FDA FAERS Adverse Event Reports

111000

Total Reports

60668

Serious Reports

108

Reporter Countries

25936751 Type 1

Serious

TRESIBA

Report Version

Receive Date

10/17/2025

Receipt Date

10/17/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

US-NOVOPROD-1534341

Authority Number

Sender Organization

NOVO NORDISK

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

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Brain operation (v28.1) Unknown

Drugs (1)

TRESIBA (INSULIN DEGLUDEC) Suspect

Route: -- | Dosage: UNK | Form: Solution for injection | 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": "69d435343b3830196fa5110b",
  "safetyreportid": "25936751",
  "authoritynumb": null,
  "companynumb": "US-NOVOPROD-1534341",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Brain operation",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "TRESIBA",
        "drugauthorizationnumb": "203314",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": "Solution for injection",
        "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": "INSULIN DEGLUDEC"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-17T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-17T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "NOVO NORDISK"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 1,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25936748 Type 1

Serious

GENTAMICIN, ACETAMINOPHEN, CEFAZOLIN SODIUM (+3 more)

Report Version

Receive Date

10/17/2025

Receipt Date

10/17/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Physician

Literature Reference

Company Number

Authority Number

EU-AEMPS-1759825

Sender Organization

B. BRAUN MEDICAL INC.

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

64.0 yr

Patient Age Group

Adult

Patient Sex

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Drug reaction with eosinophilia and systemic symptoms (v28.1) Recovered

Hepatitis cholestatic (v28.1) Recovered

Drugs (6)

GENTAMICIN (GENTAMICIN) Suspect

Route: 042 | Dosage: -- | Form: -- | Indication: Infection prophylaxis | Action: Withdrawn

Start: 05/16/2025 | End: 05/16/2025 | Duration: -- -- | Rechallenge: Unknown | Additional: Yes

Recurrences: --

ACETAMINOPHEN (ACETAMINOPHEN) Suspect

Route: 042 | Dosage: -- | Form: -- | Indication: Pain | Action: Dose Not Changed

Start: 06/25/2025 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --

Recurrences: --

CEFAZOLIN SODIUM (CEFAZOLIN SODIUM) Suspect

Route: 042 | Dosage: -- | Form: -- | Indication: Infection prophylaxis | Action: Withdrawn

Start: 05/16/2025 | End: 05/16/2025 | Duration: -- -- | Rechallenge: -- | Additional: Yes

Recurrences: --

METAMIZOL SODIUM (METAMIZOL SODIUM) Suspect

Route: 042 | Dosage: -- | Form: -- | Indication: Pain | Action: Withdrawn

Start: 06/25/2025 | End: 08/18/2025 | Duration: 54.0 day | Rechallenge: -- | Additional: Yes

Recurrences: --

ATORVASTATIN (ATORVASTATIN) Suspect

Route: 048 | Dosage: -- | Form: -- | Indication: Dyslipidaemia | Action: Withdrawn

Start: 06/29/2025 | End: 07/16/2025 | Duration: 17.0 day | Rechallenge: -- | Additional: Yes

Recurrences: --

PENTOXIFYLLINE (PENTOXIFYLLINE) Concomitant

Route: 048 | Dosage: -- | Form: -- | Indication: Peripheral arterial occlusive disease | Action: Withdrawn

Start: 04/13/2025 | End: 06/25/2025 | Duration: 73.0 day | Rechallenge: -- | Additional: Yes

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250707

Report Duplicates (1)

EVPM: EU-AEMPS-1759825

Raw JSON (click to expand)

                            {
  "_id": "69d435343b3830196fa51108",
  "safetyreportid": "25936748",
  "authoritynumb": "EU-AEMPS-1759825",
  "companynumb": null,
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": 64.0,
    "patientonsetageunit": 801,
    "patientagegroup": 5,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Drug reaction with eosinophilia and systemic symptoms",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Hepatitis cholestatic",
        "reactionoutcome": 1
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "GENTAMICIN",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 435.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": "042",
        "drugindication": "Infection prophylaxis",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-05-16T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-05-16T00:00:00",
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": 1,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "GENTAMICIN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ACETAMINOPHEN",
        "drugauthorizationnumb": "204957",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 3.0,
        "drugstructuredosageunit": "002",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": "042",
        "drugindication": "Pain",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-06-25T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "ACETAMINOPHEN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CEFAZOLIN SODIUM",
        "drugauthorizationnumb": "050779",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 2.0,
        "drugstructuredosageunit": "002",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": "042",
        "drugindication": "Infection prophylaxis",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-05-16T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-05-16T00:00:00",
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 1,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "CEFAZOLIN SODIUM"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "METAMIZOL SODIUM",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 6.0,
        "drugstructuredosageunit": "002",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": "042",
        "drugindication": "Pain",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-06-25T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-08-18T00:00:00",
        "drugtreatmentduration": 54.0,
        "drugtreatmentdurationunit": 804,
        "drugrecurreadministration": null,
        "drugadditional": 1,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "METAMIZOL SODIUM"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ATORVASTATIN",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 40.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": "048",
        "drugindication": "Dyslipidaemia",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-06-29T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-07-16T00:00:00",
        "drugtreatmentduration": 17.0,
        "drugtreatmentdurationunit": 804,
        "drugrecurreadministration": null,
        "drugadditional": 1,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "ATORVASTATIN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "PENTOXIFYLLINE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 1.2,
        "drugstructuredosageunit": "002",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": "048",
        "drugindication": "Peripheral arterial occlusive disease",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-04-13T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-06-25T00:00:00",
        "drugtreatmentduration": 73.0,
        "drugtreatmentdurationunit": 804,
        "drugrecurreadministration": null,
        "drugadditional": 1,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "PENTOXIFYLLINE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250707"
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 1,
    "literaturereference": null
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-17T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-17T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "EVPM",
      "duplicatenumb": "EU-AEMPS-1759825"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "B. BRAUN MEDICAL INC."
  },
  "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"
}
                        

25936747 Type 1

Non-Serious

DUPIXENT

Report Version

Receive Date

10/17/2025

Receipt Date

10/17/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Company Number

US-SA-2025SA309158

Authority Number

Sender Organization

SANOFI AVENTIS

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

50.0 yr

Patient Age Group

Adult

Patient Sex

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Nasal congestion (v28.1) Recovered

Drugs (1)

DUPIXENT (DUPILUMAB) Suspect

Route: 058 | Dosage: 300 MG, QOW | Form: Solution for injection | Indication: Nasal polyps | Action: Unknown

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435343b3830196fa51107",
  "safetyreportid": "25936747",
  "authoritynumb": null,
  "companynumb": "US-SA-2025SA309158",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 50.0,
    "patientonsetageunit": 801,
    "patientagegroup": 5,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Nasal congestion",
        "reactionoutcome": 1
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "DUPIXENT",
        "drugauthorizationnumb": "761055",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 300.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 2.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "300 MG, QOW",
        "drugdosageform": "Solution for injection",
        "drugadministrationroute": "058",
        "drugindication": "Nasal polyps",
        "drugstartdateformat": "610",
        "drugstartdate": "2025-07-01T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "DUPILUMAB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 3,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-17T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-17T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "SANOFI AVENTIS"
  },
  "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"
}
                        

25936749 Type 1

Serious

FERINJECT, SODIUM CHLORIDE

Report Version

Receive Date

10/17/2025

Receipt Date

10/17/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Company Number

EU-AMERICAN REGENT INC-2025003774

Authority Number

Sender Organization

AMERICAN REGENT

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

69.0 yr

Patient Age Group

Patient Sex

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Dermatitis exfoliative generalised (v28.1) Recovered

Hyperhidrosis (v28.1) Recovered

Hypopnoea (v28.1) Recovered

Headache (v28.1) Recovered

Drugs (2)

FERINJECT (FERRIC CARBOXYMALTOSE) Suspect

Route: 042 | Dosage: 1 VIAL IN 250 CC OF SALINE SOLUTION | Form: Injection | Indication: Iron deficiency | Action: Withdrawn

Start: 09/25/2025 | End: 09/25/2025 | Duration: -- -- | Rechallenge: -- | Additional: Yes

Recurrences: --

SODIUM CHLORIDE (SODIUM CHLORIDE) Concomitant

Route: 042 | Dosage: 250 CC | Form: -- | Indication: Product used for unknown indication | Action: --

Start: 09/25/2025 | End: 09/25/2025 | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250925

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435343b3830196fa51106",
  "safetyreportid": "25936749",
  "authoritynumb": null,
  "companynumb": "EU-AMERICAN REGENT INC-2025003774",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": 69.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dermatitis exfoliative generalised",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Hyperhidrosis",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Hypopnoea",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Headache",
        "reactionoutcome": 1
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "FERINJECT",
        "drugauthorizationnumb": "203565",
        "drugbatchnumb": "not reported",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "1 VIAL IN 250 CC OF SALINE SOLUTION",
        "drugdosageform": "Injection",
        "drugadministrationroute": "042",
        "drugindication": "Iron deficiency",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-09-25T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-09-25T00:00:00",
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 1,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "FERRIC CARBOXYMALTOSE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "SODIUM CHLORIDE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 250.0,
        "drugstructuredosageunit": "012",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "250 CC",
        "drugdosageform": null,
        "drugadministrationroute": "042",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-09-25T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-09-25T00:00:00",
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "SODIUM CHLORIDE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250925"
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 3,
    "literaturereference": null
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-17T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-17T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "AMERICAN REGENT"
  },
  "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"
}
                        

25936746 Type 2

Serious

UPADACITINIB

Report Version

Receive Date

10/17/2025

Receipt Date

10/17/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Fu X, Tu L, Fu Y, Wang H, Chen Y, Zhang X, et al. Upadacitinib induction therapy in Crohn^ s disease: a retrospective real-world study in biologic-refractory patients. BMC Gastroenterol. 2025;25(1):707. doi.org/10.1186/s12876-025-04305-z

Company Number

CN-ABBVIE-6505732

Authority Number

Sender Organization

ABBVIE

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

Patient Age Group

Adult

Patient Sex

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Pulmonary tuberculosis (v28.1) Unknown

Drugs (1)

UPADACITINIB (UPADACITINIB) Suspect

Route: 048 | Dosage: -- | Form: -- | Indication: Crohn^s disease | Action: Withdrawn

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435343b3830196fa51105",
  "safetyreportid": "25936746",
  "authoritynumb": null,
  "companynumb": "CN-ABBVIE-6505732",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "CN",
  "patient": {
    "patientonsetage": null,
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    "patientagegroup": 5,
    "patientweight": null,
    "patientsex": null,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Pulmonary tuberculosis",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "UPADACITINIB",
        "drugauthorizationnumb": "211675",
        "drugbatchnumb": "Not Available",
        "drugstructuredosagenumb": null,
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        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": "048",
        "drugindication": "Crohn^s disease",
        "drugstartdateformat": null,
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        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
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        "drugadditional": null,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "UPADACITINIB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "CN",
    "qualification": 3,
    "literaturereference": "Fu X, Tu L, Fu Y, Wang H, Chen Y, Zhang X, et al. Upadacitinib induction therapy in Crohn^ s disease: a retrospective real-world study in biologic-refractory patients. BMC Gastroenterol. 2025;25(1):707. doi.org/10.1186/s12876-025-04305-z"
  },
  "primarysourcecountry": "CN",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-17T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-17T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 2,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ABBVIE"
  },
  "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"
}
                        

25936744 Type 1

Serious

BALVERSA

Report Version

Receive Date

10/17/2025

Receipt Date

10/17/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Physician

Literature Reference

Company Number

JP-JNJFOC-20251022058

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

Patient Age Group

Patient Sex

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Retinal detachment (v28.1) Recovering

Blood phosphorus increased (v28.1) Recovering

Drugs (1)

BALVERSA (ERDAFITINIB) Suspect

Route: 048 | Dosage: -- | Form: Film-coated tablet | Indication: Transitional cell carcinoma | Action: Withdrawn

Start: 08/05/2025 | End: 01/01/2025 | Duration: -- -- | Rechallenge: Unknown | Additional: Yes

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435343b3830196fa51104",
  "safetyreportid": "25936744",
  "authoritynumb": null,
  "companynumb": "JP-JNJFOC-20251022058",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "JP",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": null,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Retinal detachment",
        "reactionoutcome": 2
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Blood phosphorus increased",
        "reactionoutcome": 2
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "BALVERSA",
        "drugauthorizationnumb": "212018",
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": 9.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Film-coated tablet",
        "drugadministrationroute": "048",
        "drugindication": "Transitional cell carcinoma",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-08-05T00:00:00",
        "drugenddateformat": "602",
        "drugenddate": "2025-01-01T00:00:00",
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": 1,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "ERDAFITINIB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101"
  },
  "primarysource": {
    "reportercountry": "JP",
    "qualification": 1,
    "literaturereference": null
  },
  "primarysourcecountry": "JP",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-17T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-17T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "JOHNSON AND JOHNSON"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": null,
  "seriousnessdeath": null,
  "seriousnessdisabling": null,
  "seriousnesshospitalization": null,
  "seriousnesslifethreatening": null,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25936745 Type 1

Serious

GLIVEC

Report Version

Receive Date

10/17/2025

Receipt Date

10/17/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Physician

Literature Reference

Company Number

VE-002147023-NVSC2025VE159374

Authority Number

Sender Organization

NOVARTIS

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 (1)

Polymerase chain reaction positive (v28.1) Unknown

Drugs (1)

GLIVEC (IMATINIB MESYLATE) Suspect

Route: 065 | Dosage: 400 MG | Form: -- | Indication: Chronic myeloid leukaemia | Action: Unknown

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435343b3830196fa51103",
  "safetyreportid": "25936745",
  "authoritynumb": null,
  "companynumb": "VE-002147023-NVSC2025VE159374",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "VE",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Polymerase chain reaction positive",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "GLIVEC",
        "drugauthorizationnumb": "21588",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 400.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "400 MG",
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": "Chronic myeloid leukaemia",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "IMATINIB MESYLATE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "VE",
    "qualification": 1,
    "literaturereference": null
  },
  "primarysourcecountry": "VE",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-17T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-17T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "NOVARTIS"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25936742 Type 1

Serious

CYCLOPHOSPHAMIDE, DEXAMETHASONE, IXAZOMIB (+1 more)

Report Version

Receive Date

10/17/2025

Receipt Date

10/17/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Pharmacist

Literature Reference

Company Number

CA-SANDOZ-SDZ2025CA077130

Authority Number

Sender Organization

SANDOZ

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 (3)

Infection (v28.1) Recovering

Mastitis (v28.1) Recovering

Off label use (v28.1) Recovering

Drugs (4)

CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) Suspect

Route: 065 | Dosage: UNK | Form: -- | Indication: Plasma cell myeloma | Action: Unknown

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

Recurrences: --

DEXAMETHASONE (DEXAMETHASONE) Suspect

Route: 065 | Dosage: UNK | Form: Unknown | Indication: Plasma cell myeloma | Action: Unknown

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

Recurrences: --

IXAZOMIB (IXAZOMIB) Suspect

Route: 048 | Dosage: 4 MG | Form: Capsule | Indication: Plasma cell myeloma | Action: Unknown

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

Recurrences: --

IXAZOMIB (IXAZOMIB) Suspect

Route: 048 | Dosage: 4 MG | Form: Capsule | Indication: -- | Action: Unknown

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435343b3830196fa51102",
  "safetyreportid": "25936742",
  "authoritynumb": null,
  "companynumb": "CA-SANDOZ-SDZ2025CA077130",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "CA",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Infection",
        "reactionoutcome": 2
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Mastitis",
        "reactionoutcome": 2
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Off label use",
        "reactionoutcome": 2
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CYCLOPHOSPHAMIDE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": "Plasma cell myeloma",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
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        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "CYCLOPHOSPHAMIDE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "DEXAMETHASONE",
        "drugauthorizationnumb": "13422",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": "Unknown",
        "drugadministrationroute": "065",
        "drugindication": "Plasma cell myeloma",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
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        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "DEXAMETHASONE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "IXAZOMIB",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 4.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "4 MG",
        "drugdosageform": "Capsule",
        "drugadministrationroute": "048",
        "drugindication": "Plasma cell myeloma",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "IXAZOMIB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "IXAZOMIB",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 4.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "4 MG",
        "drugdosageform": "Capsule",
        "drugadministrationroute": "048",
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "IXAZOMIB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "CA",
    "qualification": 2,
    "literaturereference": null
  },
  "primarysourcecountry": "CA",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-17T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-17T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "SANDOZ"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 1,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 2,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25936741 Type 1

Non-Serious

BOTOX, BOTOX, BOTOX (+9 more)

Report Version

Receive Date

10/17/2025

Receipt Date

10/17/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

US-ABBVIE-6497671

Authority Number

Sender Organization

ABBVIE

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

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious