FDA FAERS Adverse Event Reports

110000

Total Reports

60230

Serious Reports

108

Reporter Countries

25974053 Type 2

Serious

ESLICARBAZEPINE ACETATE, ESLICARBAZEPINE ACETATE, ESLICARBAZEPINE ACETATE (+12 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

Physician

Literature Reference

Company Number

KR-BIAL-BIAL-18009

Authority Number

Sender Organization

SUNOVION

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

Patient Age Group

Elderly

Patient Sex

Female

Patient Weight

49.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (7)

Hemihypoaesthesia (v28.1) Unknown

Feeling abnormal (v28.1) Unknown

Tinnitus (v28.1) Unknown

Somnolence (v28.1) Unknown

Decreased appetite (v28.1) Unknown

Drug titration error (v28.1) Recovered

Underdose (v28.1) Recovered

Drugs (15)

ESLICARBAZEPINE ACETATE (ESLICARBAZEPINE ACETATE) Suspect

Route: 048 | Dosage: 400 MILLIGRAM, QD | Form: Tablet | Indication: Epilepsy | Action: Dose Reduced

Start: 07/05/2024 | End: 07/05/2024 | Duration: -- -- | Rechallenge: Unknown | Additional: Yes

Recurrences: --

ESLICARBAZEPINE ACETATE (ESLICARBAZEPINE ACETATE) Suspect

Route: 048 | Dosage: 400 MILLIGRAM, QD | Form: Tablet | Indication: -- | Action: Dose Reduced

Start: 07/13/2024 | End: 07/22/2024 | Duration: 9.0 day | Rechallenge: Unknown | Additional: Yes

Recurrences: --

ESLICARBAZEPINE ACETATE (ESLICARBAZEPINE ACETATE) Suspect

Route: 048 | Dosage: 200 MILLIGRAM, QD | Form: Tablet | Indication: -- | Action: Dose Reduced

Start: 07/23/2024 | End: 08/01/2024 | Duration: 9.0 day | Rechallenge: Unknown | Additional: Yes

Recurrences: --

ESLICARBAZEPINE ACETATE (ESLICARBAZEPINE ACETATE) Suspect

Route: 048 | Dosage: 400 MILLIGRAM, QD | Form: Tablet | Indication: -- | Action: Dose Reduced

Start: 08/02/2024 | End: 08/29/2024 | Duration: 27.0 day | Rechallenge: Unknown | Additional: Yes

Recurrences: --

ESLICARBAZEPINE ACETATE (ESLICARBAZEPINE ACETATE) Suspect

Route: 048 | Dosage: 600 MILLIGRAM, QD | Form: Tablet | Indication: -- | Action: Dose Reduced

Start: 08/30/2024 | End: 11/14/2024 | Duration: 76.0 day | Rechallenge: Unknown | Additional: Yes

Recurrences: --

ESLICARBAZEPINE ACETATE (ESLICARBAZEPINE ACETATE) Suspect

Route: 048 | Dosage: 800 MILLIGRAM, QD | Form: Tablet | Indication: -- | Action: Dose Reduced

Start: 11/15/2024 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Yes

Recurrences: --

ASPIRIN (ASPIRIN) Concomitant

Route: 048 | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: Prophylaxis | Action: --

Start: 01/28/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

CLOPIDOGREL BISULFATE (CLOPIDOGREL BISULFATE) Concomitant

Route: 048 | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: Prophylaxis | Action: --

Start: 01/28/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

LIPITOR (ATORVASTATIN CALCIUM) Concomitant

Route: 048 | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: Prophylaxis | Action: --

Start: 01/28/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

LANSOPRAZOLE (LANSOPRAZOLE) Concomitant

Route: 048 | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: Gastrointestinal disorder prophylaxis | Action: --

Start: 01/28/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

Exone (--) Concomitant

Route: 048 | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: Hypertension | Action: --

Start: 02/06/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

TIANEPTINE (TIANEPTINE) Concomitant

Route: 048 | Dosage: 0.5 DOSAGE FORM, BID | Form: -- | Indication: Unevaluable therapy | Action: --

Start: 03/26/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

CHOLINE ALFOSCERATE (CHOLINE ALFOSCERATE) Concomitant

Route: 048 | Dosage: 1 DOSAGE FORM, BID | Form: -- | Indication: Unevaluable therapy | Action: --

Start: 06/04/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

CLOBAZAM (CLOBAZAM) Concomitant

Route: 048 | Dosage: 1 DOSAGE FORM, QD | Form: -- | Indication: Prophylaxis | Action: --

Start: 11/15/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

DIABEX (METFORMIN HYDROCHLORIDE) Concomitant

Route: 048 | Dosage: 1 DOSAGE FORM, BID | Form: -- | Indication: Type 2 diabetes mellitus | Action: --

Start: 02/20/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20240701

Report Duplicates (1)

BIAL: KR-BIAL-BIAL-18009

Raw JSON (click to expand)

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      {
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        "drugrecurrence": []
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        "drugindication": "Unevaluable therapy",
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        "drugstartdate": "2024-06-04T00:00:00",
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        "activesubstance": {
          "activesubstancename": "CHOLINE ALFOSCERATE"
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        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
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        "drugindication": "Prophylaxis",
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        "drugstartdate": "2024-11-15T00:00:00",
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        "activesubstance": {
          "activesubstancename": "CLOBAZAM"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "DIABEX",
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        "drugdosageform": null,
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        "drugstartdate": "2024-02-20T00:00:00",
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        "activesubstance": {
          "activesubstancename": "METFORMIN HYDROCHLORIDE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20240701"
  },
  "primarysource": {
    "reportercountry": "KR",
    "qualification": 1,
    "literaturereference": null
  },
  "primarysourcecountry": "KR",
  "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": "BIAL",
      "duplicatenumb": "KR-BIAL-BIAL-18009"
    }
  ],
  "reporttype": 2,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "SUNOVION"
  },
  "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"
}
                        

25974049 Type 1

Serious

POLATUZUMAB VEDOTIN, RITUXIMAB, CYCLOPHOSPHAMIDE (+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

Physician

Literature Reference

Company Number

RU-ROCHE-10000421516

Authority Number

Sender Organization

ROCHE

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

61.0 yr

Patient Age Group

Adult

Patient Sex

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Skin toxicity (v28.1) Unknown

Drugs (5)

POLATUZUMAB VEDOTIN (POLATUZUMAB VEDOTIN) Suspect

Route: 065 | Dosage: -- | Form: -- | Indication: Diffuse large B-cell lymphoma | Action: Withdrawn

Start: 06/22/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

RITUXIMAB (RITUXIMAB) Suspect

Route: 065 | Dosage: -- | Form: -- | Indication: Diffuse large B-cell lymphoma | Action: Withdrawn

Start: 06/22/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) Suspect

Route: 065 | Dosage: -- | Form: -- | Indication: Diffuse large B-cell lymphoma | Action: Withdrawn

Start: 06/22/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

DOXORUBICIN (DOXORUBICIN) Suspect

Route: 065 | Dosage: -- | Form: -- | Indication: Diffuse large B-cell lymphoma | Action: Withdrawn

Start: 06/22/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

VINCRISTINE (VINCRISTINE) Suspect

Route: 065 | Dosage: -- | Form: -- | Indication: Diffuse large B-cell lymphoma | Action: Withdrawn

Start: 06/22/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

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25974048 Type 1

Non-Serious

REMODULIN, REMODULIN, OPSUMIT (+17 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-UNITED THERAPEUTICS-UNT-2025-036752

Authority Number

Sender Organization

UNITED THERAPEUTICS

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

Male

Patient Weight

102.04 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Pulmonary arterial pressure abnormal (v28.1) Unknown

Drugs (20)

REMODULIN (TREPROSTINIL) Suspect

Route: 041 | Dosage: 0.0373 ?G/KG, CONTINUING | Form: Injection | Indication: Pulmonary arterial hypertension | Action: Unknown

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

Recurrences: --

REMODULIN (TREPROSTINIL) Suspect

Route: 041 | Dosage: UNK, CONTINUING | Form: Injection | Indication: -- | Action: Unknown

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

Recurrences: --

OPSUMIT (MACITENTAN) Suspect

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

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

Recurrences: --

Omega (--) Concomitant

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

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

Recurrences: --

VITAMIN D3 (CHOLECALCIFEROL) Concomitant

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

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

Recurrences: --

SIMVASTATIN (SIMVASTATIN) Concomitant

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

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

Recurrences: --

TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) Concomitant

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

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

Recurrences: --

HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) Concomitant

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

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

Recurrences: --

POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) Concomitant

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

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

Recurrences: --

ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM) Concomitant

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

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

Recurrences: --

PIOGLITAZONE (PIOGLITAZONE) Concomitant

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

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

Recurrences: --

SOTATERCEPT (SOTATERCEPT) Concomitant

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

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

Recurrences: --

IBUPROFEN (IBUPROFEN) Concomitant

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

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

Recurrences: --

OXYGEN (OXYGEN) Concomitant

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

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

Recurrences: --

BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) Concomitant

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

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

Recurrences: --

TRAZODONE HCL (TRAZODONE HYDROCHLORIDE) Concomitant

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

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

Recurrences: --

FUROSEMIDE (FUROSEMIDE) Concomitant

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

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

Recurrences: --

GLIPIZIDE (GLIPIZIDE) Concomitant

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

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

Recurrences: --

METFORMIN (METFORMIN HYDROCHLORIDE) Concomitant

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

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

Recurrences: --

CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) Concomitant

Route: -- | Dosage: UNK | 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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      {
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      {
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          "activesubstancename": "IBUPROFEN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "OXYGEN",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
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        "activesubstance": {
          "activesubstancename": "OXYGEN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "BENADRYL ALLERGY",
        "drugauthorizationnumb": null,
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        "activesubstance": {
          "activesubstancename": "DIPHENHYDRAMINE HYDROCHLORIDE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "TRAZODONE HCL",
        "drugauthorizationnumb": null,
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        },
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      },
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          "activesubstancename": "FUROSEMIDE"
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        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "GLIPIZIDE",
        "drugauthorizationnumb": null,
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          "activesubstancename": "GLIPIZIDE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "METFORMIN",
        "drugauthorizationnumb": null,
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          "activesubstancename": "METFORMIN HYDROCHLORIDE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "CYCLOBENZAPRINE HYDROCHLORIDE",
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    ],
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  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
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  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
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  "receivedate": "2025-10-29T00:00:00",
  "receivedateformat": "102",
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  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25974027 Type 2

Serious

NUPLAZID

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-011620

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

88.0 yr

Patient Age Group

Patient Sex

Male

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: -- | End: 10/21/2025 | Duration: -- -- | Rechallenge: -- | Additional: 4

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251021

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69974fc78e900fe3f48c68d5",
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        "reactionmeddraversionpt": "28.1",
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      }
    ],
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          "activesubstancename": "PIMAVANSERIN TARTRATE"
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      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251021"
  },
  "primarysource": {
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  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25974026 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-011616

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

Male

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69974fc78e900fe3f48c68d4",
  "safetyreportid": "25974026",
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      }
    ],
    "drug": [
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          "activesubstancename": "PIMAVANSERIN TARTRATE"
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  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25974028 Type 1

Serious

ENBREL, ENBREL, INFLIXIMAB (+146 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-AMGEN-CANSP2025212912

Authority Number

Sender Organization

AMGEN

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 (8)

Hip arthroplasty (v28.1) Fatal

Loss of personal independence in daily activities (v28.1) Fatal

Spinal fusion surgery (v28.1) Fatal

Walking aid user (v28.1) Fatal

Weight increased (v28.1) Fatal

Wheezing (v28.1) Fatal

Wound (v28.1) Fatal

Wound infection (v28.1) Fatal

Drugs (149)

ENBREL (ETANERCEPT) Suspect

Route: 065 | Dosage: 20 MILLIGRAM, QD | Form: Unknown formulation | Indication: Product used for unknown indication | Action: Not Applicable

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

Recurrences: --

ENBREL (ETANERCEPT) Suspect

Route: 065 | Dosage: UNK | Form: Unknown formulation | Indication: -- | Action: Not Applicable

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

Recurrences: --

INFLIXIMAB (INFLIXIMAB) Suspect

Route: 065 | Dosage: 400 MILLIGRAM | Form: Unknown formulation | Indication: Product used for unknown indication | Action: Not Applicable

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

Recurrences: --

INFLIXIMAB (INFLIXIMAB) Suspect

Route: 065 | Dosage: 500 MILLIGRAM | Form: Unknown formulation | Indication: -- | Action: Not Applicable

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

Recurrences: --

USTEKINUMAB (USTEKINUMAB) Suspect

Route: 065 | Dosage: 45 MILLIGRAM | Form: Unknown formulation | Indication: Product used for unknown indication | Action: Not Applicable

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

Recurrences: --

HYRIMOZ (ADALIMUMAB-ADAZ) Suspect

Route: 065 | Dosage: 40 MILLIGRAM, SOLUTION SUBCUTANEOUS | Form: Solution for injection | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

HYRIMOZ (ADALIMUMAB-ADAZ) Suspect

Route: 065 | Dosage: 3011.2 MILLIGRAM | Form: Solution for injection | Indication: -- | Action: --

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

Recurrences: --

HYRIMOZ (ADALIMUMAB-ADAZ) Suspect

Route: 065 | Dosage: 40 MILLIGRAM | Form: Solution for injection | Indication: -- | Action: --

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

Recurrences: --

ALENDRONATE SODIUM (ALENDRONATE SODIUM) Suspect

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

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

Recurrences: --

APREMILAST (APREMILAST) Suspect

Route: 065 | Dosage: 6 MILLIGRAM, QD, TABLET | Form: Tablet | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

APREMILAST (APREMILAST) Suspect

Route: 065 | Dosage: 3 MILLIGRAM, QD | Form: Tablet | Indication: -- | Action: --

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

Recurrences: --

APREMILAST (APREMILAST) Suspect

Route: 065 | Dosage: 60 MILLIGRAM | Form: Tablet | Indication: -- | Action: --

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

Recurrences: --

APREMILAST (APREMILAST) Suspect

Route: 065 | Dosage: 6 MILLIGRAM, QD | Form: Tablet | Indication: -- | Action: --

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

Recurrences: --

CLONIDINE HYDROCHLORIDE (CLONIDINE HYDROCHLORIDE) Suspect

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

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

Recurrences: --

DICLOFENAC POTASSIUM (DICLOFENAC POTASSIUM) Suspect

Route: 065 | Dosage: 50 MILLIGRAM | Form: Tablet | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

DICLOFENAC SODIUM (DICLOFENAC SODIUM) Suspect

Route: 065 | Dosage: 50 MILLIGRAM | Form: Suppository | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

DICLOFENAC SODIUM (DICLOFENAC SODIUM) Suspect

Route: 065 | Dosage: 100 MILLIGRAM | Form: Suppository | Indication: -- | Action: --

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

Recurrences: --

DICLOFENAC SODIUM (DICLOFENAC SODIUM) Suspect

Route: 065 | Dosage: 50 MILLIGRAM, QD | Form: Suppository | Indication: -- | Action: --

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

Recurrences: --

DICLOFENAC SODIUM (DICLOFENAC SODIUM) Suspect

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

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

Recurrences: --

DILTIAZEM (DILTIAZEM) Suspect

Route: 065 | Dosage: 25 MILLIGRAM | Form: -- | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

DILTIAZEM (DILTIAZEM) Suspect

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

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

Recurrences: --

ERELZI (ETANERCEPT-SZZS) Suspect

Route: 065 | Dosage: 50 MILLIGRAM | Form: -- | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

ERELZI (ETANERCEPT-SZZS) Suspect

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

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

Recurrences: --

MORPHINE (MORPHINE) Suspect

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

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

Recurrences: --

SULFASALAZINE (SULFASALAZINE) Suspect

Route: 065 | Dosage: 2000 MILLIGRAM, QD | Form: -- | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

SULFASALAZINE (SULFASALAZINE) Suspect

Route: 065 | Dosage: 1000 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

SULFASALAZINE (SULFASALAZINE) Suspect

Route: 065 | Dosage: 10 GRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

SULFASALAZINE (SULFASALAZINE) Suspect

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

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

Recurrences: --

SULFASALAZINE (SULFASALAZINE) Suspect

Route: 065 | Dosage: 2 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

SULFASALAZINE (SULFASALAZINE) Suspect

Route: 065 | Dosage: 500 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

DESOXIMETASONE (DESOXIMETASONE) Suspect

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

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

Recurrences: --

DESOXIMETASONE (DESOXIMETASONE) Suspect

Route: 065 | Dosage: 25 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

PREGABALIN (PREGABALIN) Suspect

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

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

Recurrences: --

QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) Suspect

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

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

Recurrences: --

OXYCODONE (OXYCODONE) Suspect

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

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

Recurrences: --

AZATHIOPRINE (AZATHIOPRINE) Suspect

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

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

Recurrences: --

METHOTREXATE (METHOTREXATE) Suspect

Route: 065 | Dosage: 20 MILLIGRAM | Form: -- | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

METHOTREXATE (METHOTREXATE) Suspect

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

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

Recurrences: --

METHOTREXATE (METHOTREXATE) Suspect

Route: 065 | Dosage: UNK UNK, QD | Form: -- | Indication: -- | Action: --

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

Recurrences: --

METHOTREXATE (METHOTREXATE) Suspect

Route: 065 | Dosage: 25 MILLIGRAM, QD | Form: -- | Indication: -- | Action: --

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

Recurrences: --

METHOTREXATE (METHOTREXATE) Suspect

Route: 065 | Dosage: 25 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

METHOTREXATE (METHOTREXATE) Suspect

Route: 065 | Dosage: 40 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

METHOTREXATE (METHOTREXATE) Suspect

Route: 065 | Dosage: 20 MILLIGRAM, QD | Form: -- | Indication: -- | Action: --

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

Recurrences: --

METHOTREXATE (METHOTREXATE) Suspect

Route: 065 | Dosage: 15 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

METHOTREXATE (METHOTREXATE) Suspect

Route: 065 | Dosage: 225 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

METHOTREXATE (METHOTREXATE) Suspect

Route: 065 | Dosage: 15 MILLIGRAM, QD | Form: -- | Indication: -- | Action: --

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

Recurrences: --

METHOTREXATE (METHOTREXATE) Suspect

Route: 065 | Dosage: 2 GRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

CELECOXIB (CELECOXIB) Suspect

Route: 065 | Dosage: 200 MILLIGRAM | Form: Tablet | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

CELECOXIB (CELECOXIB) Suspect

Route: 065 | Dosage: 1 DOSAGE FORM, QD | Form: Tablet | Indication: -- | Action: --

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

Recurrences: --

CELECOXIB (CELECOXIB) Suspect

Route: 065 | Dosage: 2 DOSAGE FORM, QD | Form: Tablet | Indication: -- | Action: --

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

Recurrences: --

TOFACITINIB (TOFACITINIB) Suspect

Route: 065 | Dosage: 10 MILLIGRAM, QD | Form: Tablet | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

TOFACITINIB CITRATE (TOFACITINIB CITRATE) Suspect

Route: 065 | Dosage: 10 MILLIGRAM, QD | Form: -- | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

TOFACITINIB CITRATE (TOFACITINIB CITRATE) Suspect

Route: 065 | Dosage: 5 MILLIGRAM, QD | Form: -- | Indication: -- | Action: --

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

Recurrences: --

BACITRACIN ZINC AND POLYMYXIN B SULFATE (BACITRACIN ZINC\POLYMYXIN B SULFATE) Suspect

Route: 065 | Dosage: 50 MILLIGRAM | Form: -- | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

BACITRACIN ZINC AND POLYMYXIN B SULFATE (BACITRACIN ZINC\POLYMYXIN B SULFATE) Suspect

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

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

Recurrences: --

BACITRACIN ZINC AND POLYMYXIN B SULFATE (BACITRACIN ZINC\POLYMYXIN B SULFATE) Suspect

Route: 065 | Dosage: 5 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

BACITRACIN ZINC AND POLYMYXIN B SULFATE (BACITRACIN ZINC\POLYMYXIN B SULFATE) Suspect

Route: 065 | Dosage: 7.5 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

BACITRACIN ZINC AND POLYMYXIN B SULFATE (BACITRACIN ZINC\POLYMYXIN B SULFATE) Suspect

Route: 065 | Dosage: 40 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

BACITRACIN ZINC AND POLYMYXIN B SULFATE (BACITRACIN ZINC\POLYMYXIN B SULFATE) Suspect

Route: 065 | Dosage: 1 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

ASPIRIN (ASPIRIN) Suspect

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

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

Recurrences: --

PANTOPRAZOLE SODIUM ANHYDROUS (PANTOPRAZOLE SODIUM ANHYDROUS) Suspect

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

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

Recurrences: --

BIOFLAVONOIDS (BIOFLAVONOIDS) Suspect

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

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

Recurrences: --

CALCIUM CARBONATE (CALCIUM CARBONATE) Suspect

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

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

Recurrences: --

CALCIUM CITRATE (CALCIUM CITRATE) Suspect

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

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

Recurrences: --

CALCIUM GLUBIONATE (CALCIUM GLUBIONATE) Suspect

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

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

Recurrences: --

CERTOLIZUMAB PEGOL (CERTOLIZUMAB PEGOL) Suspect

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

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

Recurrences: --

CERTOLIZUMAB PEGOL (CERTOLIZUMAB PEGOL) Suspect

Route: 065 | Dosage: 2 DOSAGE FORM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) Suspect

Route: 065 | Dosage: 10 MILLIGRAM, QD | Form: -- | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) Suspect

Route: 065 | Dosage: 25 MILLIGRAM, QD | Form: -- | Indication: -- | Action: --

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

Recurrences: --

CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) Suspect

Route: 065 | Dosage: 20 MILLIGRAM, QD | Form: -- | Indication: -- | Action: --

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

Recurrences: --

CHLORHEXIDINE ACETATE (CHLORHEXIDINE ACETATE) Suspect

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

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

Recurrences: --

CIMZIA (CERTOLIZUMAB PEGOL) Suspect

Route: 065 | Dosage: 400 MILLIGRAM | Form: Solution for injection | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

CIMZIA (CERTOLIZUMAB PEGOL) Suspect

Route: 065 | Dosage: 1 DOSAGE FORM, QD | Form: Solution for injection | Indication: -- | Action: --

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

Recurrences: --

CIMZIA (CERTOLIZUMAB PEGOL) Suspect

Route: 065 | Dosage: 2 DOSAGE FORM | Form: Solution for injection | Indication: -- | Action: --

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

Recurrences: --

CORTISONE ACETATE (CORTISONE ACETATE) Suspect

Route: 065 | Dosage: 25 MILLIGRAM | Form: Ointment | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

CORTISONE ACETATE (CORTISONE ACETATE) Suspect

Route: 065 | Dosage: 20 MILLIGRAM | Form: Ointment | Indication: -- | Action: --

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

Recurrences: --

CORTISONE ACETATE (CORTISONE ACETATE) Suspect

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

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

Recurrences: --

CORTISONE (CORTISONE) Suspect

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

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

Recurrences: --

DICLOFENAC DIETHYLAMINE (DICLOFENAC DIETHYLAMINE) Suspect

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

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

Recurrences: --

DICLOFENAC DIETHYLAMINE (DICLOFENAC DIETHYLAMINE) Suspect

Route: 065 | Dosage: 50 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) Suspect

Route: 065 | Dosage: 40 MILLIGRAM | Form: -- | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

SULFISOMIDINE (SULFISOMIDINE) Suspect

Route: 065 | Dosage: 25 MILLIGRAM | Form: -- | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

FOLIC ACID (FOLIC ACID) Suspect

Route: 065 | Dosage: 500 MILLIGRAM | Form: -- | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

FOLIC ACID (FOLIC ACID) Suspect

Route: 065 | Dosage: 25 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

FOLIC ACID (FOLIC ACID) Suspect

Route: 065 | Dosage: 1 GRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

FOLIC ACID (FOLIC ACID) Suspect

Route: 065 | Dosage: 15 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

FOLIC ACID (FOLIC ACID) Suspect

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

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

Recurrences: --

FOLIC ACID (FOLIC ACID) Suspect

Route: 065 | Dosage: 50 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

FOLIC ACID (FOLIC ACID) Suspect

Route: 065 | Dosage: 5 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

FOLIC ACID (FOLIC ACID) Suspect

Route: 065 | Dosage: 3 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

ENTYVIO (VEDOLIZUMAB) Suspect

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

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

Recurrences: --

FRAMYCETIN SULFATE (FRAMYCETIN SULFATE) Suspect

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

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

Recurrences: --

GOLIMUMAB (GOLIMUMAB) Suspect

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

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

Recurrences: --

HUMIRA (ADALIMUMAB) Suspect

Route: 058 | Dosage: 400 MILLIGRAM, SOLUTION SUBCUTANEOUS | Form: Solution | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

HUMIRA (ADALIMUMAB) Suspect

Route: 058 | Dosage: 4 MILLIGRAM | Form: Solution | Indication: -- | Action: --

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

Recurrences: --

HUMIRA (ADALIMUMAB) Suspect

Route: 058 | Dosage: 40 MILLIGRAM | Form: Solution | Indication: -- | Action: --

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

Recurrences: --

HUMIRA (ADALIMUMAB) Suspect

Route: 058 | Dosage: UNK | Form: Solution | Indication: -- | Action: --

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

Recurrences: --

HYDROCORTISONE SODIUM SUCCINATE (HYDROCORTISONE SODIUM SUCCINATE) Suspect

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

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

Recurrences: --

HYDROCORTISONE SODIUM SUCCINATE (HYDROCORTISONE SODIUM SUCCINATE) Suspect

Route: 065 | Dosage: 25 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

HYDROXYCHLOROQUINE (HYDROXYCHLOROQUINE) Suspect

Route: 065 | Dosage: 5 MILLIGRAM | Form: Tablet | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

HYDROXYCHLOROQUINE (HYDROXYCHLOROQUINE) Suspect

Route: 065 | Dosage: 40 MILLIGRAM, QD | Form: Tablet | Indication: -- | Action: --

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

Recurrences: --

HYDROXYCHLOROQUINE (HYDROXYCHLOROQUINE) Suspect

Route: 065 | Dosage: 400 MILLIGRAM | Form: Tablet | Indication: -- | Action: --

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

Recurrences: --

HYDROXYCHLOROQUINE (HYDROXYCHLOROQUINE) Suspect

Route: 065 | Dosage: UNK UNK, QD | Form: Tablet | Indication: -- | Action: --

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

Recurrences: --

HYDROXYCHLOROQUINE SULFATE (HYDROXYCHLOROQUINE SULFATE) Suspect

Route: 065 | Dosage: 400 MILLIGRAM, QD | Form: -- | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

HYDROXYCHLOROQUINE SULFATE (HYDROXYCHLOROQUINE SULFATE) Suspect

Route: 065 | Dosage: 400 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

HYDROXYCHLOROQUINE SULFATE (HYDROXYCHLOROQUINE SULFATE) Suspect

Route: 065 | Dosage: 4000 MILLIGRAM, QD | Form: -- | Indication: -- | Action: --

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

Recurrences: --

HYDROXYCHLOROQUINE SULFATE (HYDROXYCHLOROQUINE SULFATE) Suspect

Route: 065 | Dosage: 40 MILLIGRAM, QD | Form: -- | Indication: -- | Action: --

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

Recurrences: --

HYDROXYCHLOROQUINE SULFATE (HYDROXYCHLOROQUINE SULFATE) Suspect

Route: 065 | Dosage: 5 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) Suspect

Route: 061 | Dosage: UNK, LIQUID TOPICAL | Form: -- | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

MESALAMINE (MESALAMINE) Suspect

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

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

Recurrences: --

METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE SODIUM SUCCINATE) Suspect

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

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

Recurrences: --

MYCOPHENOLATE MOFETIL HYDROCHLORIDE (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) Suspect

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

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

Recurrences: --

NAPROXEN SODIUM (NAPROXEN SODIUM) Suspect

Route: 065 | Dosage: 100 MILLIGRAM, QD | Form: -- | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

NITROFURAZONE (NITROFURAZONE) Suspect

Route: 065 | Dosage: 25 MILLIGRAM | Form: -- | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

ORENCIA (ABATACEPT) Suspect

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

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

Recurrences: --

ORENCIA (ABATACEPT) Suspect

Route: 065 | Dosage: 120 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

ORENCIA (ABATACEPT) Suspect

Route: 065 | Dosage: 365 DOSAGE FORM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

ORENCIA (ABATACEPT) Suspect

Route: 065 | Dosage: 17.88 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

ORENCIA (ABATACEPT) Suspect

Route: 065 | Dosage: 17.86 MILLIGRAM, QD | Form: -- | Indication: -- | Action: --

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

Recurrences: --

ORENCIA (ABATACEPT) Suspect

Route: 065 | Dosage: 18 MILLIGRAM, QD | Form: -- | Indication: -- | Action: --

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

Recurrences: --

ORENCIA (ABATACEPT) Suspect

Route: 065 | Dosage: 125 MILLIGRAM, QWK | Form: -- | Indication: -- | Action: --

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

Recurrences: --

ORENCIA (ABATACEPT) Suspect

Route: 065 | Dosage: 5 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

ORENCIA (ABATACEPT) Suspect

Route: 065 | Dosage: 125 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

PARA-AMINOSALICYLIC ACID (AMINOSALICYLIC ACID) Suspect

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

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

Recurrences: --

PARA-AMINOSALICYLIC ACID (AMINOSALICYLIC ACID) Suspect

Route: 065 | Dosage: 400 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

PARA-AMINOSALICYLIC ACID (AMINOSALICYLIC ACID) Suspect

Route: 065 | Dosage: 1000 MILLIGRAM, QD | Form: -- | Indication: -- | Action: --

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

Recurrences: --

PARA-AMINOSALICYLIC ACID (AMINOSALICYLIC ACID) Suspect

Route: 065 | Dosage: 2000 MILLIGRAM, QD | Form: -- | Indication: -- | Action: --

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

Recurrences: --

PARA-AMINOSALICYLIC ACID (AMINOSALICYLIC ACID) Suspect

Route: 065 | Dosage: 500 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

SODIUM FLUORIDE (SODIUM FLUORIDE) Suspect

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

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

Recurrences: --

PHTHALYLSULFATHIAZOLE (PHTHALYLSULFATHIAZOLE) Suspect

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

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

Recurrences: --

PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HYDROCHLORIDE) Suspect

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

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

Recurrences: --

ROBAXACET (ACETAMINOPHEN\METHOCARBAMOL) Suspect

Route: 065 | Dosage: 20 MILLIGRAM | Form: -- | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

SULFAMETHOXAZOLE\TRIMETHOPRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Suspect

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

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

Recurrences: --

THYMOL (THYMOL) Suspect

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

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

Recurrences: --

THYMOL (THYMOL) Suspect

Route: 065 | Dosage: 25 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

TOCILIZUMAB (TOCILIZUMAB) Suspect

Route: 065 | Dosage: 2912 MILLIGRAM | Form: -- | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

TOCILIZUMAB (TOCILIZUMAB) Suspect

Route: 065 | Dosage: 1 DOSAGE FORM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

TOCILIZUMAB (TOCILIZUMAB) Suspect

Route: 065 | Dosage: 752.8 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

TOCILIZUMAB (TOCILIZUMAB) Suspect

Route: 065 | Dosage: 728 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

TOCILIZUMAB (TOCILIZUMAB) Suspect

Route: 065 | Dosage: 20 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

TOCILIZUMAB (TOCILIZUMAB) Suspect

Route: 065 | Dosage: 3011.2 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

TOCILIZUMAB (TOCILIZUMAB) Suspect

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

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

Recurrences: --

TOCILIZUMAB (TOCILIZUMAB) Suspect

Route: 065 | Dosage: 752 MILLIGRAM, QWK | Form: -- | Indication: -- | Action: --

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

Recurrences: --

TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) Suspect

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

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

Recurrences: --

TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) Suspect

Route: 013 | Dosage: UNK | Form: Suspension | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

TRICLOSAN (TRICLOSAN) Suspect

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

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

Recurrences: --

TYROTHRICIN (TYROTHRICIN) Suspect

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

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

Recurrences: --

TYROTHRICIN (TYROTHRICIN) Suspect

Route: 065 | Dosage: 25 MILLIGRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

VITAMIN D3 (CHOLECALCIFEROL) Suspect

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

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

Recurrences: --

Clinical Narrative

Report Duplicates (3)

MAH number: SDZ2025CA018319

HEALTHCANVIG: CA-HEALTHCANVIG-E2B_08095778

HEALTHCANVIG: E2B_08095778

Raw JSON (click to expand)

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  "companynumb": "CA-AMGEN-CANSP2025212912",
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "CA",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Hip arthroplasty",
        "reactionoutcome": 5
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Loss of personal independence in daily activities",
        "reactionoutcome": 5
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Spinal fusion surgery",
        "reactionoutcome": 5
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Walking aid user",
        "reactionoutcome": 5
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Weight increased",
        "reactionoutcome": 5
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Wheezing",
        "reactionoutcome": 5
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Wound",
        "reactionoutcome": 5
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Wound infection",
        "reactionoutcome": 5
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ENBREL",
        "drugauthorizationnumb": "103795",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 20.0,
        "drugstructuredosageunit": "003",
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        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
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        "drugdosagetext": "20 MILLIGRAM, QD",
        "drugdosageform": "Unknown formulation",
        "drugadministrationroute": "065",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
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        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "ETANERCEPT"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ENBREL",
        "drugauthorizationnumb": "103795",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
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        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": "Unknown formulation",
        "drugadministrationroute": "065",
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
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        "drugtreatmentdurationunit": null,
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        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "ETANERCEPT"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "INFLIXIMAB",
        "drugauthorizationnumb": "122136",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 400.0,
        "drugstructuredosageunit": "003",
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        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "400 MILLIGRAM",
        "drugdosageform": "Unknown formulation",
        "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": "INFLIXIMAB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "INFLIXIMAB",
        "drugauthorizationnumb": "122136",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 500.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "500 MILLIGRAM",
        "drugdosageform": "Unknown formulation",
        "drugadministrationroute": "065",
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "INFLIXIMAB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "USTEKINUMAB",
        "drugauthorizationnumb": "139331",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 45.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "45 MILLIGRAM",
        "drugdosageform": "Unknown formulation",
        "drugadministrationroute": "065",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
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        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "USTEKINUMAB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "HYRIMOZ",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 40.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "40 MILLIGRAM, SOLUTION SUBCUTANEOUS",
        "drugdosageform": "Solution for injection",
        "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": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "ADALIMUMAB-ADAZ"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "HYRIMOZ",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 3011.2,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "3011.2 MILLIGRAM",
        "drugdosageform": "Solution for injection",
        "drugadministrationroute": "065",
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
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        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "ADALIMUMAB-ADAZ"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "HYRIMOZ",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 40.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "40 MILLIGRAM",
        "drugdosageform": "Solution for injection",
        "drugadministrationroute": "065",
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "ADALIMUMAB-ADAZ"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ALENDRONATE SODIUM",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "ALENDRONATE SODIUM"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "APREMILAST",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 6.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "6 MILLIGRAM, QD, TABLET",
        "drugdosageform": "Tablet",
        "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": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "APREMILAST"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "APREMILAST",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 3.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "3 MILLIGRAM, QD",
        "drugdosageform": "Tablet",
        "drugadministrationroute": "065",
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
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  "primarysource": {
    "reportercountry": "CA",
    "qualification": 3,
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  },
  "primarysourcecountry": "CA",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
  "receiptdateformat": "102",
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  "receiver": {
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  "reportduplicate": [
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      "duplicatesource": "MAH number",
      "duplicatenumb": "SDZ2025CA018319"
    },
    {
      "duplicatesource": "HEALTHCANVIG",
      "duplicatenumb": "CA-HEALTHCANVIG-E2B_08095778"
    },
    {
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  "reporttype": 1,
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  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 1,
  "seriousnessdisabling": 2,
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  "seriousnesslifethreatening": 2,
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  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25974024 Type 1

Serious

AZITHROMYCIN, AZITHROMYCIN, AZITHROMYCIN

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

George M. ANTIBIOTICS AND JAUNDICE: A YOUNG MAN?S JOURNEY TO A PFIC2 DIAGNOSIS. J Clin Exp Hepatol. 2025;15 (Suppl1):102634 (Abstract Id: 95)(S127)

Company Number

IN-SUN PHARMACEUTICAL INDUSTRIES LTD-2025R1-528911

Authority Number

Sender Organization

RANBAXY

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

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Progressive familial intrahepatic cholestasis (v28.1) Unknown

Drugs (3)

AZITHROMYCIN (AZITHROMYCIN) Suspect

Route: 065 | Dosage: UNK UNK, SINGLE | Form: Unknown | Indication: Pyrexia | Action: Unknown

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

Recurrences: --

AZITHROMYCIN (AZITHROMYCIN) Suspect

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

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

Recurrences: --

AZITHROMYCIN (AZITHROMYCIN) Suspect

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

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

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  "_id": "69974fc78e900fe3f48c68d2",
  "safetyreportid": "25974024",
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        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Progressive familial intrahepatic cholestasis",
        "reactionoutcome": 6
      }
    ],
    "drug": [
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25974021 Type 1

Non-Serious

REVLIMID, ACETAMINOPHEN, VITAMIN B COMPLEX (+10 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-BRISTOL-MYERS SQUIBB COMPANY-2025-146804

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

74.0 yr

Patient Age Group

Elderly

Patient Sex

Male

Patient Weight

59.42 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Diarrhoea (v28.1) Recovering

Decreased appetite (v28.1) Recovering

Drugs (13)

REVLIMID (LENALIDOMIDE) Suspect

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

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

Recurrences: --

ACETAMINOPHEN (ACETAMINOPHEN) Concomitant

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

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

Recurrences: --

VITAMIN B COMPLEX (CYANOCOBALAMIN\DEXPANTHENOL\NIACINAMIDE\PYRIDOXINE HYDROCHLORIDE\RIBOFLAVIN 5^-PHOSPHATE SODIUM\THIA) Concomitant

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

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

Recurrences: --

CALCITRIOL (CALCITRIOL) Concomitant

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

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

Recurrences: --

CARVEDILOL (CARVEDILOL) Concomitant

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

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

Recurrences: --

DEXAMETHASONE (DEXAMETHASONE) Concomitant

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

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

Recurrences: --

ELIQUIS (APIXABAN) Concomitant

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

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

Recurrences: --

ALBUTEROL\IPRATROPIUM (ALBUTEROL\IPRATROPIUM) Concomitant

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

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

Recurrences: --

LISINOPRIL (LISINOPRIL) Concomitant

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

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

Recurrences: --

ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE (ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE) Concomitant

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

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

Recurrences: --

PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) Concomitant

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

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

Recurrences: --

PROAIR HFA (ALBUTEROL SULFATE) Concomitant

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

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

Recurrences: --

ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM) Concomitant

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

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

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  },
  "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"
}
                        

25974023 Type 1

Serious

CABOMETYX, CABOMETYX

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-IPSEN Group, Research and Development-2025-01086

Authority Number

Sender Organization

EXELIXIS

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

72.0 yr

Patient Age Group

Patient Sex

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Gastrointestinal toxicity (v28.1) Unknown

Skin toxicity (v28.1) Unknown

Drugs (2)

CABOMETYX (CABOZANTINIB S-MALATE) Suspect

Route: 048 | Dosage: REDUCED DOSE FROM 40 MG TO 20 MG | Form: Tablet | Indication: Product used for unknown indication | Action: Dose Reduced

Start: 10/26/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

CABOMETYX (CABOZANTINIB S-MALATE) Suspect

Route: 048 | Dosage: REDUCED DOSE FROM 40 MG TO 20 MG | Form: Tablet | Indication: -- | Action: Dose Reduced

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20241115

Report Duplicates (2)

MINISAL02: EU-MINISAL02-1020134

ICSR-EVHUMAN: ICHICSR-EVHUMAN-20250115060920_Bz3rkL

Raw JSON (click to expand)

                            {
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    "reaction": [
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        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Gastrointestinal toxicity",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Skin toxicity",
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      }
    ],
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        "drugdosagetext": "REDUCED DOSE FROM 40 MG TO 20 MG",
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        },
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      },
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        "drugadditional": null,
        "actiondrug": 2,
        "activesubstance": {
          "activesubstancename": "CABOZANTINIB S-MALATE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20241115"
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 1,
    "literaturereference": null
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-29T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "MINISAL02",
      "duplicatenumb": "EU-MINISAL02-1020134"
    },
    {
      "duplicatesource": "ICSR-EVHUMAN",
      "duplicatenumb": "ICHICSR-EVHUMAN-20250115060920_Bz3rkL"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "EXELIXIS"
  },
  "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"
}
                        

25974022 Type 1

Serious

APIXABAN, VALPROIC ACID, VALPROIC ACID (+1 more)

Report Version

Receive Date

10/29/2025

Receipt Date

10/29/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Physician

Literature Reference

Wasowski E. Valproic Acid Induction of Permeability Glycoprotein: A Clinically Relevant Drug Interaction With Apixaban. Am J Ther. 2025;32 (4):e363-e364

Company Number

US-SUN PHARMACEUTICAL INDUSTRIES LTD-2025R1-526794

Authority Number

Sender Organization

RANBAXY

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

66.0 yr

Patient Age Group

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Deep vein thrombosis (v28.1) Unknown

Drug interaction (v28.1) Unknown

Drugs (4)

APIXABAN (APIXABAN) Interacting

Route: 065 | Dosage: 5 MILLIGRAM, BID | Form: Unknown | Indication: Pulmonary embolism | Action: Withdrawn

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

Recurrences: --

VALPROIC ACID (VALPROIC ACID) Suspect

Route: 065 | Dosage: 250 MILLIGRAM, BID | Form: Unknown | Indication: Mania | Action: Unknown

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

Recurrences: --

VALPROIC ACID (VALPROIC ACID) Suspect

Route: 065 | Dosage: 500 MILLIGRAM, BID | Form: Unknown | Indication: -- | Action: Unknown

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

Recurrences: --

LITHIUM (LITHIUM) Concomitant

Route: 065 | Dosage: 300 MILLIGRAM, BID | Form: -- | Indication: Mania | Action: --

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

Recurrences: --

Clinical Narrative

Report Duplicates (1)

SUN PHARMACEUTICAL INDUSTRIES LTD: US-SUN PHARMACEUTICAL INDUSTRIES LTD-2025R1-524159

Raw JSON (click to expand)

                            {
  "_id": "69974fc78e900fe3f48c68cc",
  "safetyreportid": "25974022",
  "authoritynumb": null,
  "companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2025R1-526794",
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 66.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Deep vein thrombosis",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Drug interaction",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 3,
        "medicinalproduct": "APIXABAN",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 5.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 12.0,
        "drugintervaldosagedefinition": 805,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "5 MILLIGRAM, BID",
        "drugdosageform": "Unknown",
        "drugadministrationroute": "065",
        "drugindication": "Pulmonary embolism",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "APIXABAN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "VALPROIC ACID",
        "drugauthorizationnumb": "091037",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 250.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 12.0,
        "drugintervaldosagedefinition": 805,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "250 MILLIGRAM, BID",
        "drugdosageform": "Unknown",
        "drugadministrationroute": "065",
        "drugindication": "Mania",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
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        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "VALPROIC ACID"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "VALPROIC ACID",
        "drugauthorizationnumb": "091037",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 500.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 12.0,
        "drugintervaldosagedefinition": 805,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "500 MILLIGRAM, BID",
        "drugdosageform": "Unknown",
        "drugadministrationroute": "065",
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
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        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "VALPROIC ACID"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "LITHIUM",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 300.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 12.0,
        "drugintervaldosagedefinition": 805,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "300 MILLIGRAM, BID",
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": "Mania",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "LITHIUM"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 1,
    "literaturereference": "Wasowski E. Valproic Acid Induction of Permeability Glycoprotein: A Clinically Relevant Drug Interaction With Apixaban. Am J Ther. 2025;32 (4):e363-e364"
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-29T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "SUN PHARMACEUTICAL INDUSTRIES LTD",
      "duplicatenumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2025R1-524159"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "RANBAXY"
  },
  "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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