FDA FAERS Adverse Event Reports

110000

Total Reports

60230

Serious Reports

108

Reporter Countries

25972257 Type 2

Serious

BIMEKIZUMAB

Report Version

Receive Date

10/29/2025

Receipt Date

10/29/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

US-UCBSA-2025066857

Authority Number

Sender Organization

UCB

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

72.0 yr

Patient Age Group

Patient Sex

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Neck surgery (v28.1) Unknown

Post procedural sepsis (v28.1) Unknown

Drugs (1)

BIMEKIZUMAB (BIMEKIZUMAB) Suspect

Route: -- | Dosage: 320 MILLIGRAM, EV 8 WEEKS | Form: -- | Indication: Psoriasis | Action: Dose Not Changed

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

Recurrences: --

Clinical Narrative

Report Duplicates (1)

069: UG-069-000008322

Raw JSON (click to expand)

                            {
  "_id": "69974fbf8e900fe3f48c6274",
  "safetyreportid": "25972257",
  "authoritynumb": null,
  "companynumb": "US-UCBSA-2025066857",
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": null,
  "patient": {
    "patientonsetage": 72.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": null,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Neck surgery",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Post procedural sepsis",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "BIMEKIZUMAB",
        "drugauthorizationnumb": "761151",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 320.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 8.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "320 MILLIGRAM, EV 8 WEEKS",
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Psoriasis",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "BIMEKIZUMAB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-29T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "069",
      "duplicatenumb": "UG-069-000008322"
    }
  ],
  "reporttype": 2,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "UCB"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25972251 Type 1

Serious

YUFLYMA, YUFLYMA

Report Version

Receive Date

10/29/2025

Receipt Date

10/29/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Physician

Literature Reference

Company Number

Authority Number

EU-MINISAL02-1061025

Sender Organization

CELLTRION

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

56.0 yr

Patient Age Group

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Vitreous detachment (v28.1) Recovering

Drugs (2)

YUFLYMA (ADALIMUMAB-AATY) Suspect

Route: 058 | Dosage: 1 DOSAGE FORM, 1 PER CYLCLE | Form: Solution for injection | Indication: Psoriasis | Action: Withdrawn

Start: 05/01/2024 | End: 09/01/2025 | Duration: 1.0 yr | Rechallenge: -- | Additional: Yes

Recurrences: --

YUFLYMA (ADALIMUMAB-AATY) Suspect

Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Withdrawn

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250916

Report Duplicates (1)

MINISAL02: EU-MINISAL02-1061025

Raw JSON (click to expand)

                            {
  "_id": "69974fbf8e900fe3f48c6273",
  "safetyreportid": "25972251",
  "authoritynumb": "EU-MINISAL02-1061025",
  "companynumb": null,
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": 56.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Vitreous detachment",
        "reactionoutcome": 2
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "YUFLYMA",
        "drugauthorizationnumb": "761219",
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": 1.0,
        "drugstructuredosageunit": "032",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "1 DOSAGE FORM, 1 PER CYLCLE",
        "drugdosageform": "Solution for injection",
        "drugadministrationroute": "058",
        "drugindication": "Psoriasis",
        "drugstartdateformat": "610",
        "drugstartdate": "2024-05-01T00:00:00",
        "drugenddateformat": "610",
        "drugenddate": "2025-09-01T00:00:00",
        "drugtreatmentduration": 1.0,
        "drugtreatmentdurationunit": 801,
        "drugrecurreadministration": null,
        "drugadditional": 1,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "ADALIMUMAB-AATY"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "YUFLYMA",
        "drugauthorizationnumb": "761219",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Solution for injection",
        "drugadministrationroute": null,
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 1,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "ADALIMUMAB-AATY"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250916"
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 1,
    "literaturereference": null
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-29T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "MINISAL02",
      "duplicatenumb": "EU-MINISAL02-1061025"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "CELLTRION"
  },
  "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"
}
                        

25972250 Type 1

Serious

TADALAFIL, COCAINE, ALCOHOL

Report Version

Receive Date

10/29/2025

Receipt Date

10/29/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Company Number

EU-AFSSAPS-AVCN2025000700

Authority Number

Sender Organization

AUROBINDO

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

40.0 yr

Patient Age Group

Patient Sex

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (9)

Drug abuse (v28.1) Recovering

Coma (v28.1) Recovered

Generalised tonic-clonic seizure (v28.1) Recovered

Pneumonia aspiration (v28.1) Recovered

Confusional state (v28.1) Recovered

Agitation (v28.1) Recovered

Performance enhancing product use (v28.1) Recovering

Syphilis (v28.1) Recovering

High risk sexual behaviour (v28.1) Recovering

Drugs (3)

TADALAFIL (TADALAFIL) Suspect

Route: 048 | Dosage: UNK (REGULAR CONSUMPTION) | Form: Unknown | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

COCAINE (COCAINE) Suspect

Route: 045 | Dosage: UNK (REGULAR CONSUMPTION) | Form: Unknown | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

ALCOHOL (ALCOHOL) Suspect

Route: 048 | Dosage: 11US/J | Form: Unknown | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20210101

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69974fbf8e900fe3f48c6272",
  "safetyreportid": "25972250",
  "authoritynumb": null,
  "companynumb": "EU-AFSSAPS-AVCN2025000700",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": 40.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Drug abuse",
        "reactionoutcome": 2
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Coma",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Generalised tonic-clonic seizure",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Pneumonia aspiration",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Confusional state",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Agitation",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Performance enhancing product use",
        "reactionoutcome": 2
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Syphilis",
        "reactionoutcome": 2
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "High risk sexual behaviour",
        "reactionoutcome": 2
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "TADALAFIL",
        "drugauthorizationnumb": "206285",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK (REGULAR CONSUMPTION)",
        "drugdosageform": "Unknown",
        "drugadministrationroute": "048",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "TADALAFIL"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "COCAINE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK (REGULAR CONSUMPTION)",
        "drugdosageform": "Unknown",
        "drugadministrationroute": "045",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "COCAINE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ALCOHOL",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "11US/J",
        "drugdosageform": "Unknown",
        "drugadministrationroute": "048",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "ALCOHOL"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20210101"
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 3,
    "literaturereference": null
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-29T00:00:00",
  "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": 1,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25972248 Type 1

Serious

OMEPRAZOLE

Report Version

Receive Date

10/29/2025

Receipt Date

10/29/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

GB-MHRA-37407073

Authority Number

Sender Organization

TEVA

Sender Type

Receiver Organization

FDA

Receiver Type

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 (4)

Dysphagia (v28.1) Unknown

Dry throat (v28.1) Unknown

Oral discomfort (v28.1) Unknown

Dry mouth (v28.1) Unknown

Drugs (1)

OMEPRAZOLE (OMEPRAZOLE) Suspect

Route: 065 | Dosage: -- | Form: Gastro-resistant capsule, hard | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251009

Report Duplicates (1)

MHRAUK: GB-MHRA-37407073

Raw JSON (click to expand)

                            {
  "_id": "69974fbf8e900fe3f48c6271",
  "safetyreportid": "25972248",
  "authoritynumb": null,
  "companynumb": "GB-MHRA-37407073",
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "GB",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dysphagia",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dry throat",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Oral discomfort",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dry mouth",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "OMEPRAZOLE",
        "drugauthorizationnumb": "075347",
        "drugbatchnumb": "UNKNOWN",
        "drugstructuredosagenumb": 10.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Gastro-resistant 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": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "OMEPRAZOLE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251009"
  },
  "primarysource": {
    "reportercountry": "GB",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "GB",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-29T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "MHRAUK",
      "duplicatenumb": "GB-MHRA-37407073"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "TEVA"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25972245 Type 2

Serious

SPRAVATO, SPRAVATO, SPRAVATO (+1 more)

Report Version

Receive Date

10/29/2025

Receipt Date

10/29/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Physician

Literature Reference

Company Number

US-JNJFOC-20251029937

Authority Number

Sender Organization

JOHNSON AND JOHNSON

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

41.0 yr

Patient Age Group

Adult

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Sedation (v28.1) Recovered

Dissociation (v28.1) Recovered

Drugs (4)

SPRAVATO (ESKETAMINE) Suspect

Route: 045 | Dosage: ^56 MG, 1 TOTAL DOSES^ | Form: Nasal spray | Indication: Depression | Action: Unknown

Start: 03/14/2025 | End: 03/14/2025 | Duration: -- day | Rechallenge: Unknown | Additional: Unknown

Recurrences: --

SPRAVATO (ESKETAMINE) Suspect

Route: 045 | Dosage: ^84 MG, 20 TOTAL DOSES^ | Form: Nasal spray | Indication: -- | Action: Unknown

Start: 03/17/2025 | End: 09/24/2025 | Duration: 191.0 day | Rechallenge: Unknown | Additional: Unknown

Recurrences: --

SPRAVATO (ESKETAMINE) Suspect

Route: 045 | Dosage: ^84 MG, MOST RECENT DOSE ADMINISTERED^ | Form: Nasal spray | Indication: -- | Action: Unknown

Start: 10/22/2025 | End: 10/22/2025 | Duration: -- day | Rechallenge: Unknown | Additional: Unknown

Recurrences: --

KLONOPIN (CLONAZEPAM) Concomitant

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

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251022

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69974fbf8e900fe3f48c626f",
  "safetyreportid": "25972245",
  "authoritynumb": null,
  "companynumb": "US-JNJFOC-20251029937",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 41.0,
    "patientonsetageunit": 801,
    "patientagegroup": 5,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Sedation",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dissociation",
        "reactionoutcome": 1
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "SPRAVATO",
        "drugauthorizationnumb": "211243",
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": 56.0,
        "drugstructuredosageunit": "003",
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        "drugdosagetext": "^56 MG, 1 TOTAL DOSES^",
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        "drugadministrationroute": "045",
        "drugindication": "Depression",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-03-14T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-03-14T00:00:00",
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        "drugrecurreadministration": 3,
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          "activesubstancename": "ESKETAMINE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "SPRAVATO",
        "drugauthorizationnumb": "211243",
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        "drugdosagetext": "^84 MG, 20 TOTAL DOSES^",
        "drugdosageform": "Nasal spray",
        "drugadministrationroute": "045",
        "drugindication": null,
        "drugstartdateformat": "102",
        "drugstartdate": "2025-03-17T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-09-24T00:00:00",
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        "actiondrug": 5,
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          "activesubstancename": "ESKETAMINE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "SPRAVATO",
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        "drugbatchnumb": "24NG412X",
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        "drugcumulativedosageunit": null,
        "drugdosagetext": "^84 MG, MOST RECENT DOSE ADMINISTERED^",
        "drugdosageform": "Nasal spray",
        "drugadministrationroute": "045",
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        "drugstartdate": "2025-10-22T00:00:00",
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        "drugrecurreadministration": 3,
        "drugadditional": 3,
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        "activesubstance": {
          "activesubstancename": "ESKETAMINE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "KLONOPIN",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
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        "drugadministrationroute": null,
        "drugindication": "Product used for unknown indication",
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        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "CLONAZEPAM"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251022"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 1,
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  },
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  "receivedate": "2025-10-29T00:00:00",
  "receivedateformat": "102",
  "receiver": {
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  },
  "reportduplicate": [],
  "reporttype": 2,
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    "sendertype": 6,
    "senderorganization": "JOHNSON AND JOHNSON"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
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  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25972246 Type 1

Serious

HYALURONIDASE-ZZXF\PERTUZUMAB\TRASTUZUMAB

Report Version

Receive Date

10/29/2025

Receipt Date

10/29/2025

Transmission Date

01/19/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Company Number

CN-ROCHE-10000419768

Authority Number

Sender Organization

ROCHE

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

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)

Myelosuppression (v28.1) Recovering

Drugs (1)

HYALURONIDASE-ZZXF\PERTUZUMAB\TRASTUZUMAB (HYALURONIDASE-ZZXF\PERTUZUMAB\TRASTUZUMAB) Suspect

Route: 058 | Dosage: -- | Form: Injection | Indication: Invasive breast carcinoma | Action: Unknown

Start: 09/30/2025 | End: 09/30/2025 | Duration: -- -- | Rechallenge: -- | Additional: Unknown

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251021

Report Duplicates (1)

NMPACDR: 3201271040314202500710

Raw JSON (click to expand)

                            {
  "_id": "69974fbf8e900fe3f48c626e",
  "safetyreportid": "25972246",
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  "duplicate": 1,
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  "patient": {
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    "patientonsetageunit": 801,
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    "patientsex": 2,
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        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Myelosuppression",
        "reactionoutcome": 2
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "HYALURONIDASE-ZZXF\\PERTUZUMAB\\TRASTUZUMAB",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "B4558B01",
        "drugstructuredosagenumb": 10.0,
        "drugstructuredosageunit": "013",
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        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Injection",
        "drugadministrationroute": "058",
        "drugindication": "Invasive breast carcinoma",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-09-30T00:00:00",
        "drugenddateformat": "102",
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        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251021"
  },
  "primarysource": {
    "reportercountry": "CN",
    "qualification": 3,
    "literaturereference": null
  },
  "primarysourcecountry": "CN",
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  "receiver": {
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  },
  "reportduplicate": [
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  "reporttype": 1,
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  "transmissiondateformat": "102"
}
                        

25972247 Type 1

Serious

SPRYCEL, ONDANSETRON HYDROCHLORIDE, NURTEC ODT (+21 more)

Report Version

Receive Date

10/29/2025

Receipt Date

10/29/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Company Number

US-BRISTOL-MYERS SQUIBB COMPANY-2025-145384

Authority Number

Sender Organization

BRISTOL-MYERS SQUIBB COMPANY

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

51.0 yr

Patient Age Group

Adult

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Drug ineffective (v28.1) Unknown

Drugs (24)

SPRYCEL (DASATINIB) Suspect

Route: -- | Dosage: ROUTE: OTHER, FREQUENCY: OTHER | Form: Film-coated tablet | Indication: Chronic myeloid leukaemia | Action: Withdrawn

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

Recurrences: --

ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) Concomitant

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

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

Recurrences: --

NURTEC ODT (RIMEGEPANT SULFATE) Concomitant

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

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

Recurrences: --

IMITREX (SUMATRIPTAN SUCCINATE) Concomitant

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

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

Recurrences: --

AIMOVIG (ERENUMAB-AOOE) Concomitant

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

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

Recurrences: --

VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) Concomitant

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

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

Recurrences: --

DIAZEPAM (DIAZEPAM) Concomitant

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

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

Recurrences: --

DICLOFENAC SODIUM (DICLOFENAC SODIUM) Concomitant

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

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

Recurrences: --

URISTAT ULTRA UTI RELIEF (--) Concomitant

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

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

Recurrences: --

AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE) Concomitant

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

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

Recurrences: --

CLONAZEPAM (CLONAZEPAM) Concomitant

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

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

Recurrences: --

HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) Concomitant

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

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

Recurrences: --

TRAMADOL HCL (TRAMADOL HYDROCHLORIDE) Concomitant

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

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

Recurrences: --

LEVSIN (HYOSCYAMINE SULFATE) Concomitant

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

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

Recurrences: --

LEXAPRO (ESCITALOPRAM OXALATE) Concomitant

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

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

Recurrences: --

ESTRADIOL (ESTRADIOL) Concomitant

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

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

Recurrences: --

XYZAL ALLERGY 24HR (LEVOCETIRIZINE DIHYDROCHLORIDE) Concomitant

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

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

Recurrences: --

MAGNESIUM GLYCINATE (MAGNESIUM GLYCINATE) Concomitant

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

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

Recurrences: --

PREDNISONE (PREDNISONE) Concomitant

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

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

Recurrences: --

MELATONIN (MELATONIN) Concomitant

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

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

Recurrences: --

SINGULAIR (MONTELUKAST SODIUM) Concomitant

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

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

Recurrences: --

BOTOX (ONABOTULINUMTOXINA) Concomitant

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

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

Recurrences: --

FLUTICASONE FUROATE ELLIP (--) Concomitant

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

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

Recurrences: --

ALPRAZOLAM (ALPRAZOLAM) Concomitant

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

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

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        "reactionmeddraversionpt": "28.1",
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        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
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        "drugdosagetext": "ROUTE: OTHER, FREQUENCY: OTHER",
        "drugdosageform": "Film-coated tablet",
        "drugadministrationroute": null,
        "drugindication": "Chronic myeloid leukaemia",
        "drugstartdateformat": null,
        "drugstartdate": null,
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        "drugrecurreadministration": 3,
        "drugadditional": null,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "DASATINIB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "ONDANSETRON HYDROCHLORIDE",
        "drugauthorizationnumb": null,
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        "drugadditional": 3,
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          "activesubstancename": "ONDANSETRON HYDROCHLORIDE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "NURTEC ODT",
        "drugauthorizationnumb": null,
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        "activesubstance": {
          "activesubstancename": "RIMEGEPANT SULFATE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "IMITREX",
        "drugauthorizationnumb": null,
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        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "SUMATRIPTAN SUCCINATE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "AIMOVIG",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
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        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
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        "drugadministrationroute": null,
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "ERENUMAB-AOOE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "VALACYCLOVIR HYDROCHLORIDE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
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        "drugseparatedosagenumb": 1.0,
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  "primarysource": {
    "reportercountry": "US",
    "qualification": 3,
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  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
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  "reporttype": 1,
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  "sender": {
    "sendertype": 6,
    "senderorganization": "BRISTOL-MYERS SQUIBB COMPANY"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
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  "seriousnesslifethreatening": 2,
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  "transmissiondate": "2026-01-17T00:00:00",
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}
                        

25972244 Type 1

Non-Serious

PLEGRIDY, ELIQUIS, SOTALOL HYDROCHLORIDE (+2 more)

Report Version

Receive Date

10/29/2025

Receipt Date

10/29/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

US-BIOGEN-2025BI01321116

Authority Number

Sender Organization

BIOGEN

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

Patient Age Group

Elderly

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Drug delivery system malfunction (v28.1) Unknown

Drugs (5)

PLEGRIDY (PEGINTERFERON BETA-1A) Suspect

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

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

Recurrences: --

ELIQUIS (APIXABAN) Concomitant

Route: 065 | Dosage: -- | Form: Unknown | Indication: -- | Action: --

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

Recurrences: --

SOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE) Concomitant

Route: 065 | Dosage: -- | Form: Unknown | Indication: -- | Action: --

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

Recurrences: --

ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM) Concomitant

Route: 065 | Dosage: -- | Form: Unknown | Indication: -- | Action: --

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

Recurrences: --

LISINOPRIL (LISINOPRIL) Concomitant

Route: 065 | Dosage: -- | Form: Unknown | Indication: -- | Action: --

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

Recurrences: --

Clinical Narrative

Report Duplicates (2)

-: 552085

Raw JSON (click to expand)

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    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Drug delivery system malfunction",
        "reactionoutcome": 6
      }
    ],
    "drug": [
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        "drugdosageform": "Unknown",
        "drugadministrationroute": "065",
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "APIXABAN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "SOTALOL HYDROCHLORIDE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Unknown",
        "drugadministrationroute": "065",
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "SOTALOL HYDROCHLORIDE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "ATORVASTATIN CALCIUM",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Unknown",
        "drugadministrationroute": "065",
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "ATORVASTATIN CALCIUM"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "LISINOPRIL",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Unknown",
        "drugadministrationroute": "065",
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "LISINOPRIL"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-29T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "-",
      "duplicatenumb": "552085"
    },
    {
      "duplicatesource": "-",
      "duplicatenumb": "552085"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "BIOGEN"
  },
  "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"
}
                        

25972240 Type 1

Non-Serious

POMALYST

Report Version

Receive Date

10/29/2025

Receipt Date

10/29/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Company Number

US-BRISTOL-MYERS SQUIBB COMPANY-2025-146673

Authority Number

Sender Organization

BRISTOL-MYERS SQUIBB COMPANY

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

32.0 yr

Patient Age Group

Adult

Patient Sex

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Eye disorder (v28.1) Unknown

Off label use (v28.1) Unknown

Drugs (1)

POMALYST (POMALIDOMIDE) Suspect

Route: 048 | Dosage: -- | Form: Capsule | Indication: Plasma cell leukaemia | Action: Dose Not Changed

Start: 07/01/2025 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69974fbf8e900fe3f48c626a",
  "safetyreportid": "25972240",
  "authoritynumb": null,
  "companynumb": "US-BRISTOL-MYERS SQUIBB COMPANY-2025-146673",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 32.0,
    "patientonsetageunit": 801,
    "patientagegroup": 5,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Eye disorder",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Off label use",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "POMALYST",
        "drugauthorizationnumb": "204026",
        "drugbatchnumb": "C8045A",
        "drugstructuredosagenumb": 2.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Capsule",
        "drugadministrationroute": "048",
        "drugindication": "Plasma cell leukaemia",
        "drugstartdateformat": "610",
        "drugstartdate": "2025-07-01T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "POMALIDOMIDE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 3,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-29T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "BRISTOL-MYERS SQUIBB COMPANY"
  },
  "serious": 2,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 2,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25972242 Type 1

Non-Serious

HEMLIBRA

Report Version

Receive Date

10/29/2025

Receipt Date

10/29/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

US-ROCHE-10000415998

Authority Number

Sender Organization

ROCHE

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

Patient Age Group

Patient Sex

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Haemorrhage (v28.1) Unknown

Drugs (1)

HEMLIBRA (EMICIZUMAB-KXWH) Suspect

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

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69974fbf8e900fe3f48c6269",
  "safetyreportid": "25972242",
  "authoritynumb": null,
  "companynumb": "US-ROCHE-10000415998",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": null,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Haemorrhage",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "HEMLIBRA",
        "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": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "EMICIZUMAB-KXWH"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-29T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ROCHE"
  },
  "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"
}
                        

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