP: EU-EMA-DD-20180621-AJEVHP-122637
EVDUP#AUROBINDO: EU-AUROBINDO-AUR-APL-2018-012685
EMA: EU-EMA-DD-10000926467
EVDUP#POLPHARMA: EU-POLPHARMA-099689
EVDUP#EVDUP#BRISTOLMYERS SQUIBB: EU-BRISTOLMYERS SQUIBB COMPANY-BMS-2017-108387
EVDUP#AUROBINDO: EU-AUROBINDO-AUR-APL-2018-000340
EMA: EU-EMA-DD-RSR291120170193071
EVDUP#OTHER: RSR081220170197893
European Medicines Agency: EU-EMA-DD-20251013-7482827-153456
BRISTOL: EU-BRISTOL-MYERS SQUIBB COMPANYBMS-2017-117776
EVDUP#EUEMEAP: EU-EMA-DD-20180329-NGEVHPROD-112030
GLAXOSMITHKLINE: EU-GLAXOSMITHKLINE-CZ2018090734
EVDUP#GLAXOSMITHKLINE: EU-GLAXOSMITHKLINE-CZ2018000789
EVDUP#EUEMEAP: RSR071220170197201
EMA: EU-EMA-DD-RSR051220170195778
EVDUP#GLAXOSMITHKLINE: EU-GLAXOSMITHKLINE-CZ2018005329
EVDUP#TEVA: EU-TEVA-2017-CZ-827355
EVDUP#EUEMEAP: 10000320380
EMA: EU-EMA-DD-20-CZ020
EVDUP#BAXTER: EU-BAXTER-2018BAX016600
EMA: EU-EMA-DD-10000249824
EVDUP#GLAXOSMITHKLINE: EU-GLAXOSMITHKLINECZ2017GSK175689
BRISTOL: EU-BRISTOL-MYERS SQUIBB COMPANYBMS-2017-111952
EVDUP#EUEMEAP: 10000173950
EMA: EU-EMA-DD-PHHY2017CZ179101
EVDUP#EVDUP#: MF028-04
SA: GB-SA-2017SA264658
EVDUP#JOHNSON AND JOHNSON: 20171120069
BRISTOL: EU-BRISTOL-MYERS SQUIBB COMPANYBMS-2017-108387
EVDUP#EMA: EU-EMA-DD-20180329-mshettyp-154120
EVDUP#SAAVPROD: EU-SA-2017SA236634
EMA: EU-EMA-DD-10000582239
EVDUP#Bristol Laboratories Ltd: EU-Bristol Laboratories Ltd-BLL201712-005392
EVDUP#Apotex: EU-APOTEX-2018AP005867
EVDUP#EGIS: EU-EGIS-HUN-2017-0525
EVDUP#REG_EUDRAV: EU-VITABALANS-104-2017
EVDUP#EUEMEAP: RSR301120170193668
EMA: EU-EMA-DD-10000424410
EVDUP#BMS: EU-BRISTOL-MYERS SQUIBB COMPANY-BMS-2018-001138
EMA: EU-EMA-DD-10000094259
EVDUP#BIPROD: EU-BoehringerIngelheim-2017-BI-064251
GLENMARKPHARMACEUTICALS: EU-GLENMARKPHARMACEUTICALS-2017GMK029817
EVDUP#EUEMEAP: EU-EMA-DD-20180226-HJAINP-164952
BRISTOL: EU-BRISTOL-MYERS SQUIBB COMPANYBMS-2017-108391
EVDUP#EUEMEAP: ICHICSR-EVHUMAN-20180206180532_QOXFXC
EMA: EU-EMA-DD-20190520-gangal_s-121516
EVDUP#Linked Report: PHHY2017CZ179094
EMA: EU-EMA-DD-CZ-Accord-061354
EVDUP#GLAXOSMITHKLINE: EU-GLAXOSMITHKLINE-CZ2018037612
EVDUP#GLAXOSMITHKLINE: EU-GLAXOSMITHKLINE-CZ2018004721
EVDUP#EMA: EU-EMA-DD-20180621-ajevhp-122637
GLAXOSMITHKLINE: EU-GLAXOSMITHKLINE-CZ2018143566
EVDUP#GLAXOSMITHKLINE: EU-GLAXOSMITHKLINE-CZ2017197098
EVDUP#GLAXOSMITHKLINE: EU-GLAXOSMITHKLINE-CZ2018004746
EVDUP#GLAXOSMITHKLINE: EU-GLAXOSMITHKLINE-CZ2017197965
EVDUP#OTHER: RSR051220170195778
EMA: EU-EMA-DD-RSR011220170194148
EVDUP#Linked Report: PHHY2017CZ179101
EMA: EU-EMA-DD-2017SA236634
EVDUP#OCRF: EU-EMA-DD-20180316-MSHETTYP-150441
EMA: EU-EMA-DD-MF028-03
EVDUP#GLAXOSMITHKLINE: EU-GLAXOSMITHKLINE-CZ2017185856
EVDUP#002147023: EU-002147023-PHHY2018CZ064346
EMA: EU-EMA-DD-10000038631
EVDUP#GLAXOSMITHKLINE: EU-GLAXOSMITHKLINE-CZ2018002502
EVDUP#GLAXOSMITHKLINE: EU-GLAXOSMITHKLINE-CZ2017180180
EVDUP#GLAXOSMITHKLINE: EU-GLAXOSMITHKLINE-CZ2017GSK175689
EVDUP#LITREF: 9897689
EMA: EU-EMA-DD-10000274293
EVDUP#EUEMEAP: 10000438184
EMA: EU-EMA-DD-10000197341
EVDUP#CASE IDENTIFIERS NOT PROVIDED: 10000038631
EMA: EU-EMA-DD-PHHY2017CZ179102
EVDUP#REG_EUDRAV: EU-BOEHRINGERINGELHEIM-2017-BI-064005
EVDUP#EUEMEAP: EU-EMA-DD-20180328-NGEVHPROD-154008
EMA: EU-EMA-DD-20171130016
EVDUP#EVDUP#EMA: EU-EMA-DD-20180316-mshettyp-150441
EMA: EU-EMA-DD-10003630944
EVDUP#002147023: EU-002147023-PHHY2017CZ192901
EVDUP#EMA: EU-EMA-DD-20171130-ddevhumanwt-151632
EVDUP#GLAXOSMITHKLINE: EU-GLAXOSMITHKLINE-CZ2018031686
EVDUP#REG_EUDRAV: EU-EMA-DD-20171220-SHAEVHP-142648
EVDUP#MYLANLABS: EU-MYLANLABS-2017M1076489
EVDUP#OTHER: RCT091220170198082
BoehringerIngelheim: Z-BoehringerIngelheim-2017-BI-065484
EVDUP#GLAXOSMITHKLINE: EU-GLAXOSMITHKLINE-CZ2017185855
EVDUP#PFIZER INC: EU-PFIZER INC-2017486995
EVDUP#EUEMEAP: EU-EMA-DD-20171221-DPRABHAKAR9P-120720
EMA: EU-EMA-DD-10000272802
EVDUP#BMS: EU-BRISTOL LABORATORIES LTD-BLL201712-005392
EVDUP#EMA: EU-EMA-DD-20180315-kumarnvevhp-173750
EVDUP#NOVPHSZ: EU-NOVPHSZ-PHHY2017CZ177658
EVDUP#EMA: EU-EMA-DD-20180611-rakhievhpdd-144502
EMA: EU-EMA-DD-20171120069
EVDUP#APOTEX: EU-BoehringerIngelheim-2017-BI-064005
EMA: EU-EMA-DD-20180804-ajevhp-142525
EVDUP#Reference number: 10000094259
EMA: EU-EMA-DD-10000173950
EVDUP#GLAXOSMITHKLINE: EU-GLAXOSMITHKLINE-CZ2018000206
EVDUP#Reference number: 10000582239
EMA: EU-EMA-DD-10000097540
EVDUP#EUEMEAP: 10000637222
EMA: EU-EMA-DD-2017SA242402
EVDUP#EUEMEAP: EU-EMA-DD-20171221-MSHETTYP-121757
EVDUP#002147023: EU-NOVPHSZ-PHHY2018CZ064346
EMA: EU-EMA-DD-2017SA236895
EVDUP#OCRF: EU-GLAXOSMITHKLINE-CZ2017197996
EVDUP#AUROBINDO: EU-EMA-DD-20171220-shaevhp-142648
EMA: EU-EMA-DD-10000274065
EVDUP#Reference number: 10000424410
EVDUP#OCRF: EU-GLAXOSMITHKLINE-CZ2017190686
EVDUP#REG_EUDRAV: EU-ACCORD-061254
EMA: EU-EMA-DD-MF028-04
EVDUP#OCRF: EU-GLAXOSMITHKLINE-CZ2017183162
EMA: EU-EMA-DD-PHHY2017CZ179094
EVDUP#MEDO2008: EU-MEDO2008-L20170355
EVDUP#EMA: EU-EMA-DD-20180102-mshettyp-152727
EVDUP#EGIS: EU-EGIS-HUN-2017-0500
EVDUP#GLAXOSMITHKLINE: EU-GLAXOSMITHKLINE-CZ2017189291
EVDUP#OCRF: EU-EMA-DD-20180111-SHAEVHP-171637
EVDUP#Sanofi-Aventis: 2017SA236895
Unknown Source: EU-EMA-DD-20210119-kumarvn_p-140325
EVDUP#BMS: EU-BRISTOL-MYERS SQUIBB COMPANY-BMS-2017-108391
EVDUP#EMA: EU-EMA-DD-20180226-hjainp-164952
EVDUP#: 10000274293
EVDUP#European Medicines Agency: EU-EMA-DD-20200114-agrahari_P-142655
EVDUP#EUEMEAP: 10000414094
EVDUP#GLAXOSMITHKLINE: EU-GLAXOSMITHKLINE-CZ2017193398
EVDUP#: 10000249824
EVDUP#ICSR-EVHUMAN: ICHICSR-EVHUMAN-20180206180532_qOxfxc
EVDUP#EVDUP#: 20-CZ020
EVDUP#EUEMEAP: EU-EMA-DD-20180329-MSHETTYP-154120
EVDUP#EVDUP#EMA: EU-EMA-DD-20180329-ngevhprod-112030
EVDUP#: 10000272802
EVDUP#EUEMEAP: EU-EMA-DD-20180103-NGEVHPROD-172838
EVDUP#INFOTRV: 9897633
EVDUP#EUEMEAP: EU-EMA-DD-20180403-NGEVHPROD-163148
EVDUP#EMA: EU-EMA-DD-20180226-hjainp-125420
EVDUP#Linked Report: PHHY2017CZ179102
EVDUP#OCRF: EU-BPHAUSIAP-2017-A+-0254
EVDUP#EVDUP#: 20171130016
EVDUP#B.I. PHARMACEUTICALS: RSR151220170201852
EVDUP#Reference number: 10000157043
EVDUP#EUEMEAP: EU-EMA-DD-20171130-DDEVHUMANWT-151632
EVDUP#OTHER: RSR291120170193071
EVDUP#EUEMEAP: 10000536347
EVDUP#ACCORDHCP: EU-Accord-061354
EVDUP#BRISTOL: EU-BRISTOL-MYERS SQUIBB COMPANY-BMS-2017-108387
EVDUP#BRISTOL: EU-BRISTOL-MYERS SQUIBB COMPANY-BMS-2017-117776
EVDUP#EVDUP#: MF028-03
EVDUP#EMA: EU-EMA-DD-20180403-ngevhprod-163148
EVDUP#OCRF: EU-EMA-DD-20180102-MSHETTYP-152727
EVDUP#EMA: EU-EMA-DD-20171221-mshettyp-121757
EVDUP#BMS: EU-BRISTOL-MYERS SQUIBB COMPANY-BMS-2017-111952
EVDUP#OTHER: RCT091220170198081
EVDUP#REG_EUDRAV: EU-BOEHRINGERINGELHEIM-2017-BI-065484
EVDUP#SANAV: 2017SA242402
EVDUP#EUEMEAP: EU-EMA-DD-20180226-HJAINP-125420
EVDUP#EUEMEAP: 10000287926
EVDUP#Reference number: 10000159793
EVDUP#AUROBINDO: EU-GLENMARK PHARMACEUTICALS-2017GMK029817
EVDUP#EUEMEAP: 10000217448
EVDUP#EUEMEAP: 10000338971
EVDUP#002147023: EU-002147023-PHHY2017CZ177658
EVDUP#ACCORDHLT: EU-ACCORD-061354
EVDUP#POLPHARMA: EU-POLPHARMA-179372
EVDUP#OTHER: RSR011220170194148
EVDUP#EUEMEAP: 10000247335
EVDUP#CASE IDENTIFIERS NOT PROVIDED: 10000097540
EVDUP#APOTEX: EU-APOTEX-2018AP005863
EVDUP#Reference number: 10000153720
EVDUP#EUEMEAP: 10000197341
EVDUP#Sanofi Aventis: 2017SA236634
EVDUP#EMA: EU-EMA-DD-20180103-ngevhprod-172838
EVDUP#EMA: EU-EMA-DD-20171221-dprabhakar9p-120720
EVDUP#AUROBINDO: EU-AUROBINDO-AUR-APL-2018-013524
European Medicines Agency: EU-EMA-DD-20241205-7482645-112849
EVDUP#EMA: EU-EMA-DD-20180328-ngevhprod-154008
EVDUP#EUEMEAP: EU-EMA-DD-20180611-RAKHIEVHPDD-144502
EVDUP#APOTEX: EU-APOTEX-2018AP006567
EVDUP#EUEMEAP: 10000256337

Raw JSON (click to expand)

{ "_id": "69d435733b3830196fa53ebc", "safetyreportid": "25947871", "authoritynumb": null, "companynumb": "EU-EMA-DD-20210119-kumarvn_p-140325", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 82.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Depressed level of consciousness", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Skin laceration", "reactionoutcome": 4 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Stevens-Johnson syndrome", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Sopor", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Status epilepticus", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pneumonia", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Rash", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ACETAMINOPHEN", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Analgesic therapy", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ACETAMINOPHEN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Pain", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "IBUPROFEN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "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": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IBUPROFEN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "GLIQUIDONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "016", "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": "GLIQUIDONE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "GLIQUIDONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "016", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "GLIQUIDONE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "GLIQUIDONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "GLIQUIDONE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "GLIQUIDONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "016", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "GLIQUIDONE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "VALPROATE", "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": "Partial seizures", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "VALPROIC ACID" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "VALPROATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 30.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Seizure", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "VALPROIC ACID" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "VALPROATE", "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": "Generalised tonic-clonic seizure", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, 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Stevens-Johnson v syndrom - komplikace v r?mci neurointenzivn? p? e (Stevens-Johnson syndrome: complications as part of neurointensive care.. NEUROLOGY FOR PRACTIC. 2017;18(5):336-340; Irena Dole alov?, MD, Ph.D., prof. MD Ivan Rector, CSc., Prof. Milan Br?zdil, MD, Ph.D. Stevens-Johnson syndrome: complications as part of neurointensive care. Neurologia pre prax. 2017;18(5):288-291; Dolezelova I, Rektor I, Brazdil M. Stevens-Johnsonuv syndrom - komplikace ..." }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "EVDUP#EUEMEAP", "duplicatenumb": "RCT301120170193622" }, { "duplicatesource": "EVDUP#Report Duplicate", "duplicatenumb": "EVDUP#JOHNSON AND JOHNSON" }, { "duplicatesource": "EMA", "duplicatenumb": "EU-EMA-DD-20190522-gangal_s-181329" }, { "duplicatesource": "EVDUP#AUROBINDO", "duplicatenumb": "EU-EMA-DD-20180111-shaevhp-171637" }, { "duplicatesource": "EVDUP#Reference number", "duplicatenumb": "10000264422" }, { "duplicatesource": "E2B Re-Transmittable", "duplicatenumb": "EU-BOEHRINGERINGELHEIM-2017-BI-064005" }, { "duplicatesource": "GLAXOSMITHKLINE", "duplicatenumb": "EU-GLAXOSMITHKLINE-CZ2019095619" }, { "duplicatesource": "EVDUP#GLAXOSMITHKLINE", 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