FDA FAERS Adverse Event Reports

110500
Total Reports
60546
Serious Reports
108
Reporter Countries
Clear
25969338 Type 1
Non-Serious
MIRENA
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Physician
Literature Reference
--
Company Number
US-BAYER-2025A140753
Authority Number
--
Sender Organization
BAYER HEALTHCARE PHARMACEUTICALS INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
19.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Device expulsion (v28.1) Recovered

Drugs (1)

MIRENA (LEVONORGESTREL) Suspect
Route: 015 | Dosage: 20?G/DAY | Form: Intrauterine delivery system | Indication: Contraception | Action: Not Applicable
Auth#: 021225 | Batch#: TU04EXP | Structured Dosage: 20.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 340.0 (unit: 004)
Start: 08/27/2025 | End: 09/12/2025 | Duration: 17.0 day | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250912

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974fb58e900fe3f48c5726", "safetyreportid": "25969338", "authoritynumb": null, "companynumb": "US-BAYER-2025A140753", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 19.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Device expulsion", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "MIRENA", "drugauthorizationnumb": "021225", "drugbatchnumb": "TU04EXP", "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 340.0, "drugcumulativedosageunit": "004", "drugdosagetext": "20?G/DAY", "drugdosageform": "Intrauterine delivery system", "drugadministrationroute": "015", "drugindication": "Contraception", "drugstartdateformat": "102", "drugstartdate": "2025-08-27T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-12T00:00:00", "drugtreatmentduration": 17.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "LEVONORGESTREL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250912" }, "primarysource": { "reportercountry": "US", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BAYER HEALTHCARE PHARMACEUTICALS INC." }, "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" }
25969334 Type 1
Non-Serious
CIPROFLOXACIN HYDROCHLORIDE, KEFLEX, ADVIL (+1 more)
Report Version
1
Receive Date
10/28/2025
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-UniquePharma-US-2025UPLSPO00112
Authority Number
--
Sender Organization
UNIQUE PHARMACEUTICALS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Male
Patient Weight
200.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (7)

Gait disturbance (v28.1) Not Recovered
Muscle spasms (v28.1) Not Recovered
Balance disorder (v28.1) Not Recovered
Dysstasia (v28.1) Not Recovered
Haematuria (v28.1) Recovering
Myalgia (v28.1) Not Recovered
Pain in extremity (v28.1) Not Recovered

Drugs (4)

CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) Suspect
Route: 048 | Dosage: -- | Form: Tablet | Indication: Antibiotic prophylaxis | Action: Withdrawn
Auth#: 076639 | Batch#: Unknown | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 2.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 08/01/2025 | End: 01/01/2025 | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
KEFLEX (CEPHALEXIN) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
ADVIL (IBUPROFEN) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
HYDROCODONE (HYDROCODONE) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250801

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974fb58e900fe3f48c5725", "safetyreportid": "25969334", "authoritynumb": null, "companynumb": "US-UniquePharma-US-2025UPLSPO00112", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": 200.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gait disturbance", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Muscle spasms", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Balance disorder", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dysstasia", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Haematuria", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Myalgia", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pain in extremity", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "CIPROFLOXACIN HYDROCHLORIDE", "drugauthorizationnumb": "076639", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 2.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Antibiotic prophylaxis", "drugstartdateformat": "610", "drugstartdate": "2025-08-01T00:00:00", "drugenddateformat": "602", "drugenddate": "2025-01-01T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "CIPROFLOXACIN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "KEFLEX", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "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": "CEPHALEXIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ADVIL", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "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": 2, "medicinalproduct": "HYDROCODONE", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "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": "HYDROCODONE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250801" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "UNIQUE PHARMACEUTICALS" }, "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" }
25969333 Type 1
Non-Serious
VYLEESI, VIIBRYD, SYNTHROID (+1 more)
Report Version
1
Receive Date
10/28/2025
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-COSETTE-CP2025US001046
Authority Number
--
Sender Organization
COSETTE PHARMACEUTICALS INC
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
Elderly
Patient Sex
Female
Patient Weight
126.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Illness (v28.1) Recovered
Dysphagia (v28.1) Unknown
Feeding disorder (v28.1) Unknown
Headache (v28.1) Unknown
Vomiting (v28.1) Recovered

Drugs (4)

VYLEESI (BREMELANOTIDE ACETATE) Suspect
Route: 058 | Dosage: -- | Form: Injection | Indication: Libido decreased | Action: Withdrawn
Auth#: 210557 | Batch#: PALCB002-1 | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/10/2025 | End: 10/10/2025 | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
VIIBRYD (VILAZODONE HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SYNTHROID (LEVOTHYROXINE SODIUM) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ESTRADIOL (ESTRADIOL) Concomitant
Route: 065 | Dosage: -- | Form: Tablet | Indication: Anxiety | Action: --
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251001

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974fb58e900fe3f48c5723", "safetyreportid": "25969333", "authoritynumb": null, "companynumb": "US-COSETTE-CP2025US001046", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 76.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 126.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Illness", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dysphagia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Feeding disorder", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Headache", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vomiting", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "VYLEESI", "drugauthorizationnumb": "210557", "drugbatchnumb": "PALCB002-1", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Injection", "drugadministrationroute": "058", "drugindication": "Libido decreased", "drugstartdateformat": "102", "drugstartdate": "2025-10-10T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-10T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "BREMELANOTIDE ACETATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "VIIBRYD", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "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": { "activesubstancename": "VILAZODONE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SYNTHROID", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "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": { "activesubstancename": "LEVOTHYROXINE SODIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ESTRADIOL", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "065", "drugindication": "Anxiety", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ESTRADIOL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251001" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "COSETTE PHARMACEUTICALS INC" }, "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" }
25969331 Type 1
Non-Serious
NEMLUVIO
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Physician
Literature Reference
--
Company Number
US-GALDERMA-US2025019630
Authority Number
--
Sender Organization
GALDERMA
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Incorrect dose administered (v28.1) Recovered
Device leakage (v28.1) Recovered

Drugs (1)

NEMLUVIO (NEMOLIZUMAB-ILTO) Suspect
Route: 058 | Dosage: -- | Form: Injection | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 761390 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

092325: GL-092325-37119

Raw JSON (click to expand)

{ "_id": "69974fb58e900fe3f48c571f", "safetyreportid": "25969331", "authoritynumb": null, "companynumb": "US-GALDERMA-US2025019630", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Incorrect dose administered", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Device leakage", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "NEMLUVIO", "drugauthorizationnumb": "761390", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Injection", "drugadministrationroute": "058", "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": "NEMOLIZUMAB-ILTO" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "092325", "duplicatenumb": "GL-092325-37119" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "GALDERMA" }, "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" }
25969332 Type 2
Serious
TASIGNA
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Pharmacist
Literature Reference
--
Company Number
US-002147023-NVSC2025US166163
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
--
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 (1)

TASIGNA (NILOTINIB) Suspect
Route: 065 | Dosage: UNK | Form: Capsule, hard | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 22068 | 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": "69974fb58e900fe3f48c571e", "safetyreportid": "25969332", "authoritynumb": null, "companynumb": "US-002147023-NVSC2025US166163", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Death", "reactionoutcome": 5 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TASIGNA", "drugauthorizationnumb": "22068", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Capsule, hard", "drugadministrationroute": "065", "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": "NILOTINIB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 2, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "NOVARTIS" }, "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" }
25969330 Type 1
Serious
BERINERT, BERINERT, MYCOPHENOLATE MOFETIL (+45 more)
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
--
Authority Number
EU-EMA-DD-20251009-7482655-124521
Sender Organization
SANDOZ
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
54.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Deep vein thrombosis (v28.1) Recovered
Drug ineffective for unapproved indication (v28.1) Unknown

Drugs (48)

BERINERT (HUMAN C1-ESTERASE INHIBITOR) Suspect
Route: 065 | Dosage: 1000 IU, BIW | Form: Injection | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: 64861711B | Structured Dosage: 2000.0 (unit: 025) | Separate Dosage#: 1.0 | Interval: 1.0 wk | Cumulative: 3000.0 (unit: 025)
Start: 10/20/2014 | End: 12/08/2014 | Duration: 50.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
BERINERT (HUMAN C1-ESTERASE INHIBITOR) Suspect
Route: 065 | Dosage: DAY 1, 2, AND 3 | Form: Injection | Indication: Transplant rejection | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 025) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 3000.0 (unit: 025)
Start: 10/15/2014 | End: 10/17/2014 | Duration: 3.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL) Suspect
Route: 065 | Dosage: 1500 MG, QD | Form: Unknown | Indication: Transplant rejection | Action: Unknown
Auth#: 65379 | Batch#: -- | Structured Dosage: 1500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREDNISONE (PREDNISONE) Suspect
Route: 065 | Dosage: 10 MG, QD | Form: Unknown | Indication: Transplant rejection | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 5 G, TOT | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4326100031 | Structured Dosage: 5.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 05/20/2014 | End: 05/20/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 5 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4326100031 | Structured Dosage: 5.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/21/2014 | End: 05/21/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 10 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4326200047 | Structured Dosage: 10.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/04/2014 | End: 06/06/2014 | Duration: 3.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 10 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4326200048 | Structured Dosage: 10.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/13/2014 | End: 06/13/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 10 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4326200048 | Structured Dosage: 10.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/14/2014 | End: 06/14/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 10 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4326200048 | Structured Dosage: 10.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/11/2014 | End: 07/11/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 10 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4326200048 | Structured Dosage: 10.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/12/2014 | End: 07/12/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 10 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4326200052 | Structured Dosage: 10.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/08/2014 | End: 08/08/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 10 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4326200052 | Structured Dosage: 10.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/09/2014 | End: 08/09/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 10 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4326200054 | Structured Dosage: 10.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/15/2014 | End: 10/15/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 10 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4326200054 | Structured Dosage: 10.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/16/2014 | End: 10/16/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 10 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4326200055 | Structured Dosage: 10.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/15/2014 | End: 09/15/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 10 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4326200056 | Structured Dosage: 10.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/13/2014 | End: 11/13/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 10 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4326200061 | Structured Dosage: 10.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/14/2014 | End: 11/14/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 40 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4326300087 | Structured Dosage: 40.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/15/2014 | End: 10/15/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 40 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4326300087 | Structured Dosage: 40.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/16/2014 | End: 10/16/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 40 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4326300088 | Structured Dosage: 40.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/13/2014 | End: 11/13/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 40 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4326300088 | Structured Dosage: 40.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/14/2014 | End: 11/14/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 40 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4372000003 | Structured Dosage: 40.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/20/2014 | End: 05/20/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 40 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4372000003 | Structured Dosage: 40.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/21/2014 | End: 05/21/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 40 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4372000004 | Structured Dosage: 40.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/13/2014 | End: 06/13/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 40 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4372000004 | Structured Dosage: 40.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/14/2014 | End: 06/14/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 10 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4372000005 | Structured Dosage: 10.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/12/2014 | End: 07/12/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 40 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4372000005 | Structured Dosage: 40.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/11/2014 | End: 07/11/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 40 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4372000005 | Structured Dosage: 40.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/08/2014 | End: 08/08/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 40 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4372000005 | Structured Dosage: 40.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/09/2014 | End: 08/09/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 10 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4372000007 | Structured Dosage: 10.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/16/2014 | End: 09/16/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 40 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4372000007 | Structured Dosage: 40.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/15/2014 | End: 09/15/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 40 G | Form: Infusion | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 4372000007 | Structured Dosage: 40.0 (unit: 002) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/16/2014 | End: 09/16/2014 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 2000 MG/KG, QMO | Form: Infusion | Indication: Transplant rejection | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 2000.0 (unit: 007) | Separate Dosage#: 1.0 | Interval: 1.0 mo | Cumulative: -- (unit: --)
Start: 05/20/2014 | End: 11/14/2014 | Duration: 179.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
RITUXIMAB (RITUXIMAB) Suspect
Route: 065 | Dosage: 375 MG/M2 | Form: Unknown | Indication: Transplant rejection | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TACROLIMUS (TACROLIMUS) Suspect
Route: 065 | Dosage: -- | Form: Unknown | Indication: Transplant rejection | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) Concomitant
Route: 048 | Dosage: 10 MG | Form: Unknown | Indication: Hypertension | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/25/2014 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
BACTRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Concomitant
Route: 048 | Dosage: 400 / 80 MG | Form: Unknown | Indication: Prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/22/2014 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CALCIUM CARBONATE (CALCIUM CARBONATE) Concomitant
Route: 048 | Dosage: 3 SACHETS | Form: Unknown | Indication: Hypocalcaemia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/26/2014 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CELLCEPT (MYCOPHENOLATE MOFETIL) Concomitant
Route: 048 | Dosage: 2000 MG | Form: Unknown | Indication: Immunosuppression | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 2000.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/21/2014 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PREDNISONE (PREDNISONE) Concomitant
Route: 048 | Dosage: 5 MG | Form: Unknown | Indication: Immunosuppression | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/21/2014 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
URAPIDIL (URAPIDIL) Concomitant
Route: 048 | Dosage: 270 MG | Form: Unknown | Indication: Hypertension | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 270.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/25/2014 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
Fludex (--) Concomitant
Route: 048 | Dosage: 1.5 MG | Form: Unknown | Indication: Hypertension | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.5 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/08/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FOLIC ACID (FOLIC ACID) Concomitant
Route: 048 | Dosage: 5 MG | Form: Unknown | Indication: Prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/23/2014 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OMEPRAZOLE (OMEPRAZOLE) Concomitant
Route: 048 | Dosage: 20 MG | Form: Unknown | Indication: Prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/21/2014 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PROGRAF (TACROLIMUS) Concomitant
Route: 048 | Dosage: 3 MG | Form: Unknown | Indication: Immunosuppression | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 3.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/21/2014 | End: 06/25/2015 | Duration: 490.0 day | Rechallenge: -- | Additional: --
Recurrences: --
RENAGEL (SEVELAMER HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: 2400 MG | Form: Unknown | Indication: Hyperphosphataemia | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 2400.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/13/2014 | End: 08/20/2015 | Duration: 434.0 day | Rechallenge: -- | Additional: --
Recurrences: --
SOTALOL (SOTALOL) Concomitant
Route: 048 | Dosage: 80 MG | Form: Unknown | Indication: Hypertension | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 80.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20141210

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974fb58e900fe3f48c571d", "safetyreportid": "25969330", "authoritynumb": "EU-EMA-DD-20251009-7482655-124521", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 62.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 54.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Deep vein thrombosis", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug ineffective for unapproved indication", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "BERINERT", "drugauthorizationnumb": null, "drugbatchnumb": "64861711B", "drugstructuredosagenumb": 2000.0, "drugstructuredosageunit": "025", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": 3000.0, "drugcumulativedosageunit": "025", "drugdosagetext": "1000 IU, BIW", 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null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "375 MG/M2", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Transplant rejection", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "RITUXIMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TACROLIMUS", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Unknown", 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null, "activesubstance": { "activesubstancename": "SULFAMETHOXAZOLE\\TRIMETHOPRIM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CALCIUM CARBONATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "3 SACHETS", "drugdosageform": "Unknown", "drugadministrationroute": "048", "drugindication": "Hypocalcaemia", "drugstartdateformat": "102", "drugstartdate": "2014-02-26T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CALCIUM CARBONATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, 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null, "drugdosagetext": "270 MG", "drugdosageform": "Unknown", "drugadministrationroute": "048", "drugindication": "Hypertension", "drugstartdateformat": "102", "drugstartdate": "2014-02-25T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "URAPIDIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "Fludex", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1.5 MG", "drugdosageform": "Unknown", "drugadministrationroute": "048", "drugindication": "Hypertension", "drugstartdateformat": "102", "drugstartdate": "2015-12-08T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FOLIC ACID", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG", "drugdosageform": "Unknown", "drugadministrationroute": "048", "drugindication": "Prophylaxis", "drugstartdateformat": "102", "drugstartdate": "2014-02-23T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "FOLIC ACID" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OMEPRAZOLE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "20 MG", "drugdosageform": "Unknown", "drugadministrationroute": "048", "drugindication": "Prophylaxis", "drugstartdateformat": "102", "drugstartdate": "2014-02-21T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "OMEPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PROGRAF", 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null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2400 MG", "drugdosageform": "Unknown", "drugadministrationroute": "048", "drugindication": "Hyperphosphataemia", "drugstartdateformat": "102", "drugstartdate": "2014-06-13T00:00:00", "drugenddateformat": "102", "drugenddate": "2015-08-20T00:00:00", "drugtreatmentduration": 434.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "SEVELAMER HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SOTALOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 80.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "80 MG", "drugdosageform": "Unknown", "drugadministrationroute": "048", "drugindication": "Hypertension", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "SOTALOL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20141210" }, "primarysource": { "reportercountry": "EU", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANDOZ" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25969327 Type 1
Serious
HUMAN IMMUNOGLOBULIN G, HUMAN IMMUNOGLOBULIN G, IRBESARTAN
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/18/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Other Health Professional
Literature Reference
Hu B.Q, Wu S.X, Tong Q.W, Ye H, Jin P.P.. Efgartigimod for treating Guillain-Barre syndrome with poor response to intravenous immunoglobulin: a case report. BMC Neurology. 2025;25:1:1-5
Company Number
CN-ADMA BIOLOGICS INC.-CN-2025ADM000349
Authority Number
--
Sender Organization
ADMA BIOLOGICS
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 (5)

Respiratory failure (v28.1) Recovered
Guillain-Barre syndrome (v28.1) Recovering
Miller Fisher syndrome (v28.1) Recovering
Condition aggravated (v28.1) Recovering
Off label use (v28.1) Unknown

Drugs (3)

HUMAN IMMUNOGLOBULIN G (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 400 MG/KG, OVER 5 DAYS | Form: Intravenous injection | Indication: Miller Fisher syndrome | Action: Not Applicable
Auth#: 1255900 | Batch#: -- | Structured Dosage: 400.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/14/2025 | End: 02/18/2025 | Duration: 5.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
HUMAN IMMUNOGLOBULIN G (HUMAN IMMUNOGLOBULIN G) Suspect
Route: -- | Dosage: -- | Form: Intravenous injection | Indication: Guillain-Barre syndrome | Action: Not Applicable
Auth#: 1255900 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
IRBESARTAN (IRBESARTAN) Concomitant
Route: 065 | Dosage: UNK, UNK | Form: Unknown | Indication: Hypertension | 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: 20250214

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974fb58e900fe3f48c571c", "safetyreportid": "25969327", "authoritynumb": null, "companynumb": "CN-ADMA BIOLOGICS INC.-CN-2025ADM000349", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 58.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Respiratory failure", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Guillain-Barre syndrome", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Miller Fisher syndrome", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Condition aggravated", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Off label use", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "HUMAN IMMUNOGLOBULIN G", "drugauthorizationnumb": "1255900", "drugbatchnumb": null, "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "007", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "400 MG/KG, OVER 5 DAYS", "drugdosageform": "Intravenous injection", "drugadministrationroute": "042", "drugindication": "Miller Fisher syndrome", "drugstartdateformat": "102", "drugstartdate": "2025-02-14T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-02-18T00:00:00", "drugtreatmentduration": 5.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "HUMAN IMMUNOGLOBULIN G" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "HUMAN IMMUNOGLOBULIN G", "drugauthorizationnumb": "1255900", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Intravenous injection", "drugadministrationroute": null, "drugindication": "Guillain-Barre syndrome", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "HUMAN IMMUNOGLOBULIN G" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "IRBESARTAN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK, UNK", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Hypertension", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "IRBESARTAN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250214" }, "primarysource": { "reportercountry": "CN", "qualification": 3, "literaturereference": "Hu B.Q, Wu S.X, Tong Q.W, Ye H, Jin P.P.. Efgartigimod for treating Guillain-Barre syndrome with poor response to intravenous immunoglobulin: a case report. BMC Neurology. 2025;25:1:1-5" }, "primarysourcecountry": "CN", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ADMA BIOLOGICS" }, "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" }
25969328 Type 1
Serious
HUMAN IMMUNOGLOBULIN G, HUMAN IMMUNOGLOBULIN G, IRBESARTAN
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/17/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Other Health Professional
Literature Reference
Hu B.Q, Wu S.X, Tong Q.W, Ye H, Jin P.P.. Efgartigimod for treating Guillain-Barre syndrome with poor response to intravenous immunoglobulin: a case report. BMC Neurology. 2025;25:1:1-5
Company Number
CN-ADMA BIOLOGICS INC.-CN-2025ADM000341
Authority Number
--
Sender Organization
ADMA BIOLOGICS
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 (5)

Respiratory failure (v28.1) Recovered
Guillain-Barre syndrome (v28.1) Recovering
Miller Fisher syndrome (v28.1) Recovering
Condition aggravated (v28.1) Recovering
Off label use (v28.1) Unknown

Drugs (3)

HUMAN IMMUNOGLOBULIN G (HUMAN IMMUNOGLOBULIN G) Suspect
Route: 042 | Dosage: 400 MG/KG, OVER 5 DAYS | Form: Solution for infusion | Indication: Miller Fisher syndrome | Action: Not Applicable
Auth#: 1253890 | Batch#: -- | Structured Dosage: 400.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/14/2025 | End: 02/18/2025 | Duration: 5.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
HUMAN IMMUNOGLOBULIN G (HUMAN IMMUNOGLOBULIN G) Suspect
Route: -- | Dosage: -- | Form: Solution for infusion | Indication: Guillain-Barre syndrome | Action: Not Applicable
Auth#: 1253890 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
IRBESARTAN (IRBESARTAN) Concomitant
Route: 065 | Dosage: UNK, UNK | Form: Unknown | Indication: Hypertension | 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: 20250214

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974fb58e900fe3f48c571b", "safetyreportid": "25969328", "authoritynumb": null, "companynumb": "CN-ADMA BIOLOGICS INC.-CN-2025ADM000341", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 58.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Respiratory failure", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Guillain-Barre syndrome", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Miller Fisher syndrome", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Condition aggravated", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Off label use", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "HUMAN IMMUNOGLOBULIN G", "drugauthorizationnumb": "1253890", "drugbatchnumb": null, "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "007", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "400 MG/KG, OVER 5 DAYS", "drugdosageform": "Solution for infusion", "drugadministrationroute": "042", "drugindication": "Miller Fisher syndrome", "drugstartdateformat": "102", "drugstartdate": "2025-02-14T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-02-18T00:00:00", "drugtreatmentduration": 5.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "HUMAN IMMUNOGLOBULIN G" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "HUMAN IMMUNOGLOBULIN G", "drugauthorizationnumb": "1253890", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for infusion", "drugadministrationroute": null, "drugindication": "Guillain-Barre syndrome", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "HUMAN IMMUNOGLOBULIN G" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "IRBESARTAN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK, UNK", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Hypertension", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "IRBESARTAN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250214" }, "primarysource": { "reportercountry": "CN", "qualification": 3, "literaturereference": "Hu B.Q, Wu S.X, Tong Q.W, Ye H, Jin P.P.. Efgartigimod for treating Guillain-Barre syndrome with poor response to intravenous immunoglobulin: a case report. BMC Neurology. 2025;25:1:1-5" }, "primarysourcecountry": "CN", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ADMA BIOLOGICS" }, "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" }
25969326 Type 1
Non-Serious
MIRENA
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-BAYER-2025A140057
Authority Number
--
Sender Organization
BAYER HEALTHCARE PHARMACEUTICALS INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
19.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Procedural pain (v28.1) Unknown
Device dislocation (v28.1) Recovered

Drugs (1)

MIRENA (LEVONORGESTREL) Suspect
Route: 015 | Dosage: 20?G/DAY | Form: Intrauterine delivery system | Indication: Contraception | Action: Withdrawn
Auth#: 021225 | Batch#: TU04E70 | Structured Dosage: 20.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 09/12/2025 | End: 10/17/2025 | Duration: 36.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974fb58e900fe3f48c571a", "safetyreportid": "25969326", "authoritynumb": null, "companynumb": "US-BAYER-2025A140057", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 19.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Procedural pain", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Device dislocation", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "MIRENA", "drugauthorizationnumb": "021225", "drugbatchnumb": "TU04E70", "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "20?G/DAY", "drugdosageform": "Intrauterine delivery system", "drugadministrationroute": "015", "drugindication": "Contraception", "drugstartdateformat": "102", "drugstartdate": "2025-09-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-17T00:00:00", "drugtreatmentduration": 36.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "LEVONORGESTREL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101" }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BAYER HEALTHCARE PHARMACEUTICALS INC." }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25969323 Type 1
Non-Serious
FILSPARI
Report Version
1
Receive Date
10/28/2025
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-TRAVERE-2025TVT01828
Authority Number
--
Sender Organization
TRAVERE THERAPEUTICS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Crohn^s disease (v28.1) Unknown

Drugs (1)

FILSPARI (SPARSENTAN) Suspect
Route: 048 | Dosage: -- | Form: Tablet | Indication: IgA nephropathy | Action: Unknown
Auth#: 216403 | Batch#: 1979025 | Structured Dosage: 400.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 04/02/2024 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974fb58e900fe3f48c5719", "safetyreportid": "25969323", "authoritynumb": null, "companynumb": "US-TRAVERE-2025TVT01828", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Crohn^s disease", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "FILSPARI", "drugauthorizationnumb": "216403", "drugbatchnumb": "1979025", "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "IgA nephropathy", "drugstartdateformat": "102", "drugstartdate": "2024-04-02T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "SPARSENTAN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "TRAVERE THERAPEUTICS" }, "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" }