FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25958124 Type 1
Serious
PAROXETINE, CANNABIS SATIVA FLOWERING TOP, LEVOTHYROXINE
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
--
Authority Number
EU-AFSSAPS-AVLY2025000340
Sender Organization
MYLAN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
1.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (6)

Alloimmunisation (v28.1) Fatal
Anaemia neonatal (v28.1) Fatal
Cardiogenic shock (v28.1) Fatal
Neonatal seizure (v28.1) Fatal
Foetal growth restriction (v28.1) Recovered
Foetal exposure during pregnancy (v28.1) Recovered

Drugs (3)

PAROXETINE (PAROXETINE) Suspect
Route: -- | Dosage: 20 MILLIGRAM (THROUGHOUT THE PREGNANCY) | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 078902 | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
CANNABIS SATIVA FLOWERING TOP (CANNABIS SATIVA FLOWERING TOP) Suspect
Route: -- | Dosage: UNK, QD (3-4 JOINTS/DAY AT THE BEGINNING OF PREGNANCY THEN 1-2/DAY AT THE END OF PREGNANCY) | 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: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
LEVOTHYROXINE (LEVOTHYROXINE) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435a33b3830196fa56a11", "safetyreportid": "25958124", "authoritynumb": "EU-AFSSAPS-AVLY2025000340", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 1.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Alloimmunisation", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Anaemia neonatal", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Cardiogenic shock", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neonatal seizure", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Foetal growth restriction", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Foetal exposure during pregnancy", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "PAROXETINE", "drugauthorizationnumb": "078902", "drugbatchnumb": null, "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "20 MILLIGRAM (THROUGHOUT THE PREGNANCY)", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "PAROXETINE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CANNABIS SATIVA FLOWERING TOP", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK, QD (3-4 JOINTS/DAY AT THE BEGINNING OF PREGNANCY THEN 1-2/DAY AT THE END OF PREGNANCY)", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "CANNABIS SATIVA FLOWERING TOP" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEVOTHYROXINE", "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": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "LEVOTHYROXINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "MYLAN" }, "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" }
25958120 Type 1
Serious
TAMSULOSIN, ATORVASTATIN, TAMSULOSIN HYDROCHLORIDE (+5 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
GB
Occurrence Country
GB
Reporter Country
GB
Reporter Qualification
Pharmacist
Literature Reference
--
Company Number
GB-MHRA-TPP16888806C6309982YC1760531298476
Authority Number
--
Sender Organization
TEVA
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
60.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
76.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Erectile dysfunction (v28.1) Recovered

Drugs (8)

TAMSULOSIN (TAMSULOSIN) Suspect
Route: 065 | Dosage: -- | Form: Modified-release capsule, hard | Indication: Ill-defined disorder | Action: Unknown
Auth#: 077630 | Batch#: UNKNOWN | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/15/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ATORVASTATIN (ATORVASTATIN) Concomitant
Route: -- | Dosage: AT NIGHT | Form: -- | Indication: Ill-defined disorder | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 338.0 (unit: 032)
Start: 11/12/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN HYDROCHLORIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Ill-defined disorder | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 262.0 (unit: 032)
Start: 01/27/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MIRABEGRON (MIRABEGRON) Concomitant
Route: -- | Dosage: AROUND TEATIME | Form: -- | Indication: Ill-defined disorder | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 248.0 (unit: 032)
Start: 02/10/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FEBUXOSTAT (FEBUXOSTAT) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Ill-defined disorder | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 338.0 (unit: 032)
Start: 11/12/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
BISOPROLOL (BISOPROLOL) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Ill-defined disorder | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 338.0 (unit: 032)
Start: 11/12/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
AMLODIPINE (AMLODIPINE BESYLATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Ill-defined disorder | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 338.0 (unit: 032)
Start: 11/12/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LANSOPRAZOLE (LANSOPRAZOLE) Concomitant
Route: -- | Dosage: WITH FOOD | Form: -- | Indication: Ill-defined disorder | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 338.0 (unit: 032)
Start: 11/12/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251015

Report Duplicates (1)

MHRAUK: GB-MHRA-TPP16888806C6309982YC1760531298476

Raw JSON (click to expand)

{ "_id": "69d435a33b3830196fa56a0e", "safetyreportid": "25958120", "authoritynumb": null, "companynumb": "GB-MHRA-TPP16888806C6309982YC1760531298476", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "GB", "patient": { "patientonsetage": 60.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 76.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Erectile dysfunction", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TAMSULOSIN", "drugauthorizationnumb": "077630", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Modified-release capsule, hard", "drugadministrationroute": "065", "drugindication": "Ill-defined disorder", "drugstartdateformat": "102", "drugstartdate": "2025-10-15T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TAMSULOSIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ATORVASTATIN", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 338.0, "drugcumulativedosageunit": "032", "drugdosagetext": "AT NIGHT", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Ill-defined disorder", "drugstartdateformat": "102", "drugstartdate": "2024-11-12T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ATORVASTATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TAMSULOSIN HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 262.0, "drugcumulativedosageunit": "032", "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Ill-defined disorder", "drugstartdateformat": "102", "drugstartdate": "2025-01-27T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "TAMSULOSIN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MIRABEGRON", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 248.0, "drugcumulativedosageunit": "032", "drugdosagetext": "AROUND TEATIME", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Ill-defined disorder", "drugstartdateformat": "102", "drugstartdate": "2025-02-10T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "MIRABEGRON" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FEBUXOSTAT", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 338.0, "drugcumulativedosageunit": "032", "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Ill-defined disorder", "drugstartdateformat": "102", "drugstartdate": "2024-11-12T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "FEBUXOSTAT" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "BISOPROLOL", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 338.0, "drugcumulativedosageunit": "032", "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Ill-defined disorder", "drugstartdateformat": "102", "drugstartdate": "2024-11-12T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "BISOPROLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "AMLODIPINE", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 338.0, "drugcumulativedosageunit": "032", "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Ill-defined disorder", "drugstartdateformat": "102", "drugstartdate": "2024-11-12T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "AMLODIPINE BESYLATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LANSOPRAZOLE", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 338.0, "drugcumulativedosageunit": "032", "drugdosagetext": "WITH FOOD", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Ill-defined disorder", "drugstartdateformat": "102", "drugstartdate": "2024-11-12T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LANSOPRAZOLE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251015" }, "primarysource": { "reportercountry": "GB", "qualification": 2, "literaturereference": null }, "primarysourcecountry": "GB", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "MHRAUK", "duplicatenumb": "GB-MHRA-TPP16888806C6309982YC1760531298476" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "TEVA" }, "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" }
25958122 Type 3
Serious
OGIVRI, OGIVRI, PERJETA (+3 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
--
Authority Number
EU-MINISAL02-1060818
Sender Organization
BIOCON
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
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Pulmonary oedema (v28.1) Recovering
Cardiac failure acute (v28.1) Recovering
Body temperature increased (v28.1) Recovered

Drugs (6)

OGIVRI (TRASTUZUMAB-DKST) Suspect
Route: 042 | Dosage: 306 MILLIGRAM (SOLUTION FOR INJECTION) | Form: Unknown | Indication: Breast cancer metastatic | Action: Withdrawn
Auth#: 761074 | Batch#: -- | Structured Dosage: 306.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/05/2025 | End: 08/05/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
OGIVRI (TRASTUZUMAB-DKST) Suspect
Route: 042 | Dosage: 306 MILLIGRAM (SOLUTION FOR INJECTION) | Form: Unknown | Indication: -- | Action: Withdrawn
Auth#: 761074 | Batch#: 7802378 | Structured Dosage: 306.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/26/2025 | End: 08/26/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
PERJETA (PERTUZUMAB) Suspect
Route: 042 | Dosage: 420 MILLIGRAM | Form: Solution for injection | Indication: Breast cancer metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 420.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/05/2025 | End: 08/05/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
PERJETA (PERTUZUMAB) Suspect
Route: 042 | Dosage: 420 MILLIGRAM | Form: Solution for injection | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: 30046973 | Structured Dosage: 420.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/26/2025 | End: 08/26/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
PACLITAXEL (PACLITAXEL) Suspect
Route: 042 | Dosage: 260 MILLIGRAM | Form: Solution for injection | Indication: Breast cancer metastatic | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 260.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/05/2025 | End: 08/05/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
PACLITAXEL (PACLITAXEL) Suspect
Route: 042 | Dosage: 260 MILLIGRAM | Form: Solution for injection | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: 10000912 | Structured Dosage: 260.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/26/2025 | End: 08/26/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250904

Report Duplicates (1)

MINISAL02: EU-MINISAL02-1060818

Raw JSON (click to expand)

{ "_id": "69d435a33b3830196fa56a0d", "safetyreportid": "25958122", "authoritynumb": "EU-MINISAL02-1060818", "companynumb": null, "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pulmonary oedema", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Cardiac failure acute", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Body temperature increased", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "OGIVRI", "drugauthorizationnumb": "761074", "drugbatchnumb": null, "drugstructuredosagenumb": 306.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "306 MILLIGRAM (SOLUTION FOR INJECTION)", "drugdosageform": "Unknown", "drugadministrationroute": "042", "drugindication": "Breast cancer metastatic", "drugstartdateformat": "102", "drugstartdate": "2025-08-05T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-05T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "TRASTUZUMAB-DKST" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "OGIVRI", "drugauthorizationnumb": "761074", "drugbatchnumb": "7802378", "drugstructuredosagenumb": 306.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "306 MILLIGRAM (SOLUTION FOR INJECTION)", "drugdosageform": "Unknown", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-08-26T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-26T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "TRASTUZUMAB-DKST" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PERJETA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 420.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "420 MILLIGRAM", "drugdosageform": "Solution for injection", "drugadministrationroute": "042", "drugindication": "Breast cancer metastatic", "drugstartdateformat": "102", "drugstartdate": "2025-08-05T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-05T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "PERTUZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PERJETA", "drugauthorizationnumb": null, "drugbatchnumb": "30046973", "drugstructuredosagenumb": 420.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "420 MILLIGRAM", "drugdosageform": "Solution for injection", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-08-26T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-26T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "PERTUZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PACLITAXEL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 260.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "260 MILLIGRAM", "drugdosageform": "Solution for injection", "drugadministrationroute": "042", "drugindication": "Breast cancer metastatic", "drugstartdateformat": "102", "drugstartdate": "2025-08-05T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-05T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "PACLITAXEL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PACLITAXEL", "drugauthorizationnumb": null, "drugbatchnumb": "10000912", "drugstructuredosagenumb": 260.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "260 MILLIGRAM", "drugdosageform": "Solution for injection", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-08-26T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-26T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "PACLITAXEL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250904" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "MINISAL02", "duplicatenumb": "EU-MINISAL02-1060818" } ], "reporttype": 3, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BIOCON" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25958121 Type 1
Serious
SELEXIPAG
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
JP
Occurrence Country
JP
Reporter Country
JP
Reporter Qualification
Physician
Literature Reference
--
Company Number
JP-NShinyaku-EVA20251408501001307081
Authority Number
--
Sender Organization
JOHNSON AND JOHNSON
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
78.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Physical deconditioning (v28.1) Unknown

Drugs (1)

SELEXIPAG (SELEXIPAG) Suspect
Route: 048 | Dosage: -- | Form: Tablet | Indication: Pulmonary arterial hypertension | Action: Dose Not Changed
Auth#: 207947 | Batch#: Asked But Unknown | Structured Dosage: 1.2 (unit: 003) | Separate Dosage#: 1.0 | Interval: 24.0 hr | Cumulative: -- (unit: --)
Start: 07/23/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251008

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435a33b3830196fa56a0c", "safetyreportid": "25958121", "authoritynumb": null, "companynumb": "JP-NShinyaku-EVA20251408501001307081", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "JP", "patient": { "patientonsetage": 78.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Physical deconditioning", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "SELEXIPAG", "drugauthorizationnumb": "207947", "drugbatchnumb": "Asked But Unknown", "drugstructuredosagenumb": 1.2, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 24.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Pulmonary arterial hypertension", "drugstartdateformat": "102", "drugstartdate": "2025-07-23T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "SELEXIPAG" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251008" }, "primarysource": { "reportercountry": "JP", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "JP", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "JOHNSON AND JOHNSON" }, "serious": 1, "seriousnesscongenitalanomali": null, "seriousnessdeath": null, "seriousnessdisabling": null, "seriousnesshospitalization": 1, "seriousnesslifethreatening": null, "seriousnessother": null, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25958118 Type 1
Serious
OZEMPIC
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-NOVOPROD-1544919
Authority Number
--
Sender Organization
NOVO NORDISK
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
49.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Uterine leiomyoma (v28.1) Recovered
Depression (v28.1) Unknown

Drugs (1)

OZEMPIC (SEMAGLUTIDE) Suspect
Route: -- | Dosage: 0.5 MG, QW | Form: Solution for injection | Indication: Type 2 diabetes mellitus | Action: Dose Not Changed
Auth#: 209637 | Batch#: -- | Structured Dosage: 0.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 wk | Cumulative: -- (unit: --)
Start: 01/01/2019 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20190101

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435a33b3830196fa56a08", "safetyreportid": "25958118", "authoritynumb": null, "companynumb": "US-NOVOPROD-1544919", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 49.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Uterine leiomyoma", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Depression", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "OZEMPIC", "drugauthorizationnumb": "209637", "drugbatchnumb": null, "drugstructuredosagenumb": 0.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "0.5 MG, QW", "drugdosageform": "Solution for injection", "drugadministrationroute": null, "drugindication": "Type 2 diabetes mellitus", "drugstartdateformat": "602", "drugstartdate": "2019-01-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "SEMAGLUTIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20190101" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "NOVO NORDISK" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25958119 Type 1
Serious
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL (+49 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Other Health Professional
Literature Reference
Carattoli A, Fortini D, Galetti R, Garcia-Fernandez A, Nardi G, Orazi D et al. Isolation of NDM-1-producing Pseudomonas aeruginosa sequence type ST235 from a stem cell transplant patient in Italy, May 2013. Euro Surveill. 2013;18(46)
Company Number
EU-ADIENNEP-2024AD000045
Authority Number
--
Sender Organization
MYLAN
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
Adult
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (11)

Septic shock (v28.1) Fatal
Febrile neutropenia (v28.1) Fatal
Bone marrow failure (v28.1) Fatal
Anal abscess (v28.1) Fatal
Pseudomonal sepsis (v28.1) Fatal
Klebsiella infection (v28.1) Fatal
Enterococcal infection (v28.1) Unknown
Pyrexia (v28.1) Unknown
Bacterial infection (v28.1) Unknown
Neutropenia (v28.1) Unknown
Pseudomonas infection (v28.1) Unknown

Drugs (52)

MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Prophylaxis against graft versus host disease | Action: Not Applicable
Auth#: 065520 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: Graft versus host disease | Action: Not Applicable
Auth#: 065520 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 065520 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 065520 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
FLUDARABINE (FLUDARABINE PHOSPHATE) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Allogenic stem cell transplantation | Action: Not Applicable
Auth#: 200647 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
FLUDARABINE (FLUDARABINE PHOSPHATE) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: Bone marrow conditioning regimen | Action: Not Applicable
Auth#: 200647 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
FLUDARABINE (FLUDARABINE PHOSPHATE) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 200647 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
FLUDARABINE (FLUDARABINE PHOSPHATE) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: Not Applicable
Auth#: 200647 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
THIOTEPA (THIOTEPA) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Allogenic stem cell transplantation | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
THIOTEPA (THIOTEPA) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: Bone marrow conditioning regimen | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
THIOTEPA (THIOTEPA) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
THIOTEPA (THIOTEPA) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Prophylaxis against graft versus host disease | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
CYCLOSPORINE (CYCLOSPORINE) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Prophylaxis against graft versus host disease | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
CYCLOSPORINE (CYCLOSPORINE) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: Graft versus host disease | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
CYCLOSPORINE (CYCLOSPORINE) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
CYCLOSPORINE (CYCLOSPORINE) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
BUSULFAN (BUSULFAN) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Allogenic stem cell transplantation | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
BUSULFAN (BUSULFAN) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
BUSULFAN (BUSULFAN) Suspect
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
BUSULFAN (BUSULFAN) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
DAPTOMYCIN (DAPTOMYCIN) Concomitant
Route: -- | Dosage: 700 MILLIGRAM | Form: -- | Indication: Pseudomonas infection | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 700.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/12/2013 | End: 06/14/2013 | Duration: 3.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DAPTOMYCIN (DAPTOMYCIN) Concomitant
Route: 065 | Dosage: 700 MILLIGRAM | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 700.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/12/2013 | End: 06/14/2013 | Duration: 3.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DAPTOMYCIN (DAPTOMYCIN) Concomitant
Route: 065 | Dosage: 700 MILLIGRAM | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 700.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/12/2013 | End: 06/14/2013 | Duration: 3.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DAPTOMYCIN (DAPTOMYCIN) Concomitant
Route: -- | Dosage: 700 MILLIGRAM | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 700.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/12/2013 | End: 06/14/2013 | Duration: 3.0 day | Rechallenge: -- | Additional: --
Recurrences: --
RIFAMPIN (RIFAMPIN) Concomitant
Route: -- | Dosage: 600 MILLIGRAM | Form: -- | Indication: Pseudomonas infection | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/12/2013 | End: 06/14/2013 | Duration: 3.0 day | Rechallenge: -- | Additional: --
Recurrences: --
RIFAMPIN (RIFAMPIN) Concomitant
Route: 065 | Dosage: 600 MILLIGRAM | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/12/2013 | End: 06/14/2013 | Duration: 3.0 day | Rechallenge: -- | Additional: --
Recurrences: --
RIFAMPIN (RIFAMPIN) Concomitant
Route: 065 | Dosage: 600 MILLIGRAM | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/12/2013 | End: 06/14/2013 | Duration: 3.0 day | Rechallenge: -- | Additional: --
Recurrences: --
RIFAMPIN (RIFAMPIN) Concomitant
Route: -- | Dosage: 600 MILLIGRAM | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/12/2013 | End: 06/14/2013 | Duration: 3.0 day | Rechallenge: -- | Additional: --
Recurrences: --
TIGECYCLINE (TIGECYCLINE) Concomitant
Route: -- | Dosage: 200 MILLIGRAM | Form: -- | Indication: Pseudomonas infection | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/12/2013 | End: 06/14/2013 | Duration: 3.0 day | Rechallenge: -- | Additional: --
Recurrences: --
TIGECYCLINE (TIGECYCLINE) Concomitant
Route: 065 | Dosage: 200 MILLIGRAM | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/12/2013 | End: 06/14/2013 | Duration: 3.0 day | Rechallenge: -- | Additional: --
Recurrences: --
TIGECYCLINE (TIGECYCLINE) Concomitant
Route: 065 | Dosage: 200 MILLIGRAM | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/12/2013 | End: 06/14/2013 | Duration: 3.0 day | Rechallenge: -- | Additional: --
Recurrences: --
TIGECYCLINE (TIGECYCLINE) Concomitant
Route: -- | Dosage: 200 MILLIGRAM | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/12/2013 | End: 06/14/2013 | Duration: 3.0 day | Rechallenge: -- | Additional: --
Recurrences: --
COLISTIMETHATE SODIUM (COLISTIMETHATE SODIUM) Concomitant
Route: -- | Dosage: 9 MEGA-INTERNATIONAL UNIT | Form: -- | Indication: Klebsiella infection | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 9.0 (unit: 027) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/07/2013 | End: 06/14/2013 | Duration: 8.0 day | Rechallenge: -- | Additional: --
Recurrences: --
COLISTIMETHATE SODIUM (COLISTIMETHATE SODIUM) Concomitant
Route: 065 | Dosage: 9 MEGA-INTERNATIONAL UNIT | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 9.0 (unit: 027) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/07/2013 | End: 06/14/2013 | Duration: 8.0 day | Rechallenge: -- | Additional: --
Recurrences: --
COLISTIMETHATE SODIUM (COLISTIMETHATE SODIUM) Concomitant
Route: 065 | Dosage: 9 MEGA-INTERNATIONAL UNIT | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 9.0 (unit: 027) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/07/2013 | End: 06/14/2013 | Duration: 8.0 day | Rechallenge: -- | Additional: --
Recurrences: --
COLISTIMETHATE SODIUM (COLISTIMETHATE SODIUM) Concomitant
Route: -- | Dosage: 9 MEGA-INTERNATIONAL UNIT | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 9.0 (unit: 027) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/07/2013 | End: 06/14/2013 | Duration: 8.0 day | Rechallenge: -- | Additional: --
Recurrences: --
MEROPENEM (MEROPENEM) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: Febrile neutropenia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MEROPENEM (MEROPENEM) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MEROPENEM (MEROPENEM) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MEROPENEM (MEROPENEM) 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: --
AMIKACIN SULFATE (AMIKACIN SULFATE) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: Febrile neutropenia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/30/2013 | End: 06/14/2013 | Duration: 16.0 day | Rechallenge: -- | Additional: --
Recurrences: --
AMIKACIN SULFATE (AMIKACIN SULFATE) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/30/2013 | End: 06/14/2013 | Duration: 16.0 day | Rechallenge: -- | Additional: --
Recurrences: --
AMIKACIN SULFATE (AMIKACIN SULFATE) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/30/2013 | End: 06/14/2013 | Duration: 16.0 day | Rechallenge: -- | Additional: --
Recurrences: --
AMIKACIN SULFATE (AMIKACIN SULFATE) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/30/2013 | End: 06/14/2013 | Duration: 16.0 day | Rechallenge: -- | Additional: --
Recurrences: --
PIPERACILLIN SODIUM\TAZOBACTAM SODIUM (PIPERACILLIN SODIUM\TAZOBACTAM SODIUM) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: Febrile neutropenia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PIPERACILLIN SODIUM\TAZOBACTAM SODIUM (PIPERACILLIN SODIUM\TAZOBACTAM SODIUM) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PIPERACILLIN SODIUM\TAZOBACTAM SODIUM (PIPERACILLIN SODIUM\TAZOBACTAM SODIUM) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PIPERACILLIN SODIUM\TAZOBACTAM SODIUM (PIPERACILLIN SODIUM\TAZOBACTAM SODIUM) 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 (5)

EMA: EU-EMA-DD-20251015-7482701-105026
ADIENNEP: EU-ADIENNEP-2024AD000045
MINISAL02: EU-MINISAL02-261141
Case identifiers: 8679113
Case identifiers: 10016666215

Raw JSON (click to expand)

{ "_id": "69d435a33b3830196fa56a07", "safetyreportid": "25958119", "authoritynumb": null, "companynumb": "EU-ADIENNEP-2024AD000045", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 5, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Septic shock", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Febrile neutropenia", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Bone marrow failure", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Anal abscess", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pseudomonal sepsis", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Klebsiella infection", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Enterococcal infection", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pyrexia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Bacterial infection", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neutropenia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pseudomonas infection", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "MYCOPHENOLATE MOFETIL", "drugauthorizationnumb": "065520", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Prophylaxis against graft versus host disease", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "MYCOPHENOLATE MOFETIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "MYCOPHENOLATE MOFETIL", "drugauthorizationnumb": "065520", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Graft versus host disease", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "MYCOPHENOLATE MOFETIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "MYCOPHENOLATE MOFETIL", "drugauthorizationnumb": "065520", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "MYCOPHENOLATE MOFETIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "MYCOPHENOLATE MOFETIL", "drugauthorizationnumb": "065520", "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": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "MYCOPHENOLATE MOFETIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUDARABINE", "drugauthorizationnumb": "200647", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Allogenic stem cell transplantation", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "FLUDARABINE PHOSPHATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUDARABINE", "drugauthorizationnumb": "200647", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Bone marrow conditioning regimen", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "FLUDARABINE PHOSPHATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUDARABINE", "drugauthorizationnumb": "200647", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "FLUDARABINE PHOSPHATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUDARABINE", "drugauthorizationnumb": "200647", "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": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "FLUDARABINE PHOSPHATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "THIOTEPA", "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": "Allogenic stem cell transplantation", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "THIOTEPA" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "THIOTEPA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Bone marrow conditioning regimen", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "THIOTEPA" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "THIOTEPA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": 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Isolation of NDM-1-producing Pseudomonas aeruginosa sequence type ST235 from a stem cell transplant patient in Italy, May 2013. Euro Surveill. 2013;18(46)" }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "EMA", "duplicatenumb": "EU-EMA-DD-20251015-7482701-105026" }, { "duplicatesource": "ADIENNEP", "duplicatenumb": "EU-ADIENNEP-2024AD000045" }, { "duplicatesource": "MINISAL02", "duplicatenumb": "EU-MINISAL02-261141" }, { "duplicatesource": "Case identifiers", "duplicatenumb": "8679113" }, { "duplicatesource": "Case identifiers", "duplicatenumb": "10016666215" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "MYLAN" }, "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" }
25958117 Type 1
Serious
NEURONTIN, NEURONTIN, NEURONTIN (+5 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Consumer
Literature Reference
--
Company Number
--
Authority Number
EU-NOMAADVRE-PASRAPP-2025-V86anb
Sender Organization
MYLAN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
71.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
50.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Asphyxia (v28.1) Fatal
Swollen tongue (v28.1) Fatal
Circulatory collapse (v28.1) Fatal
Brain injury (v28.1) Fatal

Drugs (8)

NEURONTIN (GABAPENTIN) Suspect
Route: -- | Dosage: 300 MILLIGRAM, Q8H | Form: -- | Indication: Neuralgia | Action: Withdrawn
Auth#: 020235 | Batch#: 3220421a | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 8.0 hr | Cumulative: 17100.0 (unit: 003)
Start: 07/01/2025 | End: 07/19/2025 | Duration: 19.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
NEURONTIN (GABAPENTIN) Suspect
Route: 048 | Dosage: 300 MILLIGRAM, Q8H | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020235 | Batch#: 3220421a | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 8.0 hr | Cumulative: 17100.0 (unit: 003)
Start: 07/01/2025 | End: 07/19/2025 | Duration: 19.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
NEURONTIN (GABAPENTIN) Suspect
Route: 048 | Dosage: 300 MILLIGRAM, Q8H | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020235 | Batch#: 3220421a | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 8.0 hr | Cumulative: 17100.0 (unit: 003)
Start: 07/01/2025 | End: 07/19/2025 | Duration: 19.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
NEURONTIN (GABAPENTIN) Suspect
Route: -- | Dosage: 300 MILLIGRAM, Q8H | Form: -- | Indication: -- | Action: Withdrawn
Auth#: 020235 | Batch#: 3220421a | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 8.0 hr | Cumulative: 17100.0 (unit: 003)
Start: 07/01/2025 | End: 07/19/2025 | Duration: 19.0 day | Rechallenge: Unknown | Additional: --
Recurrences: --
ALBUTEROL (ALBUTEROL) Concomitant
Route: -- | Dosage: UNK, TID (2 DOSES 3 X DAILY, INH AEROSOL, SUSP ) | Form: -- | Indication: Chronic obstructive pulmonary disease | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/09/2024 | End: 07/19/2025 | Duration: 467.0 day | Rechallenge: -- | Additional: --
Recurrences: --
ALBUTEROL (ALBUTEROL) Concomitant
Route: 065 | Dosage: UNK, TID (2 DOSES 3 X DAILY, INH AEROSOL, SUSP ) | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/09/2024 | End: 07/19/2025 | Duration: 467.0 day | Rechallenge: -- | Additional: --
Recurrences: --
ALBUTEROL (ALBUTEROL) Concomitant
Route: 065 | Dosage: UNK, TID (2 DOSES 3 X DAILY, INH AEROSOL, SUSP ) | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/09/2024 | End: 07/19/2025 | Duration: 467.0 day | Rechallenge: -- | Additional: --
Recurrences: --
ALBUTEROL (ALBUTEROL) Concomitant
Route: -- | Dosage: UNK, TID (2 DOSES 3 X DAILY, INH AEROSOL, SUSP ) | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/09/2024 | End: 07/19/2025 | Duration: 467.0 day | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250719

Report Duplicates (1)

NOMAADVRE: EU-NOMAADVRE-E2B_00105120

Raw JSON (click to expand)

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"drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "GABAPENTIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ALBUTEROL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK, TID (2 DOSES 3 X DAILY, INH AEROSOL, SUSP )", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Chronic obstructive pulmonary disease", "drugstartdateformat": "102", "drugstartdate": "2024-04-09T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-07-19T00:00:00", "drugtreatmentduration": 467.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ALBUTEROL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ALBUTEROL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK, TID (2 DOSES 3 X DAILY, INH AEROSOL, SUSP )", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2024-04-09T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-07-19T00:00:00", "drugtreatmentduration": 467.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ALBUTEROL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ALBUTEROL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK, TID (2 DOSES 3 X DAILY, INH AEROSOL, SUSP )", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2024-04-09T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-07-19T00:00:00", "drugtreatmentduration": 467.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ALBUTEROL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ALBUTEROL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK, TID (2 DOSES 3 X DAILY, INH AEROSOL, SUSP )", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2024-04-09T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-07-19T00:00:00", "drugtreatmentduration": 467.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ALBUTEROL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250719" }, "primarysource": { "reportercountry": "EU", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "NOMAADVRE", "duplicatenumb": "EU-NOMAADVRE-E2B_00105120" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "MYLAN" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25958115 Type 1
Serious
IBUPROFEN, DIPHENHYDRAMINE
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
Riedel EO, Bongratz F, Zebhauser PT, M?hlau M, Wachinger C, Hedderich DM.. Febrile Infection-Related Epilepsy Syndrome (FIRES) in a Young Adult: A Case Report Highlighting Advanced Neuroimaging.. Clinical neuroradiology.. 2025;-:-
Company Number
--
Authority Number
EU-MLMSERVICE-20251009-PI671733-00030-1
Sender Organization
Kenvue
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Suicide attempt (v28.1) Recovered
Toxicity to various agents (v28.1) Recovered

Drugs (2)

IBUPROFEN (IBUPROFEN) Suspect
Route: 048 | Dosage: INGESTION | Form: Unknown | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 019012 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
DIPHENHYDRAMINE (DIPHENHYDRAMINE) Suspect
Route: 048 | Dosage: INGESTION | Form: Unknown | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435a33b3830196fa56a02", "safetyreportid": "25958115", "authoritynumb": "EU-MLMSERVICE-20251009-PI671733-00030-1", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Suicide attempt", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Toxicity to various agents", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "IBUPROFEN", "drugauthorizationnumb": "019012", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "INGESTION", "drugdosageform": "Unknown", "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "IBUPROFEN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DIPHENHYDRAMINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "INGESTION", "drugdosageform": "Unknown", "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "DIPHENHYDRAMINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": "Riedel EO, Bongratz F, Zebhauser PT, M?hlau M, Wachinger C, Hedderich DM.. Febrile Infection-Related Epilepsy Syndrome (FIRES) in a Young Adult: A Case Report Highlighting Advanced Neuroimaging.. Clinical neuroradiology.. 2025;-:-" }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "Kenvue" }, "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" }
25958114 Type 1
Serious
BIMZELX, BIMZELX
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
--
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-UCBSA-2025066455
Authority Number
--
Sender Organization
UCB
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Psoriatic arthropathy (v28.1) Unknown
Axial spondyloarthritis (v28.1) Unknown
Condition aggravated (v28.1) Unknown

Drugs (2)

BIMZELX (BIMEKIZUMAB-BKZX) Suspect
Route: -- | Dosage: 160 MILLIGRAM, EV 4 WEEKS | Form: Solution for injection in pre-filled pen | Indication: Psoriatic arthropathy | Action: Dose Not Changed
Auth#: 761151 | Batch#: -- | Structured Dosage: 160.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 4.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
BIMZELX (BIMEKIZUMAB-BKZX) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Axial spondyloarthritis | Action: Dose Not Changed
Auth#: 761151 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435a33b3830196fa56a01", "safetyreportid": "25958114", "authoritynumb": null, "companynumb": "US-UCBSA-2025066455", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": null, "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Psoriatic arthropathy", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Axial spondyloarthritis", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Condition aggravated", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "BIMZELX", "drugauthorizationnumb": "761151", "drugbatchnumb": null, "drugstructuredosagenumb": 160.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 4.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "160 MILLIGRAM, EV 4 WEEKS", "drugdosageform": "Solution for injection in pre-filled pen", "drugadministrationroute": null, "drugindication": "Psoriatic arthropathy", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "BIMEKIZUMAB-BKZX" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "BIMZELX", "drugauthorizationnumb": "761151", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Axial spondyloarthritis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "BIMEKIZUMAB-BKZX" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "UCB" }, "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" }
25958112 Type 1
Serious
KESIMPTA
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-002147023-NVSC2025SI160260
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
58.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Blood immunoglobulin G decreased (v28.1) Unknown

Drugs (1)

KESIMPTA (OFATUMUMAB) Suspect
Route: 065 | Dosage: UNK | Form: Solution for injection in pre-filled pen | Indication: Product used for unknown indication | Action: Unknown
Auth#: 125326 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435a33b3830196fa56a00", "safetyreportid": "25958112", "authoritynumb": null, "companynumb": "EU-002147023-NVSC2025SI160260", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 58.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blood immunoglobulin G decreased", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "KESIMPTA", "drugauthorizationnumb": "125326", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Solution for injection in pre-filled pen", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "OFATUMUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "NOVARTIS" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }