FDA FAERS Adverse Event Reports

111000

Total Reports

60668

Serious Reports

108

Reporter Countries

25974510 Type 1

Non-Serious

TYLENOL

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-KENVUE-20251005136

Authority Number

Sender Organization

Kenvue

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)

Adverse event (v28.1) Unknown

Drugs (1)

TYLENOL (ACETAMINOPHEN) Suspect

Route: 065 | Dosage: -- | Form: Unknown | 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": "69e7691c5eb43a53b3ff1ea0",
  "safetyreportid": "25974510",
  "authoritynumb": null,
  "companynumb": "US-KENVUE-20251005136",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": null,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Adverse event",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "TYLENOL",
        "drugauthorizationnumb": "019872",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Unknown",
        "drugadministrationroute": "065",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "ACETAMINOPHEN"
        },
        "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": "Kenvue"
  },
  "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"
}
                        

25974507 Type 1

Serious

TIROFIBAN, ASPIRIN, HEPARIN

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

EU-AFSSAPS-PA2025000979

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

44.0 yr

Patient Age Group

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Shock haemorrhagic (v28.1) Fatal

Drugs (3)

TIROFIBAN (TIROFIBAN) Suspect

Route: 051 | Dosage: 1 DOSAGE FORM | Form: Unknown | Indication: Aneurysm | Action: Not Applicable

Start: 10/06/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4

Recurrences: --

ASPIRIN (ASPIRIN) Suspect

Route: 042 | Dosage: 250 MILLIGRAM | Form: Unknown | Indication: Aneurysm | Action: Not Applicable

Start: 10/06/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4

Recurrences: --

HEPARIN (HEPARIN SODIUM) Suspect

Route: 042 | Dosage: 4000 INTERNATIONAL UNIT | Form: Unknown | Indication: Aneurysm | Action: Not Applicable

Start: 10/06/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251006

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69e7691c5eb43a53b3ff1e9f",
  "safetyreportid": "25974507",
  "authoritynumb": null,
  "companynumb": "EU-AFSSAPS-PA2025000979",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": 44.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Shock haemorrhagic",
        "reactionoutcome": 5
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "TIROFIBAN",
        "drugauthorizationnumb": "216379",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 1.0,
        "drugstructuredosageunit": "032",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "1 DOSAGE FORM",
        "drugdosageform": "Unknown",
        "drugadministrationroute": "051",
        "drugindication": "Aneurysm",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-10-06T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "TIROFIBAN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ASPIRIN",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 250.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "250 MILLIGRAM",
        "drugdosageform": "Unknown",
        "drugadministrationroute": "042",
        "drugindication": "Aneurysm",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-10-06T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "ASPIRIN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "HEPARIN",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 4000.0,
        "drugstructuredosageunit": "025",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "4000 INTERNATIONAL UNIT",
        "drugdosageform": "Unknown",
        "drugadministrationroute": "042",
        "drugindication": "Aneurysm",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-10-06T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "HEPARIN SODIUM"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251006"
  },
  "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": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "AUROBINDO"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 1,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25974509 Type 2

Serious

NUPLAZID, ATORVASTATIN, BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE (+2 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

Consumer

Literature Reference

Company Number

US-ACADIA PHARMACEUTICALS INC.-ACA-2025-PIM-011629

Authority Number

Sender Organization

ACADIA PHARMACEUTICALS

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)

Death (v28.1) Fatal

Drugs (5)

NUPLAZID (PIMAVANSERIN TARTRATE) Suspect

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

Start: 11/22/2019 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4

Recurrences: --

ATORVASTATIN (ATORVASTATIN) Concomitant

Route: -- | Dosage: -- | Form: Tablet | Indication: -- | Action: --

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

Recurrences: --

BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE (ACETAMINOPHEN\BUTALBITAL\CAFFEINE) Concomitant

Route: -- | Dosage: -- | Form: Capsule | Indication: -- | Action: --

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

Recurrences: --

CARBIDOPA\LEVODOPA (CARBIDOPA\LEVODOPA) Concomitant

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

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

Recurrences: --

ESCITALOPRAM (ESCITALOPRAM OXALATE) Concomitant

Route: -- | Dosage: -- | Form: Tablet | Indication: -- | Action: --

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69e7691c5eb43a53b3ff1e9e",
  "safetyreportid": "25974509",
  "authoritynumb": null,
  "companynumb": "US-ACADIA PHARMACEUTICALS INC.-ACA-2025-PIM-011629",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Death",
        "reactionoutcome": 5
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "NUPLAZID",
        "drugauthorizationnumb": "210793",
        "drugbatchnumb": "6210888",
        "drugstructuredosagenumb": 34.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "34 MILLIGRAM, QD",
        "drugdosageform": "Capsule",
        "drugadministrationroute": "048",
        "drugindication": "Parkinson^s disease",
        "drugstartdateformat": "102",
        "drugstartdate": "2019-11-22T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "PIMAVANSERIN TARTRATE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "ATORVASTATIN",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Tablet",
        "drugadministrationroute": null,
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "ATORVASTATIN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Capsule",
        "drugadministrationroute": null,
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "ACETAMINOPHEN\\BUTALBITAL\\CAFFEINE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "CARBIDOPA\\LEVODOPA",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "CARBIDOPA\\LEVODOPA"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "ESCITALOPRAM",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Tablet",
        "drugadministrationroute": null,
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "ESCITALOPRAM OXALATE"
        },
        "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": 2,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ACADIA PHARMACEUTICALS"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 1,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25974508 Type 1

Serious

ETONOGESTREL

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

EU-ORGANON-O2509SVN002410

Authority Number

Sender Organization

ORGANON

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

36.0 yr

Patient Age Group

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Implant site necrosis (v28.1) Recovered w/ Sequelae

Fat necrosis (v28.1) Recovered w/ Sequelae

Postoperative wound infection (v28.1) Recovered w/ Sequelae

Complication of device removal (v28.1) Recovered

Product use in unapproved indication (v28.1) Unknown

Drugs (1)

ETONOGESTREL (ETONOGESTREL) Suspect

Route: -- | Dosage: 1 IMPLANT | Form: -- | Indication: Assisted fertilisation | Action: Withdrawn

Start: 07/24/2025 | End: 08/13/2025 | Duration: 21.0 day | Rechallenge: Unknown | Additional: Yes

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69e7691c5eb43a53b3ff1e9c",
  "safetyreportid": "25974508",
  "authoritynumb": null,
  "companynumb": "EU-ORGANON-O2509SVN002410",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": null,
  "patient": {
    "patientonsetage": 36.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Implant site necrosis",
        "reactionoutcome": 4
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Fat necrosis",
        "reactionoutcome": 4
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Postoperative wound infection",
        "reactionoutcome": 4
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Complication of device removal",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Product use in unapproved indication",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ETONOGESTREL",
        "drugauthorizationnumb": "21529",
        "drugbatchnumb": "B117577",
        "drugstructuredosagenumb": 1.0,
        "drugstructuredosageunit": "032",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "1 IMPLANT",
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Assisted fertilisation",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-07-24T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-08-13T00:00:00",
        "drugtreatmentduration": 21.0,
        "drugtreatmentdurationunit": 804,
        "drugrecurreadministration": 3,
        "drugadditional": 1,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "ETONOGESTREL"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101"
  },
  "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": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ORGANON"
  },
  "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"
}
                        

25974506 Type 1

Serious

RIVAROXABAN

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

Physician

Literature Reference

Company Number

EU-MINISAL02-1062704

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

92.0 yr

Patient Age Group

Patient Sex

Female

Patient Weight

62.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Dermatitis allergic (v28.1) Not Recovered

Urticaria (v28.1) Not Recovered

Skin discolouration (v28.1) Not Recovered

Drugs (1)

RIVAROXABAN (RIVAROXABAN) Suspect

Route: 048 | Dosage: 5 MILLIGRAM, ONCE A DAY (2,5 MG X 2 /DIE) | Form: Unknown | Indication: Thrombosis | Action: Withdrawn

Start: 06/01/2025 | End: 10/12/2025 | Duration: -- -- | Rechallenge: -- | Additional: No

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250601

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69e7691c5eb43a53b3ff1e9a",
  "safetyreportid": "25974506",
  "authoritynumb": null,
  "companynumb": "EU-MINISAL02-1062704",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": 92.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": 62.0,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dermatitis allergic",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Urticaria",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Skin discolouration",
        "reactionoutcome": 3
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "RIVAROXABAN",
        "drugauthorizationnumb": "208544",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 5.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "5 MILLIGRAM, ONCE A DAY (2,5 MG X 2 /DIE)",
        "drugdosageform": "Unknown",
        "drugadministrationroute": "048",
        "drugindication": "Thrombosis",
        "drugstartdateformat": "610",
        "drugstartdate": "2025-06-01T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-10-12T00:00:00",
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 2,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "RIVAROXABAN"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250601"
  },
  "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": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "AUROBINDO"
  },
  "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"
}
                        

25974505 Type 1

Serious

CARVYKTI

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

Consumer

Literature Reference

Company Number

US-JNJFOC-20251018224

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

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Hospitalisation (v28.1) Unknown

Drugs (1)

CARVYKTI (CILTACABTAGENE AUTOLEUCEL) Suspect

Route: 065 | Dosage: -- | Form: Dispersion for infusion | Indication: Product used for unknown indication | Action: Not Applicable

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69e7691c5eb43a53b3ff1e99",
  "safetyreportid": "25974505",
  "authoritynumb": null,
  "companynumb": "US-JNJFOC-20251018224",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Hospitalisation",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CARVYKTI",
        "drugauthorizationnumb": "125746",
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Dispersion for infusion",
        "drugadministrationroute": "065",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "CILTACABTAGENE AUTOLEUCEL"
        },
        "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": "JOHNSON AND JOHNSON"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 1,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 2,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-19T00:00:00",
  "transmissiondateformat": "102"
}
                        

25974504 Type 2

Serious

PREDNISONE, ENTYVIO, ENTYVIO (+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

Other Health Professional

Literature Reference

Company Number

CA-TEVA-VS-3386589

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

70.0 yr

Patient Age Group

Patient Sex

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (15)

Crohn^s disease (v28.1) Not Recovered

Viral infection (v28.1) Not Recovered

Pruritus (v28.1) Not Recovered

Derealisation (v28.1) Not Recovered

Anger (v28.1) Not Recovered

Diarrhoea (v28.1) Not Recovered

Product dose omission issue (v28.1) Not Recovered

Scabies (v28.1) Not Recovered

Transplantation complication (v28.1) Not Recovered

Affect lability (v28.1) Not Recovered

Rash (v28.1) Not Recovered

Gastrointestinal disorder (v28.1) Not Recovered

Therapeutic product effect decreased (v28.1) Not Recovered

Illness (v28.1) Not Recovered

Malaise (v28.1) Not Recovered

Drugs (4)

PREDNISONE (PREDNISONE) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

ENTYVIO (VEDOLIZUMAB) Suspect

Route: 042 | Dosage: ENTYVIO FOR I.V. INFUSION | Form: Powder for solution for infusion | Indication: Crohn^s disease | Action: Unknown

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

Recurrences: --

ENTYVIO (VEDOLIZUMAB) Suspect

Route: 042 | Dosage: ENTYVIO FOR I.V. INFUSION | Form: Powder for solution for infusion | Indication: Crohn^s disease | Action: Unknown

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

Recurrences: --

ENTYVIO (VEDOLIZUMAB) Suspect

Route: 042 | Dosage: DOSE FORM: POWDER FOR SOLUTION INTRAVENOUS, ENTYVIO FOR I.V. INFUSION | Form: -- | Indication: Crohn^s disease | Action: Unknown

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

Recurrences: --

Clinical Narrative

Report Duplicates (2)

Market Authorization Holder AER Number: 2021TUS078940

Health Canada: E2B_08128530

Raw JSON (click to expand)

                            {
  "_id": "69e7691c5eb43a53b3ff1e98",
  "safetyreportid": "25974504",
  "authoritynumb": null,
  "companynumb": "CA-TEVA-VS-3386589",
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "CA",
  "patient": {
    "patientonsetage": 70.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Crohn^s disease",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Viral infection",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Pruritus",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Derealisation",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Anger",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Diarrhoea",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Product dose omission issue",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Scabies",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Transplantation complication",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Affect lability",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Rash",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Gastrointestinal disorder",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Therapeutic product effect decreased",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Illness",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Malaise",
        "reactionoutcome": 3
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "PREDNISONE",
        "drugauthorizationnumb": "080356",
        "drugbatchnumb": "UNKNOWN",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "DOSE FORM: NOT SPECIFIED",
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
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        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "PREDNISONE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ENTYVIO",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "UNKNOWN",
        "drugstructuredosagenumb": 300.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "ENTYVIO FOR I.V. INFUSION",
        "drugdosageform": "Powder for solution for infusion",
        "drugadministrationroute": "042",
        "drugindication": "Crohn^s disease",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "VEDOLIZUMAB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ENTYVIO",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "UNKNOWN",
        "drugstructuredosagenumb": 300.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "ENTYVIO FOR I.V. INFUSION",
        "drugdosageform": "Powder for solution for infusion",
        "drugadministrationroute": "042",
        "drugindication": "Crohn^s disease",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "VEDOLIZUMAB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ENTYVIO",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "UNKNOWN",
        "drugstructuredosagenumb": 300.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "DOSE FORM: POWDER FOR SOLUTION INTRAVENOUS, ENTYVIO FOR I.V. INFUSION",
        "drugdosageform": null,
        "drugadministrationroute": "042",
        "drugindication": "Crohn^s disease",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "VEDOLIZUMAB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "CA",
    "qualification": 3,
    "literaturereference": null
  },
  "primarysourcecountry": "CA",
  "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": "Market Authorization Holder AER Number",
      "duplicatenumb": "2021TUS078940"
    },
    {
      "duplicatesource": "Health Canada",
      "duplicatenumb": "E2B_08128530"
    }
  ],
  "reporttype": 2,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "TEVA"
  },
  "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"
}
                        

25974503 Type 1

Non-Serious

JOENJA, ACETAMINOPHEN, ADAPALENE (+32 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-PHARMING-PHAUS2025001498

Authority Number

Sender Organization

PHARMING GROUP

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 (2)

Skin infection (v28.1) Unknown

Headache (v28.1) Unknown

Drugs (35)

JOENJA (LENIOLISIB PHOSPHATE) Suspect

Route: 048 | Dosage: 70 MILLIGRAM, BID | Form: TABLET, FILM COATED | Indication: Activated PI3 kinase delta syndrome | Action: Dose Not Changed

Start: 07/31/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

ACETAMINOPHEN (ACETAMINOPHEN) Concomitant

Route: 048 | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

ADAPALENE (ADAPALENE) Concomitant

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

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

Recurrences: --

ALBUTEROL SULFATE (ALBUTEROL SULFATE) Concomitant

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

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

Recurrences: --

AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) Concomitant

Route: 048 | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

AZELASTINE HYDROCHLORIDE (AZELASTINE HYDROCHLORIDE) Concomitant

Route: 045 | Dosage: -- | Form: Solution | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

BUDESONIDE\FORMOTEROL FUMARATE (BUDESONIDE\FORMOTEROL FUMARATE) Concomitant

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

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

Recurrences: --

CETIRIZINE HCL (CETIRIZINE HYDROCHLORIDE) Concomitant

Route: 048 | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

CLEMASTINE FUMARATE (CLEMASTINE FUMARATE) Concomitant

Route: 048 | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) Concomitant

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

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

Recurrences: --

CLONIDINE HYDROCHLORIDE (CLONIDINE HYDROCHLORIDE) Concomitant

Route: 048 | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

MUPIROCIN (MUPIROCIN) Concomitant

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

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

Recurrences: --

DEXAMETHASONE (DEXAMETHASONE) Concomitant

Route: 048 | Dosage: -- | Form: Solution | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

EPINEPHRINE (EPINEPHRINE) Concomitant

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

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

Recurrences: --

FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) Concomitant

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

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

Recurrences: --

GABAPENTIN (GABAPENTIN) Concomitant

Route: 048 | Dosage: -- | Form: Capsule | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

GINGER ROOT /01646602/ (--) Concomitant

Route: 048 | Dosage: -- | Form: Capsule | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

HYOSCYAMINE SULFATE (HYOSCYAMINE SULFATE) Concomitant

Route: 048 | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

IBUPROFEN (IBUPROFEN) Concomitant

Route: 048 | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

PRIVIGEN (HUMAN IMMUNOGLOBULIN G) Concomitant

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

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

Recurrences: --

IPRATROPIUM BROMIDE (IPRATROPIUM BROMIDE) Concomitant

Route: 045 | Dosage: -- | Form: Solution | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

KETOCONAZOLE (KETOCONAZOLE) Concomitant

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

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

Recurrences: --

MAGNESIUM OXIDE (MAGNESIUM OXIDE) Concomitant

Route: 048 | Dosage: -- | Form: Capsule | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

MELOXICAM (MELOXICAM) Concomitant

Route: 048 | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE SODIUM SUCCINATE) Concomitant

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

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

Recurrences: --

METRONIDAZOLE (METRONIDAZOLE) Concomitant

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

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

Recurrences: --

ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) Concomitant

Route: 048 | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

PIMECROLIMUS (PIMECROLIMUS) Concomitant

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

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

Recurrences: --

SACCHAROMYCES CEREVISIAE (SACCHAROMYCES CEREVISIAE) Concomitant

Route: 048 | Dosage: -- | Form: Capsule | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) Concomitant

Route: 045 | Dosage: -- | Form: AEROSOL | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) Concomitant

Route: 048 | Dosage: -- | Form: Capsule | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

LEXAPRO (ESCITALOPRAM OXALATE) Concomitant

Route: 048 | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) Concomitant

Route: 048 | Dosage: -- | Form: Capsule | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

WEYGOVY (--) Concomitant

Route: 058 | Dosage: -- | Form: Solution | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

HUMIRA (ADALIMUMAB) Concomitant

Route: 058 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

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      {
        "drugcharacterization": 2,
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      {
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        "drugdosageform": "Cream",
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          "activesubstancename": "PIMECROLIMUS"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "SACCHAROMYCES CEREVISIAE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
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          "activesubstancename": "SACCHAROMYCES CEREVISIAE"
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        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "TRIAMCINOLONE ACETONIDE",
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        "drugdosageform": "AEROSOL",
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      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "CLINDAMYCIN HYDROCHLORIDE",
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        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "LEXAPRO",
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          "activesubstancename": "ESCITALOPRAM OXALATE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "MINOCYCLINE HYDROCHLORIDE",
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      {
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          "activesubstancename": "ADALIMUMAB"
        },
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      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
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  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
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  "receivedateformat": "102",
  "receiver": {
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  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25974500 Type 2

Serious

NUPLAZID

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-ACADIA PHARMACEUTICALS INC.-ACA-2025-PIM-011655

Authority Number

Sender Organization

ACADIA PHARMACEUTICALS

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

84.0 yr

Patient Age Group

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Death (v28.1) Fatal

Drugs (1)

NUPLAZID (PIMAVANSERIN TARTRATE) Suspect

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

Start: 04/01/2019 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251001

Report Duplicates (0)

Raw JSON (click to expand)

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  "_id": "69e7691c5eb43a53b3ff1e95",
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  "companynumb": "US-ACADIA PHARMACEUTICALS INC.-ACA-2025-PIM-011655",
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  "occurcountry": "US",
  "patient": {
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    "patientweight": null,
    "patientsex": 2,
    "reaction": [
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        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Death",
        "reactionoutcome": 5
      }
    ],
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        "drugcharacterization": 1,
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        "drugcumulativedosageunit": null,
        "drugdosagetext": "34 MILLIGRAM, QD",
        "drugdosageform": "Capsule",
        "drugadministrationroute": "048",
        "drugindication": "Parkinson^s disease",
        "drugstartdateformat": "610",
        "drugstartdate": "2019-04-01T00:00:00",
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          "activesubstancename": "PIMAVANSERIN TARTRATE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251001"
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    "qualification": 5,
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    "receivertype": 6,
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  "reporttype": 2,
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    "sendertype": 6,
    "senderorganization": "ACADIA PHARMACEUTICALS"
  },
  "serious": 1,
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  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25974502 Type 1

Serious

METHOTREXATE, MYOCHRYSINE, ACETAMINOPHEN (+72 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

Other Health Professional

Literature Reference

Company Number

CA-TEVA-VS-3386636

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 (2)

Maternal exposure during pregnancy (v28.1) Unknown

Congenital anomaly (v28.1) Unknown

Drugs (75)

METHOTREXATE (METHOTREXATE) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

MYOCHRYSINE (GOLD SODIUM THIOMALATE) Suspect

Route: 030 | Dosage: DOSE FORM: SOLUTION INTRAMUSCULAR | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

ACETAMINOPHEN (ACETAMINOPHEN) Suspect

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

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

Recurrences: --

ACTEMRA (TOCILIZUMAB) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

LEFLUNOMIDE (LEFLUNOMIDE) Suspect

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

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

Recurrences: --

HAIR KERATIN AMINO ACIDS GOLD COMPLEX (HAIR KERATIN AMINO ACIDS GOLD COMPLEX) Suspect

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

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

Recurrences: --

AIMOVIG (ERENUMAB-AOOE) Suspect

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

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

Recurrences: --

MYRBETRIQ (MIRABEGRON) Suspect

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

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

Recurrences: --

LAMICTAL (LAMOTRIGINE) Suspect

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

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

Recurrences: --

CORTISONE ACETATE (CORTISONE ACETATE) Suspect

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

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

Recurrences: --

COSENTYX (SECUKINUMAB) Suspect

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

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

Recurrences: --

GOLD SODIUM THIOMALATE (GOLD SODIUM THIOMALATE) Suspect

Route: 030 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

OXYCODONE TEREPHTHALATE (OXYCODONE TEREPHTHALATE) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

FOSAMAX (ALENDRONATE SODIUM) Suspect

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

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

Recurrences: --

HYDROXYCHLOROQUINE (HYDROXYCHLOROQUINE) Suspect

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

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

Recurrences: --

HYDROXYCHLOROQUINE (HYDROXYCHLOROQUINE) Suspect

Route: 065 | Dosage: HYDROXYCHLOROQUINE SULFATE | Form: Tablet | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

ATOMOXETINE (ATOMOXETINE) Suspect

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

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

Recurrences: --

DOMPERIDONE MALEATE (DOMPERIDONE MALEATE) Suspect

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

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

Recurrences: --

NAPROXEN SODIUM (NAPROXEN SODIUM) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

FLUMETHASONE (FLUMETHASONE) Suspect

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

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

Recurrences: --

FLUMETHASONE (FLUMETHASONE) Suspect

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

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

Recurrences: --

ORENCIA (ABATACEPT) Suspect

Route: 065 | Dosage: ROUTE OF ADMINISTRATION: INTRAVENOUS BOLUS | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

MAGNESIUM CITRATE (MAGNESIUM CITRATE) Suspect

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

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

Recurrences: --

FOLIC ACID (FOLIC ACID) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

CALCIUM (CALCIUM) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED, CALCIUM ASCORBATE | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

CALCIUM (CALCIUM) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED, CALCIUM CITRATE | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

CIMZIA (CERTOLIZUMAB PEGOL) Suspect

Route: 058 | Dosage: -- | Form: Solution for injection | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

VITAMIN C (ASCORBIC ACID) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

PREDNISONE (PREDNISONE) Suspect

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

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

Recurrences: --

NUCALA (MEPOLIZUMAB) Suspect

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

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

Recurrences: --

BUTRANS (BUPRENORPHINE) Suspect

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

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

Recurrences: --

HUMIRA (ADALIMUMAB) Suspect

Route: 058 | Dosage: DOSE FORM: SOLUTION SUBCUTANEOUS | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

ADALIMUMAB (ADALIMUMAB) Suspect

Route: 058 | Dosage: DOSE FORM: SOLUTION SUBCUTANEOUS | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

INFLIXIMAB (INFLIXIMAB) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

PSEUDOEPHEDRINE (PSEUDOEPHEDRINE) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

CALCIUM GLUBIONATE (CALCIUM GLUBIONATE) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

OXYCODONE (OXYCODONE) Suspect

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

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

Recurrences: --

AZATHIOPRINE (AZATHIOPRINE) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

METFORMIN HYDROCHLORIDE\SITAGLIPTIN PHOSPHATE (METFORMIN HYDROCHLORIDE\SITAGLIPTIN PHOSPHATE) Suspect

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

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

Recurrences: --

PREDNISONE (PREDNISONE) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

MINOCYCLINE (MINOCYCLINE HYDROCHLORIDE) Suspect

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

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

Recurrences: --

CANDESARTAN (CANDESARTAN) Suspect

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

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

Recurrences: --

SULFASALAZINE (SULFASALAZINE) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

SIMPONI (GOLIMUMAB) Suspect

Route: 058 | Dosage: DOSE FORM: SOLUTION SUBCUTANEOUS | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

NAPROXEN (NAPROXEN) Suspect

Route: 065 | Dosage: DOSE FORM: TABLET (ENTERIC-COATED) | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN\CODEINE PHOSPHATE) Suspect

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

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

Recurrences: --

CELEBREX (CELECOXIB) Suspect

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

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

Recurrences: --

HYDROCORTISONE (HYDROCORTISONE) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

HYDROCORTISONE (HYDROCORTISONE) Suspect

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

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

Recurrences: --

DICLOFENAC (DICLOFENAC) Suspect

Route: 065 | Dosage: DICLOFENAC POTASSIUM | Form: Tablet | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

DICLOFENAC (DICLOFENAC) Suspect

Route: 065 | Dosage: DICLOFENAC SODIUM, DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

DICLOFENAC (DICLOFENAC) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

TOPIRAMATE (TOPIRAMATE) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

BOTULINUM TOXIN TYPE A (BOTULINUM TOXIN TYPE A) Suspect

Route: 030 | Dosage: DOSE FORM: POWDER FOR SOLUTION | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

XELJANZ (TOFACITINIB CITRATE) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

RITUXIMAB (RITUXIMAB) Suspect

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

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

Recurrences: --

RAMIPRIL (RAMIPRIL) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

CHLORHEXIDINE GLUCONATE\ISOPROPYL ALCOHOL (CHLORHEXIDINE GLUCONATE\ISOPROPYL ALCOHOL) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

CHLORHEXIDINE GLUCONATE\ISOPROPYL ALCOHOL (CHLORHEXIDINE GLUCONATE\ISOPROPYL ALCOHOL) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

CETIRIZINE (CETIRIZINE HYDROCHLORIDE) Suspect

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

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

Recurrences: --

ZINC CITRATE (ZINC CITRATE) Suspect

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

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

Recurrences: --

BERINERT (HUMAN C1-ESTERASE INHIBITOR) Suspect

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

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

Recurrences: --

PHTHALYLSULFATHIAZOLE (PHTHALYLSULFATHIAZOLE) Suspect

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

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

Recurrences: --

METHYLPREDNISOLONE (METHYLPREDNISOLONE) Suspect

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

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

Recurrences: --

METHYLPREDNISOLONE (METHYLPREDNISOLONE) Suspect

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

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

Recurrences: --

ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) Suspect

Route: 065 | Dosage: DOSE FORM: LIQUID TOPICAL, ROA: OTHER | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

ERGOCALCIFEROL (ERGOCALCIFEROL) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

CETIRIZINE HYDROCHLORIDE\PSEUDOEPHEDRINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE\PSEUDOEPHEDRINE HYDROCHLORIDE) Suspect

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

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

Recurrences: --

ARAVA (LEFLUNOMIDE) Suspect

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

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

Recurrences: --

NICOTINAMIDE (NIACINAMIDE) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

CHOLECALCIFEROL (CHOLECALCIFEROL) Suspect

Route: 065 | Dosage: DOSE FORM: NOT SPECIFIED | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE) Suspect

Route: 030 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

ALENDRONIC ACID (ALENDRONIC ACID) Suspect

Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

ALENDRONIC ACID (ALENDRONIC ACID) Suspect

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

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

Recurrences: --

Clinical Narrative

Report Duplicates (2)

Market Authorization Holder AER Number: CANSP2025122064

Health Canada: E2B_08137564

Raw JSON (click to expand)

                            {
  "_id": "69e7691c5eb43a53b3ff1e94",
  "safetyreportid": "25974502",
  "authoritynumb": null,
  "companynumb": "CA-TEVA-VS-3386636",
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "CA",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Maternal exposure during pregnancy",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Congenital anomaly",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "METHOTREXATE",
        "drugauthorizationnumb": "081099",
        "drugbatchnumb": "UNKNOWN",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "DOSE FORM: NOT SPECIFIED",
        "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": "METHOTREXATE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "MYOCHRYSINE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "UNKNOWN",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "DOSE FORM: SOLUTION INTRAMUSCULAR",
        "drugdosageform": null,
        "drugadministrationroute": "030",
        "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": "GOLD SODIUM THIOMALATE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ACETAMINOPHEN",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "UNKNOWN",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "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": "ACETAMINOPHEN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ACTEMRA",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "UNKNOWN",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "DOSE FORM: NOT SPECIFIED",
        "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": "TOCILIZUMAB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "LEFLUNOMIDE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "UNKNOWN",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Tablet",
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        "drugindication": "Product used for unknown indication",
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        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "ALENDRONATE SODIUM",
        "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": "ALENDRONIC ACID"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "CA",
    "qualification": 3,
    "literaturereference": null
  },
  "primarysourcecountry": "CA",
  "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": "Market Authorization Holder AER Number",
      "duplicatenumb": "CANSP2025122064"
    },
    {
      "duplicatesource": "Health Canada",
      "duplicatenumb": "E2B_08137564"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "TEVA"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 1,
  "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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