FDA FAERS Adverse Event Reports

110500

Total Reports

60546

Serious Reports

108

Reporter Countries

25971571 Type 1

Non-Serious

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE

Report Version

Receive Date

10/29/2025

Receipt Date

10/29/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Contella L, Kang P, Wolf CE, Thomas VL, Gildenberg M, Snyder ML, Melanson SEF, Tolan NV. Urine methamphetamine-to-amphetamine ratio by LC-MS/MS to differentiate methamphetamine use from pharmaceutical impurity in patients prescribed amphetamine. Journal of Mass Spectrometry and Advances in the Clinical Lab. 2025;37:49-55

Company Number

US-ALKEM LABORATORIES LIMITED-US-ALKEM-2025-09354

Authority Number

Sender Organization

ALKEM

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

Patient Age Group

Patient Sex

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Product impurity (v28.1) Unknown

Drugs (1)

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE (AMPHETAMINE ASPARTATE\AMPHETAMINE SULFATE\DEXTROAMPHETAMINE SACCHARATE\DEXTROAMPHETAMINE SULFATE) Suspect

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

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69974fbd8e900fe3f48c607e",
  "safetyreportid": "25971571",
  "authoritynumb": null,
  "companynumb": "US-ALKEM LABORATORIES LIMITED-US-ALKEM-2025-09354",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": null,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Product impurity",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE",
        "drugauthorizationnumb": "217787",
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": "Unknown",
        "drugadministrationroute": "065",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "AMPHETAMINE ASPARTATE\\AMPHETAMINE SULFATE\\DEXTROAMPHETAMINE SACCHARATE\\DEXTROAMPHETAMINE SULFATE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 3,
    "literaturereference": "Contella L, Kang P, Wolf CE, Thomas VL, Gildenberg M, Snyder ML, Melanson SEF, Tolan NV. Urine methamphetamine-to-amphetamine ratio by LC-MS/MS to differentiate methamphetamine use from pharmaceutical impurity in patients prescribed amphetamine. Journal of Mass Spectrometry and Advances in the Clinical Lab. 2025;37:49-55"
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-29T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ALKEM"
  },
  "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"
}
                        

25971565 Type 2

Serious

TYSABRI

Report Version

Receive Date

10/29/2025

Receipt Date

10/29/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Company Number

US-BIOGEN-2087694

Authority Number

Sender Organization

BIOGEN

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

36.0 yr

Patient Age Group

Patient Sex

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Pyrexia (v28.1) Recovering

Rash (v28.1) Recovering

Headache (v28.1) Recovering

Drugs (1)

TYSABRI (NATALIZUMAB) Suspect

Route: -- | Dosage: -- | Form: Solution for infusion | Indication: Multiple sclerosis | Action: Dose Not Changed

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251001

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69974fbd8e900fe3f48c607d",
  "safetyreportid": "25971565",
  "authoritynumb": null,
  "companynumb": "US-BIOGEN-2087694",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 36.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Pyrexia",
        "reactionoutcome": 2
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Rash",
        "reactionoutcome": 2
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Headache",
        "reactionoutcome": 2
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "TYSABRI",
        "drugauthorizationnumb": "125104",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Solution for infusion",
        "drugadministrationroute": null,
        "drugindication": "Multiple sclerosis",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "NATALIZUMAB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251001"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 3,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-29T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 2,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "BIOGEN"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 1,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 2,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25971564 Type 1

Serious

DICLOFENAC, DICLOFENAC

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

JP-002147023-NVSJ2024JP007708

Authority Number

Sender Organization

Haleon PLC

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

Patient Age Group

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Diverticulum intestinal haemorrhagic (v28.1) Unknown

Drugs (2)

DICLOFENAC (DICLOFENAC) Suspect

Route: 048 | Dosage: TIME INTERVAL: AS NECESSARY: DOSE FORM: 37.5MG, LONG TIME | Form: Prolonged-release capsule | Indication: Back pain | Action: Unknown

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

Recurrences: --

DICLOFENAC (DICLOFENAC) Suspect

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

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

Recurrences: --

Clinical Narrative

Report Duplicates (2)

Novartis: JP-002147023-NVSJ2024JP007708

Novartis: NVSJ2024JP007708

Raw JSON (click to expand)

                            {
  "_id": "69974fbd8e900fe3f48c607c",
  "safetyreportid": "25971564",
  "authoritynumb": null,
  "companynumb": "JP-002147023-NVSJ2024JP007708",
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "JP",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Diverticulum intestinal haemorrhagic",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "DICLOFENAC",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "TIME INTERVAL: AS NECESSARY: DOSE FORM: 37.5MG, LONG TIME",
        "drugdosageform": "Prolonged-release capsule",
        "drugadministrationroute": "048",
        "drugindication": "Back pain",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "DICLOFENAC"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "DICLOFENAC",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Arthralgia",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "DICLOFENAC"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "JP",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "JP",
  "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": "Novartis",
      "duplicatenumb": "JP-002147023-NVSJ2024JP007708"
    },
    {
      "duplicatesource": "Novartis",
      "duplicatenumb": "NVSJ2024JP007708"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "Haleon PLC"
  },
  "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"
}
                        

25971562 Type 2

Serious

SYNTHROID

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-ABBVIE-6522237

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

99.0 yr

Patient Age Group

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Death (v28.1) Fatal

Dysphagia (v28.1) Unknown

Drugs (1)

SYNTHROID (LEVOTHYROXINE SODIUM) Suspect

Route: 050 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable

Start: 11/15/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250901

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69974fbd8e900fe3f48c607a",
  "safetyreportid": "25971562",
  "authoritynumb": null,
  "companynumb": "US-ABBVIE-6522237",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 99.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Death",
        "reactionoutcome": 5
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dysphagia",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "SYNTHROID",
        "drugauthorizationnumb": "21402",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 100.0,
        "drugstructuredosageunit": "004",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": "050",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": "102",
        "drugstartdate": "2023-11-15T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "LEVOTHYROXINE SODIUM"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250901"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-29T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 2,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ABBVIE"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 1,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 2,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25971560 Type 1

Serious

XOLAIR

Report Version

Receive Date

10/29/2025

Receipt Date

10/29/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

US-ROCHE-10000420130

Authority Number

Sender Organization

ROCHE

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

24.0 yr

Patient Age Group

Adult

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Anaphylactic reaction (v28.1) Unknown

Drugs (1)

XOLAIR (OMALIZUMAB) Suspect

Route: 058 | Dosage: STRENGTH: 300 MG/2ML | Form: Direct auto-injector | Indication: Urticaria | Action: Dose Not Changed

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251015

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69974fbd8e900fe3f48c6078",
  "safetyreportid": "25971560",
  "authoritynumb": null,
  "companynumb": "US-ROCHE-10000420130",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 24.0,
    "patientonsetageunit": 801,
    "patientagegroup": 5,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Anaphylactic reaction",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "XOLAIR",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": 300.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 4.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "STRENGTH: 300 MG/2ML",
        "drugdosageform": "Direct auto-injector",
        "drugadministrationroute": "058",
        "drugindication": "Urticaria",
        "drugstartdateformat": "610",
        "drugstartdate": "2025-05-01T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "OMALIZUMAB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251015"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-29T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ROCHE"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": null,
  "seriousnessdeath": null,
  "seriousnessdisabling": null,
  "seriousnesshospitalization": null,
  "seriousnesslifethreatening": null,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25971554 Type 2

Serious

SKYRIZI

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-ABBVIE-6516419

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

59.0 yr

Patient Age Group

Patient Sex

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Obstruction (v28.1) Recovered

Obstruction (v28.1) Unknown

Drugs (1)

SKYRIZI (RISANKIZUMAB-RZAA) Suspect

Route: 058 | Dosage: -- | Form: -- | Indication: Crohn^s disease | Action: Unknown

Start: 01/01/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250901

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69974fbd8e900fe3f48c6077",
  "safetyreportid": "25971554",
  "authoritynumb": null,
  "companynumb": "US-ABBVIE-6516419",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 59.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Obstruction",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Obstruction",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "SKYRIZI",
        "drugauthorizationnumb": "761105",
        "drugbatchnumb": "Not Available",
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        "drugadministrationroute": "058",
        "drugindication": "Crohn^s disease",
        "drugstartdateformat": "602",
        "drugstartdate": "2023-01-01T00:00:00",
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        "drugtreatmentduration": null,
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        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "RISANKIZUMAB-RZAA"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250901"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-29T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 2,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ABBVIE"
  },
  "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"
}
                        

25971547 Type 1

Serious

ADVIL, VOLTAREN, NEXIUM 24HR (+29 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

CA-HALEON-2269655

Authority Number

Sender Organization

Haleon PLC

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

Patient Age Group

Patient Sex

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (8)

Nephrolithiasis (v28.1) Unknown

Hyperhidrosis (v28.1) Unknown

Nausea (v28.1) Unknown

Nightmare (v28.1) Unknown

Off label use (v28.1) Unknown

Product use in unapproved indication (v28.1) Unknown

Sedation (v28.1) Unknown

Drug ineffective (v28.1) Unknown

Drugs (32)

ADVIL (IBUPROFEN) Suspect

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

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

Recurrences: --

VOLTAREN (DICLOFENAC SODIUM) Suspect

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

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

Recurrences: --

NEXIUM 24HR (ESOMEPRAZOLE MAGNESIUM) Suspect

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

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

Recurrences: --

ESOMEPRAZOLE MAGNESIUM\NAPROXEN (ESOMEPRAZOLE MAGNESIUM\NAPROXEN) Suspect

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

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

Recurrences: --

GABAPENTIN (GABAPENTIN) Suspect

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

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

Recurrences: --

HYDROMORPHONE (HYDROMORPHONE) Suspect

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

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

Recurrences: --

HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE) Suspect

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

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

Recurrences: --

KETAMINE (KETAMINE) Suspect

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

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

Recurrences: --

MAXALT (RIZATRIPTAN BENZOATE) Suspect

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

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

Recurrences: --

MORPHINE SULFATE (MORPHINE SULFATE) Suspect

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

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

Recurrences: --

NORTRIPTYLINE (NORTRIPTYLINE) Suspect

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

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

Recurrences: --

ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE) Suspect

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

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

Recurrences: --

PROPRANOLOL (PROPRANOLOL HYDROCHLORIDE) Suspect

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

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

Recurrences: --

TENORETIC (ATENOLOL\CHLORTHALIDONE) Suspect

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

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

Recurrences: --

ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE (ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE) Suspect

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

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

Recurrences: --

ACETAMINOPHEN\TRAMADOL HYDROCHLORIDE (ACETAMINOPHEN\TRAMADOL HYDROCHLORIDE) Suspect

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

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

Recurrences: --

ALMOTRIPTAN MALATE (ALMOTRIPTAN MALATE) Suspect

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

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

Recurrences: --

AMITRIPTYLINE (AMITRIPTYLINE) Suspect

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

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

Recurrences: --

BOTOX (ONABOTULINUMTOXINA) Suspect

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

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

Recurrences: --

BOTULINUM TOXIN TYPE A (BOTULINUM TOXIN TYPE A) Suspect

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

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

Recurrences: --

CELEBREX (CELECOXIB) Suspect

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

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

Recurrences: --

CODEINE (CODEINE) Suspect

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

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

Recurrences: --

CODEINE (CODEINE) Suspect

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

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

Recurrences: --

DEMEROL (MEPERIDINE HYDROCHLORIDE) Suspect

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

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

Recurrences: --

DIHYDROERGOTAMINE (DIHYDROERGOTAMINE) Suspect

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

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

Recurrences: --

ENDOCET (ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE) Suspect

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

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

Recurrences: --

DULOXETINE (DULOXETINE) Suspect

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

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

Recurrences: --

TOPAMAX (TOPIRAMATE) Suspect

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

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

Recurrences: --

TORADOL (KETOROLAC TROMETHAMINE) Suspect

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

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

Recurrences: --

ACETAMINOPHEN\TRAMADOL (ACETAMINOPHEN\TRAMADOL) Suspect

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

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

Recurrences: --

TYLENOL (ACETAMINOPHEN) Suspect

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

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

Recurrences: --

VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE) Suspect

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

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

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  "_id": "69974fbd8e900fe3f48c6076",
  "safetyreportid": "25971547",
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  "patient": {
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    "patientagegroup": null,
    "patientweight": null,
    "patientsex": null,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Nephrolithiasis",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Hyperhidrosis",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Nausea",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Nightmare",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Off label use",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Product use in unapproved indication",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Sedation",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Drug ineffective",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ADVIL",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
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          "activesubstancename": "IBUPROFEN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "VOLTAREN",
        "drugauthorizationnumb": null,
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        "drugindication": "Migraine",
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        "drugrecurreadministration": 3,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "DICLOFENAC SODIUM"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "NEXIUM 24HR",
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        "drugrecurreadministration": 3,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "ESOMEPRAZOLE MAGNESIUM"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ESOMEPRAZOLE MAGNESIUM\\NAPROXEN",
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        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "GABAPENTIN",
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        },
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      },
      {
        "drugcharacterization": 1,
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          "activesubstancename": "HYDROMORPHONE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "HYDROMORPHONE HYDROCHLORIDE",
        "drugauthorizationnumb": null,
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          "activesubstancename": "HYDROMORPHONE HYDROCHLORIDE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "KETAMINE",
        "drugauthorizationnumb": null,
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          "activesubstancename": "KETAMINE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "MAXALT",
        "drugauthorizationnumb": null,
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        "drugdosageform": "Tablet",
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        "drugindication": "Product used for unknown indication",
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        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "RIZATRIPTAN BENZOATE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "MORPHINE SULFATE",
        "drugauthorizationnumb": null,
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        "drugindication": "Migraine",
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        "drugadditional": 3,
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          "activesubstancename": "MORPHINE SULFATE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "NORTRIPTYLINE",
        "drugauthorizationnumb": null,
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        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Capsule",
        "drugadministrationroute": null,
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
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  },
  "primarysource": {
    "reportercountry": "CA",
    "qualification": 5,
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  },
  "primarysourcecountry": "CA",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
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  "receivedate": "2025-10-29T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
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  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "Haleon PLC"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
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  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25971546 Type 2

Serious

LAZCLUZE, BACLOFEN, CALTRATE (+13 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-JNJFOC-20251030671

Authority Number

Sender Organization

JOHNSON AND JOHNSON

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

60.0 yr

Patient Age Group

Adult

Patient Sex

Male

Patient Weight

78.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Haematochezia (v28.1) Not Recovered

Constipation (v28.1) Not Recovered

Diarrhoea (v28.1) Not Recovered

Rash (v28.1) Not Recovered

Drugs (16)

LAZCLUZE (LAZERTINIB) Suspect

Route: 048 | Dosage: -- | Form: Tablet | Indication: Lung neoplasm malignant | Action: Dose Not Changed

Start: 08/11/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

BACLOFEN (BACLOFEN) Concomitant

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

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

Recurrences: --

CALTRATE (CALCIUM CARBONATE) Concomitant

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

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

Recurrences: --

CLINDAMYCIN (CLINDAMYCIN) Concomitant

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

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

Recurrences: --

DOXYCYCLINE (DOXYCYCLINE) Concomitant

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

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

Recurrences: --

FLUDEOXYGLUCOSE (FLUDEOXYGLUCOSE) Concomitant

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

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

Recurrences: --

ONDANSETRON (ONDANSETRON) Concomitant

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

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

Recurrences: --

VITAMIN B6 (PYRIDOXINE HYDROCHLORIDE) Concomitant

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

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

Recurrences: --

VIAGRA (SILDENAFIL CITRATE) Concomitant

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

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

Recurrences: --

SUCRALFATE (SUCRALFATE) Concomitant

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

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

Recurrences: --

TAMSULOSIN (TAMSULOSIN) Concomitant

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

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

Recurrences: --

VITAMIN B12 (CYANOCOBALAMIN) Concomitant

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

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

Recurrences: --

FOLIC ACID (FOLIC ACID) Concomitant

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

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

Recurrences: --

GABAPENTIN (GABAPENTIN) Concomitant

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

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

Recurrences: --

ELIQUIS (APIXABAN) Concomitant

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

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

Recurrences: --

DEXAMETHASONE (DEXAMETHASONE) Concomitant

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

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

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        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Constipation",
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      {
        "reactionmeddraversionpt": "28.1",
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        "reactionmeddraversionpt": "28.1",
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        "drugrecurrence": []
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        "drugcharacterization": 2,
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      {
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      {
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  "primarysource": {
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    "qualification": 5,
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  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
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  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
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  "reportduplicate": [],
  "reporttype": 2,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "JOHNSON AND JOHNSON"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
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  "transmissiondate": "2026-01-17T00:00:00",
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}
                        

25971545 Type 1

Non-Serious

POMALYST, ASPIRIN, CLARITIN (+13 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

Pharmacist

Literature Reference

Company Number

US-BRISTOL-MYERS SQUIBB COMPANY-2025-146668

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

75.0 yr

Patient Age Group

Elderly

Patient Sex

Female

Patient Weight

107.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Pollakiuria (v28.1) Not Recovered

Pain in extremity (v28.1) Not Recovered

Drugs (16)

POMALYST (POMALIDOMIDE) Suspect

Route: 048 | Dosage: 1 CAPSULE DAILY FOR 21 DAYS ON AND 7 DAYS OFF | Form: Capsule | Indication: Plasma cell myeloma | Action: Dose Not Changed

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

Recurrences: --

ASPIRIN (ASPIRIN) Concomitant

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

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

Recurrences: --

CLARITIN (LORATADINE) Concomitant

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

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

Recurrences: --

COD LIVER OIL (COD LIVER OIL) Concomitant

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

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

Recurrences: --

ENALAPRIL MALEATE (ENALAPRIL MALEATE) Concomitant

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

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

Recurrences: --

ESCITALOPRAM (ESCITALOPRAM OXALATE) Concomitant

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

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

Recurrences: --

FISH OIL (FISH OIL) Concomitant

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

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

Recurrences: --

LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HYDROCHLORIDE) Concomitant

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

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

Recurrences: --

MAGNESIUM OXIDE (MAGNESIUM OXIDE) Concomitant

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

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

Recurrences: --

VITAMINS (VITAMINS) Concomitant

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

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

Recurrences: --

VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) Concomitant

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

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

Recurrences: --

VITAMIN B12 (CYANOCOBALAMIN) Concomitant

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

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

Recurrences: --

VITAMIN B1 (THIAMINE HYDROCHLORIDE) Concomitant

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

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

Recurrences: --

VITAMIN D3 (CHOLECALCIFEROL) Concomitant

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

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

Recurrences: --

VITAMIN K (PHYTONADIONE) Concomitant

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

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

Recurrences: --

ZYRTEC (CETIRIZINE HYDROCHLORIDE) Concomitant

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

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250905

Report Duplicates (0)

Raw JSON (click to expand)

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      {
        "drugcharacterization": 2,
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    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250905"
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  "primarysource": {
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    "qualification": 2,
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  "receivedateformat": "102",
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  },
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  "seriousnessdeath": 2,
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  "transmissiondate": "2026-01-18T00:00:00",
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}
                        

25971544 Type 2

Serious

IMBRUVICA, TYLENOL, VITAMIN B12 (+2 more)

Report Version

Receive Date

10/29/2025

Receipt Date

10/29/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

US-ABBVIE-6513977

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

75.0 yr

Patient Age Group

Patient Sex

Male

Patient Weight

80.739 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (6)

Gallbladder disorder (v28.1) Recovered

Fatigue (v28.1) Not Recovered

Headache (v28.1) Recovered

Dysphagia (v28.1) Recovered

Hiatus hernia (v28.1) Recovered

Oesophageal perforation (v28.1) Recovered

Drugs (5)

IMBRUVICA (IBRUTINIB) Suspect

Route: 048 | Dosage: FORM STRENGTH: 140 MG | Form: Capsule | Indication: Non-Hodgkin^s lymphoma | Action: Dose Not Changed

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

Recurrences: --

TYLENOL (ACETAMINOPHEN) Concomitant

Route: -- | Dosage: AS NEEDED | Form: -- | Indication: Headache | Action: --

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

Recurrences: --

VITAMIN B12 (CYANOCOBALAMIN) Concomitant

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

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

Recurrences: --

AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) Concomitant

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

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

Recurrences: --

OMEPRAZOLE (OMEPRAZOLE) Concomitant

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

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20220101

Report Duplicates (0)

Raw JSON (click to expand)

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  "_id": "69974fbd8e900fe3f48c6073",
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    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Gallbladder disorder",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Fatigue",
        "reactionoutcome": 3
      },
      {
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      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dysphagia",
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      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Hiatus hernia",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Oesophageal perforation",
        "reactionoutcome": 1
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "IMBRUVICA",
        "drugauthorizationnumb": "205552",
        "drugbatchnumb": "Not Available",
        "drugstructuredosagenumb": 280.0,
        "drugstructuredosageunit": "003",
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        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
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        "drugdosagetext": "FORM STRENGTH: 140 MG",
        "drugdosageform": "Capsule",
        "drugadministrationroute": "048",
        "drugindication": "Non-Hodgkin^s lymphoma",
        "drugstartdateformat": "602",
        "drugstartdate": "2021-01-01T00:00:00",
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        "drugenddate": null,
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        "drugtreatmentdurationunit": null,
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        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "IBRUTINIB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "TYLENOL",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
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        "drugcumulativedosageunit": null,
        "drugdosagetext": "AS NEEDED",
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Headache",
        "drugstartdateformat": null,
        "drugstartdate": null,
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        "drugtreatmentdurationunit": null,
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        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "ACETAMINOPHEN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "VITAMIN B12",
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        "drugseparatedosagenumb": 1.0,
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        "drugindication": "Vitamin supplementation",
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        "drugtreatmentdurationunit": null,
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        "activesubstance": {
          "activesubstancename": "CYANOCOBALAMIN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "AMLODIPINE BESYLATE",
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        "drugbatchnumb": null,
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        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Product used for unknown indication",
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        "drugstartdate": null,
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        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "AMLODIPINE BESYLATE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "OMEPRAZOLE",
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        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
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        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
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        "drugindication": "Antacid therapy",
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        "activesubstance": {
          "activesubstancename": "OMEPRAZOLE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20220101"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-29T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 2,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ABBVIE"
  },
  "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"
}
                        

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