FDA FAERS Adverse Event Reports

25947430 Type 2

Non-Serious

CORTICOTROPIN

Report Version

1

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/18/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-MALLINCKRODT-MNK202506337

Authority Number

--

Sender Organization

MALLINCKRODT

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

No

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

62.0 yr

Patient Age Group

Adult

Patient Sex

Female

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Injection site bruising (v28.1) Unknown

Drugs (1)

CORTICOTROPIN (CORTICOTROPIN) Suspect

Route: 058 | Dosage: 80 UNITS | Form: Gel for injection | Indication: Ocular pemphigoid | Action: Dose Not Changed

Start: 10/08/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251008

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435713b3830196fa53d07",
  "safetyreportid": "25947430",
  "authoritynumb": null,
  "companynumb": "US-MALLINCKRODT-MNK202506337",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 62.0,
    "patientonsetageunit": 801,
    "patientagegroup": 5,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Injection site bruising",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CORTICOTROPIN",
        "drugauthorizationnumb": "008372",
        "drugbatchnumb": "UNKNOWN",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "80 UNITS",
        "drugdosageform": "Gel for injection",
        "drugadministrationroute": "058",
        "drugindication": "Ocular pemphigoid",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-10-08T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "CORTICOTROPIN"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251008"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-22T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-22T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 2,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "MALLINCKRODT"
  },
  "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"
}
                        

25947426 Type 1

Serious

IBUPROFEN

Report Version

1

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/19/2026

Primary Source Country

EU

Occurrence Country

EU

Reporter Country

EU

Reporter Qualification

Physician

Literature Reference

Alberto AJ, Pinto AR, Guerra J, Rebelo Gomes E.. Intentional Use of Known Allergens for Self-Harm Behavior.. Acta medica portuguesa.. 2025;38(10):680-1

Company Number

EU-MLMSERVICE-20251007-PI670074-00030-1

Authority Number

--

Sender Organization

AUROBINDO

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

13.0 yr

Patient Age Group

--

Patient Sex

Female

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Angioedema (v28.1) Unknown

Intentional self-injury (v28.1) Unknown

Drug hypersensitivity (v28.1) Unknown

Drugs (1)

IBUPROFEN (IBUPROFEN) Suspect

Route: 065 | Dosage: UNK | Form: Unknown | Indication: Product used for unknown indication | Action: Not Applicable

Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435713b3830196fa53d02",
  "safetyreportid": "25947426",
  "authoritynumb": null,
  "companynumb": "EU-MLMSERVICE-20251007-PI670074-00030-1",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": 13.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Angioedema",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Intentional self-injury",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Drug hypersensitivity",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "IBUPROFEN",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": "Unknown",
        "drugadministrationroute": "065",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "IBUPROFEN"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 1,
    "literaturereference": "Alberto AJ, Pinto AR, Guerra J, Rebelo Gomes E.. Intentional Use of Known Allergens for Self-Harm Behavior.. Acta medica portuguesa.. 2025;38(10):680-1"
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-22T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-22T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "AUROBINDO"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 1,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-19T00:00:00",
  "transmissiondateformat": "102"
}
                        

25947427 Type 2

Non-Serious

CORTICOTROPIN

Report Version

1

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/18/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-MALLINCKRODT-MNK202506086

Authority Number

--

Sender Organization

MALLINCKRODT

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

No

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

52.0 yr

Patient Age Group

Adult

Patient Sex

Male

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Weight increased (v28.1) Unknown

Abdominal distension (v28.1) Unknown

Insomnia (v28.1) Unknown

Drugs (1)

CORTICOTROPIN (CORTICOTROPIN) Suspect

Route: 058 | Dosage: 80 UNITS | Form: Gel for injection | Indication: Sarcoidosis | Action: Dose Not Changed

Start: 09/08/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250901

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435713b3830196fa53d05",
  "safetyreportid": "25947427",
  "authoritynumb": null,
  "companynumb": "US-MALLINCKRODT-MNK202506086",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 52.0,
    "patientonsetageunit": 801,
    "patientagegroup": 5,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Weight increased",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Abdominal distension",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Insomnia",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CORTICOTROPIN",
        "drugauthorizationnumb": "008372",
        "drugbatchnumb": "UNKNOWN",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 3.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "80 UNITS",
        "drugdosageform": "Gel for injection",
        "drugadministrationroute": "058",
        "drugindication": "Sarcoidosis",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-09-08T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "CORTICOTROPIN"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250901"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-22T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-22T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 2,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "MALLINCKRODT"
  },
  "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"
}
                        

25947425 Type 2

Serious

BUDESONIDE\FORMOTEROL\GLYCOPYRRONIUM

Report Version

1

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/17/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-AstraZeneca-CH-00973013A

Authority Number

--

Sender Organization

ALEXION PHARMACEUTICALS

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

Female

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (6)

Oral pain (v28.1) Recovering

Oral candidiasis (v28.1) Recovering

Dysphagia (v28.1) Recovering

Mouth haemorrhage (v28.1) Recovering

Weight decreased (v28.1) Recovering

Stomatitis (v28.1) Recovering

Drugs (1)

BUDESONIDE\FORMOTEROL\GLYCOPYRRONIUM (BUDESONIDE\FORMOTEROL\GLYCOPYRRONIUM) Suspect

Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: Withdrawn

Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435713b3830196fa53d00",
  "safetyreportid": "25947425",
  "authoritynumb": null,
  "companynumb": "US-AstraZeneca-CH-00973013A",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Oral pain",
        "reactionoutcome": 2
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Oral candidiasis",
        "reactionoutcome": 2
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dysphagia",
        "reactionoutcome": 2
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Mouth haemorrhage",
        "reactionoutcome": 2
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Weight decreased",
        "reactionoutcome": 2
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Stomatitis",
        "reactionoutcome": 2
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "BUDESONIDE\\FORMOTEROL\\GLYCOPYRRONIUM",
        "drugauthorizationnumb": "212122",
        "drugbatchnumb": "Unknown",
        "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": 3,
        "drugadditional": 1,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "BUDESONIDE\\FORMOTEROL\\GLYCOPYRRONIUM"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-22T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-22T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 2,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ALEXION PHARMACEUTICALS"
  },
  "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"
}
                        

25947423 Type 1

Serious

VEOZAH

Report Version

1

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/18/2026

Primary Source Country

EU

Occurrence Country

EU

Reporter Country

EU

Reporter Qualification

Physician

Literature Reference

--

Company Number

EU-ASTELLAS-2025-AER-056691

Authority Number

--

Sender Organization

ASTELLAS

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

Female

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Hepatotoxicity (v28.1) Unknown

Hepatic enzyme increased (v28.1) Unknown

Drugs (1)

VEOZAH (FEZOLINETANT) Suspect

Route: 065 | Dosage: -- | Form: Unknown | Indication: Product used for unknown indication | Action: Withdrawn

Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435713b3830196fa53cf9",
  "safetyreportid": "25947423",
  "authoritynumb": null,
  "companynumb": "EU-ASTELLAS-2025-AER-056691",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Hepatotoxicity",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Hepatic enzyme increased",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "VEOZAH",
        "drugauthorizationnumb": "216578",
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Unknown",
        "drugadministrationroute": "065",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "FEZOLINETANT"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 1,
    "literaturereference": null
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-22T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-22T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ASTELLAS"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": null,
  "seriousnessdeath": null,
  "seriousnessdisabling": null,
  "seriousnesshospitalization": null,
  "seriousnesslifethreatening": null,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25947422 Type 3

Serious

TOFACITINIB

Report Version

1

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/17/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Other Health Professional

Literature Reference

Zisman E, et al. Autoimmune Hemolytic Anemia From Tofacitinib Use in a Patient With Ulcerative Colitis. ACG Case Reports Journal 11: e01528, No. 10, Oct 2024.

Company Number

US-DEXPHARM-2025-4927

Authority Number

--

Sender Organization

DEXCEL LTD.

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

47.0 yr

Patient Age Group

Adult

Patient Sex

Female

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Off label use (v28.1) Recovered

Autoimmune haemolytic anaemia (v28.1) Recovered

Drugs (1)

TOFACITINIB (TOFACITINIB) Suspect

Route: -- | Dosage: -- | Form: -- | Indication: Colitis ulcerative | Action: Withdrawn

Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435713b3830196fa53cf8",
  "safetyreportid": "25947422",
  "authoritynumb": null,
  "companynumb": "US-DEXPHARM-2025-4927",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 47.0,
    "patientonsetageunit": 801,
    "patientagegroup": 5,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Off label use",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Autoimmune haemolytic anaemia",
        "reactionoutcome": 1
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "TOFACITINIB",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Colitis ulcerative",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": 1,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "TOFACITINIB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 3,
    "literaturereference": "Zisman E, et al. Autoimmune Hemolytic Anemia From Tofacitinib Use in a Patient With Ulcerative Colitis. ACG Case Reports Journal 11: e01528, No. 10, Oct 2024."
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-22T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-22T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 3,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "DEXCEL LTD."
  },
  "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"
}
                        

25947408 Type 2

Non-Serious

NUPLAZID

Report Version

1

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/18/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Pharmacist

Literature Reference

--

Company Number

US-ACADIA PHARMACEUTICALS INC.-ACA-2025-PIM-011362

Authority Number

--

Sender Organization

ACADIA 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

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Product use issue (v28.1) Unknown

Drugs (1)

NUPLAZID (PIMAVANSERIN TARTRATE) Suspect

Route: 048 | Dosage: 34 MILLIGRAM, QD | Form: Capsule | Indication: Parkinson^s disease | Action: Dose Not Changed

Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435713b3830196fa53cf0",
  "safetyreportid": "25947408",
  "authoritynumb": null,
  "companynumb": "US-ACADIA PHARMACEUTICALS INC.-ACA-2025-PIM-011362",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Product use issue",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "NUPLAZID",
        "drugauthorizationnumb": "210793",
        "drugbatchnumb": "3223578",
        "drugstructuredosagenumb": 34.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "34 MILLIGRAM, QD",
        "drugdosageform": "Capsule",
        "drugadministrationroute": "048",
        "drugindication": "Parkinson^s disease",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "PIMAVANSERIN TARTRATE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 2,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-22T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-22T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 2,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ACADIA PHARMACEUTICALS"
  },
  "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"
}
                        

25947407 Type 1

Non-Serious

BOTOX

Report Version

1

Receive Date

10/22/2025

Receipt Date

10/22/2025

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-ABBVIE-6503818

Authority Number

--

Sender Organization

ABBVIE

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

No

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

--

Patient Age Group

--

Patient Sex

Female

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Off label use (v28.1) Unknown

Drugs (1)

BOTOX (ONABOTULINUMTOXINA) Suspect

Route: 065 | Dosage: TIME INTERVAL: AS NECESSARY: CHIN | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable

Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435713b3830196fa53cf1",
  "safetyreportid": "25947407",
  "authoritynumb": null,
  "companynumb": "US-ABBVIE-6503818",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Off label use",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "BOTOX",
        "drugauthorizationnumb": "103000",
        "drugbatchnumb": "Not available",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "TIME INTERVAL: AS NECESSARY: CHIN",
        "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": "ONABOTULINUMTOXINA"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 3,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-22T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-22T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ABBVIE"
  },
  "serious": 2,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 2,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25947410 Type 1

Non-Serious

SKYRIZI

Report Version

1

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/17/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-ABBVIE-6512832

Authority Number

--

Sender Organization

ABBVIE

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

No

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

--

Patient Age Group

--

Patient Sex

Female

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Fluid retention (v28.1) Unknown

Abdominal distension (v28.1) Unknown

Drugs (1)

SKYRIZI (RISANKIZUMAB-RZAA) Suspect

Route: 058 | Dosage: -- | Form: -- | Indication: Crohn^s disease | Action: Unknown

Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250901

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435713b3830196fa53cf2",
  "safetyreportid": "25947410",
  "authoritynumb": null,
  "companynumb": "US-ABBVIE-6512832",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Fluid retention",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Abdominal distension",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "SKYRIZI",
        "drugauthorizationnumb": "761105",
        "drugbatchnumb": "Not available",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": "058",
        "drugindication": "Crohn^s disease",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "RISANKIZUMAB-RZAA"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250901"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-22T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-22T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ABBVIE"
  },
  "serious": 2,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 2,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25947411 Type 1

Serious

DYSPORT

Report Version

1

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/19/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-IPSEN Group, Research and Development-2025-26024

Authority Number

--

Sender Organization

IPSEN BIOPHARMACEUTICALS, INC.

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

61.0 yr

Patient Age Group

Adult

Patient Sex

Female

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (6)

Rectal haemorrhage (v28.1) Unknown

Dysphagia (v28.1) Unknown

Dyspnoea (v28.1) Unknown

Gastrointestinal injury (v28.1) Unknown

Delayed recovery from anaesthesia (v28.1) Unknown

Weaning failure (v28.1) Unknown

Drugs (1)

DYSPORT (ABOBOTULINUMTOXINA) Suspect

Route: 030 | Dosage: SDV 500UNIT | Form: Powder for solution for injection | Indication: Product used for unknown indication | Action: Withdrawn

Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435713b3830196fa53cf3",
  "safetyreportid": "25947411",
  "authoritynumb": null,
  "companynumb": "US-IPSEN Group, Research and Development-2025-26024",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 61.0,
    "patientonsetageunit": 801,
    "patientagegroup": 5,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Rectal haemorrhage",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dysphagia",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dyspnoea",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Gastrointestinal injury",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Delayed recovery from anaesthesia",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Weaning failure",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "DYSPORT",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 2000.0,
        "drugstructuredosageunit": "025",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 12.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "SDV 500UNIT",
        "drugdosageform": "Powder for solution for injection",
        "drugadministrationroute": "030",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": null,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "ABOBOTULINUMTOXINA"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-22T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-22T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "IPSEN BIOPHARMACEUTICALS, INC."
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 1,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-19T00:00:00",
  "transmissiondateformat": "102"
}
                        