FDA FAERS Adverse Event Reports

111000

Total Reports

60668

Serious Reports

108

Reporter Countries

25935335 Type 1

Serious

BENDAMUSTINE, CYCLOPHOSPHAMIDE, RITUXIMAB (+6 more)

Report Version

Receive Date

10/17/2025

Receipt Date

10/17/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Sorin B, Vigneron J, Fadlallah J, Mondesir J, Fieschi C, Oksenhendler E, et al. Campylobacter infection in 4 patients treated with ibrutinib. European Journal of Clinical Microbiology and Infectious Diseases. 2022;41(5): 849-852. doi:10.1007/s10096-022-04433-4.

Company Number

Authority Number

EU-ROCHE-3129810

Sender Organization

DR REDDYS

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

78.0 yr

Patient Age Group

Elderly

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Adenocarcinoma of colon (v28.1) Fatal

Panniculitis (v28.1) Recovered

Hypogammaglobulinaemia (v28.1) Unknown

Campylobacter infection (v28.1) Recovered

Drugs (9)

BENDAMUSTINE (BENDAMUSTINE) Suspect

Route: 065 | Dosage: UNK, AS A PART OF R-BENDA THERAPY | Form: -- | Indication: Chronic lymphocytic leukaemia | Action: Not Applicable

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

Recurrences: --

CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) Suspect

Route: 065 | Dosage: UNK, AS A PART OF R-FC THERAPY AND RCP THERAPY | Form: -- | Indication: Chronic lymphocytic leukaemia | Action: Not Applicable

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

Recurrences: --

RITUXIMAB (RITUXIMAB) Suspect

Route: 065 | Dosage: CONCENTRATE FOR CONCENTRATE FOR SOLUTION FOR INFUSION | Form: -- | Indication: Chronic lymphocytic leukaemia | Action: Not Applicable

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

Recurrences: --

PREDNISONE (PREDNISONE) Suspect

Route: 065 | Dosage: UNK, AS A PART OF R-CP THERAPY | Form: -- | Indication: Chronic lymphocytic leukaemia | Action: Not Applicable

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

Recurrences: --

IBRUTINIB (IBRUTINIB) Suspect

Route: 065 | Dosage: -- | Form: -- | Indication: Chronic lymphocytic leukaemia | Action: Dose Not Changed

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

Recurrences: --

OFATUMUMAB (OFATUMUMAB) Suspect

Route: 065 | Dosage: -- | Form: -- | Indication: Chronic lymphocytic leukaemia | Action: Not Applicable

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

Recurrences: --

FLUDARABINE (FLUDARABINE PHOSPHATE) Suspect

Route: 065 | Dosage: UNK, AS A PART OF R-FC THERAPY | Form: -- | Indication: Chronic lymphocytic leukaemia | Action: Not Applicable

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

Recurrences: --

CHLORAMBUCIL (CHLORAMBUCIL) Suspect

Route: 065 | Dosage: -- | Form: -- | Indication: Chronic lymphocytic leukaemia | Action: Not Applicable

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

Recurrences: --

AMOXICILLIN (AMOXICILLIN) Concomitant

Route: -- | Dosage: -- | Form: -- | Indication: Antibiotic prophylaxis | Action: Unknown

Start: -- | End: -- | Duration: 15.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

Clinical Narrative

Report Duplicates (10)

Adis: NZ-Adis-3690477-303733

EVDUP#MYLANLABS: EU-MYLANLABS-2022M1051376

Adis: NZ-Adis-3690477-303762

EVDUP#MYLANLABS: EU-ROCHE-3129810

ROCHE: EU-EMA-2022802-AUTODUP-1659469230641

CELLTRION HEALTHCARE HUNGARY KFT: EU-CELLTRION HEALTHCARE HUNGARY KFT-2022FR011241

CELLTRION INC.: EU-CELLTRION INC.-2022FR011241

Link Report No.: EU-ROCHE-3127858

Link Report No.: EU-ROCHE-3129808

EVDUP#STADA: EU-STADA-254851

Raw JSON (click to expand)

                            {
  "_id": "69d4352c3b3830196fa50aef",
  "safetyreportid": "25935335",
  "authoritynumb": "EU-ROCHE-3129810",
  "companynumb": null,
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
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    "patientonsetageunit": 801,
    "patientagegroup": 6,
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    "reaction": [
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        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Adenocarcinoma of colon",
        "reactionoutcome": 5
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Panniculitis",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Hypogammaglobulinaemia",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Campylobacter infection",
        "reactionoutcome": 1
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "BENDAMUSTINE",
        "drugauthorizationnumb": "205376",
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
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        "drugintervaldosageunitnumb": null,
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        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK, AS A PART OF R-BENDA THERAPY",
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": "Chronic lymphocytic leukaemia",
        "drugstartdateformat": null,
        "drugstartdate": null,
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        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CYCLOPHOSPHAMIDE",
        "drugauthorizationnumb": "212501",
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
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        "drugcumulativedosagenumb": null,
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        "drugdosagetext": "UNK, AS A PART OF R-FC THERAPY AND RCP THERAPY",
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": "Chronic lymphocytic leukaemia",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
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        "drugtreatmentdurationunit": null,
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        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "CYCLOPHOSPHAMIDE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "RITUXIMAB",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
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        "drugintervaldosagedefinition": null,
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        "drugdosagetext": "CONCENTRATE FOR CONCENTRATE FOR SOLUTION FOR INFUSION",
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": "Chronic lymphocytic leukaemia",
        "drugstartdateformat": null,
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        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "RITUXIMAB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "PREDNISONE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK, AS A PART OF R-CP THERAPY",
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": "Chronic lymphocytic leukaemia",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
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        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
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          "activesubstancename": "PREDNISONE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "IBRUTINIB",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "Unknown",
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        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
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        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": "Chronic lymphocytic leukaemia",
        "drugstartdateformat": null,
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        "drugenddateformat": null,
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        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
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        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "IBRUTINIB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "OFATUMUMAB",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": "Chronic lymphocytic leukaemia",
        "drugstartdateformat": null,
        "drugstartdate": null,
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        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "OFATUMUMAB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "FLUDARABINE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK, AS A PART OF R-FC THERAPY",
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": "Chronic lymphocytic leukaemia",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
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        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "FLUDARABINE PHOSPHATE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CHLORAMBUCIL",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
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        "drugindication": "Chronic lymphocytic leukaemia",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
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        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "CHLORAMBUCIL"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "AMOXICILLIN",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
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        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Antibiotic prophylaxis",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": 15.0,
        "drugtreatmentdurationunit": 804,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "AMOXICILLIN"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 3,
    "literaturereference": "Sorin B, Vigneron J, Fadlallah J, Mondesir J, Fieschi C, Oksenhendler E, et al. Campylobacter infection in 4 patients treated with ibrutinib. European Journal of Clinical Microbiology and Infectious Diseases. 2022;41(5): 849-852. doi:10.1007/s10096-022-04433-4."
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-17T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-17T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "Adis",
      "duplicatenumb": "NZ-Adis-3690477-303733"
    },
    {
      "duplicatesource": "EVDUP#MYLANLABS",
      "duplicatenumb": "EU-MYLANLABS-2022M1051376"
    },
    {
      "duplicatesource": "Adis",
      "duplicatenumb": "NZ-Adis-3690477-303762"
    },
    {
      "duplicatesource": "EVDUP#MYLANLABS",
      "duplicatenumb": "EU-ROCHE-3129810"
    },
    {
      "duplicatesource": "ROCHE",
      "duplicatenumb": "EU-EMA-2022802-AUTODUP-1659469230641"
    },
    {
      "duplicatesource": "CELLTRION HEALTHCARE HUNGARY KFT",
      "duplicatenumb": "EU-CELLTRION HEALTHCARE HUNGARY KFT-2022FR011241"
    },
    {
      "duplicatesource": "CELLTRION INC.",
      "duplicatenumb": "EU-CELLTRION INC.-2022FR011241"
    },
    {
      "duplicatesource": "Link Report No.",
      "duplicatenumb": "EU-ROCHE-3127858"
    },
    {
      "duplicatesource": "Link Report No.",
      "duplicatenumb": "EU-ROCHE-3129808"
    },
    {
      "duplicatesource": "EVDUP#STADA",
      "duplicatenumb": "EU-STADA-254851"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "DR REDDYS"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": null,
  "seriousnessdeath": 1,
  "seriousnessdisabling": null,
  "seriousnesshospitalization": null,
  "seriousnesslifethreatening": null,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25935334 Type 1

Non-Serious

WINREVAIR, WINREVAIR, WINREVAIR (+1 more)

Report Version

Receive Date

10/17/2025

Receipt Date

10/17/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

US-009507513-2339878

Authority Number

Sender Organization

MERCK SHARP & DOHME LLC

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

17.0 yr

Patient Age Group

Patient Sex

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Acne (v28.1) Not Recovered

Product use issue (v28.1) Unknown

Drugs (4)

WINREVAIR (SOTATERCEPT-CSRK) Suspect

Route: -- | Dosage: DOSE DECREASED TO 0.3MG/KG | Form: -- | Indication: -- | Action: Dose Reduced

Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: No

Recurrences: --

WINREVAIR (SOTATERCEPT-CSRK) Suspect

Route: -- | Dosage: DOSE: UNKOWN | Form: -- | Indication: -- | Action: Dose Reduced

Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: No

Recurrences: --

WINREVAIR (SOTATERCEPT-CSRK) Suspect

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

Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: No

Recurrences: --

WINREVAIR (SOTATERCEPT-CSRK) Suspect

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

Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: No

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d4352c3b3830196fa50aed",
  "safetyreportid": "25935334",
  "authoritynumb": null,
  "companynumb": "US-009507513-2339878",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
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    "patientonsetageunit": 801,
    "patientagegroup": null,
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    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Acne",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Product use issue",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "WINREVAIR",
        "drugauthorizationnumb": "761363",
        "drugbatchnumb": null,
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        "drugdosagetext": "DOSE DECREASED TO 0.3MG/KG",
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        "drugrecurreadministration": 3,
        "drugadditional": 2,
        "actiondrug": 2,
        "activesubstance": {
          "activesubstancename": "SOTATERCEPT-CSRK"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
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        "drugdosagetext": "DOSE: UNKOWN",
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        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
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          "activesubstancename": "SOTATERCEPT-CSRK"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
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        "drugauthorizationnumb": "761363",
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        "activesubstance": {
          "activesubstancename": "SOTATERCEPT-CSRK"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-17T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-17T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "MERCK SHARP & DOHME LLC"
  },
  "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"
}
                        

25935331 Type 2

Serious

VELTASSA

Report Version

Receive Date

10/17/2025

Receipt Date

10/17/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Company Number

US-BEH-2025221793

Authority Number

Sender Organization

CSL BEHRING

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

Patient Age Group

Adult

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Dyspnoea (v28.1) Unknown

Coronary arterial stent insertion (v28.1) Unknown

Drugs (1)

VELTASSA (PATIROMER) Suspect

Route: 065 | Dosage: 8.4 G, QD (30 PACKETS) | Form: Powder for oral suspension | Indication: Hyperkalaemia | Action: Unknown

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d4352c3b3830196fa50aeb",
  "safetyreportid": "25935331",
  "authoritynumb": null,
  "companynumb": "US-BEH-2025221793",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": 5,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dyspnoea",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Coronary arterial stent insertion",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "VELTASSA",
        "drugauthorizationnumb": "205739",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 8.4,
        "drugstructuredosageunit": "002",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "8.4 G, QD (30 PACKETS)",
        "drugdosageform": "Powder for oral suspension",
        "drugadministrationroute": "065",
        "drugindication": "Hyperkalaemia",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "PATIROMER"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 3,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-17T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-17T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 2,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "CSL BEHRING"
  },
  "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"
}
                        

25935332 Type 1

Serious

GOLD BOND ORIGINAL STRENGTH

Report Version

Receive Date

10/17/2025

Receipt Date

10/17/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Lawyer

Literature Reference

Company Number

US-OPELLA-2025OHG030369

Authority Number

Sender Organization

CHATTEM

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 (2)

Mesothelioma (v28.1) Fatal

Exposure to chemical pollution (v28.1) Fatal

Drugs (1)

GOLD BOND ORIGINAL STRENGTH (MENTHOL) Suspect

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

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20240301

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d4352c3b3830196fa50aea",
  "safetyreportid": "25935332",
  "authoritynumb": null,
  "companynumb": "US-OPELLA-2025OHG030369",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Mesothelioma",
        "reactionoutcome": 5
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Exposure to chemical pollution",
        "reactionoutcome": 5
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "GOLD BOND ORIGINAL STRENGTH",
        "drugauthorizationnumb": "59",
        "drugbatchnumb": "Asked But Unknown",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Unknown",
        "drugadministrationroute": "065",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "MENTHOL"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20240301"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 4,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-17T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-17T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
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  "sender": {
    "sendertype": 6,
    "senderorganization": "CHATTEM"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": null,
  "seriousnessdeath": 1,
  "seriousnessdisabling": null,
  "seriousnesshospitalization": null,
  "seriousnesslifethreatening": null,
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  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25935333 Type 1

Serious

ENTYVIO

Report Version

Receive Date

10/17/2025

Receipt Date

10/17/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Physician

Literature Reference

Company Number

BR-TAKEDA-2025TUS090212

Authority Number

Sender Organization

TAKEDA

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

50.0 yr

Patient Age Group

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Pericarditis (v28.1) Unknown

Sacroiliitis (v28.1) Unknown

Drugs (1)

ENTYVIO (VEDOLIZUMAB) Suspect

Route: -- | Dosage: UNK | Form: -- | Indication: Crohn^s disease | Action: Dose Not Changed

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d4352c3b3830196fa50ae9",
  "safetyreportid": "25935333",
  "authoritynumb": null,
  "companynumb": "BR-TAKEDA-2025TUS090212",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "BR",
  "patient": {
    "patientonsetage": 50.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Pericarditis",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Sacroiliitis",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ENTYVIO",
        "drugauthorizationnumb": "125476",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Crohn^s disease",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "VEDOLIZUMAB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "BR",
    "qualification": 1,
    "literaturereference": null
  },
  "primarysourcecountry": "BR",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-17T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-17T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "TAKEDA"
  },
  "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"
}
                        

25935330 Type 1

Serious

CYCLOPHOSPHAMIDE, KEYTRUDA, PACLITAXEL (+2 more)

Report Version

Receive Date

10/17/2025

Receipt Date

10/17/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Company Number

Authority Number

EU-AFSSAPS-MA2025001226

Sender Organization

DR REDDYS

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

46.0 yr

Patient Age Group

Adult

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (6)

Thrombocytopenia (v28.1) Recovered

Leukocytosis (v28.1) Recovered

Epistaxis (v28.1) Recovered

Hand dermatitis (v28.1) Recovered

Asthenia (v28.1) Recovered

Diarrhoea (v28.1) Recovered

Drugs (5)

CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) Suspect

Route: 042 | Dosage: START DATE: 18-MAY-2022 | Form: -- | Indication: Triple negative breast cancer | Action: Not Applicable

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

Recurrences: --

KEYTRUDA (PEMBROLIZUMAB) Suspect

Route: 042 | Dosage: KEYTRUDA 25 MG/ML, SOLUTION FOR INFUSION?START DATE: 18-MAY-2022 | Form: Solution for infusion | Indication: Triple negative breast cancer | Action: Dose Not Changed

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

Recurrences: --

PACLITAXEL (PACLITAXEL) Suspect

Route: 042 | Dosage: START DATE: 18-MAY-2022 | Form: -- | Indication: Triple negative breast cancer | Action: Withdrawn

Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Yes

Recurrences: --

CARBOPLATIN (CARBOPLATIN) Suspect

Route: 042 | Dosage: START DATE: 18-MAY-2022 | Form: -- | Indication: Triple negative breast cancer | Action: Withdrawn

Start: -- | End: -- | Duration: -- -- | Rechallenge: No | Additional: Yes

Recurrences: --

EPIRUBICIN (EPIRUBICIN) Suspect

Route: 042 | Dosage: START DATE: 18-MAY-2022 | Form: -- | Indication: Triple negative breast cancer | Action: Not Applicable

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20220101

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d4352c3b3830196fa50ae7",
  "safetyreportid": "25935330",
  "authoritynumb": "EU-AFSSAPS-MA2025001226",
  "companynumb": null,
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": 46.0,
    "patientonsetageunit": 801,
    "patientagegroup": 5,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Thrombocytopenia",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Leukocytosis",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Epistaxis",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Hand dermatitis",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Asthenia",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Diarrhoea",
        "reactionoutcome": 1
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CYCLOPHOSPHAMIDE",
        "drugauthorizationnumb": "212501",
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": 1.0,
        "drugstructuredosageunit": "032",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "START DATE: 18-MAY-2022",
        "drugdosageform": null,
        "drugadministrationroute": "042",
        "drugindication": "Triple negative breast cancer",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "CYCLOPHOSPHAMIDE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "KEYTRUDA",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": 200.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "KEYTRUDA 25 MG/ML, SOLUTION FOR INFUSION?START DATE: 18-MAY-2022",
        "drugdosageform": "Solution for infusion",
        "drugadministrationroute": "042",
        "drugindication": "Triple negative breast cancer",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
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        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "PEMBROLIZUMAB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "PACLITAXEL",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": 1.0,
        "drugstructuredosageunit": "032",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "START DATE: 18-MAY-2022",
        "drugdosageform": null,
        "drugadministrationroute": "042",
        "drugindication": "Triple negative breast cancer",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
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        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 2,
        "drugadditional": 1,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "PACLITAXEL"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CARBOPLATIN",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": 1.0,
        "drugstructuredosageunit": "032",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "START DATE: 18-MAY-2022",
        "drugdosageform": null,
        "drugadministrationroute": "042",
        "drugindication": "Triple negative breast cancer",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
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        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 2,
        "drugadditional": 1,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "CARBOPLATIN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "EPIRUBICIN",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": 1.0,
        "drugstructuredosageunit": "032",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "START DATE: 18-MAY-2022",
        "drugdosageform": null,
        "drugadministrationroute": "042",
        "drugindication": "Triple negative breast cancer",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "EPIRUBICIN"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20220101"
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 3,
    "literaturereference": null
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-17T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-17T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "DR REDDYS"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": null,
  "seriousnessdeath": null,
  "seriousnessdisabling": null,
  "seriousnesshospitalization": null,
  "seriousnesslifethreatening": null,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25935327 Type 1

Serious

GOLD BOND ORIGINAL STRENGTH

Report Version

Receive Date

10/17/2025

Receipt Date

10/17/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Lawyer

Literature Reference

Company Number

US-OPELLA-2025OHG030348

Authority Number

Sender Organization

CHATTEM

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

Patient Age Group

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Mesothelioma (v28.1) Unknown

Exposure to chemical pollution (v28.1) Unknown

Occupational exposure to toxic agent (v28.1) Unknown

Drugs (1)

GOLD BOND ORIGINAL STRENGTH (MENTHOL) Suspect

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

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20241001

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d4352c3b3830196fa50ae4",
  "safetyreportid": "25935327",
  "authoritynumb": null,
  "companynumb": "US-OPELLA-2025OHG030348",
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    "reaction": [
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        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Mesothelioma",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Exposure to chemical pollution",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Occupational exposure to toxic agent",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "GOLD BOND ORIGINAL STRENGTH",
        "drugauthorizationnumb": "59",
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": null,
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        "drugdosageform": "Powder",
        "drugadministrationroute": "065",
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        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "MENTHOL"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20241001"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 4,
    "literaturereference": null
  },
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  "quarter": "2025Q4",
  "receiptdate": "2025-10-17T00:00:00",
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  "receivedate": "2025-10-17T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
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  "reportduplicate": [],
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  "transmissiondate": "2026-01-17T00:00:00",
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}
                        

25935326 Type 2

Serious

VEDOLIZUMAB, ROSUVASTATIN, TYLENOL (+3 more)

Report Version

Receive Date

10/17/2025

Receipt Date

10/17/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

CA-TAKEDA-2025TUS090405

Authority Number

Sender Organization

TAKEDA

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

38.0 yr

Patient Age Group

Patient Sex

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Clostridium difficile colitis (v28.1) Recovering

Drugs (6)

VEDOLIZUMAB (VEDOLIZUMAB) Suspect

Route: -- | Dosage: 300 MILLIGRAM | Form: Powder for solution for infusion | Indication: Colitis ulcerative | Action: Dose Not Changed

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

Recurrences: --

ROSUVASTATIN (ROSUVASTATIN) Concomitant

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

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

Recurrences: --

TYLENOL (ACETAMINOPHEN) Concomitant

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

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

Recurrences: --

HYDROMORPHONE (HYDROMORPHONE) Concomitant

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

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

Recurrences: --

MESALAMINE (MESALAMINE) Concomitant

Route: -- | Dosage: 4.8 GRAM | Form: -- | Indication: -- | Action: --

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

Recurrences: --

PREDNISONE (PREDNISONE) Concomitant

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

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

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  "patient": {
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        "reactionmeddraversionpt": "28.1",
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        "reactionoutcome": 2
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
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        "drugstartdateformat": null,
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          "activesubstancename": "VEDOLIZUMAB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "ROSUVASTATIN",
        "drugauthorizationnumb": null,
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        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "TYLENOL",
        "drugauthorizationnumb": null,
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        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "MESALAMINE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 4.8,
        "drugstructuredosageunit": "002",
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        "drugdosagetext": "4.8 GRAM",
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      },
      {
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    ],
    "summary_narrativeincludeclinical": null
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  "primarysource": {
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    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "CA",
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  "receiptdateformat": "102",
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  "receivedateformat": "102",
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  "reportduplicate": [],
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25935325 Type 1

Serious

MIRTAZAPINE, MIRTAZAPINE, MIRTAZAPINE (+21 more)

Report Version

Receive Date

10/17/2025

Receipt Date

10/17/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Company Number

Authority Number

GB-MHRA-MED-202510141607062430-NTZQJ

Sender Organization

MYLAN

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

77.0 yr

Patient Age Group

Patient Sex

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Myelodysplastic syndrome (v28.1) Not Recovered

Pancytopenia (v28.1) Not Recovered

Drugs (24)

MIRTAZAPINE (MIRTAZAPINE) Suspect

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

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

Recurrences: --

MIRTAZAPINE (MIRTAZAPINE) Suspect

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

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

Recurrences: --

MIRTAZAPINE (MIRTAZAPINE) Suspect

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

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

Recurrences: --

MIRTAZAPINE (MIRTAZAPINE) Suspect

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

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

Recurrences: --

MEMANTINE (MEMANTINE) Concomitant

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

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

Recurrences: --

MEMANTINE (MEMANTINE) Concomitant

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

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

Recurrences: --

MEMANTINE (MEMANTINE) Concomitant

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

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

Recurrences: --

MEMANTINE (MEMANTINE) Concomitant

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

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

Recurrences: --

ALENDRONIC ACID (ALENDRONIC ACID) Concomitant

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

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

Recurrences: --

ALENDRONIC ACID (ALENDRONIC ACID) Concomitant

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

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

Recurrences: --

ALENDRONIC ACID (ALENDRONIC ACID) Concomitant

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

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

Recurrences: --

ALENDRONIC ACID (ALENDRONIC ACID) Concomitant

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

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

Recurrences: --

APIXABAN (APIXABAN) Concomitant

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

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

Recurrences: --

APIXABAN (APIXABAN) Concomitant

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

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

Recurrences: --

APIXABAN (APIXABAN) Concomitant

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

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

Recurrences: --

APIXABAN (APIXABAN) Concomitant

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

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

Recurrences: --

ENOXAPARIN SODIUM (ENOXAPARIN SODIUM) Concomitant

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

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

Recurrences: --

ENOXAPARIN SODIUM (ENOXAPARIN SODIUM) Concomitant

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

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

Recurrences: --

ENOXAPARIN SODIUM (ENOXAPARIN SODIUM) Concomitant

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

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

Recurrences: --

ENOXAPARIN SODIUM (ENOXAPARIN SODIUM) Concomitant

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

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

Recurrences: --

FOLIC ACID (FOLIC ACID) Concomitant

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

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

Recurrences: --

FOLIC ACID (FOLIC ACID) Concomitant

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

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

Recurrences: --

FOLIC ACID (FOLIC ACID) Concomitant

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

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

Recurrences: --

FOLIC ACID (FOLIC ACID) Concomitant

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

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

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  "companynumb": null,
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        "reactionmeddraversionpt": "28.1",
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      },
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        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Pancytopenia",
        "reactionoutcome": 3
      }
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}
                        

25935322 Type 1

Serious

CANDESARTAN, CANDESARTAN, CANDESARTAN (+1 more)

Report Version

Receive Date

10/17/2025

Receipt Date

10/17/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

GB-MHRA-WEBRADR-202510141742448210-MHRVQ

Authority Number

Sender Organization

MYLAN

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

20.0 yr

Patient Age Group

Patient Sex

Female

Patient Weight

86.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Rash (v28.1) Recovered

Throat irritation (v28.1) Recovered

Drugs (4)

CANDESARTAN (CANDESARTAN) Suspect

Route: -- | Dosage: 10 MILLIGRAM | Form: -- | Indication: Migraine | Action: Withdrawn

Start: 02/08/2023 | End: 02/24/2023 | Duration: 17.0 day | Rechallenge: -- | Additional: Yes

Recurrences: --

CANDESARTAN (CANDESARTAN) Suspect

Route: 065 | Dosage: 10 MILLIGRAM | Form: -- | Indication: -- | Action: Withdrawn

Start: 02/08/2023 | End: 02/24/2023 | Duration: 17.0 day | Rechallenge: -- | Additional: Yes

Recurrences: --

CANDESARTAN (CANDESARTAN) Suspect

Route: 065 | Dosage: 10 MILLIGRAM | Form: -- | Indication: -- | Action: Withdrawn

Start: 02/08/2023 | End: 02/24/2023 | Duration: 17.0 day | Rechallenge: -- | Additional: Yes

Recurrences: --

CANDESARTAN (CANDESARTAN) Suspect

Route: -- | Dosage: 10 MILLIGRAM | Form: -- | Indication: -- | Action: Withdrawn

Start: 02/08/2023 | End: 02/24/2023 | Duration: 17.0 day | Rechallenge: -- | Additional: Yes

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230221

Report Duplicates (0)

Raw JSON (click to expand)

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  "companynumb": "GB-MHRA-WEBRADR-202510141742448210-MHRVQ",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "GB",
  "patient": {
    "patientonsetage": 20.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": 86.0,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Rash",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Throat irritation",
        "reactionoutcome": 1
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CANDESARTAN",
        "drugauthorizationnumb": "078702",
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        "drugstructuredosagenumb": 10.0,
        "drugstructuredosageunit": "003",
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        "drugintervaldosageunitnumb": null,
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        "drugcumulativedosageunit": null,
        "drugdosagetext": "10 MILLIGRAM",
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Migraine",
        "drugstartdateformat": "102",
        "drugstartdate": "2023-02-08T00:00:00",
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        "drugenddate": "2023-02-24T00:00:00",
        "drugtreatmentduration": 17.0,
        "drugtreatmentdurationunit": 804,
        "drugrecurreadministration": null,
        "drugadditional": 1,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "CANDESARTAN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CANDESARTAN",
        "drugauthorizationnumb": "078702",
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        "drugcumulativedosageunit": null,
        "drugdosagetext": "10 MILLIGRAM",
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": null,
        "drugstartdateformat": "102",
        "drugstartdate": "2023-02-08T00:00:00",
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        "drugenddate": "2023-02-24T00:00:00",
        "drugtreatmentduration": 17.0,
        "drugtreatmentdurationunit": 804,
        "drugrecurreadministration": null,
        "drugadditional": 1,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "CANDESARTAN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CANDESARTAN",
        "drugauthorizationnumb": "078702",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 10.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "10 MILLIGRAM",
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": null,
        "drugstartdateformat": "102",
        "drugstartdate": "2023-02-08T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2023-02-24T00:00:00",
        "drugtreatmentduration": 17.0,
        "drugtreatmentdurationunit": 804,
        "drugrecurreadministration": null,
        "drugadditional": 1,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "CANDESARTAN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CANDESARTAN",
        "drugauthorizationnumb": "078702",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 10.0,
        "drugstructuredosageunit": "003",
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        "drugintervaldosageunitnumb": null,
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        "drugcumulativedosageunit": null,
        "drugdosagetext": "10 MILLIGRAM",
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": null,
        "drugstartdateformat": "102",
        "drugstartdate": "2023-02-08T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2023-02-24T00:00:00",
        "drugtreatmentduration": 17.0,
        "drugtreatmentdurationunit": 804,
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        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "CANDESARTAN"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230221"
  },
  "primarysource": {
    "reportercountry": "GB",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "GB",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-17T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-17T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "MYLAN"
  },
  "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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