FDA FAERS Adverse Event Reports

111000

Total Reports

60668

Serious Reports

108

Reporter Countries

25952412 Type 3

Serious

BEVACIZUMAB, ATEZOLIZUMAB, LEVOTHYROXINE (+2 more)

Report Version

Receive Date

10/23/2025

Receipt Date

10/23/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Mateos ST. Torres Mateos S, Ruiz Gines MA, Torres Fernandez M.. MACRO-TSH AND BIOLOGICAL DRUGS: AN ASSOCIATION TO KEEP IN MIND ?. Clinical Chemistry and Laboratory Medicine.. 2025;63(S1):S11169

Company Number

Authority Number

EU-EMA-DD-20251008-7482647-082306

Sender Organization

BIOCON

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 (2)

Hyperthyroidism (v28.1) Unknown

Blood thyroid stimulating hormone increased (v28.1) Recovering

Drugs (5)

BEVACIZUMAB (BEVACIZUMAB) Suspect

Route: 065 | Dosage: UNK | Form: Solution for injection in vial | Indication: Hepatocellular carcinoma | Action: Unknown

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

Recurrences: --

ATEZOLIZUMAB (ATEZOLIZUMAB) Suspect

Route: 065 | Dosage: UNK | Form: Unknown | Indication: Hepatocellular carcinoma | Action: Unknown

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

Recurrences: --

LEVOTHYROXINE (LEVOTHYROXINE) Concomitant

Route: 065 | Dosage: 25 MICROGRAM, QD | Form: Unknown | Indication: Autoimmune hypothyroidism | Action: --

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

Recurrences: --

LEVOTHYROXINE (LEVOTHYROXINE) Concomitant

Route: 065 | Dosage: 112 MICROGRAM, QD | Form: Unknown | Indication: Blood thyroid stimulating hormone increased | Action: --

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

Recurrences: --

LEVOTHYROXINE (LEVOTHYROXINE) Concomitant

Route: 065 | Dosage: 125 TO 150 MICROGRAM, QD | Form: Unknown | Indication: Hyperthyroidism | Action: --

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

Recurrences: --

Clinical Narrative

Report Duplicates (5)

EMA: EU-EMA-DD-20251008-7482647-082306

SAMSUNG BIOEPIS: EU-SAMSUNG BIOEPIS-SB-2025-32151

AMGEN: EU-AMGEN-ESPSP2025191117

Case identifiers: 10020157861

Case identifiers: 10020164984

Raw JSON (click to expand)

                            {
  "_id": "69d435853b3830196fa55109",
  "safetyreportid": "25952412",
  "authoritynumb": "EU-EMA-DD-20251008-7482647-082306",
  "companynumb": null,
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": null,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Hyperthyroidism",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Blood thyroid stimulating hormone increased",
        "reactionoutcome": 2
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "BEVACIZUMAB",
        "drugauthorizationnumb": "761175",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": "Solution for injection in vial",
        "drugadministrationroute": "065",
        "drugindication": "Hepatocellular carcinoma",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "BEVACIZUMAB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ATEZOLIZUMAB",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": "Unknown",
        "drugadministrationroute": "065",
        "drugindication": "Hepatocellular carcinoma",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "ATEZOLIZUMAB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "LEVOTHYROXINE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 25.0,
        "drugstructuredosageunit": "004",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "25 MICROGRAM, QD",
        "drugdosageform": "Unknown",
        "drugadministrationroute": "065",
        "drugindication": "Autoimmune hypothyroidism",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "LEVOTHYROXINE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "LEVOTHYROXINE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 112.0,
        "drugstructuredosageunit": "004",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "112 MICROGRAM, QD",
        "drugdosageform": "Unknown",
        "drugadministrationroute": "065",
        "drugindication": "Blood thyroid stimulating hormone increased",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "LEVOTHYROXINE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "LEVOTHYROXINE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "125 TO 150 MICROGRAM, QD",
        "drugdosageform": "Unknown",
        "drugadministrationroute": "065",
        "drugindication": "Hyperthyroidism",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "LEVOTHYROXINE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 3,
    "literaturereference": "Mateos ST. Torres Mateos S, Ruiz Gines MA, Torres Fernandez M.. MACRO-TSH AND BIOLOGICAL DRUGS: AN ASSOCIATION TO KEEP IN MIND ?. Clinical Chemistry and Laboratory Medicine.. 2025;63(S1):S11169"
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-23T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-23T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "EMA",
      "duplicatenumb": "EU-EMA-DD-20251008-7482647-082306"
    },
    {
      "duplicatesource": "SAMSUNG BIOEPIS",
      "duplicatenumb": "EU-SAMSUNG BIOEPIS-SB-2025-32151"
    },
    {
      "duplicatesource": "AMGEN",
      "duplicatenumb": "EU-AMGEN-ESPSP2025191117"
    },
    {
      "duplicatesource": "Case identifiers",
      "duplicatenumb": "10020157861"
    },
    {
      "duplicatesource": "Case identifiers",
      "duplicatenumb": "10020164984"
    }
  ],
  "reporttype": 3,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "BIOCON"
  },
  "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"
}
                        

25952413 Type 2

Serious

DURVALUMAB

Report Version

Receive Date

10/23/2025

Receipt Date

10/23/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

IN-AstraZeneca-CH-00974668A

Authority Number

Sender Organization

ALEXION PHARMACEUTICALS

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

Patient Age Group

Elderly

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Pulmonary oedema (v28.1) Fatal

Cough (v28.1) Fatal

Diarrhoea (v28.1) Fatal

Haemoglobin decreased (v28.1) Fatal

Drugs (1)

DURVALUMAB (DURVALUMAB) Suspect

Route: -- | Dosage: 1500 MILLIGRAM, Q3W | Form: -- | Indication: Bile duct cancer | Action: Withdrawn

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435853b3830196fa55107",
  "safetyreportid": "25952413",
  "authoritynumb": null,
  "companynumb": "IN-AstraZeneca-CH-00974668A",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "IN",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": 6,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Pulmonary oedema",
        "reactionoutcome": 5
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Cough",
        "reactionoutcome": 5
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Diarrhoea",
        "reactionoutcome": 5
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Haemoglobin decreased",
        "reactionoutcome": 5
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "DURVALUMAB",
        "drugauthorizationnumb": "761069",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 1500.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 3.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "1500 MILLIGRAM, Q3W",
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Bile duct cancer",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": null,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "DURVALUMAB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "IN",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "IN",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-23T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-23T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 2,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ALEXION PHARMACEUTICALS"
  },
  "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"
}
                        

25952414 Type 1

Serious

IMJUDO, IMFINZI

Report Version

Receive Date

10/23/2025

Receipt Date

10/23/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Physician

Literature Reference

Company Number

Authority Number

EU-HALMED-300091330

Sender Organization

ALEXION PHARMACEUTICALS

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

74.0 yr

Patient Age Group

Elderly

Patient Sex

Male

Patient Weight

68.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Condition aggravated (v28.1) Recovered

Subungual abscess (v28.1) Recovered

Drugs (2)

IMJUDO (TREMELIMUMAB\TREMELIMUMAB-ACTL) Suspect

Route: -- | Dosage: UNK | Form: -- | Indication: Hepatocellular carcinoma | Action: Withdrawn

Start: 05/02/2025 | End: 05/02/2025 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes

Recurrences: --

IMFINZI (DURVALUMAB) Suspect

Route: -- | Dosage: UNK | Form: -- | Indication: Hepatocellular carcinoma | Action: Withdrawn

Start: 05/02/2025 | End: 05/02/2025 | Duration: 1.0 day | Rechallenge: Unknown | Additional: Yes

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250509

Report Duplicates (2)

HALMED: EU-HALMED-300091330

656: 00-656-401-056

Raw JSON (click to expand)

                            {
  "_id": "69d435853b3830196fa55106",
  "safetyreportid": "25952414",
  "authoritynumb": "EU-HALMED-300091330",
  "companynumb": null,
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": 74.0,
    "patientonsetageunit": 801,
    "patientagegroup": 6,
    "patientweight": 68.0,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Condition aggravated",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Subungual abscess",
        "reactionoutcome": 1
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "IMJUDO",
        "drugauthorizationnumb": "761289",
        "drugbatchnumb": "UNK",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Hepatocellular carcinoma",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-05-02T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-05-02T00:00:00",
        "drugtreatmentduration": 1.0,
        "drugtreatmentdurationunit": 804,
        "drugrecurreadministration": 3,
        "drugadditional": 1,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "TREMELIMUMAB\\TREMELIMUMAB-ACTL"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "IMFINZI",
        "drugauthorizationnumb": "761069",
        "drugbatchnumb": "UNK",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Hepatocellular carcinoma",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-05-02T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-05-02T00:00:00",
        "drugtreatmentduration": 1.0,
        "drugtreatmentdurationunit": 804,
        "drugrecurreadministration": 3,
        "drugadditional": 1,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "DURVALUMAB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250509"
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 1,
    "literaturereference": null
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-23T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-23T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "HALMED",
      "duplicatenumb": "EU-HALMED-300091330"
    },
    {
      "duplicatesource": "656",
      "duplicatenumb": "00-656-401-056"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ALEXION PHARMACEUTICALS"
  },
  "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"
}
                        

25952411 Type 2

Serious

INFLIXIMAB

Report Version

Receive Date

10/23/2025

Receipt Date

10/23/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Amiot A, Bertrand A, Meyer A, Kirchgesner J, Uzzan M, Abitbol V, et al. Effectiveness and safety of third-line advanced therapies in patients with ulcerative colitis: A multicentre retrospective cohort study Third-line treatment in UC. Clinics and Research in Hepatology and Gastroenterology. 2025;49(9): 1-8. doi:https://doi.org/10.1016/j.clinre.2025.102699.

Company Number

EU-JNJFOC-20251024309

Authority Number

Sender Organization

JOHNSON AND JOHNSON

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

54.0 yr

Patient Age Group

Adult

Patient Sex

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Epstein-Barr virus associated lymphoproliferative disorder (v28.1) Unknown

Drugs (1)

INFLIXIMAB (INFLIXIMAB) Suspect

Route: 041 | Dosage: -- | Form: Solution for infusion | Indication: Colitis ulcerative | Action: Unknown

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435853b3830196fa55105",
  "safetyreportid": "25952411",
  "authoritynumb": null,
  "companynumb": "EU-JNJFOC-20251024309",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": 54.0,
    "patientonsetageunit": 801,
    "patientagegroup": 5,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Epstein-Barr virus associated lymphoproliferative disorder",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "INFLIXIMAB",
        "drugauthorizationnumb": "103772",
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Solution for infusion",
        "drugadministrationroute": "041",
        "drugindication": "Colitis ulcerative",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "INFLIXIMAB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 3,
    "literaturereference": "Amiot A, Bertrand A, Meyer A, Kirchgesner J, Uzzan M, Abitbol V, et al. Effectiveness and safety of third-line advanced therapies in patients with ulcerative colitis: A multicentre retrospective cohort study Third-line treatment in UC. Clinics and Research in Hepatology and Gastroenterology. 2025;49(9): 1-8. doi:https://doi.org/10.1016/j.clinre.2025.102699."
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-23T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-23T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
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  },
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  "reporttype": 2,
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    "senderorganization": "JOHNSON AND JOHNSON"
  },
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  "seriousnessdeath": 2,
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  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25952410 Type 2

Serious

BUDESONIDE\FORMOTEROL\GLYCOPYRRONIUM

Report Version

Receive Date

10/23/2025

Receipt Date

10/23/2025

Transmission Date

01/19/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

US-AstraZeneca-CH-00976174A

Authority Number

Sender Organization

ALEXION PHARMACEUTICALS

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

Patient Age Group

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Death (v28.1) Fatal

Drugs (1)

BUDESONIDE\FORMOTEROL\GLYCOPYRRONIUM (BUDESONIDE\FORMOTEROL\GLYCOPYRRONIUM) Suspect

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

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250909

Report Duplicates (0)

Raw JSON (click to expand)

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25952408 Type 1

Serious

TYMLOS, TYMLOS, ANORO ELLIPTA (+15 more)

Report Version

Receive Date

10/23/2025

Receipt Date

10/23/2025

Transmission Date

01/19/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

US-RADIUS HEALTH INC.-US-RADIUS-25054884

Authority Number

Sender Organization

RADIUS PHARM

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

Patient Age Group

Patient Sex

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Dementia (v28.1) Not Recovered

Drugs (18)

TYMLOS (ABALOPARATIDE) Suspect

Route: 058 | Dosage: 80 MICROGRAM, QD | Form: Sub-cutaneous injection | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

TYMLOS (ABALOPARATIDE) Suspect

Route: 058 | Dosage: 80 MICROGRAM, QD | Form: Sub-cutaneous injection | Indication: -- | Action: Unknown

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

Recurrences: --

ANORO ELLIPTA (UMECLIDINIUM BROMIDE\VILANTEROL TRIFENATATE) Concomitant

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

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

Recurrences: --

ASPIRIN (ASPIRIN) Concomitant

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

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

Recurrences: --

DIVALPROEX SODIUM (DIVALPROEX SODIUM) Concomitant

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

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

Recurrences: --

FLUTICASONE (FLUTICASONE) Concomitant

Route: -- | Dosage: UNK 50MCG/AC | Form: Suspension | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

FOLIC ACID (FOLIC ACID) Concomitant

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

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

Recurrences: --

FUROSEMIDE (FUROSEMIDE) Concomitant

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

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

Recurrences: --

LEVOTHYROXINE (LEVOTHYROXINE) Concomitant

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

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

Recurrences: --

LORATADINE (LORATADINE) Concomitant

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

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

Recurrences: --

METOPROLOL SUCCINATE (METOPROLOL SUCCINATE) Concomitant

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

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

Recurrences: --

OMEPRAZOLE (OMEPRAZOLE) Concomitant

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

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

Recurrences: --

PRAVASTATIN (PRAVASTATIN) Concomitant

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

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

Recurrences: --

RISPERDAL (RISPERIDONE) Concomitant

Route: -- | Dosage: 0.5 MILLIGRAM | Form: Tablet | Indication: Product used for unknown indication | Action: --

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

Recurrences: --

RISPERDAL (RISPERIDONE) Concomitant

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

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

Recurrences: --

SODIUM CHLORIDE (SODIUM CHLORIDE) Concomitant

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

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

Recurrences: --

MIRTAZAPINE (MIRTAZAPINE) Concomitant

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

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

Recurrences: --

TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN HYDROCHLORIDE) Concomitant

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

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

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      },
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          "activesubstancename": "LORATADINE"
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        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "METOPROLOL SUCCINATE",
        "drugauthorizationnumb": null,
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          "activesubstancename": "METOPROLOL SUCCINATE"
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        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
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        "drugcumulativedosagenumb": null,
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        "drugdosagetext": "UNK",
        "drugdosageform": "Tablet",
        "drugadministrationroute": null,
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
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        "drugtreatmentdurationunit": null,
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        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "PRAVASTATIN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "RISPERDAL",
        "drugauthorizationnumb": null,
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        "drugstructuredosagenumb": 0.5,
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        "drugdosagetext": "0.5 MILLIGRAM",
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        "activesubstance": {
          "activesubstancename": "RISPERIDONE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "RISPERDAL",
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        "drugstructuredosagenumb": 3.0,
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          "activesubstancename": "RISPERIDONE"
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        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
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          "activesubstancename": "SODIUM CHLORIDE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "MIRTAZAPINE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
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        "drugdosageform": "Tablet",
        "drugadministrationroute": null,
        "drugindication": "Product used for unknown indication",
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        "drugenddateformat": null,
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        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "MIRTAZAPINE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "TAMSULOSIN HYDROCHLORIDE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
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        "drugdosageform": "Capsule",
        "drugadministrationroute": null,
        "drugindication": "Product used for unknown indication",
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        "drugstartdate": null,
        "drugenddateformat": null,
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        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "TAMSULOSIN HYDROCHLORIDE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-23T00:00:00",
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  "receivedate": "2025-10-23T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
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    "sendertype": 6,
    "senderorganization": "RADIUS PHARM"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
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  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-19T00:00:00",
  "transmissiondateformat": "102"
}
                        

25952402 Type 1

Serious

ACETAMINOPHEN, NURTEC ODT, NURTEC ODT (+3 more)

Report Version

Receive Date

10/23/2025

Receipt Date

10/23/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Company Number

US-PFIZER INC-PV202500069890

Authority Number

Sender Organization

Kenvue

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 (2)

Apgar score abnormal (v28.1) Unknown

Foetal exposure during pregnancy (v28.1) Unknown

Drugs (6)

ACETAMINOPHEN (ACETAMINOPHEN) Suspect

Route: 064 | Dosage: 1000 MILLIGRAM, AS NEEDED | Form: Unknown | Indication: Migraine | Action: Not Applicable

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

Recurrences: --

NURTEC ODT (RIMEGEPANT SULFATE) Suspect

Route: 064 | Dosage: 75 MILLIGRAM, AS NEEDED | Form: Dispersible tablet | Indication: Migraine | Action: Not Applicable

Start: 03/26/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4

Recurrences: --

NURTEC ODT (RIMEGEPANT SULFATE) Suspect

Route: 064 | Dosage: 75 MILLIGRAM, EVERY OTHER DAY | Form: Dispersible tablet | Indication: -- | Action: Not Applicable

Start: 01/06/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4

Recurrences: --

METOCLOPRAMIDE (METOCLOPRAMIDE) Suspect

Route: 064 | Dosage: 10 MILLIGRAM, AS NEEDED | Form: Unknown | Indication: Migraine | Action: Not Applicable

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

Recurrences: --

ONDANSETRON (ONDANSETRON) Suspect

Route: 064 | Dosage: 4 MILLIGRAM, AS NEEDED | Form: Unknown | Indication: Migraine | Action: Not Applicable

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

Recurrences: --

ONDANSETRON (ONDANSETRON) Suspect

Route: -- | Dosage: -- | Form: Unknown | Indication: Nausea | Action: Not Applicable

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435853b3830196fa55101",
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  "companynumb": "US-PFIZER INC-PV202500069890",
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  "patient": {
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    "reaction": [
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        "reactionmeddraversionpt": "28.1",
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      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Foetal exposure during pregnancy",
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      }
    ],
    "drug": [
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        "drugcharacterization": 1,
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      {
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          "activesubstancename": "METOCLOPRAMIDE"
        },
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      },
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        "drugauthorizationnumb": null,
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        "drugdosageform": "Unknown",
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        "drugstartdateformat": null,
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          "activesubstancename": "ONDANSETRON"
        },
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      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 3,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-23T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-23T00:00:00",
  "receivedateformat": "102",
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  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25952406 Type 1

Non-Serious

JAKAFI

Report Version

Receive Date

10/23/2025

Receipt Date

10/23/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

US-INCYTE CORPORATION-2025IN011285

Authority Number

Sender Organization

INCYTE

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

47.392 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Ill-defined disorder (v28.1) Unknown

Product availability issue (v28.1) Unknown

Drugs (1)

JAKAFI (RUXOLITINIB) Suspect

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

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435853b3830196fa55100",
  "safetyreportid": "25952406",
  "authoritynumb": null,
  "companynumb": "US-INCYTE CORPORATION-2025IN011285",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": null,
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    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": 47.392,
    "patientsex": null,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Ill-defined disorder",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Product availability issue",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "JAKAFI",
        "drugauthorizationnumb": "202192",
        "drugbatchnumb": "4714085",
        "drugstructuredosagenumb": 10.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
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        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "10 MILLIGRAM",
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "RUXOLITINIB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-23T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-23T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "INCYTE"
  },
  "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"
}
                        

25952403 Type 1

Non-Serious

BREZTRI

Report Version

Receive Date

10/23/2025

Receipt Date

10/23/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

US-AstraZeneca-CH-00975040AP

Authority Number

Sender Organization

ALEXION PHARMACEUTICALS

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 (1)

Dyspnoea (v28.1) Unknown

Drugs (1)

BREZTRI (BUDESONIDE\FORMOTEROL\GLYCOPYRROLATE) Suspect

Route: 065 | Dosage: 160 MICROGRAM | Form: -- | Indication: -- | Action: Dose Not Changed

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435853b3830196fa550ff",
  "safetyreportid": "25952403",
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  "duplicate": null,
  "fulfillexpeditecriteria": 2,
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    "patientonsetage": null,
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    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dyspnoea",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "BREZTRI",
        "drugauthorizationnumb": "212122",
        "drugbatchnumb": "6103950B00",
        "drugstructuredosagenumb": null,
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        "drugdosagetext": "160 MICROGRAM",
        "drugdosageform": null,
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        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "BUDESONIDE\\FORMOTEROL\\GLYCOPYRROLATE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-23T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-23T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ALEXION PHARMACEUTICALS"
  },
  "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"
}
                        

25952401 Type 3

Serious

ADALIMUMAB, ADALIMUMAB, ADALIMUMAB (+2 more)

Report Version

Receive Date

10/23/2025

Receipt Date

10/23/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Costa S, Dias J, Carvalho R, Rego A, Feliciano T. More than a gut feeling: a case series on ENT manifestations of Crohn^s disease.. Portuguese Journal of Otorhinolaryngology - Head and Neck Surgery.. 2025;63:323-329

Company Number

Authority Number

EU-EMA-DD-20251008-7482831-100626

Sender Organization

BIOCON

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 (3)

Crohn^s disease (v28.1) Unknown

Angioedema (v28.1) Unknown

Nasal pruritus (v28.1) Unknown

Drugs (5)

ADALIMUMAB (ADALIMUMAB) Suspect

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

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

Recurrences: --

ADALIMUMAB (ADALIMUMAB) Suspect

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

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

Recurrences: --

ADALIMUMAB (ADALIMUMAB) Suspect

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

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

Recurrences: --

ADALIMUMAB (ADALIMUMAB) Suspect

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

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

Recurrences: --

ADALIMUMAB (ADALIMUMAB) Suspect

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

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

Recurrences: --

Clinical Narrative

Report Duplicates (6)

EMA: EU-EMA-DD-20251008-7482831-100626

ABBVIE: EU-ABBVIE-6476940

AMGEN: EU-AMGEN-PRTSP2025190941

Case identifiers: 10020151845

Case identifiers: 10020164092

AMGEN: EU-AMGEN-PRTSP2025190846

Raw JSON (click to expand)

                            {
  "_id": "69d435853b3830196fa550fe",
  "safetyreportid": "25952401",
  "authoritynumb": "EU-EMA-DD-20251008-7482831-100626",
  "companynumb": null,
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": null,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Crohn^s disease",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Angioedema",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Nasal pruritus",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ADALIMUMAB",
        "drugauthorizationnumb": "761154",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": "Unknown",
        "drugadministrationroute": "058",
        "drugindication": "Crohn^s disease",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "ADALIMUMAB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ADALIMUMAB",
        "drugauthorizationnumb": "761154",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Unknown",
        "drugadministrationroute": null,
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "ADALIMUMAB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ADALIMUMAB",
        "drugauthorizationnumb": "761154",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Unknown",
        "drugadministrationroute": null,
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "ADALIMUMAB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ADALIMUMAB",
        "drugauthorizationnumb": "761154",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Unknown",
        "drugadministrationroute": null,
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "ADALIMUMAB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ADALIMUMAB",
        "drugauthorizationnumb": "761154",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Unknown",
        "drugadministrationroute": null,
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "ADALIMUMAB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 3,
    "literaturereference": "Costa S, Dias J, Carvalho R, Rego A, Feliciano T. More than a gut feeling: a case series on ENT manifestations of Crohn^s disease.. Portuguese Journal of Otorhinolaryngology - Head and Neck Surgery.. 2025;63:323-329"
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-23T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-23T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "EMA",
      "duplicatenumb": "EU-EMA-DD-20251008-7482831-100626"
    },
    {
      "duplicatesource": "ABBVIE",
      "duplicatenumb": "EU-ABBVIE-6476940"
    },
    {
      "duplicatesource": "AMGEN",
      "duplicatenumb": "EU-AMGEN-PRTSP2025190941"
    },
    {
      "duplicatesource": "Case identifiers",
      "duplicatenumb": "10020151845"
    },
    {
      "duplicatesource": "Case identifiers",
      "duplicatenumb": "10020164092"
    },
    {
      "duplicatesource": "AMGEN",
      "duplicatenumb": "EU-AMGEN-PRTSP2025190846"
    }
  ],
  "reporttype": 3,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "BIOCON"
  },
  "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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