FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25942238 Type 1
Serious
XGEVA, SODIUM CHLORIDE
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CN-AMGEN-CHNSP2025206141
Authority Number
--
Sender Organization
AMGEN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
51.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
58.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Neutrophil count decreased (v28.1) Recovering

Drugs (2)

XGEVA (DENOSUMAB) Suspect
Route: 040 | Dosage: 120 MILLIGRAM, QD (INTRAVENOUS DRIP) | Form: Solution for injection | Indication: Lung neoplasm malignant | Action: Withdrawn
Auth#: 125320 | Batch#: 1189532 | Structured Dosage: 120.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 08/09/2025 | End: 08/09/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
SODIUM CHLORIDE (SODIUM CHLORIDE) Concomitant
Route: 040 | Dosage: 100 MILLIGRAM (ONCE) | Form: Injection | Indication: -- | Action: --
Auth#: -- | Batch#: 12505028 | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/09/2025 | End: 07/09/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250809

Report Duplicates (1)

NMPACDR: 4509011013497202501011

Raw JSON (click to expand)

{ "_id": "69d435563b3830196fa527cd", "safetyreportid": "25942238", "authoritynumb": null, "companynumb": "CN-AMGEN-CHNSP2025206141", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 51.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 58.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neutrophil count decreased", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "XGEVA", "drugauthorizationnumb": "125320", "drugbatchnumb": "1189532", "drugstructuredosagenumb": 120.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "120 MILLIGRAM, QD (INTRAVENOUS DRIP)", "drugdosageform": "Solution for injection", "drugadministrationroute": "040", "drugindication": "Lung neoplasm malignant", "drugstartdateformat": "102", "drugstartdate": "2025-08-09T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-09T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "DENOSUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SODIUM CHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": "12505028", "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 MILLIGRAM (ONCE)", "drugdosageform": "Injection", "drugadministrationroute": "040", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-07-09T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-07-09T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "SODIUM CHLORIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250809" }, "primarysource": { "reportercountry": "CN", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CN", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "NMPACDR", "duplicatenumb": "4509011013497202501011" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "AMGEN" }, "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" }
25942240 Type 1
Non-Serious
DUPIXENT
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
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-SA-2025SA311582
Authority Number
--
Sender Organization
SANOFI AVENTIS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
9.0 yr
Patient Age Group
Child
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Dermatitis (v28.1) Recovering
Rash (v28.1) Recovering
Product use in unapproved indication (v28.1) Unknown

Drugs (1)

DUPIXENT (DUPILUMAB) Suspect
Route: 058 | Dosage: 300 MG, QOW | Form: Solution for injection | Indication: Dermatitis | Action: Unknown
Auth#: 761055 | Batch#: -- | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 11/01/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435563b3830196fa527cf", "safetyreportid": "25942240", "authoritynumb": null, "companynumb": "US-SA-2025SA311582", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 9.0, "patientonsetageunit": 801, "patientagegroup": 3, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dermatitis", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Rash", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product use in unapproved indication", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": "761055", "drugbatchnumb": null, "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "300 MG, QOW", "drugdosageform": "Solution for injection", "drugadministrationroute": "058", "drugindication": "Dermatitis", "drugstartdateformat": "610", "drugstartdate": "2023-11-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANOFI AVENTIS" }, "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" }
25942239 Type 1
Non-Serious
REPATHA, INFLUENZA VIRUS VACCINE
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-AMGEN-USASP2025204322
Authority Number
--
Sender Organization
AMGEN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (9)

Oropharyngeal pain (v28.1) Unknown
Rhinorrhoea (v28.1) Unknown
Back pain (v28.1) Recovering
Pain in extremity (v28.1) Unknown
Cough (v28.1) Recovering
Chronic fatigue syndrome (v28.1) Unknown
Chest discomfort (v28.1) Unknown
Pollakiuria (v28.1) Recovering
Arthralgia (v28.1) Unknown

Drugs (2)

REPATHA (EVOLOCUMAB) Suspect
Route: 065 | Dosage: UNK | Form: Unknown formulation | Indication: Blood cholesterol increased | Action: Withdrawn
Auth#: 125522 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
INFLUENZA VIRUS VACCINE (INFLUENZA VIRUS VACCINE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

AMGEN INC: US-AMGEN INC-25-0284355-SR-01

Raw JSON (click to expand)

{ "_id": "69d435563b3830196fa527ce", "safetyreportid": "25942239", "authoritynumb": null, "companynumb": "US-AMGEN-USASP2025204322", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Oropharyngeal pain", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Rhinorrhoea", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Back pain", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pain in extremity", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Cough", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Chronic fatigue syndrome", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Chest discomfort", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pollakiuria", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Arthralgia", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "REPATHA", "drugauthorizationnumb": "125522", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown formulation", "drugadministrationroute": "065", "drugindication": "Blood cholesterol increased", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "EVOLOCUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "INFLUENZA VIRUS VACCINE", "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": "INFLUENZA VIRUS VACCINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "AMGEN INC", "duplicatenumb": "US-AMGEN INC-25-0284355-SR-01" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "AMGEN" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25942236 Type 1
Non-Serious
PROLIA
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-AMGEN-USASP2025206698
Authority Number
--
Sender Organization
AMGEN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Arteriosclerosis (v28.1) Unknown

Drugs (1)

PROLIA (DENOSUMAB) Suspect
Route: 065 | Dosage: UNK | Form: Solution for injection | Indication: Product used for unknown indication | Action: Unknown
Auth#: 125320 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

AMGEN INC: US-AMGEN INC-25-0288476-SR-01

Raw JSON (click to expand)

{ "_id": "69d435563b3830196fa527cc", "safetyreportid": "25942236", "authoritynumb": null, "companynumb": "US-AMGEN-USASP2025206698", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Arteriosclerosis", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "PROLIA", "drugauthorizationnumb": "125320", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Solution for injection", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DENOSUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "AMGEN INC", "duplicatenumb": "US-AMGEN INC-25-0288476-SR-01" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "AMGEN" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25942235 Type 1
Serious
DARZALEX, POMALIDOMIDE, DEXAMETHASONE (+3 more)
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
--
Authority Number
EU-AFSSAPS-TS2025001059
Sender Organization
JOHNSON AND JOHNSON
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
83.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
62.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Lung disorder (v28.1) Recovering

Drugs (6)

DARZALEX (DARATUMUMAB) Suspect
Route: 042 | Dosage: -- | Form: Concentrate for solution for infusion | Indication: Plasma cell myeloma | Action: Not Applicable
Auth#: 761036 | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2023 | End: 08/01/2025 | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
POMALIDOMIDE (POMALIDOMIDE) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Plasma cell myeloma | Action: Not Applicable
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2023 | End: 08/01/2025 | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
DEXAMETHASONE (DEXAMETHASONE) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Plasma cell myeloma | Action: Not Applicable
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2023 | End: 08/01/2025 | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Depression | Action: Withdrawn
Auth#: -- | Batch#: Unknown | Structured Dosage: 37.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: 09/25/2025 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
SOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Hypertensive heart disease | Action: Withdrawn
Auth#: -- | Batch#: Unknown | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: 09/25/2025 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Hypertensive heart disease | Action: Withdrawn
Auth#: -- | Batch#: Unknown | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 12.0 hr | Cumulative: -- (unit: --)
Start: -- | End: 09/25/2025 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250901

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435563b3830196fa527c9", "safetyreportid": "25942235", "authoritynumb": "EU-AFSSAPS-TS2025001059", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 83.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 62.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Lung disorder", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DARZALEX", "drugauthorizationnumb": "761036", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Concentrate for solution for infusion", "drugadministrationroute": "042", "drugindication": "Plasma cell myeloma", "drugstartdateformat": "602", "drugstartdate": "2023-01-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2025-08-01T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "DARATUMUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "POMALIDOMIDE", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Plasma cell myeloma", "drugstartdateformat": "602", "drugstartdate": "2023-01-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2025-08-01T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "POMALIDOMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DEXAMETHASONE", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Plasma cell myeloma", "drugstartdateformat": "602", "drugstartdate": "2023-01-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2025-08-01T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "DEXAMETHASONE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CLOMIPRAMINE HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 37.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Depression", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": "102", "drugenddate": "2025-09-25T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "CLOMIPRAMINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "SOTALOL HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Hypertensive heart disease", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": "102", "drugenddate": "2025-09-25T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "SOTALOL HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "NICARDIPINE HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 50.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 12.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Hypertensive heart disease", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": "102", "drugenddate": "2025-09-25T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "NICARDIPINE HYDROCHLORIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250901" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "JOHNSON AND JOHNSON" }, "serious": 1, "seriousnesscongenitalanomali": null, "seriousnessdeath": null, "seriousnessdisabling": null, "seriousnesshospitalization": 1, "seriousnesslifethreatening": null, "seriousnessother": null, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25942233 Type 1
Non-Serious
SKYRIZI, SKYRIZI
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-ABBVIE-6509592
Authority Number
--
Sender Organization
ABBVIE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
Adult
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Injection site pain (v28.1) Unknown
Device leakage (v28.1) Not Recovered

Drugs (2)

SKYRIZI (RISANKIZUMAB-RZAA) Suspect
Route: 058 | Dosage: FORM STRENGTH: 360 MILLIGRAM | Form: Solution for injection in pre-filled injector | Indication: Colitis ulcerative | Action: Unknown
Auth#: 761105 | Batch#: Not available | Structured Dosage: 360.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SKYRIZI (RISANKIZUMAB-RZAA) Suspect
Route: 042 | Dosage: -- | Form: Solution for infusion | Indication: Colitis ulcerative | Action: Unknown
Auth#: 761262 | Batch#: Not Available | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435563b3830196fa527c8", "safetyreportid": "25942233", "authoritynumb": null, "companynumb": "US-ABBVIE-6509592", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 5, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Injection site pain", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Device leakage", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "SKYRIZI", "drugauthorizationnumb": "761105", "drugbatchnumb": "Not available", "drugstructuredosagenumb": 360.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FORM STRENGTH: 360 MILLIGRAM", "drugdosageform": "Solution for injection in pre-filled injector", "drugadministrationroute": "058", "drugindication": "Colitis ulcerative", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "RISANKIZUMAB-RZAA" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "SKYRIZI", "drugauthorizationnumb": "761262", "drugbatchnumb": "Not Available", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for infusion", "drugadministrationroute": "042", "drugindication": "Colitis ulcerative", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "RISANKIZUMAB-RZAA" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "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" }
25942234 Type 2
Serious
QULIPTA, TOPAMAX
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/18/2026
Primary Source Country
CA
Occurrence Country
CA
Reporter Country
CA
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CA-ABBVIE-6511192
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
79.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Death (v28.1) Fatal

Drugs (2)

QULIPTA (ATOGEPANT) Suspect
Route: 048 | Dosage: LAST ADMIN DATE: 2025 | Form: -- | Indication: Migraine | Action: Not Applicable
Auth#: 215206 | Batch#: not available | Structured Dosage: 60.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 05/02/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
TOPAMAX (TOPIRAMATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 04/01/2024 | End: 01/01/2025 | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435563b3830196fa527c6", "safetyreportid": "25942234", "authoritynumb": null, "companynumb": "CA-ABBVIE-6511192", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CA", "patient": { "patientonsetage": 79.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Death", "reactionoutcome": 5 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "QULIPTA", "drugauthorizationnumb": "215206", "drugbatchnumb": "not available", "drugstructuredosagenumb": 60.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "LAST ADMIN DATE: 2025", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Migraine", "drugstartdateformat": "102", "drugstartdate": "2025-05-02T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ATOGEPANT" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TOPAMAX", "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": "Product used for unknown indication", "drugstartdateformat": "610", "drugstartdate": "2024-04-01T00:00:00", "drugenddateformat": "602", "drugenddate": "2025-01-01T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "TOPIRAMATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101" }, "primarysource": { "reportercountry": "CA", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CA", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ABBVIE" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25942232 Type 1
Non-Serious
TYLENOL
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-KENVUE-20251004655
Authority Number
--
Sender Organization
Kenvue
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
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Liver disorder (v28.1) Unknown

Drugs (1)

TYLENOL (ACETAMINOPHEN) Suspect
Route: 065 | Dosage: -- | Form: Unknown | Indication: Product used for unknown indication | Action: Unknown
Auth#: 019872 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435563b3830196fa527c5", "safetyreportid": "25942232", "authoritynumb": null, "companynumb": "US-KENVUE-20251004655", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Liver disorder", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TYLENOL", "drugauthorizationnumb": "019872", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Unknown", "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": "ACETAMINOPHEN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "Kenvue" }, "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" }
25942231 Type 1
Serious
KEYTRUDA, LENVIMA, AQUAPHOR (+9 more)
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-009507513-2338592
Authority Number
--
Sender Organization
MERCK SHARP & DOHME LLC
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Male
Patient Weight
104.33 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Gait inability (v28.1) Not Recovered
Biliary catheter insertion (v28.1) Not Recovered
Arthralgia (v28.1) Not Recovered
Hepatic function abnormal (v28.1) Not Recovered

Drugs (12)

KEYTRUDA (PEMBROLIZUMAB) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Renal cell carcinoma | Action: Unknown
Auth#: 125514 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
LENVIMA (LENVATINIB) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Renal cell carcinoma | Action: Withdrawn
Auth#: -- | Batch#: 44611819 | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: No
Recurrences: --
AQUAPHOR (PETROLATUM) Concomitant
Route: -- | Dosage: 41% | Form: Ointment | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SENNA-S (DOCUSATE SODIUM\SENNOSIDES) Concomitant
Route: -- | Dosage: 8.6MG - 50 MG | Form: Tablet | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MIRALAX (POLYETHYLENE GLYCOL 3350) Concomitant
Route: -- | Dosage: 17 G / DOSE POWDER | Form: Powder | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
COLACE (DOCUSATE SODIUM) Concomitant
Route: -- | Dosage: 100 MG CAPSULE | Form: Capsule | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VITAMIN D3 (CHOLECALCIFEROL) Concomitant
Route: -- | Dosage: 10 MCG CAPSULE | Form: Capsule | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MORPHINE SULFATE (MORPHINE SULFATE) Concomitant
Route: -- | Dosage: 15 MG TABLET | Form: Tablet | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MORPHINE SULFATE (MORPHINE SULFATE) Concomitant
Route: -- | Dosage: 30 MG TABLET | Form: Tablet | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VALSARTAN (VALSARTAN) Concomitant
Route: -- | Dosage: 320 MG TABLET | Form: Tablet | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
GABAPENTIN (GABAPENTIN) Concomitant
Route: -- | Dosage: 300 MG CAPSULE | Form: Capsule | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SYNTHROID (LEVOTHYROXINE SODIUM) Concomitant
Route: -- | Dosage: 175 MCG TABLET | Form: Tablet | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

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"safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "MERCK SHARP & DOHME LLC" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25942230 Type 1
Non-Serious
LENALIDOMIDE, ACETAMINOPHEN, ACYCLOVIR (+12 more)
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Pharmacist
Literature Reference
--
Company Number
US-BRISTOL-MYERS SQUIBB COMPANY-2025-141926
Authority Number
--
Sender Organization
BRISTOL-MYERS SQUIBB COMPANY
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
63.0 yr
Patient Age Group
Adult
Patient Sex
Male
Patient Weight
90.3 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Oedema peripheral (v28.1) Not Recovered

Drugs (15)

LENALIDOMIDE (LENALIDOMIDE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Plasma cell myeloma | Action: Dose Not Changed
Auth#: 021880 | Batch#: -- | Structured Dosage: 25.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.5 day | Cumulative: -- (unit: --)
Start: 07/25/2025 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
ACETAMINOPHEN (ACETAMINOPHEN) Concomitant
Route: -- | 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: --
ACYCLOVIR (ACYCLOVIR) Concomitant
Route: -- | 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: --
ASPIRIN (ASPIRIN) Concomitant
Route: -- | 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: --
CALCIUM CITRATE\VITAMIN D (CALCIUM CITRATE\VITAMIN D) Concomitant
Route: -- | 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: --
DEXAMETHASONE (DEXAMETHASONE) Concomitant
Route: -- | 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: --
HYDROMORPHONE (HYDROMORPHONE) Concomitant
Route: -- | 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: --
HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) Concomitant
Route: -- | 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: --
LOSARTAN (LOSARTAN) Concomitant
Route: -- | 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: --
METOCLOPRAMIDE (METOCLOPRAMIDE) Concomitant
Route: -- | 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: --
MORPHINE (MORPHINE) Concomitant
Route: -- | 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: --
NALOXONE (NALOXONE) Concomitant
Route: -- | 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: --
ONDANSETRON (ONDANSETRON) Concomitant
Route: -- | 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: --
PROCHLORPERAZINE (PROCHLORPERAZINE) Concomitant
Route: -- | 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: --
ZOLPIDEM (ZOLPIDEM TARTRATE) Concomitant
Route: -- | 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: --

Clinical Narrative

CASE EVENT DATE: 20250725

Report Duplicates (0)

--

Raw JSON (click to expand)

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"drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ACYCLOVIR", "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": "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": "ACYCLOVIR" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ASPIRIN", "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": "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": "ASPIRIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CALCIUM CITRATE\\VITAMIN D", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, 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null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ONDANSETRON" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PROCHLORPERAZINE", "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": "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": "PROCHLORPERAZINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ZOLPIDEM", "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": "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": "ZOLPIDEM TARTRATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250725" }, "primarysource": { "reportercountry": "US", "qualification": 2, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BRISTOL-MYERS SQUIBB COMPANY" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }