FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25951519 Type 2
Serious
CELLCEPT, CELLCEPT, TYLENOL (+8 more)
Report Version
2
Receive Date
10/23/2025
Receipt Date
10/29/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Physician
Literature Reference
--
Company Number
US-ROCHE-10000403348
Authority Number
--
Sender Organization
ROCHE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
65.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
81.6 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Immunodeficiency (v28.1) Not Recovered
Proteinuria (v28.1) Not Recovered
Stress (v28.1) Unknown
Immunosuppression (v28.1) Not Recovered
Hyperparathyroidism (v28.1) Not Recovered

Drugs (11)

CELLCEPT (MYCOPHENOLATE MOFETIL) Suspect
Route: 048 | Dosage: -- | Form: Tablet | Indication: Renal transplant | Action: Dose Not Changed
Auth#: -- | Batch#: 181069653 | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.5 day | Cumulative: -- (unit: --)
Start: 01/05/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CELLCEPT (MYCOPHENOLATE MOFETIL) Suspect
Route: 048 | Dosage: -- | Form: Capsule | Indication: -- | Action: Dose Not Changed
Auth#: -- | Batch#: Unknown | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.5 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
TYLENOL (ACETAMINOPHEN) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: -- | Interval: 6.0 hr | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
XANAX (ALPRAZOLAM) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: Anxiety | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 0.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VITAMIN D3 (CHOLECALCIFEROL) Concomitant
Route: 048 | Dosage: 10 MCG | Form: Tablet | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SENSIPAR (CINACALCET HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: 1 TAB ORAL ON MONDAY AND THURSDAY | Form: Tablet | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 30.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
NEURONTIN (GABAPENTIN) Concomitant
Route: 048 | Dosage: -- | Form: Capsule | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PREDNISONE (PREDNISONE) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
RAPAMUNE (SIROLIMUS) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.3 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ACETAMINOPHEN (ACETAMINOPHEN) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 6.0 hr | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CINACALCET (CINACALCET) Concomitant
Route: 048 | Dosage: 1 TABLET ORAL ON MONDAYS AND THURSDAYS. | Form: Tablet | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20160225

Report Duplicates (0)

--

Raw JSON (click to expand)

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"drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ALPRAZOLAM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "VITAMIN D3", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10 MCG", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CHOLECALCIFEROL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SENSIPAR", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 30.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 TAB ORAL ON MONDAY AND THURSDAY", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CINACALCET HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "NEURONTIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, 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"drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PREDNISONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "RAPAMUNE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.3, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "SIROLIMUS" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ACETAMINOPHEN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 6.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CINACALCET", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 TABLET ORAL ON MONDAYS AND THURSDAYS.", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CINACALCET" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20160225" }, "primarysource": { "reportercountry": "US", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 2, "sender": { "sendertype": 6, "senderorganization": "ROCHE" }, "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" }
25951677 Type 1
Serious
KEYTRUDA, LIPITOR, COENZYME Q10 (+6 more)
Report Version
2
Receive Date
10/23/2025
Receipt Date
10/29/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Physician
Literature Reference
--
Company Number
US-009507513-2338419
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
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (15)

Malignant neoplasm progression (v28.1) Unknown
Drug intolerance (v28.1) Unknown
Tinnitus (v28.1) Unknown
Deafness (v28.1) Unknown
Renal failure (v28.1) Recovering
Fatigue (v28.1) Unknown
Acute kidney injury (v28.1) Unknown
Neuropathy peripheral (v28.1) Unknown
Skin toxicity (v28.1) Unknown
Anaemia (v28.1) Unknown
Light chain analysis abnormal (v28.1) Unknown
Blood immunoglobulin G increased (v28.1) Unknown
Blood immunoglobulin A increased (v28.1) Unknown
Inflammation (v28.1) Unknown
Dyspnoea (v28.1) Unknown

Drugs (9)

KEYTRUDA (PEMBROLIZUMAB) Suspect
Route: 042 | Dosage: 200 MG EVERY 3 WEEKS CYCLES: 2/3 | Form: -- | Indication: HER2 positive bladder cancer | Action: Withdrawn
Auth#: 125514 | Batch#: -- | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: 08/08/2025 | End: 09/23/2025 | Duration: 47.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
LIPITOR (ATORVASTATIN CALCIUM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
COENZYME Q10 (DIETARY SUPPLEMENT\UBIDECARENONE) 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: --
AMLODIPINE (AMLODIPINE BESYLATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FERROUS SULFATE (FERROUS SULFATE) Concomitant
Route: 048 | Dosage: 325 MG (65 MG IRON) | Form: Tablet | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/28/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OMEGA-3 ACIDS (OMEGA-3 FATTY ACIDS) Concomitant
Route: -- | Dosage: 350 MG-235 MG-90 MG-597 MG CAPSULE.DELAYED RELEASE | Form: Capsule | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/28/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: 37.5 MG TABLET | Form: Tablet | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/28/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VITAMIN B12 (CYANOCOBALAMIN) Concomitant
Route: -- | Dosage: 1,000 MCG TABLET | Form: Tablet | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/28/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435e13b3830196fa5a2d1", "safetyreportid": "25951677", "authoritynumb": null, "companynumb": "US-009507513-2338419", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Malignant neoplasm progression", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug intolerance", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Tinnitus", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Deafness", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Renal failure", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Fatigue", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Acute kidney injury", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neuropathy peripheral", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Skin toxicity", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Anaemia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Light chain analysis abnormal", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blood immunoglobulin G increased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blood immunoglobulin A increased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Inflammation", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": 6 } ], "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": "200 MG EVERY 3 WEEKS CYCLES: 2/3", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "HER2 positive bladder cancer", "drugstartdateformat": "102", "drugstartdate": "2025-08-08T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-23T00:00:00", "drugtreatmentduration": 47.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "PEMBROLIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LIPITOR", "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": "ATORVASTATIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "COENZYME Q10", "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": "DIETARY SUPPLEMENT\\UBIDECARENONE" }, "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": "AMLODIPINE", "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": "AMLODIPINE BESYLATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FERROUS SULFATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "325 MG (65 MG IRON)", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2022-11-28T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "FERROUS SULFATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OMEGA-3 ACIDS", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "350 MG-235 MG-90 MG-597 MG CAPSULE.DELAYED RELEASE", "drugdosageform": "Capsule", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2022-11-28T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "OMEGA-3 FATTY ACIDS" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "VENLAFAXINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "37.5 MG TABLET", "drugdosageform": "Tablet", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2022-11-28T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "VENLAFAXINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "VITAMIN B12", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1,000 MCG TABLET", "drugdosageform": "Tablet", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2022-11-28T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CYANOCOBALAMIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101" }, "primarysource": { "reportercountry": "US", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 2, "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" }
25950872 Type 2
Serious
VENCLEXTA, VENCLEXTA
Report Version
2
Receive Date
10/23/2025
Receipt Date
10/28/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-ABBVIE-6512984
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
62.0 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)

VENCLEXTA (VENETOCLAX) Suspect
Route: 048 | Dosage: TAKE 2 TABLETS WITH FOOD FOR 14 DAYS ON AND THEN 14 DAYS OFF OF A 28 DAY CYCLE | Form: Tablet | Indication: Acute myeloid leukaemia | Action: Not Applicable
Auth#: 208573 | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
VENCLEXTA (VENETOCLAX) Suspect
Route: 048 | Dosage: 200 MG DAILY X21DAYS EVERY 28 DAY CYCLE | Form: Tablet | Indication: Acute myeloid leukaemia | Action: Not Applicable
Auth#: 208573 | Batch#: -- | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435df3b3830196fa5a194", "safetyreportid": "25950872", "authoritynumb": null, "companynumb": "US-ABBVIE-6512984", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 62.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Death", "reactionoutcome": 5 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "VENCLEXTA", "drugauthorizationnumb": "208573", "drugbatchnumb": null, "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "TAKE 2 TABLETS WITH FOOD FOR 14 DAYS ON AND THEN 14 DAYS OFF OF A 28 DAY CYCLE", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Acute myeloid leukaemia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "VENETOCLAX" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "VENCLEXTA", "drugauthorizationnumb": "208573", "drugbatchnumb": null, "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "200 MG DAILY X21DAYS EVERY 28 DAY CYCLE", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Acute myeloid leukaemia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "VENETOCLAX" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 2, "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": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25952932 Type 1
Non-Serious
NURTEC ODT
Report Version
2
Receive Date
10/23/2025
Receipt Date
10/28/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-PFIZER INC-202500208499
Authority Number
--
Sender Organization
PFIZER
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
76.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Brain fog (v28.1) Unknown

Drugs (1)

NURTEC ODT (RIMEGEPANT SULFATE) Suspect
Route: 048 | Dosage: 1 DF, EVERY OTHER DAY | Form: Orodispersible tablet | Indication: -- | Action: Unknown
Auth#: 212728 | Batch#: 6089463 | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435dd3b3830196fa59f6d", "safetyreportid": "25952932", "authoritynumb": null, "companynumb": "US-PFIZER INC-202500208499", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 76.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Brain fog", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "NURTEC ODT", "drugauthorizationnumb": "212728", "drugbatchnumb": "6089463", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DF, EVERY OTHER DAY", "drugdosageform": "Orodispersible tablet", "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "RIMEGEPANT SULFATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 2, "sender": { "sendertype": 6, "senderorganization": "PFIZER" }, "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" }
25952671 Type 1
Serious
ABILIFY, ABILIFY, CLOZAPINE (+1 more)
Report Version
2
Receive Date
10/23/2025
Receipt Date
10/28/2025
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-AEMPS-1760810
Sender Organization
OTSUKA
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
41.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Neuroleptic malignant syndrome (v28.1) Fatal

Drugs (4)

ABILIFY (ARIPIPRAZOLE) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Psychotic disorder | Action: Not Applicable
Auth#: 021436 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: 4
Recurrences: --
ABILIFY (ARIPIPRAZOLE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Delusion | Action: Not Applicable
Auth#: 021436 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: 4
Recurrences: --
CLOZAPINE (CLOZAPINE) Suspect
Route: -- | Dosage: 3 DF, QD (3 TABLETS EVERY 24 HOURS) | Form: -- | Indication: Psychotic disorder | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 3.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
CLOZAPINE (CLOZAPINE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Delusion | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250913

Report Duplicates (1)

AEMPS: EU-AEMPS-1760810

Raw JSON (click to expand)

{ "_id": "69d435dd3b3830196fa59f14", "safetyreportid": "25952671", "authoritynumb": "EU-AEMPS-1760810", "companynumb": null, "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 41.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neuroleptic malignant syndrome", "reactionoutcome": 5 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ABILIFY", "drugauthorizationnumb": "021436", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Psychotic disorder", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ARIPIPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ABILIFY", "drugauthorizationnumb": "021436", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Delusion", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ARIPIPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CLOZAPINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 3.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "3 DF, QD (3 TABLETS EVERY 24 HOURS)", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Psychotic disorder", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "CLOZAPINE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CLOZAPINE", "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": "Delusion", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "CLOZAPINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250913" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "AEMPS", "duplicatenumb": "EU-AEMPS-1760810" } ], "reporttype": 1, "safetyreportversion": 2, "sender": { "sendertype": 6, "senderorganization": "OTSUKA" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25950579 Type 1
Serious
KISQALI, KISQALI, FEMARA (+1 more)
Report Version
2
Receive Date
10/23/2025
Receipt Date
10/28/2025
Transmission Date
01/18/2026
Primary Source Country
RS
Occurrence Country
RS
Reporter Country
RS
Reporter Qualification
Physician
Literature Reference
--
Company Number
RS-002147023-NVSC2025RS159257
Authority Number
--
Sender Organization
NOVARTIS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
33.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (6)

Death (v28.1) Fatal
Metastases to liver (v28.1) Unknown
Metastases to meninges (v28.1) Unknown
Malignant neoplasm progression (v28.1) Unknown
Mastoiditis (v28.1) Unknown
Breast cancer metastatic (v28.1) Unknown

Drugs (4)

KISQALI (RIBOCICLIB SUCCINATE) Suspect
Route: 065 | Dosage: UNK | Form: Film-coated tablet | Indication: Breast cancer metastatic | Action: Not Applicable
Auth#: 209092 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2021 | End: 11/01/2021 | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
KISQALI (RIBOCICLIB SUCCINATE) Suspect
Route: 065 | Dosage: UNK | Form: Film-coated tablet | Indication: -- | Action: Not Applicable
Auth#: 209092 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/06/2022 | End: 12/01/2022 | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
FEMARA (LETROZOLE) Suspect
Route: 065 | Dosage: UNK | Form: Film-coated tablet | Indication: Breast cancer metastatic | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2021 | End: 11/01/2021 | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
FASLODEX (FULVESTRANT) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/06/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20210301

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435dc3b3830196fa59e70", "safetyreportid": "25950579", "authoritynumb": null, "companynumb": "RS-002147023-NVSC2025RS159257", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "RS", "patient": { "patientonsetage": 33.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Death", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Metastases to liver", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Metastases to meninges", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Malignant neoplasm progression", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Mastoiditis", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Breast cancer metastatic", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "KISQALI", "drugauthorizationnumb": "209092", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Film-coated tablet", "drugadministrationroute": "065", "drugindication": "Breast cancer metastatic", "drugstartdateformat": "610", "drugstartdate": "2021-01-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2021-11-01T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "RIBOCICLIB SUCCINATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "KISQALI", "drugauthorizationnumb": "209092", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Film-coated tablet", "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2022-07-06T00:00:00", "drugenddateformat": "610", "drugenddate": "2022-12-01T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "RIBOCICLIB SUCCINATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FEMARA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Film-coated tablet", "drugadministrationroute": "065", "drugindication": "Breast cancer metastatic", "drugstartdateformat": "610", "drugstartdate": "2021-01-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2021-11-01T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "LETROZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FASLODEX", "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": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2022-07-06T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FULVESTRANT" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20210301" }, "primarysource": { "reportercountry": "RS", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "RS", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 2, "sender": { "sendertype": 6, "senderorganization": "NOVARTIS" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25951226 Type 2
Serious
ISTURISA, ATORVASTATIN CALCIUM, COLACE (+8 more)
Report Version
2
Receive Date
10/23/2025
Receipt Date
10/28/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-RECORDATI RARE DISEASE INC.-2025007485
Authority Number
--
Sender Organization
RECORDATI
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
76.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
79.773 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Death (v28.1) Fatal

Drugs (11)

ISTURISA (OSILODROSTAT PHOSPHATE) Suspect
Route: 048 | Dosage: 2 MG, BID, TABLET | Form: TABLET, FILM COATED | Indication: Ectopic ACTH syndrome | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 2.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/01/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM) Concomitant
Route: 048 | Dosage: 40 MG, QD, TABLET | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/10/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
COLACE (DOCUSATE SODIUM) Concomitant
Route: 048 | Dosage: 100 MG, QD, CAPSULE | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/10/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
LISINOPRIL (LISINOPRIL) Concomitant
Route: 048 | Dosage: 10 MG, QD, TABLET | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/10/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
MINERALS\VITAMINS (MINERALS\VITAMINS) Concomitant
Route: 048 | Dosage: 1 TABLET, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/10/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
BUMETANIDE (BUMETANIDE) Concomitant
Route: 048 | Dosage: 1 MG, QD, TABLET | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 09/03/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
LANTUS (INSULIN GLARGINE) Concomitant
Route: 058 | Dosage: 100 UNIT/ML, DAILY, SOLUTION | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/10/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: 500 MG, BID, TABLET | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 2.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 09/10/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
METOPROLOL SUCCINATE (METOPROLOL SUCCINATE) Concomitant
Route: 048 | Dosage: 100 MG, DAILY, TABLET ER | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/10/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) Concomitant
Route: 048 | Dosage: 10 MILLIEQUIVALENT, DAILY, ER TABLET | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/10/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
SPIRONOLACTONE (SPIRONOLACTONE) Concomitant
Route: 048 | Dosage: 25 MG, QD, TABLET | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 09/10/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251014

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435db3b3830196fa59d72", "safetyreportid": "25951226", "authoritynumb": null, "companynumb": "US-RECORDATI RARE DISEASE INC.-2025007485", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 76.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 79.773, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Death", "reactionoutcome": 5 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ISTURISA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 2.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2 MG, BID, TABLET", "drugdosageform": "TABLET, FILM COATED", "drugadministrationroute": "048", "drugindication": "Ectopic ACTH syndrome", "drugstartdateformat": "610", "drugstartdate": "2025-10-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "OSILODROSTAT PHOSPHATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ATORVASTATIN CALCIUM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "40 MG, QD, TABLET", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2024-10-10T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ATORVASTATIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "COLACE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 MG, QD, CAPSULE", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2024-10-10T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "DOCUSATE SODIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LISINOPRIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10 MG, QD, TABLET", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2024-10-10T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "LISINOPRIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MINERALS\\VITAMINS", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 TABLET, DAILY", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2024-10-10T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "MINERALS\\VITAMINS" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "BUMETANIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 MG, QD, TABLET", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2025-09-03T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "BUMETANIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LANTUS", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 UNIT/ML, DAILY, SOLUTION", "drugdosageform": null, "drugadministrationroute": "058", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2025-09-10T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "INSULIN GLARGINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "METFORMIN HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 2.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "500 MG, BID, TABLET", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2025-09-10T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METFORMIN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "METOPROLOL SUCCINATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 MG, DAILY, TABLET ER", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2025-09-10T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "METOPROLOL SUCCINATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "POTASSIUM CHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10 MILLIEQUIVALENT, DAILY, ER TABLET", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2025-09-10T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "POTASSIUM CHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SPIRONOLACTONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "25 MG, QD, TABLET", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2025-09-10T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "SPIRONOLACTONE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251014" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 2, "sender": { "sendertype": 6, "senderorganization": "RECORDATI" }, "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" }
25953628 Type 1
Serious
LORAZEPAM, LORAZEPAM, LORAZEPAM (+1 more)
Report Version
3
Receive Date
10/23/2025
Receipt Date
10/28/2025
Transmission Date
01/19/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
Shyy, W.. Benzodiazepine-Induced Acute Psychosis Leading to Self-Enucleation and Auto-Cannibalism. Cureus. 2025;17(9):e92000
Company Number
US-PFIZER INC-PV202500124018
Authority Number
--
Sender Organization
PFIZER
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
62.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Substance-induced psychotic disorder (v28.1) Recovered

Drugs (4)

LORAZEPAM (LORAZEPAM) Suspect
Route: 042 | Dosage: 1 MG, AT 6 P.M. | Form: -- | Indication: Anxiety | Action: Unknown
Auth#: 074243 | Batch#: -- | Structured Dosage: 1.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
LORAZEPAM (LORAZEPAM) Suspect
Route: 042 | Dosage: 2 MG, AT 7 A.M. | Form: -- | Indication: Claustrophobia | Action: Unknown
Auth#: 074243 | Batch#: -- | Structured Dosage: 2.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
LORAZEPAM (LORAZEPAM) Suspect
Route: 042 | Dosage: 1 MG, AFTER 10:20 AM | Form: -- | Indication: -- | Action: Unknown
Auth#: 074243 | Batch#: -- | Structured Dosage: 1.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
HYDROMORPHONE (HYDROMORPHONE) Concomitant
Route: 042 | Dosage: 1 MG (THREE DOSES, OVER A 10-HOUR PERIOD) | Form: -- | Indication: Pain management | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 10.0 hr | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

MLMSERVICE: US-MLMSERVICE-20251015-PI678062-00206-1

Raw JSON (click to expand)

{ "_id": "69d435db3b3830196fa59d1b", "safetyreportid": "25953628", "authoritynumb": null, "companynumb": "US-PFIZER INC-PV202500124018", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 62.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Substance-induced psychotic disorder", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "LORAZEPAM", "drugauthorizationnumb": "074243", "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 MG, AT 6 P.M.", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Anxiety", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LORAZEPAM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LORAZEPAM", "drugauthorizationnumb": "074243", "drugbatchnumb": null, "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2 MG, AT 7 A.M.", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Claustrophobia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LORAZEPAM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LORAZEPAM", "drugauthorizationnumb": "074243", "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 MG, AFTER 10:20 AM", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LORAZEPAM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "HYDROMORPHONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 MG (THREE DOSES, OVER A 10-HOUR PERIOD)", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Pain management", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 10.0, "drugtreatmentdurationunit": 805, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "HYDROMORPHONE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": "Shyy, W.. Benzodiazepine-Induced Acute Psychosis Leading to Self-Enucleation and Auto-Cannibalism. Cureus. 2025;17(9):e92000" }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "MLMSERVICE", "duplicatenumb": "US-MLMSERVICE-20251015-PI678062-00206-1" } ], "reporttype": 1, "safetyreportversion": 3, "sender": { "sendertype": 6, "senderorganization": "PFIZER" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 1, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-19T00:00:00", "transmissiondateformat": "102" }
25954104 Type 2
Serious
EPIDIOLEX, ACETAMINOPHEN, LAMICTAL (+32 more)
Report Version
2
Receive Date
10/23/2025
Receipt Date
10/28/2025
Transmission Date
01/19/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-JAZZ PHARMACEUTICALS-2025-US-024249
Authority Number
--
Sender Organization
JAZZ
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
64.6 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Atypical pneumonia (v28.1) Not Recovered

Drugs (35)

EPIDIOLEX (CANNABIDIOL) Suspect
Route: -- | Dosage: 6 MILLILITER (600 MILLIGRAM), BID, VIA G-TUBE | Form: Oral solution | Indication: Lennox-Gastaut syndrome | Action: Unknown
Auth#: 210365 | Batch#: W006788 | Structured Dosage: 6.0 (unit: 012) | Separate Dosage#: 1.0 | Interval: 12.0 hr | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
ACETAMINOPHEN (ACETAMINOPHEN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LAMICTAL (LAMOTRIGINE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CUVITRU (HUMAN IMMUNOGLOBULIN G) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LIDOCAINE (LIDOCAINE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MEDIUM-CHAIN TRIGLYCERIDES (MEDIUM-CHAIN TRIGLYCERIDES) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SODIUM CHLORIDE (SODIUM CHLORIDE) Concomitant
Route: -- | Dosage: UNK | Form: Nebuliser solution | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CLONAZEPAM (CLONAZEPAM) Concomitant
Route: -- | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
BANZEL (RUFINAMIDE) Concomitant
Route: -- | Dosage: -- | Form: Suspension | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MIDAZOLAM (MIDAZOLAM) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EPINEPHRINE (EPINEPHRINE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ATROVENT (IPRATROPIUM BROMIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MIRALAX (POLYETHYLENE GLYCOL 3350) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
XOPENEX (LEVALBUTEROL HYDROCHLORIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
DIETARY SUPPLEMENT (DIETARY SUPPLEMENT) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MINERALS\VITAMINS (MINERALS\VITAMINS) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SODIUM CHLORIDE (SODIUM CHLORIDE) Concomitant
Route: -- | Dosage: UNK | Form: Nebuliser solution | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
AMOXICILLIN (AMOXICILLIN) Concomitant
Route: -- | Dosage: UNK | Form: Capsule | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ALBUTEROL SULFATE (ALBUTEROL SULFATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ADVAIR HFA (FLUTICASONE PROPIONATE\SALMETEROL XINAFOATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MOMETASONE FUROATE (MOMETASONE FUROATE) Concomitant
Route: -- | Dosage: -- | Form: Cream | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CLONIDINE HYDROCHLORIDE (CLONIDINE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
RUFINAMIDE (RUFINAMIDE) Concomitant
Route: -- | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
DIVALPROEX SODIUM (DIVALPROEX SODIUM) Concomitant
Route: -- | Dosage: -- | Form: Capsule | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MUPIROCIN (MUPIROCIN) Concomitant
Route: -- | Dosage: -- | Form: Ointment | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
GAMUNEX-C (HUMAN IMMUNOGLOBULIN G) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
BACITRACIN ZINC (--) Concomitant
Route: -- | Dosage: -- | Form: Ointment | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
NYSTATIN (NYSTATIN) Concomitant
Route: -- | Dosage: -- | Form: Cream | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
NAYZILAM (MIDAZOLAM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VALPROIC ACID (VALPROIC ACID) Concomitant
Route: -- | Dosage: -- | Form: Solution | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
BRIVIACT (BRIVARACETAM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CARNITOR (LEVOCARNITINE) Concomitant
Route: -- | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PEDIASURE [CARBOHYDRATES NOS;FATS NOS;MINERALS NOS;PROTEIN;VITAMINS NO (--) Concomitant
Route: -- | Dosage: -- | Form: Solution | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EPIPEN (EPINEPHRINE) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435da3b3830196fa59cc8", "safetyreportid": "25954104", "authoritynumb": null, "companynumb": "US-JAZZ PHARMACEUTICALS-2025-US-024249", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": 64.6, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Atypical pneumonia", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "EPIDIOLEX", "drugauthorizationnumb": "210365", "drugbatchnumb": "W006788", "drugstructuredosagenumb": 6.0, "drugstructuredosageunit": "012", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 12.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "6 MILLILITER (600 MILLIGRAM), BID, VIA G-TUBE", "drugdosageform": "Oral solution", "drugadministrationroute": null, "drugindication": 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"drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LEVOCARNITINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PEDIASURE [CARBOHYDRATES NOS;FATS NOS;MINERALS NOS;PROTEIN;VITAMINS NO", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution", "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "EPIPEN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "EPINEPHRINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 2, "sender": { "sendertype": 6, "senderorganization": "JAZZ" }, "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" }
25953211 Type 2
Serious
METHOTREXATE SODIUM, METHOTREXATE SODIUM, ERELZI (+27 more)
Report Version
2
Receive Date
10/23/2025
Receipt Date
10/28/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
EU-SANDOZ-SDZ2024DE021345
Authority Number
--
Sender Organization
PFIZER
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (13)

Hypertensive crisis (v28.1) Recovered
Cataract (v28.1) Recovered
Low density lipoprotein increased (v28.1) Recovered
Hip arthroplasty (v28.1) Recovered
Depression (v28.1) Unknown
Left ventricular dysfunction (v28.1) Recovered
Aortic valve disease mixed (v28.1) Unknown
Cardiac failure (v28.1) Unknown
COVID-19 (v28.1) Recovered
Folate deficiency (v28.1) Recovered
Asthma (v28.1) Unknown
Periodontitis (v28.1) Recovered
Urinary tract infection (v28.1) Unknown

Drugs (30)

METHOTREXATE SODIUM (METHOTREXATE SODIUM) Suspect
Route: 065 | Dosage: MTX 5.0 | Form: -- | Indication: -- | Action: Unknown
Auth#: 011719 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
METHOTREXATE SODIUM (METHOTREXATE SODIUM) Suspect
Route: 065 | Dosage: MTX 10.0 | Form: -- | Indication: -- | Action: Unknown
Auth#: 011719 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ERELZI (ETANERCEPT-SZZS) Suspect
Route: 065 | Dosage: 50 MG | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 50.0 (unit: 003)
Start: 03/01/2018 | End: 01/01/2019 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ERELZI (ETANERCEPT-SZZS) Suspect
Route: 065 | Dosage: 50 MG | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 50.0 (unit: 003)
Start: 02/01/2019 | End: 05/01/2019 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ERELZI (ETANERCEPT-SZZS) Suspect
Route: 065 | Dosage: 50 MG | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 50.0 (unit: 003)
Start: 06/01/2019 | End: 05/01/2020 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ERELZI (ETANERCEPT-SZZS) Suspect
Route: 065 | Dosage: 50 MG | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 50.0 (unit: 003)
Start: 07/01/2020 | End: 05/01/2021 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ERELZI (ETANERCEPT-SZZS) Suspect
Route: 065 | Dosage: 50 MG | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 50.0 (unit: 003)
Start: 06/01/2021 | End: 02/01/2023 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ERELZI (ETANERCEPT-SZZS) Suspect
Route: 065 | Dosage: 50 MG | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 50.0 (unit: 003)
Start: 03/01/2022 | End: 06/01/2022 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ERELZI (ETANERCEPT-SZZS) Suspect
Route: 065 | Dosage: 50 MG | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 50.0 (unit: 003)
Start: 08/10/2022 | End: 06/01/2023 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ERELZI (ETANERCEPT-SZZS) Suspect
Route: 065 | Dosage: 50 MG | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 50.0 (unit: 003)
Start: 08/22/2023 | End: 10/01/2023 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ERELZI (ETANERCEPT-SZZS) Suspect
Route: 065 | Dosage: 50 MG, QW | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 wk | Cumulative: 50.0 (unit: 003)
Start: -- | End: 10/17/2023 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ERELZI (ETANERCEPT-SZZS) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 50.0 (unit: 003)
Start: 12/05/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ERELZI (ETANERCEPT-SZZS) Suspect
Route: 042 | Dosage: 50MG/EVERY 7 DAYS | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 50.0 (unit: 003)
Start: -- | End: 12/03/2024 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ERELZI (ETANERCEPT-SZZS) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 50.0 (unit: 003)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ORENCIA (ABATACEPT) Suspect
Route: 065 | Dosage: 1000 MG, Q4W (1000MG /ALL 4 WEEKS) | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1000.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/10/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
APIXABAN (APIXABAN) Concomitant
Route: 065 | Dosage: 5 MG | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
METOPROLOL (METOPROLOL) Concomitant
Route: 065 | Dosage: 47.5 MG | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 47.5 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
RAMIPRIL (RAMIPRIL) Concomitant
Route: 065 | Dosage: 5 MG | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ATORVASTATIN (ATORVASTATIN) Concomitant
Route: 065 | Dosage: 40 MG | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PANTOPRAZOLE (PANTOPRAZOLE) Concomitant
Route: 065 | Dosage: 40 MG | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VITAMIN D3 (CHOLECALCIFEROL) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FOLIC ACID (FOLIC ACID) Concomitant
Route: 065 | Dosage: 5 MG | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PIRETANIDE (PIRETANIDE) Concomitant
Route: 065 | Dosage: 6 MG | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 6.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PREDNISONE (PREDNISONE) Concomitant
Route: 065 | Dosage: 5 MG | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PREDNISONE (PREDNISONE) Concomitant
Route: 065 | Dosage: 1 MG | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FEBUXOSTAT (FEBUXOSTAT) Concomitant
Route: 065 | Dosage: 80 MG | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 80.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
TRAMADOL (TRAMADOL) Concomitant
Route: 065 | Dosage: 100 MG | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
NOVALGIN (METAMIZOLE SODIUM) (METAMIZOLE SODIUM) Concomitant
Route: 065 | Dosage: 500 MG | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ZOPICLONE (ZOPICLONE) Concomitant
Route: 065 | Dosage: 7.5 MG | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 7.5 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
AMITRIPTYLINE (AMITRIPTYLINE) Concomitant
Route: 065 | Dosage: 10 MG | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20220815

Report Duplicates (1)

SANDOZ: EU-SANDOZ-SDZ2024DE021345

Raw JSON (click to expand)

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"28.1", "reactionmeddrapt": "Aortic valve disease mixed", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Cardiac failure", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "COVID-19", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Folate deficiency", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Asthma", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Periodontitis", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Urinary tract infection", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "METHOTREXATE SODIUM", "drugauthorizationnumb": "011719", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "MTX 5.0", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "METHOTREXATE SODIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METHOTREXATE SODIUM", "drugauthorizationnumb": "011719", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "MTX 10.0", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, 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"drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ETANERCEPT-SZZS" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ERELZI", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 50.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": 50.0, "drugcumulativedosageunit": "003", "drugdosagetext": "50 MG", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": "610", "drugstartdate": "2019-02-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2019-05-01T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ETANERCEPT-SZZS" }, "drugrecurrence": [] }, { 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"drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "AMITRIPTYLINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20220815" }, "primarysource": { "reportercountry": "EU", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "SANDOZ", "duplicatenumb": "EU-SANDOZ-SDZ2024DE021345" } ], "reporttype": 2, "safetyreportversion": 2, "sender": { "sendertype": 6, "senderorganization": "PFIZER" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }