FDA FAERS Adverse Event Reports

111000

Total Reports

60668

Serious Reports

108

Reporter Countries

25934266 Type 1

Serious

PERJETA, HERCEPTIN

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

Physician

Literature Reference

Company Number

PK-ROCHE-10000408690

Authority Number

Sender Organization

ROCHE

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

40.0 yr

Patient Age Group

Adult

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Metastases to lung (v28.1) Recovering

Metastases to bone (v28.1) Recovering

Drugs (2)

PERJETA (PERTUZUMAB) Suspect

Route: 065 | Dosage: -- | Form: -- | Indication: Breast cancer | Action: Dose Not Changed

Start: 07/01/2022 | End: 06/01/2025 | Duration: 4.0 yr | Rechallenge: -- | Additional: --

Recurrences: --

HERCEPTIN (TRASTUZUMAB) Suspect

Route: 065 | Dosage: -- | Form: -- | Indication: Breast cancer | Action: Unknown

Start: 07/01/2022 | End: 06/01/2025 | Duration: 4.0 yr | Rechallenge: -- | Additional: Unknown

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435293b3830196fa506b6",
  "safetyreportid": "25934266",
  "authoritynumb": null,
  "companynumb": "PK-ROCHE-10000408690",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "PK",
  "patient": {
    "patientonsetage": 40.0,
    "patientonsetageunit": 801,
    "patientagegroup": 5,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Metastases to lung",
        "reactionoutcome": 2
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Metastases to bone",
        "reactionoutcome": 2
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "PERJETA",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 3.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": "Breast cancer",
        "drugstartdateformat": "610",
        "drugstartdate": "2022-07-01T00:00:00",
        "drugenddateformat": "610",
        "drugenddate": "2025-06-01T00:00:00",
        "drugtreatmentduration": 4.0,
        "drugtreatmentdurationunit": 801,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "PERTUZUMAB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "HERCEPTIN",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 3.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": "Breast cancer",
        "drugstartdateformat": "610",
        "drugstartdate": "2022-07-01T00:00:00",
        "drugenddateformat": "610",
        "drugenddate": "2025-06-01T00:00:00",
        "drugtreatmentduration": 4.0,
        "drugtreatmentdurationunit": 801,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "TRASTUZUMAB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "PK",
    "qualification": 1,
    "literaturereference": null
  },
  "primarysourcecountry": "PK",
  "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": "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"
}
                        

25934264 Type 2

Serious

ENHERTU

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

SG-AstraZeneca-CH-00970480A

Authority Number

Sender Organization

DAIICHI

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

Patient Age Group

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Death (v28.1) Fatal

Drugs (1)

ENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) Suspect

Route: 041 | Dosage: 300 MILLIGRAM, Q3W | Form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | Indication: Breast cancer metastatic | Action: Withdrawn

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

Recurrences: --

Clinical Narrative

Report Duplicates (1)

ASTRAZENECA: SG-ASTRAZENECA-202510ASI010701SG

Raw JSON (click to expand)

                            {
  "_id": "69d435293b3830196fa506b4",
  "safetyreportid": "25934264",
  "authoritynumb": null,
  "companynumb": "SG-AstraZeneca-CH-00970480A",
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "SG",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Death",
        "reactionoutcome": 5
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ENHERTU",
        "drugauthorizationnumb": "761139",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 300.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 3.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "300 MILLIGRAM, Q3W",
        "drugdosageform": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
        "drugadministrationroute": "041",
        "drugindication": "Breast cancer metastatic",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "FAM-TRASTUZUMAB DERUXTECAN-NXKI"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "SG",
    "qualification": 1,
    "literaturereference": null
  },
  "primarysourcecountry": "SG",
  "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": "ASTRAZENECA",
      "duplicatenumb": "SG-ASTRAZENECA-202510ASI010701SG"
    }
  ],
  "reporttype": 2,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "DAIICHI"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 1,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 2,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25934265 Type 1

Serious

QUETIAPINE, CLONAZEPAM, ARIPIPRAZOLE (+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

Physician

Literature Reference

Company Number

Authority Number

EU-HALMED-300091191

Sender Organization

CHEPLAPHARM

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

15.0 yr

Patient Age Group

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Suicide attempt (v28.1) Unknown

Somnolence (v28.1) Unknown

Hypotension (v28.1) Unknown

Blood creatine phosphokinase increased (v28.1) Unknown

Intentional overdose (v28.1) Unknown

Drugs (4)

QUETIAPINE (QUETIAPINE) Suspect

Route: 048 | Dosage: DF = 3 BLISTERA | Form: Unknown | Indication: Suicidal ideation | Action: Not Applicable

Start: 08/17/2025 | End: 08/17/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: 4

Recurrences: --

CLONAZEPAM (CLONAZEPAM) Suspect

Route: 048 | Dosage: DF = BOCICA | Form: Tablet | Indication: Suicidal ideation | Action: Not Applicable

Start: 08/17/2025 | End: 08/17/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: 4

Recurrences: --

ARIPIPRAZOLE (ARIPIPRAZOLE) Concomitant

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

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

Recurrences: --

SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE) Concomitant

Route: 048 | Dosage: UNK | Form: Film-coated tablet | Indication: -- | Action: --

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250817

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435293b3830196fa506b5",
  "safetyreportid": "25934265",
  "authoritynumb": "EU-HALMED-300091191",
  "companynumb": null,
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": 15.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Suicide attempt",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Somnolence",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Hypotension",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Blood creatine phosphokinase increased",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Intentional overdose",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "QUETIAPINE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "DF = 3 BLISTERA",
        "drugdosageform": "Unknown",
        "drugadministrationroute": "048",
        "drugindication": "Suicidal ideation",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-08-17T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-08-17T00:00:00",
        "drugtreatmentduration": 1.0,
        "drugtreatmentdurationunit": 804,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "QUETIAPINE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CLONAZEPAM",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "DF = BOCICA",
        "drugdosageform": "Tablet",
        "drugadministrationroute": "048",
        "drugindication": "Suicidal ideation",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-08-17T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-08-17T00:00:00",
        "drugtreatmentduration": 1.0,
        "drugtreatmentdurationunit": 804,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "CLONAZEPAM"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "ARIPIPRAZOLE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": "Unknown",
        "drugadministrationroute": null,
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "ARIPIPRAZOLE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "SERTRALINE HYDROCHLORIDE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": "Film-coated tablet",
        "drugadministrationroute": "048",
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "SERTRALINE HYDROCHLORIDE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250817"
  },
  "primarysource": {
    "reportercountry": "CO",
    "qualification": 1,
    "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": "CHEPLAPHARM"
  },
  "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"
}
                        

25934260 Type 1

Serious

ENHERTU

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

TR-DSJP-DS-2025-169825-TR

Authority Number

Sender Organization

DAIICHI

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

54.0 yr

Patient Age Group

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Syncope (v28.1) Recovered

Vomiting (v28.1) Recovered

Somnolence (v28.1) Recovered

Irritability (v28.1) Not Recovered

Malaise (v28.1) Unknown

Drugs (1)

ENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) Suspect

Route: 065 | Dosage: 400 MG | Form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | Indication: Breast cancer metastatic | Action: Unknown

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435293b3830196fa506b1",
  "safetyreportid": "25934260",
  "authoritynumb": null,
  "companynumb": "TR-DSJP-DS-2025-169825-TR",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "TR",
  "patient": {
    "patientonsetage": 54.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Syncope",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Vomiting",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Somnolence",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Irritability",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Malaise",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ENHERTU",
        "drugauthorizationnumb": "761139",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 400.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "400 MG",
        "drugdosageform": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
        "drugadministrationroute": "065",
        "drugindication": "Breast cancer metastatic",
        "drugstartdateformat": "610",
        "drugstartdate": "2025-01-01T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "FAM-TRASTUZUMAB DERUXTECAN-NXKI"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101"
  },
  "primarysource": {
    "reportercountry": "TR",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "TR",
  "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": "DAIICHI"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 1,
  "seriousnesslifethreatening": 1,
  "seriousnessother": 2,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25934259 Type 1

Non-Serious

POMALYST, POMALYST, POMALYST

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-BRISTOL-MYERS SQUIBB COMPANY-2025-142010

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

65.0 yr

Patient Age Group

Elderly

Patient Sex

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Rash (v28.1) Unknown

Drugs (3)

POMALYST (POMALIDOMIDE) Suspect

Route: -- | Dosage: 1 TIME A DAY | Form: Capsule | Indication: Plasma cell myeloma refractory | Action: Withdrawn

Start: 07/01/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

POMALYST (POMALIDOMIDE) Suspect

Route: -- | Dosage: -- | Form: -- | Indication: Plasma cell myeloma | Action: Withdrawn

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

Recurrences: --

POMALYST (POMALIDOMIDE) Suspect

Route: -- | Dosage: -- | Form: -- | Indication: Prostate cancer | Action: Withdrawn

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250901

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435293b3830196fa506ae",
  "safetyreportid": "25934259",
  "authoritynumb": null,
  "companynumb": "US-BRISTOL-MYERS SQUIBB COMPANY-2025-142010",
  "duplicate": null,
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  "occurcountry": "US",
  "patient": {
    "patientonsetage": 65.0,
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      {
        "reactionmeddraversionpt": "28.1",
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      }
    ],
    "drug": [
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        "drugcharacterization": 1,
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        "drugstructuredosagenumb": 2.0,
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        "drugintervaldosagedefinition": 804,
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        "drugcumulativedosageunit": null,
        "drugdosagetext": "1 TIME A DAY",
        "drugdosageform": "Capsule",
        "drugadministrationroute": null,
        "drugindication": "Plasma cell myeloma refractory",
        "drugstartdateformat": "610",
        "drugstartdate": "2023-07-01T00:00:00",
        "drugenddateformat": null,
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        "actiondrug": 1,
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          "activesubstancename": "POMALIDOMIDE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "POMALYST",
        "drugauthorizationnumb": "204026",
        "drugbatchnumb": null,
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        "drugindication": "Plasma cell myeloma",
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        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
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        "drugauthorizationnumb": "204026",
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        "drugindication": "Prostate cancer",
        "drugstartdateformat": null,
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        "drugenddateformat": null,
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        "actiondrug": 1,
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          "activesubstancename": "POMALIDOMIDE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250901"
  },
  "primarysource": {
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    "qualification": 3,
    "literaturereference": null
  },
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  "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": "BRISTOL-MYERS SQUIBB COMPANY"
  },
  "serious": 2,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 2,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25934258 Type 1

Serious

CARBOPLATIN, ETOPOSIDE, TECENTRIQ

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-ST2025000549

Sender Organization

HIKMA

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

67.0 yr

Patient Age Group

Patient Sex

Female

Patient Weight

69.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (7)

Arthralgia (v28.1) Not Recovered

Anaemia (v28.1) Recovered

Thrombocytopenia (v28.1) Recovered

Decreased appetite (v28.1) Recovered

Fatigue (v28.1) Recovering

Dyspnoea (v28.1) Recovering

Stomatitis (v28.1) Not Recovered

Drugs (3)

CARBOPLATIN (CARBOPLATIN) Suspect

Route: 042 | Dosage: 1 DOSAGE FORM, 3W | Form: Unknown | Indication: Lung squamous cell carcinoma metastatic | Action: --

Start: 03/19/2025 | End: 05/26/2025 | Duration: 69.0 day | Rechallenge: -- | Additional: --

Recurrences: --

ETOPOSIDE (ETOPOSIDE) Suspect

Route: 042 | Dosage: 176 MILLIGRAM | Form: Unknown | Indication: Lung squamous cell carcinoma metastatic | Action: --

Start: 03/19/2025 | End: 05/28/2025 | Duration: 71.0 day | Rechallenge: -- | Additional: --

Recurrences: --

TECENTRIQ (ATEZOLIZUMAB) Suspect

Route: 042 | Dosage: 1200 MILLIGRAM, 3W | Form: Unknown | Indication: Lung squamous cell carcinoma metastatic | Action: --

Start: 04/09/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250419

Report Duplicates (1)

AFSSAPS: EU-AFSSAPS-ST2025000549

Raw JSON (click to expand)

                            {
  "_id": "69d435293b3830196fa506ab",
  "safetyreportid": "25934258",
  "authoritynumb": "EU-AFSSAPS-ST2025000549",
  "companynumb": null,
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": 67.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": 69.0,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Arthralgia",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Anaemia",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Thrombocytopenia",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Decreased appetite",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Fatigue",
        "reactionoutcome": 2
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dyspnoea",
        "reactionoutcome": 2
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Stomatitis",
        "reactionoutcome": 3
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CARBOPLATIN",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "unknown",
        "drugstructuredosagenumb": 1.0,
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        "drugcumulativedosageunit": null,
        "drugdosagetext": "1 DOSAGE FORM, 3W",
        "drugdosageform": "Unknown",
        "drugadministrationroute": "042",
        "drugindication": "Lung squamous cell carcinoma metastatic",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-03-19T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-05-26T00:00:00",
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        "drugtreatmentdurationunit": 804,
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          "activesubstancename": "CARBOPLATIN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ETOPOSIDE",
        "drugauthorizationnumb": "074290",
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": 176.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": null,
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        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "176 MILLIGRAM",
        "drugdosageform": "Unknown",
        "drugadministrationroute": "042",
        "drugindication": "Lung squamous cell carcinoma metastatic",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-03-19T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-05-28T00:00:00",
        "drugtreatmentduration": 71.0,
        "drugtreatmentdurationunit": 804,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "ETOPOSIDE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "TECENTRIQ",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": 1200.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 3.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "1200 MILLIGRAM, 3W",
        "drugdosageform": "Unknown",
        "drugadministrationroute": "042",
        "drugindication": "Lung squamous cell carcinoma metastatic",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-04-09T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "ATEZOLIZUMAB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250419"
  },
  "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": [
    {
      "duplicatesource": "AFSSAPS",
      "duplicatenumb": "EU-AFSSAPS-ST2025000549"
    }
  ],
  "reporttype": 1,
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    "sendertype": 6,
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  },
  "serious": 1,
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  "seriousnesslifethreatening": 2,
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  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25934254 Type 1

Serious

IBUPROFEN

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

Demenj M, Reljic V, Manojlovic Gacic E, Vilotijevic M, Zivanovic D. Toxic epidermal necrolysis: lessons from three fatal cases. Acta dermatovenerologica Alpina, Pannonica, et Adriatica. 2025;34(3):139-44. DOI:10.15570/actaapa.2025.27.

Company Number

RS-MLMSERVICE-20251004-PI661687-00030-3

Authority Number

Sender Organization

GALPHARM INTERNATIONAL

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 (3)

Toxic epidermal necrolysis (v28.1) Fatal

Multiple organ dysfunction syndrome (v28.1) Fatal

Shock (v28.1) Fatal

Drugs (1)

IBUPROFEN (IBUPROFEN) Suspect

Route: 048 | Dosage: UNKNOWN, UNKNOWN | Form: Tablet | Indication: Product used for unknown indication | Action: Not Applicable

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

Recurrences: --

Clinical Narrative

Report Duplicates (1)

MLMSERVICE: RS-MLMSERVICE-20251004-PI661687-00030-3

Raw JSON (click to expand)

                            {
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  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "RS",
  "patient": {
    "patientonsetage": 50.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Toxic epidermal necrolysis",
        "reactionoutcome": 5
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Multiple organ dysfunction syndrome",
        "reactionoutcome": 5
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Shock",
        "reactionoutcome": 5
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "IBUPROFEN",
        "drugauthorizationnumb": "072096",
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": null,
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        "drugdosagetext": "UNKNOWN, UNKNOWN",
        "drugdosageform": "Tablet",
        "drugadministrationroute": "048",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
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        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "IBUPROFEN"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "RS",
    "qualification": 1,
    "literaturereference": "Demenj M, Reljic V, Manojlovic Gacic E, Vilotijevic M, Zivanovic D. Toxic epidermal necrolysis: lessons from three fatal cases. Acta dermatovenerologica Alpina, Pannonica, et Adriatica. 2025;34(3):139-44. DOI:10.15570/actaapa.2025.27."
  },
  "primarysourcecountry": "RS",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-17T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-17T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
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    }
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    "senderorganization": "GALPHARM INTERNATIONAL"
  },
  "serious": 1,
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  "seriousnessdeath": 1,
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  "seriousnesslifethreatening": 1,
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  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25934252 Type 1

Non-Serious

HUMIRA, HUMIRA, HUMIRA

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-ABBVIE-6506736

Authority Number

Sender Organization

ABBVIE

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

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)

Vascular pain (v28.1) Unknown

Arthralgia (v28.1) Unknown

Drugs (3)

HUMIRA (ADALIMUMAB) Suspect

Route: 058 | Dosage: -- | Form: Solution for injection | Indication: Crohn^s disease | Action: Withdrawn

Start: 01/01/2021 | End: -- | Duration: 3.0 yr | Rechallenge: -- | Additional: --

Recurrences: --

HUMIRA (ADALIMUMAB) Suspect

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

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

Recurrences: --

HUMIRA (ADALIMUMAB) Suspect

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

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

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  "_id": "69d435293b3830196fa506a7",
  "safetyreportid": "25934252",
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  "companynumb": "US-ABBVIE-6506736",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": 5,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Vascular pain",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Arthralgia",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "HUMIRA",
        "drugauthorizationnumb": "125057",
        "drugbatchnumb": null,
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        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Solution for injection",
        "drugadministrationroute": "058",
        "drugindication": "Crohn^s disease",
        "drugstartdateformat": "602",
        "drugstartdate": "2021-01-01T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": 3.0,
        "drugtreatmentdurationunit": 801,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "ADALIMUMAB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "HUMIRA",
        "drugauthorizationnumb": "125057",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
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        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Psoriasis",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
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        "activesubstance": {
          "activesubstancename": "ADALIMUMAB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "HUMIRA",
        "drugauthorizationnumb": "125057",
        "drugbatchnumb": null,
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        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Rheumatoid arthritis",
        "drugstartdateformat": null,
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        "drugtreatmentdurationunit": null,
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        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "ADALIMUMAB"
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        "drugrecurrence": []
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  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
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  "receivedateformat": "102",
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    "sendertype": 6,
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  "serious": 2,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
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  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25934247 Type 1

Serious

METHOTREXATE, DOXORUBICIN, METHYLPREDNISOLONE (+2 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

Physician

Literature Reference

Company Number

Authority Number

EU-AEMPS-1751937

Sender Organization

ACCORD

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

8.0 yr

Patient Age Group

Child

Patient Sex

Female

Patient Weight

26.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Septic shock (v28.1) Recovered

Gastrointestinal fungal infection (v28.1) Recovered

Gastrointestinal haemorrhage (v28.1) Recovered

Drugs (5)

METHOTREXATE (METHOTREXATE) Interacting

Route: -- | Dosage: -- | Form: -- | Indication: Burkitt^s lymphoma | Action: Withdrawn

Start: 02/19/2025 | End: 02/19/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes

Recurrences: --

DOXORUBICIN (DOXORUBICIN) Interacting

Route: -- | Dosage: -- | Form: -- | Indication: Burkitt^s lymphoma | Action: Withdrawn

Start: 02/20/2025 | End: 02/20/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes

Recurrences: --

METHYLPREDNISOLONE (METHYLPREDNISOLONE) Interacting

Route: -- | Dosage: -- | Form: -- | Indication: Burkitt^s lymphoma | Action: Dose Reduced

Start: 02/19/2025 | End: 02/26/2025 | Duration: 8.0 day | Rechallenge: -- | Additional: Yes

Recurrences: --

VINCRISTINE SULFATE (VINCRISTINE SULFATE) Interacting

Route: -- | Dosage: -- | Form: -- | Indication: Burkitt^s lymphoma | Action: Withdrawn

Start: 02/19/2025 | End: 02/19/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes

Recurrences: --

CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) Interacting

Route: -- | Dosage: -- | Form: -- | Indication: Burkitt^s lymphoma | Action: Withdrawn

Start: 02/20/2025 | End: 02/22/2025 | Duration: 3.0 day | Rechallenge: -- | Additional: Yes

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250301

Report Duplicates (0)

Raw JSON (click to expand)

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  "safetyreportid": "25934247",
  "authoritynumb": "EU-AEMPS-1751937",
  "companynumb": null,
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
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  "patient": {
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        "reactionmeddraversionpt": "28.1",
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        "reactionoutcome": 1
      },
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        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Gastrointestinal fungal infection",
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      },
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      }
    ],
    "drug": [
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        "drugcharacterization": 3,
        "medicinalproduct": "METHOTREXATE",
        "drugauthorizationnumb": "040716",
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        "drugtreatmentdurationunit": 804,
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        "drugrecurrence": []
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      {
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        "drugauthorizationnumb": null,
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        "drugrecurrence": []
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        "drugauthorizationnumb": null,
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        "drugtreatmentduration": 3.0,
        "drugtreatmentdurationunit": 804,
        "drugrecurreadministration": null,
        "drugadditional": 1,
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    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250301"
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 1,
    "literaturereference": null
  },
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  "receiptdateformat": "102",
  "receivedate": "2025-10-17T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
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  },
  "reportduplicate": [],
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  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25934250 Type 2

Serious

RITUXIMAB, RITUXIMAB, MYCOPHENOLATE MOFETIL (+13 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

Zhang K, Zhao P, Huang B, Wang Y, Bi T, Gao P. Clinical characteristics and treatment response of patients with SLE complicated with thrombotic thrombocytopenic purpura. Lupus Science and Medicine. 2025-Sep-29;12 (2):1-10. doi:10.1136/lupus-2025-001740.

Company Number

CN-ROCHE-10000409938

Authority Number

Sender Organization

ROCHE

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

Patient Age Group

Patient Sex

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

COVID-19 (v28.1) Unknown

Pneumonia (v28.1) Unknown

Urinary tract infection (v28.1) Unknown

Off label use (v28.1) Unknown

Drugs (16)

RITUXIMAB (RITUXIMAB) Suspect

Route: 042 | Dosage: -- | Form: Infusion | Indication: Systemic lupus erythematosus | Action: Unknown