FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25954090 Type 1
Non-Serious
KEYTRUDA, KEYTRUDA
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-009507513-2335575
Authority Number
--
Sender Organization
MERCK SHARP & DOHME LLC
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
73.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Blood test abnormal (v28.1) Unknown
Fatigue (v28.1) Recovering
Hypoacusis (v28.1) Recovering

Drugs (2)

KEYTRUDA (PEMBROLIZUMAB) Suspect
Route: 042 | Dosage: -- | Form: -- | Indication: Endometrial cancer | Action: Dose Increased
Auth#: 125514 | Batch#: -- | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: 10/15/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
KEYTRUDA (PEMBROLIZUMAB) Suspect
Route: 042 | Dosage: -- | Form: -- | Indication: Endometrial cancer | Action: Dose Increased
Auth#: 125514 | Batch#: -- | Structured Dosage: 400.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 6.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250528

Report Duplicates (1)

MSD: 500UW00000mvZjlYAE|30092025140008|1572

Raw JSON (click to expand)

{ "_id": "69d4358e3b3830196fa55807", "safetyreportid": "25954090", "authoritynumb": null, "companynumb": "US-009507513-2335575", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 73.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blood test abnormal", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Fatigue", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypoacusis", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "KEYTRUDA", "drugauthorizationnumb": "125514", "drugbatchnumb": null, "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Endometrial cancer", "drugstartdateformat": "102", "drugstartdate": "2024-10-15T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 3, "activesubstance": { "activesubstancename": "PEMBROLIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "KEYTRUDA", "drugauthorizationnumb": "125514", "drugbatchnumb": null, "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 6.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Endometrial cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 3, "activesubstance": { "activesubstancename": "PEMBROLIZUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250528" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "MSD", "duplicatenumb": "500UW00000mvZjlYAE|30092025140008|1572" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "MERCK SHARP & DOHME LLC" }, "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" }
25954094 Type 1
Serious
CLARITHROMYCIN, ASPIRIN, ATORVASTATIN (+4 more)
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/18/2026
Primary Source Country
GB
Occurrence Country
GB
Reporter Country
GB
Reporter Qualification
Physician
Literature Reference
--
Company Number
--
Authority Number
GB-MHRA-TPP33993856C11598338YC1760605661715
Sender Organization
SANDOZ
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
80.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
81.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Lip swelling (v28.1) Recovering
Pharyngeal swelling (v28.1) Unknown

Drugs (7)

CLARITHROMYCIN (CLARITHROMYCIN) Suspect
Route: 065 | Dosage: TAKE ONE TABLET TWICE A DAY FOR 7 DAYS, TO TREA... | Form: Film-coated tablet | Indication: Product used for unknown indication | Action: Unknown
Auth#: 65136 | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 12.0 hr | Cumulative: -- (unit: --)
Start: 10/13/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ASPIRIN (ASPIRIN) Concomitant
Route: 065 | Dosage: ONE TO BE TAKEN DAILY | Form: -- | Indication: Ill-defined disorder | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/04/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ATORVASTATIN (ATORVASTATIN) Concomitant
Route: 065 | Dosage: TAKE ONE DAILY TO REDUCE CARDIOVASCULAR RISK | Form: -- | Indication: Ill-defined disorder | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/21/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
DOVONEX (CALCIPOTRIENE) Concomitant
Route: 065 | Dosage: USE TWICE DAILY | Form: -- | Indication: Ill-defined disorder | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/10/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FLUCLOXACILLIN (FLUCLOXACILLIN) Concomitant
Route: 065 | Dosage: TAKE ONE CAPSULE FOUR TIMES A DAY FOR 5 DAYS | Form: -- | Indication: Ill-defined disorder | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/08/2025 | End: 10/13/2025 | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
RAMIPRIL (RAMIPRIL) Concomitant
Route: 065 | Dosage: ONE TO BE TAKEN DAILY | Form: -- | Indication: Ill-defined disorder | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/27/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
TIMOLOL (TIMOLOL) Concomitant
Route: 065 | Dosage: PUT ONE DROP INTO THE AFFECTED EYE(S) ONCE DAILY | Form: -- | Indication: Ill-defined disorder | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/03/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

MHRA: GB-MHRA-TPP33993856C11598338YC1760605661715

Raw JSON (click to expand)

{ "_id": "69d4358e3b3830196fa5580a", "safetyreportid": "25954094", "authoritynumb": "GB-MHRA-TPP33993856C11598338YC1760605661715", "companynumb": null, "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "GB", "patient": { "patientonsetage": 80.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 81.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Lip swelling", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pharyngeal swelling", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "CLARITHROMYCIN", "drugauthorizationnumb": "65136", "drugbatchnumb": null, "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 12.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "TAKE ONE TABLET TWICE A DAY FOR 7 DAYS, TO TREA...", "drugdosageform": "Film-coated tablet", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2025-10-13T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CLARITHROMYCIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ASPIRIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "ONE TO BE TAKEN DAILY", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Ill-defined disorder", "drugstartdateformat": "102", "drugstartdate": "2024-06-04T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ASPIRIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ATORVASTATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "TAKE ONE DAILY TO REDUCE CARDIOVASCULAR RISK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Ill-defined disorder", "drugstartdateformat": "102", "drugstartdate": "2025-05-21T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ATORVASTATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DOVONEX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "USE TWICE DAILY", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Ill-defined disorder", "drugstartdateformat": "102", "drugstartdate": "2023-11-10T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CALCIPOTRIENE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FLUCLOXACILLIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "TAKE ONE CAPSULE FOUR TIMES A DAY FOR 5 DAYS", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Ill-defined disorder", "drugstartdateformat": "102", "drugstartdate": "2025-10-08T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-13T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "FLUCLOXACILLIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "RAMIPRIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "ONE TO BE TAKEN DAILY", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Ill-defined disorder", "drugstartdateformat": "102", "drugstartdate": "2025-05-27T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "RAMIPRIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TIMOLOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "PUT ONE DROP INTO THE AFFECTED EYE(S) ONCE DAILY", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Ill-defined disorder", "drugstartdateformat": "102", "drugstartdate": "2025-06-03T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "TIMOLOL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "GB", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "GB", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "MHRA", "duplicatenumb": "GB-MHRA-TPP33993856C11598338YC1760605661715" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANDOZ" }, "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" }
25954088 Type 2
Serious
RINVOQ
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-ABBVIE-6511874
Authority Number
--
Sender Organization
ABBVIE
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
Adult
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Endometriosis (v28.1) Unknown

Drugs (1)

RINVOQ (UPADACITINIB) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 211675 | Batch#: 1296877 | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 04/17/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4358e3b3830196fa55804", "safetyreportid": "25954088", "authoritynumb": null, "companynumb": "US-ABBVIE-6511874", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Endometriosis", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "RINVOQ", "drugauthorizationnumb": "211675", "drugbatchnumb": "1296877", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2024-04-17T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "UPADACITINIB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ABBVIE" }, "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" }
25954092 Type 2
Serious
MCP, MCP, ASPIRIN LYSINE (+40 more)
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/19/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-EMA-DD-20240715-7482677-084326
Authority Number
--
Sender Organization
TEVA
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
63.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
65.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (12)

Stevens-Johnson syndrome (v28.1) Recovered
Pyrexia (v28.1) Unknown
Pruritus (v28.1) Unknown
Skin disorder (v28.1) Unknown
Leukocytosis (v28.1) Unknown
Blood urea increased (v28.1) Unknown
Ocular hyperaemia (v28.1) Unknown
Rash (v28.1) Unknown
Blood creatinine increased (v28.1) Unknown
Erythema multiforme (v28.1) Recovered
Pruritus (v28.1) Unknown
Oral mucosal eruption (v28.1) Unknown

Drugs (43)

MCP (METOCLOPRAMIDE HYDROCHLORIDE) Suspect
Route: 042 | Dosage: -- | Form: -- | Indication: Illness | Action: Withdrawn
Auth#: 070184 | Batch#: UNKNOWN | Structured Dosage: 3.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/07/1998 | End: 11/07/1998 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
MCP (METOCLOPRAMIDE HYDROCHLORIDE) Suspect
Route: 048 | Dosage: AMP 1; MCP (METOCLOPRAMIDE) | Form: -- | Indication: Illness | Action: Withdrawn
Auth#: 070184 | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/06/1998 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
ASPIRIN LYSINE (ASPIRIN LYSINE) Suspect
Route: 042 | Dosage: -- | Form: -- | Indication: Angina pectoris | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 250.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/07/1998 | End: 11/07/1998 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
NITROGLYCERIN (NITROGLYCERIN) Suspect
Route: 042 | Dosage: -- | Form: -- | Indication: Angina pectoris | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/07/1998 | End: 11/08/1998 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
NITROGLYCERIN (NITROGLYCERIN) Suspect
Route: 042 | Dosage: -- | Form: -- | Indication: Angina pectoris | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/07/1998 | End: 11/08/1998 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
NITROGLYCERIN (NITROGLYCERIN) Suspect
Route: 048 | Dosage: UNSPECIFIED | Form: -- | Indication: Angina pectoris | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: 11/09/1998 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
NITROGLYCERIN (NITROGLYCERIN) Suspect
Route: 042 | Dosage: UNK | Form: -- | Indication: Angina pectoris | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/07/1998 | End: 11/08/1998 | Duration: 2.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
INSULIN NOS (INSULIN NOS) Concomitant
Route: 058 | Dosage: -- | Form: -- | Indication: Diabetes mellitus | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
Ismn basics (--) Concomitant
Route: 048 | Dosage: 60 MG, QD | Form: -- | Indication: Coronary artery disease | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 60.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: 11/06/1998 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
AQUAPHOR (PETROLATUM) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Hypertension | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: 11/06/1998 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
AQUAPHOR (PETROLATUM) Concomitant
Route: 048 | Dosage: 40 MG, QD | Form: -- | Indication: Hypertension | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 11/08/1998 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
ASPIRIN (ASPIRIN) Suspect
Route: 048 | Dosage: ASS MINI (ACETYLSALICYLIC ACID) | Form: -- | Indication: Coronary artery disease | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
CARVEDILOL (CARVEDILOL) Concomitant
Route: 048 | Dosage: 19.75 MG | Form: -- | Indication: Hypertension | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 39.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
URAPIDIL (URAPIDIL) Suspect
Route: 042 | Dosage: AMP 1 | Form: -- | Indication: Angina pectoris | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/07/1998 | End: 11/07/1998 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
FUROSEMIDE (FUROSEMIDE) Suspect
Route: 048 | Dosage: 2 DOSAGE FORM, QD 06-NOV-1998 00:00 | Form: -- | Indication: Oedema | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 2.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: 11/06/1998 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
AMOXICILLIN (AMOXICILLIN) Suspect
Route: 048 | Dosage: UNSPECIFIED; AMOXICILLIN (AMOXICILLIN) | Form: -- | Indication: Bronchitis | Action: Withdrawn
Auth#: 061926 | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/07/1998 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
ACETAMINOPHEN (ACETAMINOPHEN) Suspect
Route: 054 | Dosage: -- | Form: -- | Indication: Pyrexia | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 1000.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/08/1998 | End: 11/09/1998 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
ALLOPURINOL (ALLOPURINOL) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Hyperuricaemia | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 450.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/25/1998 | End: 11/06/1998 | Duration: 42.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
NITROGLYCERIN (NITROGLYCERIN) Suspect
Route: 048 | Dosage: UNSPECIFIED | Form: -- | Indication: Angina pectoris | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/07/1998 | End: 11/07/1998 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
NITROGLYCERIN (NITROGLYCERIN) Suspect
Route: 048 | Dosage: UNSPECIFIED | Form: -- | Indication: Angina pectoris | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/09/1998 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
FLUVASTATIN SODIUM (FLUVASTATIN SODIUM) Suspect
Route: 048 | Dosage: 40 MG, QD23-OCT-1998 00:00 | Form: Capsule, hard | Indication: Hypercholesterolaemia | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/23/1998 | End: 11/06/1998 | Duration: 14.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
ACTRAPID (INSULIN HUMAN) Suspect
Route: 042 | Dosage: 70 IU 07-NOV-1998 00:00 | Form: -- | Indication: Diabetes mellitus | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 70.0 (unit: 025) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/07/1998 | End: 11/07/1998 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
PANTOZOL (PANTOPRAZOLE SODIUM) Suspect
Route: 048 | Dosage: TAB 1 | Form: Tablet | Indication: Gastric ulcer | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/07/1998 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
NOVALGIN (METAMIZOLE SODIUM) (METAMIZOLE SODIUM) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Pain | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 20.0 (unit: 031) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/07/1998 | End: 11/07/1998 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
ISOSORBIDE DINITRATE (ISOSORBIDE DINITRATE) Suspect
Route: 048 | Dosage: 20 MG, BID 08-NOV-1998 00:00 | Form: -- | Indication: Coronary artery disease | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 40.0 (unit: 003)
Start: 11/08/1998 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
MOLSIDOMINE (MOLSIDOMINE) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Coronary artery disease | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: 11/06/1998 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
ACETYLCYSTEINE (ACETYLCYSTEINE) Suspect
Route: 048 | Dosage: -- | Form: Tablet | Indication: Mucosal inflammation | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 20.0 (unit: 031) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: 11/09/1998 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
ACETYLCYSTEINE (ACETYLCYSTEINE) Suspect
Route: 048 | Dosage: TAB 1 UNK, QD; ACC (ACETYLCYSTEINE) | Form: Tablet | Indication: Mucosal inflammation | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 11/08/1998 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
MORPHINE (MORPHINE) Suspect
Route: 042 | Dosage: MORPHINE (MORPHINE) | Form: -- | Indication: Pain | Action: Withdrawn
Auth#: 079040 | Batch#: UNKNOWN | Structured Dosage: 3.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/07/1998 | End: 11/07/1998 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
MOLSIDOMINE (MOLSIDOMINE) Suspect
Route: 048 | Dosage: 8 MG, QD 06-NOV-1998 00:00 | Form: -- | Indication: Coronary artery disease | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 8.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
MOLSIDOMINE (MOLSIDOMINE) Suspect
Route: 048 | Dosage: UNK UNK, QD (I TAB) 08-NOV-1998 00:00 | Form: -- | Indication: Coronary artery disease | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 8.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: 11/06/1998 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
HEPARIN (HEPARIN SODIUM) Suspect
Route: 042 | Dosage: UNSPECIFIED 07-NOV-1998 00:00 | Form: -- | Indication: Thrombosis | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 7500.0 (unit: 025) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: 11/09/1998 | Duration: 2.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
HEPARIN (HEPARIN SODIUM) Suspect
Route: 058 | Dosage: UNSPECIFIED 07-NOV-1998 00:00 | Form: -- | Indication: Thrombosis | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 5000.0 (unit: 025) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: 11/07/1998 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
ACETYLCYSTEINE (ACETYLCYSTEINE) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Cough | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 20.0 (unit: 031) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/09/1998 | End: 11/09/1998 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
LASIX (FUROSEMIDE) Suspect
Route: 042 | Dosage: -- | Form: -- | Indication: Coronary artery insufficiency | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/07/1998 | End: 11/07/1998 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
DIAZEPAM (DIAZEPAM) Suspect
Route: 048 | Dosage: DIAZEPAM (DIAZEPAM) | Form: -- | Indication: Restlessness | Action: Withdrawn
Auth#: 071307 | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/07/1998 | End: 11/07/1998 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
FUROSEMIDE (FUROSEMIDE) Suspect
Route: 048 | Dosage: UNSPECIFIED 07-NOV-1998 00:00 | Form: -- | Indication: Coronary artery insufficiency | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 80.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
FUROSEMIDE (FUROSEMIDE) Suspect
Route: 048 | Dosage: UNSPECIFIED | Form: -- | Indication: Coronary artery insufficiency | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/07/1998 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
FUROSEMIDE (FUROSEMIDE) Suspect
Route: 042 | Dosage: UNSPECIFIED 07-NOV-1998 00:00 | Form: -- | Indication: Coronary artery insufficiency | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: 11/07/1998 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
FUROSEMIDE (FUROSEMIDE) Suspect
Route: 042 | Dosage: -- | Form: -- | Indication: Coronary artery insufficiency | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
FUROSEMIDE (FUROSEMIDE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Coronary artery insufficiency | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: 11/07/1998 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
FUROSEMIDE (FUROSEMIDE) Suspect
Route: 048 | Dosage: 1 UNK, BID(TAB 2) 06-NOV-1998 00:00 | Form: -- | Indication: Coronary artery insufficiency | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 1.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
URAPIDIL (URAPIDIL) Suspect
Route: 042 | Dosage: UNK (AMP 1) | Form: -- | Indication: Angina pectoris | Action: Withdrawn
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: 11/07/1998 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 19981108

Report Duplicates (16)

EVDUP#ORG100006023: EU-SANDOZ-PHHO1999DE01797
European Medicines Agency: EU-EMA-DD-20240715-7482677-084326
EVDUP#ORG100006023: EU-002147023-PHHO1999DE01797
EVDUP#aventis pharma deutschland gmbh: 199910462hpd
EVDUP#altana pharma ag: 0202/99/0011
EVDUP#glaxo smithkline gmbh + co.kg: d3165
EVDUP#bayer vital gmbh co kg: 9900911
EVDUP#novartis pharma gmbh: d-9900438
EVDUP#schwarz pharma deutschland gmbh: 001#0#1999-00113
EVDUP#sandoz pharmaceuticals gmbh: 99001028
EVDUP#projekt schoepf: 719519
EVDUP#BFARM: EU-BFARM-99000798
EVDUP#schwarz pharma deutschland gmbh: 001#0#1999-00112
EVDUP#celltech pharma gmbh+co. kg: opti-1999-001
EVDUP#novo nordisk pharma gmbh: 111992
European Medicines Agency: EU-EMA-DD-20251003-7482675-070448

Raw JSON (click to expand)

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"reactionmeddrapt": "Ocular hyperaemia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Rash", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blood creatinine increased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Erythema multiforme", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pruritus", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Oral mucosal eruption", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "MCP", "drugauthorizationnumb": "070184", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 3.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, 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[] }, { "drugcharacterization": 1, "medicinalproduct": "NITROGLYCERIN", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Angina pectoris", "drugstartdateformat": "102", "drugstartdate": "1998-11-07T00:00:00", "drugenddateformat": "102", "drugenddate": "1998-11-08T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "NITROGLYCERIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "NITROGLYCERIN", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 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"drugenddateformat": "102", "drugenddate": "1998-11-07T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FUROSEMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DIAZEPAM", "drugauthorizationnumb": "071307", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DIAZEPAM (DIAZEPAM)", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Restlessness", "drugstartdateformat": "102", "drugstartdate": "1998-11-07T00:00:00", "drugenddateformat": "102", "drugenddate": "1998-11-07T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "DIAZEPAM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FUROSEMIDE", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 80.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNSPECIFIED 07-NOV-1998 00:00", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Coronary artery insufficiency", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FUROSEMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FUROSEMIDE", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNSPECIFIED", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Coronary artery insufficiency", "drugstartdateformat": "102", "drugstartdate": "1998-11-07T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FUROSEMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FUROSEMIDE", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNSPECIFIED 07-NOV-1998 00:00", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Coronary artery insufficiency", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": "102", "drugenddate": "1998-11-07T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FUROSEMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FUROSEMIDE", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Coronary artery insufficiency", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FUROSEMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FUROSEMIDE", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Coronary artery insufficiency", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": "102", "drugenddate": "1998-11-07T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FUROSEMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FUROSEMIDE", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 UNK, BID(TAB 2) 06-NOV-1998 00:00", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Coronary artery insufficiency", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FUROSEMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "URAPIDIL", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK (AMP 1)", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Angina pectoris", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": "102", "drugenddate": "1998-11-07T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "URAPIDIL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 19981108" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "EVDUP#ORG100006023", "duplicatenumb": "EU-SANDOZ-PHHO1999DE01797" }, { "duplicatesource": "European Medicines Agency", "duplicatenumb": "EU-EMA-DD-20240715-7482677-084326" }, { "duplicatesource": "EVDUP#ORG100006023", "duplicatenumb": "EU-002147023-PHHO1999DE01797" }, { "duplicatesource": "EVDUP#aventis pharma deutschland gmbh", "duplicatenumb": "199910462hpd" }, { "duplicatesource": "EVDUP#altana pharma ag", "duplicatenumb": "0202/99/0011" }, { "duplicatesource": "EVDUP#glaxo smithkline gmbh + co.kg", "duplicatenumb": "d3165" }, { "duplicatesource": "EVDUP#bayer vital gmbh co kg", "duplicatenumb": "9900911" }, { "duplicatesource": "EVDUP#novartis pharma gmbh", "duplicatenumb": "d-9900438" }, { "duplicatesource": "EVDUP#schwarz pharma deutschland gmbh", "duplicatenumb": "001#0#1999-00113" }, { "duplicatesource": "EVDUP#sandoz pharmaceuticals gmbh", "duplicatenumb": "99001028" }, { "duplicatesource": "EVDUP#projekt schoepf", "duplicatenumb": "719519" }, { "duplicatesource": "EVDUP#BFARM", "duplicatenumb": "EU-BFARM-99000798" }, { "duplicatesource": "EVDUP#schwarz pharma deutschland gmbh", "duplicatenumb": "001#0#1999-00112" }, { "duplicatesource": "EVDUP#celltech pharma gmbh+co. kg", "duplicatenumb": "opti-1999-001" }, { "duplicatesource": "EVDUP#novo nordisk pharma gmbh", "duplicatenumb": "111992" }, { "duplicatesource": "European Medicines Agency", "duplicatenumb": "EU-EMA-DD-20251003-7482675-070448" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "TEVA" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-19T00:00:00", "transmissiondateformat": "102" }
25954084 Type 1
Serious
OZEMPIC, OZEMPIC, OZEMPIC (+3 more)
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-NOVOPROD-1544013
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
78.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Cardiac failure congestive (v28.1) Recovering
Pneumonia (v28.1) Recovered
Asthenia (v28.1) Recovered
Decreased appetite (v28.1) Unknown
Blood glucose increased (v28.1) Unknown

Drugs (6)

OZEMPIC (SEMAGLUTIDE) Suspect
Route: 058 | Dosage: 0.25 MG, QW | Form: Solution for injection | Indication: Type 2 diabetes mellitus | Action: Dose Increased
Auth#: 209637 | Batch#: -- | Structured Dosage: 0.25 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 wk | Cumulative: -- (unit: --)
Start: 01/01/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OZEMPIC (SEMAGLUTIDE) Suspect
Route: 058 | Dosage: 0.5 MG, QW | Form: Solution for injection | Indication: -- | Action: Dose Increased
Auth#: 209637 | Batch#: -- | Structured Dosage: 0.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 wk | Cumulative: -- (unit: --)
Start: 01/01/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OZEMPIC (SEMAGLUTIDE) Suspect
Route: 058 | Dosage: DOSE INCREASE: 2 MG | Form: Solution for injection | Indication: -- | Action: Dose Increased
Auth#: 209637 | Batch#: -- | Structured Dosage: 1.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 wk | Cumulative: -- (unit: --)
Start: 01/01/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OZEMPIC (SEMAGLUTIDE) Suspect
Route: 058 | Dosage: DOSE DECREASE: 1 MG | Form: Solution for injection | Indication: -- | Action: Dose Increased
Auth#: 209637 | Batch#: -- | Structured Dosage: 2.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 wk | Cumulative: -- (unit: --)
Start: 02/01/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OZEMPIC (SEMAGLUTIDE) Suspect
Route: 058 | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Dose Increased
Auth#: 209637 | Batch#: RAR0068 | Structured Dosage: 1.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 wk | Cumulative: -- (unit: --)
Start: 09/01/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
NOVOLIN N (INSULIN HUMAN) Suspect
Route: 058 | Dosage: 30 UNITS TWICE DAILY BEFORE MEALS, PRIOR TO STARTING OZEMPIC. | Form: Suspension for injection | Indication: Type 2 diabetes mellitus | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2024 | End: 02/01/2025 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250201

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4358e3b3830196fa55802", "safetyreportid": "25954084", "authoritynumb": null, "companynumb": "US-NOVOPROD-1544013", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 78.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Cardiac failure congestive", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pneumonia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Asthenia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Decreased appetite", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blood glucose increased", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "OZEMPIC", "drugauthorizationnumb": "209637", "drugbatchnumb": null, "drugstructuredosagenumb": 0.25, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "0.25 MG, QW", "drugdosageform": "Solution for injection", "drugadministrationroute": "058", "drugindication": "Type 2 diabetes mellitus", "drugstartdateformat": "602", "drugstartdate": "2024-01-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 3, "activesubstance": { "activesubstancename": "SEMAGLUTIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "OZEMPIC", "drugauthorizationnumb": "209637", "drugbatchnumb": null, "drugstructuredosagenumb": 0.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "0.5 MG, QW", "drugdosageform": "Solution for injection", "drugadministrationroute": "058", "drugindication": null, "drugstartdateformat": "602", "drugstartdate": "2024-01-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 3, "activesubstance": { "activesubstancename": "SEMAGLUTIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "OZEMPIC", "drugauthorizationnumb": "209637", "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE INCREASE: 2 MG", "drugdosageform": "Solution for injection", "drugadministrationroute": "058", "drugindication": null, "drugstartdateformat": "602", "drugstartdate": "2025-01-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 3, "activesubstance": { "activesubstancename": "SEMAGLUTIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "OZEMPIC", "drugauthorizationnumb": "209637", "drugbatchnumb": null, "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE DECREASE: 1 MG", "drugdosageform": "Solution for injection", "drugadministrationroute": "058", "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2025-02-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 3, "activesubstance": { "activesubstancename": "SEMAGLUTIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "OZEMPIC", "drugauthorizationnumb": "209637", "drugbatchnumb": "RAR0068", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for injection", "drugadministrationroute": "058", "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2025-09-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 3, "activesubstance": { "activesubstancename": "SEMAGLUTIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "NOVOLIN N", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "30 UNITS TWICE DAILY BEFORE MEALS, PRIOR TO STARTING OZEMPIC.", "drugdosageform": "Suspension for injection", "drugadministrationroute": "058", "drugindication": "Type 2 diabetes mellitus", "drugstartdateformat": "602", "drugstartdate": "2024-01-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2025-02-01T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "INSULIN HUMAN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250201" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "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" }
25954087 Type 1
Serious
IRBESARTAN
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Consumer
Literature Reference
--
Company Number
--
Authority Number
EU-AFSSAPS-ST2025001113
Sender Organization
TEVA
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
77.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Wrong drug (v28.1) Recovered
Hypotension (v28.1) Recovering

Drugs (1)

IRBESARTAN (IRBESARTAN) Suspect
Route: 048 | Dosage: TIME INTERVAL: TOTAL | Form: -- | Indication: Medication error | Action: Withdrawn
Auth#: 077159 | Batch#: UNKNOWN | Structured Dosage: 150.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: 150.0 (unit: 003)
Start: 08/06/2025 | End: 08/06/2025 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250806

Report Duplicates (1)

AFSSAPS: EU-AFSSAPS-ST2025001113

Raw JSON (click to expand)

{ "_id": "69d4358e3b3830196fa55801", "safetyreportid": "25954087", "authoritynumb": "EU-AFSSAPS-ST2025001113", "companynumb": null, "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 77.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Wrong drug", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypotension", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "IRBESARTAN", "drugauthorizationnumb": "077159", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 150.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": 150.0, "drugcumulativedosageunit": "003", "drugdosagetext": "TIME INTERVAL: TOTAL", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Medication error", "drugstartdateformat": "102", "drugstartdate": "2025-08-06T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-06T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "IRBESARTAN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250806" }, "primarysource": { "reportercountry": "EU", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "AFSSAPS", "duplicatenumb": "EU-AFSSAPS-ST2025001113" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "TEVA" }, "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" }
25954086 Type 1
Non-Serious
LATISSE
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-ABBVIE-6507676
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
59.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Skin discolouration (v28.1) Unknown
Lid sulcus deepened (v28.1) Unknown
Skin atrophy (v28.1) Unknown

Drugs (1)

LATISSE (BIMATOPROST) Suspect
Route: 061 | Dosage: -- | Form: Eye drops, solution | Indication: Product used for unknown indication | Action: Withdrawn
Auth#: 022369 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4358e3b3830196fa557ff", "safetyreportid": "25954086", "authoritynumb": null, "companynumb": "US-ABBVIE-6507676", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 59.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Skin discolouration", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Lid sulcus deepened", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Skin atrophy", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "LATISSE", "drugauthorizationnumb": "022369", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Eye drops, solution", "drugadministrationroute": "061", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "BIMATOPROST" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "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": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25954082 Type 1
Non-Serious
SKYRIZI
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
--
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
--
Authority Number
783353
Sender Organization
FDA-CTU
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
3
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)

Adverse event (v28.1) --

Drugs (1)

SKYRIZI (RISANKIZUMAB-RZAA) Suspect
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": "69d4358e3b3830196fa557fe", "safetyreportid": "25954082", "authoritynumb": "783353", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Adverse event", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "SKYRIZI", "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": "RISANKIZUMAB-RZAA" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "FDA-CTU" }, "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" }
25954083 Type 1
Serious
MONTELUKAST, Letrozole CPAP, VitE (+11 more)
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
--
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
--
Authority Number
783358
Sender Organization
FDA-CTU
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
3
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
60.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
58.5 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (6)

Feeling of despair (v28.1) --
Fatigue (v28.1) --
Self-destructive behaviour (v28.1) --
Self-injurious ideation (v28.1) --
Nightmare (v28.1) --
Therapy cessation (v28.1) --

Drugs (14)

MONTELUKAST (MONTELUKAST) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Radiation fibrosis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 1.0 yr | Rechallenge: -- | Additional: No
Recurrences: --
Letrozole CPAP (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VitE (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FISH OIL (FISH OIL) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VitC (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
Ca (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VitD with K2 (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CLARITIN (LORATADINE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MAGNESIUM (MAGNESIUM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ASPIRIN (ASPIRIN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MELATONIN (MELATONIN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
Tylenol and/or Motrin (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PEPCID (FAMOTIDINE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FIBER THERAPY (CALCIUM POLYCARBOPHIL) (CALCIUM POLYCARBOPHIL) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251022

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4358e3b3830196fa557fd", "safetyreportid": "25954083", "authoritynumb": "783358", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": 60.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 58.5, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Feeling of despair", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Fatigue", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Self-destructive behaviour", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Self-injurious ideation", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nightmare", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Therapy cessation", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "MONTELUKAST", "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": "Radiation fibrosis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 801, "drugrecurreadministration": null, "drugadditional": 2, "actiondrug": null, "activesubstance": { "activesubstancename": "MONTELUKAST" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "Letrozole CPAP", "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": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "VitE", "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": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FISH OIL", "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": "FISH OIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "VitC", "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": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "Ca", "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": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "VitD with K2", "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": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CLARITIN", "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": "LORATADINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MAGNESIUM", "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": "MAGNESIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ASPIRIN", "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": "ASPIRIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MELATONIN", "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": "MELATONIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "Tylenol and/or Motrin", "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": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PEPCID", "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": "FAMOTIDINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FIBER THERAPY (CALCIUM POLYCARBOPHIL)", "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": "CALCIUM POLYCARBOPHIL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251022" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "FDA-CTU" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 1, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25954081 Type 1
Serious
GABAPENTIN, BUSPIRONE
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/18/2026
Primary Source Country
GB
Occurrence Country
GB
Reporter Country
GB
Reporter Qualification
Consumer
Literature Reference
--
Company Number
--
Authority Number
GB-MHRA-MED-202510171508586380-YZNMT
Sender Organization
SANDOZ
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
28.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
68.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Depression suicidal (v28.1) Recovered

Drugs (2)

GABAPENTIN (GABAPENTIN) Suspect
Route: 065 | Dosage: UNK 100 MG ONCE | Form: Unknown | Indication: Adverse drug reaction | Action: Unknown
Auth#: 75539 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/03/2025 | End: 10/03/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
BUSPIRONE (BUSPIRONE HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Anxiety | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/01/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251003

Report Duplicates (1)

MHRA: GB-MHRA-MED-202510171508586380-YZNMT

Raw JSON (click to expand)

{ "_id": "69d4358e3b3830196fa557fc", "safetyreportid": "25954081", "authoritynumb": "GB-MHRA-MED-202510171508586380-YZNMT", "companynumb": null, "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "GB", "patient": { "patientonsetage": 28.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 68.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Depression suicidal", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "GABAPENTIN", "drugauthorizationnumb": "75539", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK 100 MG ONCE", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Adverse drug reaction", "drugstartdateformat": "102", "drugstartdate": "2025-10-03T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-03T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "GABAPENTIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "BUSPIRONE", "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": "Anxiety", "drugstartdateformat": "102", "drugstartdate": "2025-03-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "BUSPIRONE HYDROCHLORIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251003" }, "primarysource": { "reportercountry": "GB", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "GB", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "MHRA", "duplicatenumb": "GB-MHRA-MED-202510171508586380-YZNMT" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANDOZ" }, "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" }