FDA FAERS Adverse Event Reports

111000

Total Reports

60668

Serious Reports

108

Reporter Countries

25937137 Type 1

Serious

SYNTHROID, SYNTHROID, SYNTHROID (+1 more)

Report Version

Receive Date

10/17/2025

Receipt Date

10/27/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Pharmacist

Literature Reference

Company Number

BR-ABBOTT-2025A-1403107

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

Female

Patient Weight

64.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (21)

Blood thyroid stimulating hormone increased (v28.1) Not Recovered

Arthralgia (v28.1) Unknown

Confusional state (v28.1) Recovering

Pain in extremity (v28.1) Recovered

Hypoaesthesia (v28.1) Recovered

Menopause (v28.1) Unknown

Product quality issue (v28.1) Unknown

Alopecia (v28.1) Recovering

Swelling (v28.1) Recovering

Cancer surgery (v28.1) Unknown

Dysstasia (v28.1) Recovering

Mental disorder (v28.1) Recovering

Arrhythmia (v28.1) Recovered

Panic attack (v28.1) Recovering

Drug ineffective (v28.1) Unknown

Fatigue (v28.1) Recovering

Depression (v28.1) Recovering

Nail disorder (v28.1) Not Recovered

Pain in extremity (v28.1) Recovering

Overweight (v28.1) Unknown

Back pain (v28.1) Not Recovered

Drugs (4)

SYNTHROID (LEVOTHYROXINE SODIUM) Suspect

Route: 048 | Dosage: 1 TABLET A DAY | Form: Tablet | Indication: Papillary thyroid cancer | Action: Dose Not Changed

Start: 01/01/2009 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

SYNTHROID (LEVOTHYROXINE SODIUM) Suspect

Route: 048 | Dosage: 1 TABLET A DAY | Form: Tablet | Indication: Papillary thyroid cancer | Action: Dose Not Changed

Start: 01/01/2009 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

SYNTHROID (LEVOTHYROXINE SODIUM) Suspect

Route: 048 | Dosage: -- | Form: Tablet | Indication: Papillary thyroid cancer | Action: Dose Not Changed

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

Recurrences: --

SYNTHROID (LEVOTHYROXINE SODIUM) Suspect

Route: 048 | Dosage: -- | Form: Tablet | Indication: Papillary thyroid cancer | Action: Dose Not Changed

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250501

Report Duplicates (1)

ABBOTT: BR-ABBOTT-2025A-1403107

Raw JSON (click to expand)

                            {
  "_id": "69d435c23b3830196fa58594",
  "safetyreportid": "25937137",
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  "companynumb": "BR-ABBOTT-2025A-1403107",
  "duplicate": 1,
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      },
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      },
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      },
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      },
      {
        "reactionmeddraversionpt": "28.1",
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      },
      {
        "reactionmeddraversionpt": "28.1",
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        "reactionoutcome": 2
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Cancer surgery",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
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      },
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      },
      {
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      },
      {
        "reactionmeddraversionpt": "28.1",
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      },
      {
        "reactionmeddraversionpt": "28.1",
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      },
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        "reactionmeddraversionpt": "28.1",
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        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
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      }
    ],
    "drug": [
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      {
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        },
        "drugrecurrence": []
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      },
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    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250501"
  },
  "primarysource": {
    "reportercountry": "BR",
    "qualification": 2,
    "literaturereference": null
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  "receivedateformat": "102",
  "receiver": {
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  "safetyreportversion": 2,
  "sender": {
    "sendertype": 6,
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  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
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  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25934464 Type 2

Serious

FEMARA, PALBOCICLIB, BISOPROLOL (+6 more)

Report Version

Receive Date

10/17/2025

Receipt Date

10/27/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Physician

Literature Reference

Company Number

EU-002147023-NVSC2025DE160174

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

74.0 yr

Patient Age Group

Patient Sex

Female

Patient Weight

72.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (6)

Death (v28.1) Fatal

Acute myocardial infarction (v28.1) Recovered

Breast cancer (v28.1) Unknown

Malignant neoplasm progression (v28.1) Unknown

Cardiogenic shock (v28.1) Unknown

Atrioventricular block complete (v28.1) Unknown

Drugs (9)

FEMARA (LETROZOLE) Suspect

Route: 048 | Dosage: 2.5 MG, QD (DAY 1 TO DAY 21, EVERY 28 DAY CYCLE) | Form: Film-coated tablet | Indication: Breast cancer | Action: Not Applicable

Start: 05/13/2021 | End: 03/09/2022 | Duration: 301.0 day | Rechallenge: -- | Additional: 4

Recurrences: --

PALBOCICLIB (PALBOCICLIB) Suspect

Route: 048 | Dosage: 125 MG, CYCLIC (DAY 1 TO DAY 21, EVERY 28 DAY CYCLE ) | Form: Capsule | Indication: Breast cancer | Action: Withdrawn

Start: 05/13/2021 | End: 03/02/2022 | Duration: 294.0 day | Rechallenge: -- | Additional: Yes

Recurrences: --

BISOPROLOL (BISOPROLOL) Concomitant

Route: 065 | Dosage: UNK | Form: -- | Indication: Hypertension | Action: Dose Not Changed

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

Recurrences: --

FENTANYL (FENTANYL) Concomitant

Route: 065 | Dosage: UNK | Form: -- | Indication: Procedural pain | Action: Dose Not Changed

Start: 01/01/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

METOCLOPRAMIDE (METOCLOPRAMIDE) Concomitant

Route: 065 | Dosage: UNK | Form: -- | Indication: Prophylaxis | Action: Dose Not Changed

Start: 05/01/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

ASPIRIN (ASPIRIN) Concomitant

Route: 048 | Dosage: 100 MG | Form: -- | Indication: Product used for unknown indication | Action: Dose Not Changed

Start: 05/18/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

TICAGRELOR (TICAGRELOR) Concomitant

Route: 048 | Dosage: 90 MG | Form: -- | Indication: Product used for unknown indication | Action: Dose Not Changed

Start: 05/18/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

RAMIPRIL (RAMIPRIL) Concomitant

Route: 048 | Dosage: 2.5 MG | Form: -- | Indication: Product used for unknown indication | Action: Dose Not Changed

Start: 05/19/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

ATORVASTATIN (ATORVASTATIN) Concomitant

Route: 048 | Dosage: 40 MG | Form: -- | Indication: Product used for unknown indication | Action: Dose Not Changed

Start: 05/19/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20210518

Report Duplicates (0)

Raw JSON (click to expand)

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  "_id": "69d435bf3b3830196fa584de",
  "safetyreportid": "25934464",
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  "companynumb": "EU-002147023-NVSC2025DE160174",
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  "patient": {
    "patientonsetage": 74.0,
    "patientonsetageunit": 801,
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    "patientsex": 2,
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        "reactionmeddraversionpt": "28.1",
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        "reactionoutcome": 5
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Acute myocardial infarction",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Breast cancer",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
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        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Cardiogenic shock",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Atrioventricular block complete",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
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        "drugauthorizationnumb": "20726",
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        "drugstartdateformat": "102",
        "drugstartdate": "2021-05-13T00:00:00",
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        "drugenddate": "2022-03-09T00:00:00",
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      {
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        "drugenddate": "2022-03-02T00:00:00",
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      },
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        "drugdosagetext": "UNK",
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": "Hypertension",
        "drugstartdateformat": null,
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          "activesubstancename": "BISOPROLOL"
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        "drugrecurrence": []
      },
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        "drugcharacterization": 2,
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        "drugadministrationroute": "065",
        "drugindication": "Procedural pain",
        "drugstartdateformat": "602",
        "drugstartdate": "2021-01-01T00:00:00",
        "drugenddateformat": null,
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        "activesubstance": {
          "activesubstancename": "FENTANYL"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
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        "drugstartdateformat": "610",
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        "drugenddateformat": null,
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          "activesubstancename": "METOCLOPRAMIDE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
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        "drugauthorizationnumb": null,
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        "drugcumulativedosageunit": null,
        "drugdosagetext": "100 MG",
        "drugdosageform": null,
        "drugadministrationroute": "048",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": "102",
        "drugstartdate": "2021-05-18T00:00:00",
        "drugenddateformat": null,
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        "activesubstance": {
          "activesubstancename": "ASPIRIN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "TICAGRELOR",
        "drugauthorizationnumb": null,
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        "drugstructuredosagenumb": 90.0,
        "drugstructuredosageunit": "003",
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        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "90 MG",
        "drugdosageform": null,
        "drugadministrationroute": "048",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": "102",
        "drugstartdate": "2021-05-18T00:00:00",
        "drugenddateformat": null,
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        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "TICAGRELOR"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "RAMIPRIL",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 2.5,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "2.5 MG",
        "drugdosageform": null,
        "drugadministrationroute": "048",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": "102",
        "drugstartdate": "2021-05-19T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "RAMIPRIL"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "ATORVASTATIN",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 40.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "40 MG",
        "drugdosageform": null,
        "drugadministrationroute": "048",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": "102",
        "drugstartdate": "2021-05-19T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "ATORVASTATIN"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20210518"
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 1,
    "literaturereference": null
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-27T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-17T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 2,
  "safetyreportversion": 3,
  "sender": {
    "sendertype": 6,
    "senderorganization": "NOVARTIS"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 1,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 1,
  "seriousnesslifethreatening": 1,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25934959 Type 2

Serious

RINVOQ, RINVOQ

Report Version

Receive Date

10/17/2025

Receipt Date

10/27/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

CA-ABBVIE-6506464

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

62.0 yr

Patient Age Group

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Hip arthroplasty (v28.1) Recovered

Drugs (2)

RINVOQ (UPADACITINIB) Suspect

Route: 048 | Dosage: FORM STRENGTH-15 MG | Form: Tablet | Indication: Rheumatoid arthritis | Action: Withdrawn

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

Recurrences: --

RINVOQ (UPADACITINIB) Suspect

Route: 048 | Dosage: -- | Form: -- | Indication: Rheumatoid arthritis | Action: Withdrawn

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251010

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435bf3b3830196fa583f4",
  "safetyreportid": "25934959",
  "authoritynumb": null,
  "companynumb": "CA-ABBVIE-6506464",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "CA",
  "patient": {
    "patientonsetage": 62.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Hip arthroplasty",
        "reactionoutcome": 1
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "RINVOQ",
        "drugauthorizationnumb": "211675",
        "drugbatchnumb": "1262601",
        "drugstructuredosagenumb": 15.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "FORM STRENGTH-15 MG",
        "drugdosageform": "Tablet",
        "drugadministrationroute": "048",
        "drugindication": "Rheumatoid arthritis",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": "610",
        "drugenddate": "2025-08-01T00:00:00",
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 1,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "UPADACITINIB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "RINVOQ",
        "drugauthorizationnumb": "211675",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 15.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": "048",
        "drugindication": "Rheumatoid arthritis",
        "drugstartdateformat": "602",
        "drugstartdate": "2025-01-01T00:00:00",
        "drugenddateformat": "602",
        "drugenddate": "2025-01-01T00:00:00",
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 1,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "UPADACITINIB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251010"
  },
  "primarysource": {
    "reportercountry": "CA",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "CA",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-27T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-17T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 2,
  "safetyreportversion": 2,
  "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"
}
                        

25936865 Type 2

Non-Serious

CORTICOTROPIN

Report Version

Receive Date

10/17/2025

Receipt Date

10/27/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

US-MALLINCKRODT-MNK202502250

Authority Number

Sender Organization

MALLINCKRODT

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

69.0 yr

Patient Age Group

Elderly

Patient Sex

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Eye colour change (v28.1) Not Recovered

Injection site bruising (v28.1) Unknown

Abdominal distension (v28.1) Unknown

Drugs (1)

CORTICOTROPIN (CORTICOTROPIN) Suspect

Route: 058 | Dosage: -- | Form: Gel for injection | Indication: Keratitis | Action: Dose Not Changed

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435bc3b3830196fa581aa",
  "safetyreportid": "25936865",
  "authoritynumb": null,
  "companynumb": "US-MALLINCKRODT-MNK202502250",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 69.0,
    "patientonsetageunit": 801,
    "patientagegroup": 6,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Eye colour change",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Injection site bruising",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Abdominal distension",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CORTICOTROPIN",
        "drugauthorizationnumb": "008372",
        "drugbatchnumb": "UNKNOWN",
        "drugstructuredosagenumb": 1.0,
        "drugstructuredosageunit": "012",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Gel for injection",
        "drugadministrationroute": "058",
        "drugindication": "Keratitis",
        "drugstartdateformat": "610",
        "drugstartdate": "2025-01-01T00:00:00",
        "drugenddateformat": "602",
        "drugenddate": "2025-01-01T00:00:00",
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "CORTICOTROPIN"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-27T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-17T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 2,
  "safetyreportversion": 2,
  "sender": {
    "sendertype": 6,
    "senderorganization": "MALLINCKRODT"
  },
  "serious": 2,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 2,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25936649 Type 1

Serious

RITUXIMAB, CYTARABINE\DAUNORUBICIN

Report Version

Receive Date

10/17/2025

Receipt Date

10/27/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Joshi, G.. Pediatric Acute Megakaryoblastic Leukemia with a GATA2 Mutation and Monosomy 7: A Case Report and Clinical Management Challenges. Reports. 2025;8(3)

Company Number

EU-SANDOZ-SDZ2025PL072607

Authority Number

Sender Organization

PFIZER

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

10.0 yr

Patient Age Group

Patient Sex

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Hepatotoxicity (v28.1) Recovering

Off label use (v28.1) Unknown

Drugs (2)

RITUXIMAB (RITUXIMAB) Suspect

Route: -- | Dosage: UNK | Form: -- | Indication: Interstitial lung disease | Action: Unknown

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

Recurrences: --

CYTARABINE\DAUNORUBICIN (CYTARABINE\DAUNORUBICIN) Suspect

Route: -- | Dosage: TWO INDUCTION CYCLES WITH A FIXED-DOSE LIPOSOMAL FORMULATION OF DAUNORUBICIN AND CYTARABINE (123 IU/ | Form: -- | Indication: Acute megakaryocytic leukaemia | Action: Unknown

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

Recurrences: --

Clinical Narrative

Report Duplicates (1)

SANDOZ: EU-SANDOZ-SDZ2025PL072607

Raw JSON (click to expand)

                            {
  "_id": "69d435bb3b3830196fa58096",
  "safetyreportid": "25936649",
  "authoritynumb": null,
  "companynumb": "EU-SANDOZ-SDZ2025PL072607",
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": 10.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Hepatotoxicity",
        "reactionoutcome": 2
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Off label use",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "RITUXIMAB",
        "drugauthorizationnumb": "761103",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Interstitial lung disease",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "RITUXIMAB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CYTARABINE\\DAUNORUBICIN",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "TWO INDUCTION CYCLES WITH A FIXED-DOSE LIPOSOMAL FORMULATION OF DAUNORUBICIN AND CYTARABINE (123 IU/",
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Acute megakaryocytic leukaemia",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "CYTARABINE\\DAUNORUBICIN"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 3,
    "literaturereference": "Joshi, G.. Pediatric Acute Megakaryoblastic Leukemia with a GATA2 Mutation and Monosomy 7: A Case Report and Clinical Management Challenges. Reports. 2025;8(3)"
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-27T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-17T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "SANDOZ",
      "duplicatenumb": "EU-SANDOZ-SDZ2025PL072607"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 2,
  "sender": {
    "sendertype": 6,
    "senderorganization": "PFIZER"
  },
  "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"
}
                        

25934958 Type 2

Serious

VYEPTI, VENTOLIN, CYMBALTA (+7 more)

Report Version

Receive Date

10/17/2025

Receipt Date

10/27/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Company Number

CA-LUNDBECK-DKLU4020565

Authority Number

Sender Organization

LUNDBECK

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

37.0 yr

Patient Age Group

Adult

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Thrombosis (v28.1) Recovered

Drugs (10)

VYEPTI (EPTINEZUMAB-JJMR) Suspect

Route: 041 | Dosage: 100 MILLIGRAM | Form: Solution for infusion | Indication: Migraine | Action: Dose Not Changed

Start: 07/04/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

VENTOLIN (ALBUTEROL SULFATE) Concomitant

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

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

Recurrences: --

CYMBALTA (DULOXETINE HYDROCHLORIDE) Concomitant

Route: -- | Dosage: 60 MILLIGRAM | Form: -- | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

DEXILANT (DEXLANSOPRAZOLE) Concomitant

Route: -- | Dosage: 60 MILLIGRAM | Form: -- | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

ALESSE 28 (ETHINYL ESTRADIOL\LEVONORGESTREL) Concomitant

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

Start: 04/26/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

SYMBICORT (BUDESONIDE\FORMOTEROL FUMARATE DIHYDRATE) Concomitant

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

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

Recurrences: --

DEXLANSOPRAZOLE (DEXLANSOPRAZOLE) Concomitant

Route: -- | Dosage: 60 MILLIGRAM | Form: -- | Indication: Product used for unknown indication | Action: --

Start: 06/15/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

BETAHISTINE (BETAHISTINE) Concomitant

Route: -- | Dosage: 8 MILLIGRAM | Form: -- | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

CHOLECALCIFEROL (CHOLECALCIFEROL) Concomitant

Route: -- | Dosage: 1000 UNITS | Form: -- | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

DULOXETINE (DULOXETINE) Concomitant

Route: -- | Dosage: 60 MILLIGRAM | Form: -- | Indication: Product used for unknown indication | Action: --

Start: 05/17/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251001

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435ba3b3830196fa58013",
  "safetyreportid": "25934958",
  "authoritynumb": null,
  "companynumb": "CA-LUNDBECK-DKLU4020565",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "CA",
  "patient": {
    "patientonsetage": 37.0,
    "patientonsetageunit": 801,
    "patientagegroup": 5,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Thrombosis",
        "reactionoutcome": 1
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "VYEPTI",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "2818199",
        "drugstructuredosagenumb": 100.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 12.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "100 MILLIGRAM",
        "drugdosageform": "Solution for infusion",
        "drugadministrationroute": "041",
        "drugindication": "Migraine",
        "drugstartdateformat": "102",
        "drugstartdate": "2024-07-04T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
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          "activesubstancename": "EPTINEZUMAB-JJMR"
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      {
        "drugcharacterization": 2,
        "medicinalproduct": "VENTOLIN",
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          "activesubstancename": "ALBUTEROL SULFATE"
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      },
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        "medicinalproduct": "CYMBALTA",
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        "activesubstance": {
          "activesubstancename": "DULOXETINE HYDROCHLORIDE"
        },
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      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "DEXILANT",
        "drugauthorizationnumb": null,
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          "activesubstancename": "DEXLANSOPRAZOLE"
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        "drugcharacterization": 2,
        "medicinalproduct": "ALESSE 28",
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          "activesubstancename": "BETAHISTINE"
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      },
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        "medicinalproduct": "CHOLECALCIFEROL",
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        },
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      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251001"
  },
  "primarysource": {
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  },
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}
                        

25935982 Type 1

Non-Serious

MIRENA

Report Version

Receive Date

10/17/2025

Receipt Date

10/27/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Company Number

US-BAYER-2025A137041

Authority Number

Sender Organization

BAYER HEALTHCARE PHARMACEUTICALS INC.

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

36.0 yr

Patient Age Group

Adult

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Device expulsion (v28.1) Recovered

Drugs (1)

MIRENA (LEVONORGESTREL) Suspect

Route: 015 | Dosage: 20?G/DAY | Form: Intrauterine delivery system | Indication: -- | Action: Not Applicable

Start: 09/19/2025 | End: 10/16/2025 | Duration: 28.0 day | Rechallenge: -- | Additional: 4

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251016

Report Duplicates (0)

Raw JSON (click to expand)

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25936987 Type 1

Serious

POMALIDOMIDE, BORTEZOMIB, ENOXAPARIN SODIUM (+2 more)

Report Version

Receive Date

10/17/2025

Receipt Date

10/27/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Physician

Literature Reference

Company Number

EU-SA-2025SA289395

Authority Number

Sender Organization

MYLAN

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

78.0 yr

Patient Age Group

Patient Sex

Male

Patient Weight

70.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Gastric ulcer (v28.1) Recovered

Drugs (5)

POMALIDOMIDE (POMALIDOMIDE) Suspect

Route: -- | Dosage: 4 MILLIGRAM, QD | Form: -- | Indication: Plasma cell myeloma | Action: Not Applicable

Start: 07/18/2025 | End: 09/10/2025 | Duration: 55.0 day | Rechallenge: Unknown | Additional: 4

Recurrences: --

BORTEZOMIB (BORTEZOMIB) Suspect

Route: -- | Dosage: 2.35 MILLIGRAM, CYCLE (2.35 MG, QCY (2.35 MG, CYCLIC (4 DAYS)) | Form: -- | Indication: Plasma cell myeloma | Action: Not Applicable

Start: 07/18/2025 | End: 09/08/2025 | Duration: 53.0 day | Rechallenge: Unknown | Additional: 4

Recurrences: --

ENOXAPARIN SODIUM (ENOXAPARIN SODIUM) Suspect

Route: -- | Dosage: 6000 INTERNATIONAL UNIT, QD | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable

Start: 09/08/2025 | End: 09/11/2025 | Duration: 72.0 hr | Rechallenge: -- | Additional: 4

Recurrences: --

DEXAMETHASONE (DEXAMETHASONE) Suspect

Route: -- | Dosage: 10 MILLIGRAM, QD | Form: -- | Indication: Plasma cell myeloma | Action: Not Applicable

Start: 07/18/2025 | End: 09/10/2025 | Duration: -- -- | Rechallenge: -- | Additional: 4

Recurrences: --

ASPIRIN (ASPIRIN) Concomitant

Route: -- | Dosage: UNK | Form: -- | Indication: Thrombosis prophylaxis | Action: --

Start: 03/25/2025 | End: 09/08/2025 | Duration: 168.0 day | Rechallenge: -- | Additional: --

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250912

Report Duplicates (0)

Raw JSON (click to expand)

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  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 2,
  "sender": {
    "sendertype": 6,
    "senderorganization": "MYLAN"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 1,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25935119 Type 1

Non-Serious

ORENCIA

Report Version

Receive Date

10/17/2025

Receipt Date

10/27/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

US-BRISTOL-MYERS SQUIBB COMPANY-2025-137100

Authority Number

Sender Organization

BRISTOL-MYERS SQUIBB COMPANY

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

88.0 yr

Patient Age Group

Elderly

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Visual impairment (v28.1) Unknown

Device failure (v28.1) Unknown

Fatigue (v28.1) Unknown

Drugs (1)

ORENCIA (ABATACEPT) Suspect

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

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

Recurrences: --

Clinical Narrative

Report Duplicates (1)

{INT} BMS_Athena: EUhena-United States-04971293

Raw JSON (click to expand)

                            {
  "_id": "69d435b63b3830196fa57c19",
  "safetyreportid": "25935119",
  "authoritynumb": null,
  "companynumb": "US-BRISTOL-MYERS SQUIBB COMPANY-2025-137100",
  "duplicate": 1,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 88.0,
    "patientonsetageunit": 801,
    "patientagegroup": 6,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Visual impairment",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Device failure",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Fatigue",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ORENCIA",
        "drugauthorizationnumb": "125118",
        "drugbatchnumb": "2085457",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Solution for injection",
        "drugadministrationroute": "058",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "ABATACEPT"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-27T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-17T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "{INT} BMS_Athena",
      "duplicatenumb": "EUhena-United States-04971293"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 2,
  "sender": {
    "sendertype": 6,
    "senderorganization": "BRISTOL-MYERS SQUIBB COMPANY"
  },
  "serious": 2,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 2,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25934822 Type 1

Serious

PREGABALIN, PREGABALIN, PREGABALIN (+59 more)

Report Version

Receive Date

10/17/2025

Receipt Date

10/27/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Physician

Literature Reference

Company Number

Authority Number

EU-BASGAGES-2025-006346

Sender Organization

TEVA

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

48.0 yr

Patient Age Group

Patient Sex

Male

Patient Weight

78.5 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (7)

Urinary retention (v28.1) Recovering

Urinary hesitation (v28.1) Recovering

Constipation (v28.1) Recovering

Functional gastrointestinal disorder (v28.1) Recovering

Underdose (v28.1) Unknown

Weight increased (v28.1) Not Recovered

Drug level decreased (v28.1) Recovered

Drugs (62)

PREGABALIN (PREGABALIN) Suspect

Route: 065 | Dosage: 400 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 05/28/2025 | End: 06/01/2025 | Duration: 5.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

PREGABALIN (PREGABALIN) Suspect

Route: 065 | Dosage: 25 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 05/07/2025 | End: 05/07/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

PREGABALIN (PREGABALIN) Suspect

Route: 065 | Dosage: 75 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 05/08/2025 | End: 05/08/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

PREGABALIN (PREGABALIN) Suspect

Route: 065 | Dosage: 375 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 08/13/2025 | End: 08/28/2025 | Duration: 16.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

PREGABALIN (PREGABALIN) Suspect

Route: 065 | Dosage: 300 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 05/20/2025 | End: 05/20/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

PREGABALIN (PREGABALIN) Suspect

Route: 065 | Dosage: 500 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 06/03/2025 | End: 06/04/2025 | Duration: 2.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

PREGABALIN (PREGABALIN) Suspect

Route: 065 | Dosage: 300 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 08/29/2025 | End: 09/05/2025 | Duration: 8.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

PREGABALIN (PREGABALIN) Suspect

Route: 065 | Dosage: 600 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 06/05/2025 | End: 08/04/2025 | Duration: 2.0 mo | Rechallenge: -- | Additional: Unknown

Recurrences: --

PREGABALIN (PREGABALIN) Suspect

Route: 065 | Dosage: 125 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 05/09/2025 | End: 05/09/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

PREGABALIN (PREGABALIN) Suspect

Route: 065 | Dosage: 350 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 05/22/2025 | End: 05/27/2025 | Duration: 6.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

PREGABALIN (PREGABALIN) Suspect

Route: 065 | Dosage: 450 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 08/08/2025 | End: 08/12/2025 | Duration: 5.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

PREGABALIN (PREGABALIN) Suspect

Route: 065 | Dosage: 325 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 05/21/2025 | End: 05/21/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

PREGABALIN (PREGABALIN) Suspect

Route: 065 | Dosage: 200 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 05/13/2025 | End: 05/13/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

PREGABALIN (PREGABALIN) Suspect

Route: 065 | Dosage: 250 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 05/15/2025 | End: 05/19/2025 | Duration: 5.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

PREGABALIN (PREGABALIN) Suspect

Route: 065 | Dosage: 450 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 06/02/2025 | End: 06/02/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

PREGABALIN (PREGABALIN) Suspect

Route: 065 | Dosage: 150 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 05/10/2025 | End: 05/12/2025 | Duration: 3.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

PREGABALIN (PREGABALIN) Suspect

Route: 065 | Dosage: 225 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 05/14/2025 | End: 05/14/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

PREGABALIN (PREGABALIN) Suspect

Route: 065 | Dosage: 525 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 08/05/2025 | End: 08/07/2025 | Duration: 3.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

NALTREXONE (NALTREXONE) Concomitant

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

Start: 05/07/2025 | End: 06/13/2025 | Duration: 38.0 day | Rechallenge: -- | Additional: --

Recurrences: --

KETAMINE HYDROCHLORIDE (KETAMINE HYDROCHLORIDE) Suspect

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

Start: 05/15/2025 | End: 05/15/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

KETAMINE HYDROCHLORIDE (KETAMINE HYDROCHLORIDE) Suspect

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

Start: 07/14/2025 | End: 07/14/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

KETAMINE HYDROCHLORIDE (KETAMINE HYDROCHLORIDE) Suspect

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

Start: 06/05/2025 | End: 06/05/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

KETAMINE HYDROCHLORIDE (KETAMINE HYDROCHLORIDE) Suspect

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

Start: 06/17/2025 | End: 06/17/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

KETAMINE HYDROCHLORIDE (KETAMINE HYDROCHLORIDE) Suspect

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

Start: 05/13/2025 | End: 05/13/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

KETAMINE HYDROCHLORIDE (KETAMINE HYDROCHLORIDE) Suspect

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

Start: 07/31/2025 | End: 07/31/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

KETAMINE HYDROCHLORIDE (KETAMINE HYDROCHLORIDE) Suspect

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

Start: 06/19/2025 | End: 06/19/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

KETAMINE HYDROCHLORIDE (KETAMINE HYDROCHLORIDE) Suspect

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

Start: 07/07/2025 | End: 07/07/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

KETAMINE HYDROCHLORIDE (KETAMINE HYDROCHLORIDE) Suspect

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

Start: 06/10/2025 | End: 06/10/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

KETAMINE HYDROCHLORIDE (KETAMINE HYDROCHLORIDE) Suspect

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

Start: 05/22/2025 | End: 05/22/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

KETAMINE HYDROCHLORIDE (KETAMINE HYDROCHLORIDE) Suspect

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

Start: 06/26/2025 | End: 06/26/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

KETAMINE HYDROCHLORIDE (KETAMINE HYDROCHLORIDE) Suspect

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

Start: 05/27/2025 | End: 05/27/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

KETAMINE HYDROCHLORIDE (KETAMINE HYDROCHLORIDE) Suspect

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

Start: 06/03/2025 | End: 06/03/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

KETAMINE HYDROCHLORIDE (KETAMINE HYDROCHLORIDE) Suspect

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

Start: 06/24/2025 | End: 06/24/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

KETAMINE HYDROCHLORIDE (KETAMINE HYDROCHLORIDE) Suspect

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

Start: 07/21/2025 | End: 07/21/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

KETAMINE HYDROCHLORIDE (KETAMINE HYDROCHLORIDE) Suspect

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

Start: 07/28/2025 | End: 07/28/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

KETAMINE HYDROCHLORIDE (KETAMINE HYDROCHLORIDE) Suspect

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

Start: 06/12/2025 | End: 06/12/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

KETAMINE HYDROCHLORIDE (KETAMINE HYDROCHLORIDE) Suspect

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

Start: 05/20/2025 | End: 05/20/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

ENOXAPARIN SODIUM (ENOXAPARIN SODIUM) Concomitant

Route: 065 | Dosage: 40 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: --

Start: 05/13/2025 | End: 06/09/2025 | Duration: 28.0 day | Rechallenge: -- | Additional: --

Recurrences: --

MELATONIN (MELATONIN) Suspect

Route: 065 | Dosage: 2 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 07/30/2025 | End: 09/05/2025 | Duration: 38.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

MELATONIN (MELATONIN) Suspect

Route: 065 | Dosage: 4 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 05/07/2025 | End: 07/29/2025 | Duration: 84.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

ESKETAMINE (ESKETAMINE) Concomitant

Route: 042 | Dosage: 50 MG, QW | Form: -- | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

LORAZEPAM (LORAZEPAM) Suspect

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

Start: 06/10/2025 | End: 06/11/2025 | Duration: 2.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

LORAZEPAM (LORAZEPAM) Suspect

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

Start: 06/12/2025 | End: 06/14/2025 | Duration: 3.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

LORAZEPAM (LORAZEPAM) Suspect

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

Start: 05/16/2025 | End: 06/09/2025 | Duration: 25.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

LORAZEPAM (LORAZEPAM) Suspect

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

Start: 06/15/2025 | End: 06/18/2025 | Duration: 4.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

LORAZEPAM (LORAZEPAM) Suspect

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

Start: 06/19/2025 | End: 07/15/2025 | Duration: 27.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

LAVENDER OIL (LAVENDER OIL) Concomitant

Route: 065 | Dosage: 160 MG, DAILY | Form: Capsule, soft | Indication: Product used for unknown indication | Action: --

Start: 05/07/2025 | End: 09/05/2025 | Duration: 122.0 day | Rechallenge: -- | Additional: --

Recurrences: --

ARIPIPRAZOLE (ARIPIPRAZOLE) Suspect

Route: 065 | Dosage: 2.5 MG, DAILY | Form: Tablet | Indication: Product used for unknown indication | Action: Unknown

Start: 05/07/2025 | End: 05/16/2025 | Duration: 10.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

ARIPIPRAZOLE (ARIPIPRAZOLE) Suspect

Route: 065 | Dosage: 5 MG, DAILY | Form: Tablet | Indication: Product used for unknown indication | Action: Unknown

Start: 05/17/2025 | End: 09/05/2025 | Duration: 112.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

GINKGO (GINKGO) Suspect

Route: 065 | Dosage: 240 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 05/07/2025 | End: 06/18/2025 | Duration: 43.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

ASPIRIN (ASPIRIN) Concomitant

Route: 065 | Dosage: -- | Form: Film-coated tablet | Indication: Product used for unknown indication | Action: --

Start: 05/07/2025 | End: 09/05/2025 | Duration: 122.0 day | Rechallenge: -- | Additional: --

Recurrences: --

IVABRADINE (IVABRADINE) Suspect

Route: 065 | Dosage: 5 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 05/20/2025 | End: 07/15/2025 | Duration: 57.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

IVABRADINE (IVABRADINE) Suspect

Route: 065 | Dosage: 2.5 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 05/07/2025 | End: 05/19/2025 | Duration: 13.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

KETOTIFEN (KETOTIFEN) Suspect

Route: 065 | Dosage: 2 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 05/07/2025 | End: 07/15/2025 | Duration: 70.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

MIRTAZAPINE (MIRTAZAPINE) Suspect

Route: 065 | Dosage: 30 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 08/11/2025 | End: 09/05/2025 | Duration: 26.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

MIRTAZAPINE (MIRTAZAPINE) Suspect

Route: 065 | Dosage: 45 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 05/07/2025 | End: 08/10/2025 | Duration: 96.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) Suspect

Route: 065 | Dosage: 75 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 05/08/2025 | End: 05/14/2025 | Duration: 7.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) Suspect

Route: 065 | Dosage: 150 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 08/15/2025 | End: 09/05/2025 | Duration: 22.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) Suspect

Route: 065 | Dosage: 187.5 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 07/30/2025 | End: 08/14/2025 | Duration: 16.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) Suspect

Route: 065 | Dosage: 150 MG, DAILY | Form: -- | Indication: Product used for unknown indication | Action: Unknown

Start: 05/15/2025 | End: 07/29/2025 | Duration: 76.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

XYZAL (LEVOCETIRIZINE DIHYDROCHLORIDE) Suspect

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

Start: 05/07/2025 | End: 09/05/2025 | Duration: 122.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

Daflon (--) Concomitant

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

Start: 05/07/2025 | End: 09/05/2025 | Duration: 122.0 day | Rechallenge: -- | Additional: --

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250507

Report Duplicates (5)

EVDUP#BASGAGES: EU-BASGAGES-2025-006346

EVDUP#OTSUKA: EU-OTSUKA-2025_023278

EVDUP#OTSUKA: EU-MMM-Otsuka-Y9HV7LK4

European Medicines Agency: EU-EMA-DD-20251007-7482655-061150

AGES - ?-sterreichische Agentur f??r Gesundheit...: EU-BASGAGES-2025-006346

Raw JSON (click to expand)

                            {
  "_id": "69d435b63b3830196fa57bf8",
  "safetyreportid": "25934822",
  "authoritynumb": "EU-BASGAGES-2025-006346",
  "companynumb": null,
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
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      {
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    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250507"
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 1,
    "literaturereference": null
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-27T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-17T00:00:00",
  "receivedateformat": "102",
  "receiver": {
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    "receiverorganization": "FDA"
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  "reportduplicate": [
    {
      "duplicatesource": "EVDUP#BASGAGES",
      "duplicatenumb": "EU-BASGAGES-2025-006346"
    },
    {
      "duplicatesource": "EVDUP#OTSUKA",
      "duplicatenumb": "EU-OTSUKA-2025_023278"
    },
    {
      "duplicatesource": "EVDUP#OTSUKA",
      "duplicatenumb": "EU-MMM-Otsuka-Y9HV7LK4"
    },
    {
      "duplicatesource": "European Medicines Agency",
      "duplicatenumb": "EU-EMA-DD-20251007-7482655-061150"
    },
    {
      "duplicatesource": "AGES - ?-sterreichische Agentur f??r Gesundheit...",
      "duplicatenumb": "EU-BASGAGES-2025-006346"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 2,
  "sender": {
    "sendertype": 6,
    "senderorganization": "TEVA"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

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