FDA FAERS Adverse Event Reports

111000

Total Reports

60668

Serious Reports

108

Reporter Countries

25956014 Type 2

Serious

BEVACIZUMAB

Report Version

Receive Date

10/24/2025

Receipt Date

10/24/2025

Transmission Date

01/19/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Chitoran E, Rotaru V, Gelal A, Ionescu S, Gullo G, Stefan D, et al. Using Artificial Intelligence to Develop Clinical Decision Support Systems-The Evolving Road of Personalized Oncologic Therapy. Diagnostics. 2025;15 (18): doi:10.3390/diagnostics15182391.

Company Number

EU-ROCHE-10000411905

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 (35)

Sepsis (v28.1) Unknown

Abscess (v28.1) Unknown

Urinary tract infection (v28.1) Unknown

Wound complication (v28.1) Unknown

Pneumonia (v28.1) Unknown

Infection (v28.1) Unknown

Embolism (v28.1) Unknown

Haemorrhage (v28.1) Unknown

Arrhythmia (v28.1) Unknown

Hypertension (v28.1) Unknown

Gastrointestinal haemorrhage (v28.1) Unknown

Ileus (v28.1) Unknown

Fistula (v28.1) Unknown

Abdominal pain (v28.1) Unknown

Gastritis (v28.1) Unknown

Stomatitis (v28.1) Unknown

Nausea (v28.1) Unknown

Vomiting (v28.1) Unknown

Diarrhoea (v28.1) Unknown

Proteinuria (v28.1) Unknown

Renal failure (v28.1) Unknown

Urogenital fistula (v28.1) Unknown

Anaemia (v28.1) Unknown

Leukopenia (v28.1) Unknown

Thrombocytopenia (v28.1) Unknown

Neutropenia (v28.1) Unknown

Pancytopenia (v28.1) Unknown

Headache (v28.1) Unknown

Migraine (v28.1) Unknown

Neuropathy peripheral (v28.1) Unknown

Rhinitis (v28.1) Unknown

Dyspnoea (v28.1) Unknown

Dehydration (v28.1) Unknown

Decreased appetite (v28.1) Unknown

Skin disorder (v28.1) Unknown

Drugs (1)

BEVACIZUMAB (BEVACIZUMAB) Suspect

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

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435993b3830196fa56139",
  "safetyreportid": "25956014",
  "authoritynumb": null,
  "companynumb": "EU-ROCHE-10000411905",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": null,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Sepsis",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Abscess",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Urinary tract infection",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Wound complication",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Pneumonia",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Infection",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Embolism",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Haemorrhage",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Arrhythmia",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Hypertension",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Gastrointestinal haemorrhage",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Ileus",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Fistula",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Abdominal pain",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Gastritis",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Stomatitis",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Nausea",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Vomiting",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Diarrhoea",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Proteinuria",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Renal failure",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Urogenital fistula",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Anaemia",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Leukopenia",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Thrombocytopenia",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Neutropenia",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Pancytopenia",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Headache",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Migraine",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Neuropathy peripheral",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Rhinitis",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dyspnoea",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dehydration",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Decreased appetite",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Skin disorder",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "BEVACIZUMAB",
        "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": "Neoplasm",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "BEVACIZUMAB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 3,
    "literaturereference": "Chitoran E, Rotaru V, Gelal A, Ionescu S, Gullo G, Stefan D, et al. Using Artificial Intelligence to Develop Clinical Decision Support Systems-The Evolving Road of Personalized Oncologic Therapy. Diagnostics. 2025;15 (18): doi:10.3390/diagnostics15182391."
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-24T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-24T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 2,
  "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": "2026-01-19T00:00:00",
  "transmissiondateformat": "102"
}
                        

25956019 Type 1

Non-Serious

CETIRIZINE

Report Version

Receive Date

10/24/2025

Receipt Date

10/24/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

US-Bion-015281

Authority Number

Sender Organization

BIONPHARMA INC.

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

Patient Age Group

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (8)

Skin burning sensation (v28.1) Unknown

Feeling abnormal (v28.1) Unknown

Abdominal discomfort (v28.1) Unknown

Diarrhoea (v28.1) Unknown

Ear discomfort (v28.1) Unknown

Oral discomfort (v28.1) Unknown

Heart rate irregular (v28.1) Unknown

Drug hypersensitivity (v28.1) Unknown

Drugs (1)

CETIRIZINE (CETIRIZINE HYDROCHLORIDE) Suspect

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

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251012

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435993b3830196fa56138",
  "safetyreportid": "25956019",
  "authoritynumb": null,
  "companynumb": "US-Bion-015281",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Skin burning sensation",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Feeling abnormal",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Abdominal discomfort",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Diarrhoea",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Ear discomfort",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Oral discomfort",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Heart rate irregular",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Drug hypersensitivity",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CETIRIZINE",
        "drugauthorizationnumb": "022429",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 10.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Capsule",
        "drugadministrationroute": "048",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-10-11T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "CETIRIZINE HYDROCHLORIDE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251012"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-24T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-24T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "BIONPHARMA INC."
  },
  "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"
}
                        

25956017 Type 2

Serious

CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL

Report Version

Receive Date

10/24/2025

Receipt Date

10/24/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Pharmacist

Literature Reference

Company Number

GB-UCBSA-2025063445

Authority Number

Sender Organization

UCB

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

33.0 yr

Patient Age Group

Patient Sex

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Juvenile idiopathic arthritis (v28.1) Recovered

Off label use (v28.1) Unknown

Intentional dose omission (v28.1) Unknown

Drugs (2)

CERTOLIZUMAB PEGOL (CERTOLIZUMAB PEGOL) Suspect

Route: -- | Dosage: 200 MILLIGRAM, EV 2 WEEKS(QOW) | Form: Solution for injection in pre-filled pen | Indication: Juvenile idiopathic arthritis | Action: Dose Not Changed

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

Recurrences: --

CERTOLIZUMAB PEGOL (CERTOLIZUMAB PEGOL) Suspect

Route: -- | Dosage: -- | Form: -- | Indication: Off label use | Action: Dose Not Changed

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435993b3830196fa56137",
  "safetyreportid": "25956017",
  "authoritynumb": null,
  "companynumb": "GB-UCBSA-2025063445",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": null,
  "patient": {
    "patientonsetage": 33.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": null,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Juvenile idiopathic arthritis",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Off label use",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Intentional dose omission",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CERTOLIZUMAB PEGOL",
        "drugauthorizationnumb": "125160",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 200.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 2.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "200 MILLIGRAM, EV 2 WEEKS(QOW)",
        "drugdosageform": "Solution for injection in pre-filled pen",
        "drugadministrationroute": null,
        "drugindication": "Juvenile idiopathic arthritis",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "CERTOLIZUMAB PEGOL"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CERTOLIZUMAB PEGOL",
        "drugauthorizationnumb": "125160",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Off label use",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "CERTOLIZUMAB PEGOL"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "GB",
    "qualification": 2,
    "literaturereference": null
  },
  "primarysourcecountry": "GB",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-24T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-24T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 2,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "UCB"
  },
  "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"
}
                        

25956015 Type 1

Non-Serious

INFLECTRA

Report Version

Receive Date

10/24/2025

Receipt Date

10/24/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Company Number

US-CELLTRION INC.-2024US027331

Authority Number

Sender Organization

CELLTRION

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

Patient Age Group

Patient Sex

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Product dose omission issue (v28.1) Unknown

Drugs (1)

INFLECTRA (INFLIXIMAB-DYYB) Suspect

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

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435993b3830196fa56135",
  "safetyreportid": "25956015",
  "authoritynumb": null,
  "companynumb": "US-CELLTRION INC.-2024US027331",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": null,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Product dose omission issue",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "INFLECTRA",
        "drugauthorizationnumb": "125544",
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": "Powder for injection",
        "drugadministrationroute": null,
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "INFLIXIMAB-DYYB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 3,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-24T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-24T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "CELLTRION"
  },
  "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"
}
                        

25956005 Type 1

Non-Serious

ALPRAZOLAM, OLANZAPINE, OLANZAPINE (+9 more)

Report Version

Receive Date

10/24/2025

Receipt Date

10/24/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Physician

Literature Reference

Wang Z, Tanco K, Liu E, Madireddy S, Renee Warner K, Smith TJ. A case report: Treating insomnia with olanzapine in cancer patients. Palliat-Support-Care. 2025;23 e121

Company Number

US-STRIDES ARCOLAB LIMITED-2025SP009229

Authority Number

Sender Organization

STRIDES

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

5.0 (unit: 800)

Patient Age Group

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Drug ineffective (v28.1) Unknown

Off label use (v28.1) Unknown

Drugs (12)

ALPRAZOLAM (ALPRAZOLAM) Suspect

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

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

Recurrences: --

OLANZAPINE (OLANZAPINE) Suspect

Route: 065 | Dosage: 5 MILLIGRAM, QD | Form: Unknown | Indication: Nausea | Action: Not Applicable