FDA FAERS Adverse Event Reports

111000

Total Reports

60668

Serious Reports

108

Reporter Countries

25972740 Type 2

Serious

SKYRIZI

Report Version

Receive Date

10/29/2025

Receipt Date

10/29/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

EU-ABBVIE-6523560

Authority Number

Sender Organization

ABBVIE

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

73.0 yr

Patient Age Group

Patient Sex

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Cerebrovascular accident (v28.1) Fatal

Drugs (1)

SKYRIZI (RISANKIZUMAB-RZAA) Suspect

Route: 058 | Dosage: FORM STRENGTH - 75 MG | Form: -- | Indication: Psoriasis | Action: Not Applicable

Start: 09/01/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251001

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435e33b3830196fa5a5b8",
  "safetyreportid": "25972740",
  "authoritynumb": null,
  "companynumb": "EU-ABBVIE-6523560",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": 73.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Cerebrovascular accident",
        "reactionoutcome": 5
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "SKYRIZI",
        "drugauthorizationnumb": "761105",
        "drugbatchnumb": "Not available",
        "drugstructuredosagenumb": 150.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 84.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "FORM STRENGTH - 75 MG",
        "drugdosageform": null,
        "drugadministrationroute": "058",
        "drugindication": "Psoriasis",
        "drugstartdateformat": "610",
        "drugstartdate": "2022-09-01T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "RISANKIZUMAB-RZAA"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251001"
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-29T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 2,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ABBVIE"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 1,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 2,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25972739 Type 1

Non-Serious

BIMZELX

Report Version

Receive Date

10/29/2025

Receipt Date

10/29/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Company Number

US-UCBSA-2025046692

Authority Number

Sender Organization

UCB

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

28.0 yr

Patient Age Group

Patient Sex

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Injection site reaction (v28.1) Unknown

Product dose omission issue (v28.1) Unknown

Drugs (1)

BIMZELX (BIMEKIZUMAB-BKZX) Suspect

Route: -- | Dosage: 320 MILLIGRAM, EV 4 WEEKS | Form: Solution for injection in pre-filled syringe | Indication: Hidradenitis | Action: Dose Not Changed

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435e33b3830196fa5a5b7",
  "safetyreportid": "25972739",
  "authoritynumb": null,
  "companynumb": "US-UCBSA-2025046692",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": null,
  "patient": {
    "patientonsetage": 28.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": null,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Injection site reaction",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Product dose omission issue",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "BIMZELX",
        "drugauthorizationnumb": "761151",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 320.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 4.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "320 MILLIGRAM, EV 4 WEEKS",
        "drugdosageform": "Solution for injection in pre-filled syringe",
        "drugadministrationroute": null,
        "drugindication": "Hidradenitis",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "BIMEKIZUMAB-BKZX"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 3,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-29T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "UCB"
  },
  "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"
}
                        

25972742 Type 1

Serious

AMOXICILLIN

Report Version

Receive Date

10/29/2025

Receipt Date

10/29/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Physician

Literature Reference

Company Number

GB-MHRA-TPP392378C6336892YC1760366314134

Authority Number

Sender Organization

MICRO LABS LIMITED

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

52.0 yr

Patient Age Group

Adult

Patient Sex

Female

Patient Weight

102.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Chest discomfort (v28.1) Unknown

Rash (v28.1) Recovered

Malaise (v28.1) Unknown

Dyspnoea (v28.1) Unknown

Drug hypersensitivity (v28.1) Unknown

Drugs (1)

AMOXICILLIN (AMOXICILLIN) Suspect

Route: -- | Dosage: -- | Form: Capsule | Indication: Ill-defined disorder | Action: Unknown

Start: 06/04/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown

Recurrences: --

Clinical Narrative

Report Duplicates (1)

MHRA: GB-MHRA-TPP392378C6336892YC1760366314134

Raw JSON (click to expand)

                            {
  "_id": "69d435e33b3830196fa5a5bb",
  "safetyreportid": "25972742",
  "authoritynumb": null,
  "companynumb": "GB-MHRA-TPP392378C6336892YC1760366314134",
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "GB",
  "patient": {
    "patientonsetage": 52.0,
    "patientonsetageunit": 801,
    "patientagegroup": 5,
    "patientweight": 102.0,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Chest discomfort",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Rash",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Malaise",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dyspnoea",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Drug hypersensitivity",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "AMOXICILLIN",
        "drugauthorizationnumb": "207471",
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": 500.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Capsule",
        "drugadministrationroute": null,
        "drugindication": "Ill-defined disorder",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-06-04T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "AMOXICILLIN"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "GB",
    "qualification": 1,
    "literaturereference": null
  },
  "primarysourcecountry": "GB",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-29T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "MHRA",
      "duplicatenumb": "GB-MHRA-TPP392378C6336892YC1760366314134"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "MICRO LABS LIMITED"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 1,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25972736 Type 1

Non-Serious

BIMZELX

Report Version

Receive Date

10/29/2025

Receipt Date

10/29/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Physician

Literature Reference

Company Number

US-UCBSA-2025046616

Authority Number

Sender Organization

UCB

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)

Pruritus (v28.1) Unknown

Drugs (1)

BIMZELX (BIMEKIZUMAB-BKZX) Suspect

Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Dose Not Changed

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435e33b3830196fa5a5b5",
  "safetyreportid": "25972736",
  "authoritynumb": null,
  "companynumb": "US-UCBSA-2025046616",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": null,
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": null,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Pruritus",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "BIMZELX",
        "drugauthorizationnumb": "761151",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "BIMEKIZUMAB-BKZX"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 1,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-29T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "UCB"
  },
  "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"
}
                        

25972734 Type 1

Non-Serious

BIMZELX

Report Version

Receive Date

10/29/2025

Receipt Date

10/29/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Company Number

US-UCBSA-2025046588

Authority Number

Sender Organization

UCB

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

36.0 yr

Patient Age Group

Patient Sex

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Hidradenitis (v28.1) Unknown

Condition aggravated (v28.1) Unknown

Drugs (1)

BIMZELX (BIMEKIZUMAB-BKZX) Suspect

Route: -- | Dosage: 320 MILLIGRAM, EV 2 WEEKS(QOW) | Form: Solution for injection in pre-filled pen | Indication: Hidradenitis | Action: Dose Not Changed

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435e33b3830196fa5a5b3",
  "safetyreportid": "25972734",
  "authoritynumb": null,
  "companynumb": "US-UCBSA-2025046588",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": null,
  "patient": {
    "patientonsetage": 36.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": null,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Hidradenitis",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Condition aggravated",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "BIMZELX",
        "drugauthorizationnumb": "761151",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 320.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 2.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "320 MILLIGRAM, EV 2 WEEKS(QOW)",
        "drugdosageform": "Solution for injection in pre-filled pen",
        "drugadministrationroute": null,
        "drugindication": "Hidradenitis",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "BIMEKIZUMAB-BKZX"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 3,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-29T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "UCB"
  },
  "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"
}
                        

25972737 Type 1

Non-Serious

BIMZELX, BIMZELX

Report Version

Receive Date

10/29/2025

Receipt Date

10/29/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Company Number

US-UCBSA-2025046656

Authority Number

Sender Organization

UCB

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

51.0 yr

Patient Age Group

Patient Sex

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Psoriasis (v28.1) Unknown

Drugs (2)

BIMZELX (BIMEKIZUMAB-BKZX) Suspect

Route: -- | Dosage: 160 MILLIGRAM, EV 4 WEEKS | Form: Solution for injection in pre-filled pen | Indication: Psoriatic arthropathy | Action: Dose Not Changed

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

Recurrences: --

BIMZELX (BIMEKIZUMAB-BKZX) Suspect

Route: -- | Dosage: -- | Form: -- | Indication: Psoriasis | Action: Dose Not Changed

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435e33b3830196fa5a5b4",
  "safetyreportid": "25972737",
  "authoritynumb": null,
  "companynumb": "US-UCBSA-2025046656",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": null,
  "patient": {
    "patientonsetage": 51.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": null,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Psoriasis",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "BIMZELX",
        "drugauthorizationnumb": "761151",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 160.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 4.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "160 MILLIGRAM, EV 4 WEEKS",
        "drugdosageform": "Solution for injection in pre-filled pen",
        "drugadministrationroute": null,
        "drugindication": "Psoriatic arthropathy",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "BIMEKIZUMAB-BKZX"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "BIMZELX",
        "drugauthorizationnumb": "761151",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Psoriasis",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "BIMEKIZUMAB-BKZX"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 3,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-29T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "UCB"
  },
  "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"
}
                        

25972735 Type 1

Non-Serious

BIMZELX

Report Version

Receive Date

10/29/2025

Receipt Date

10/29/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Company Number

US-UCBSA-2025046615

Authority Number

Sender Organization

UCB

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

61.0 yr

Patient Age Group

Patient Sex

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Device difficult to use (v28.1) Unknown

Needle issue (v28.1) Unknown

Product dose omission issue (v28.1) Unknown

Drugs (1)

BIMZELX (BIMEKIZUMAB-BKZX) Suspect

Route: -- | Dosage: 320 MILLIGRAM, EV 2 WEEKS(QOW) | Form: Solution for injection in pre-filled syringe | Indication: Product used for unknown indication | Action: Not Applicable

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d435e33b3830196fa5a5b2",
  "safetyreportid": "25972735",
  "authoritynumb": null,
  "companynumb": "US-UCBSA-2025046615",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": null,
  "patient": {
    "patientonsetage": 61.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": null,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Device difficult to use",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Needle issue",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Product dose omission issue",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "BIMZELX",
        "drugauthorizationnumb": "761151",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 320.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 2.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "320 MILLIGRAM, EV 2 WEEKS(QOW)",
        "drugdosageform": "Solution for injection in pre-filled syringe",
        "drugadministrationroute": null,
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "BIMEKIZUMAB-BKZX"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 3,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-29T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-29T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "UCB"
  },
  "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"
}
                        

25972720 Type 2

Serious

FOSCARBIDOPA\FOSLEVODOPA, Maxi Kalz, MAGNESIUM CARBONATE\MAGNESIUM OXIDE (+12 more)

Report Version

Receive Date

10/29/2025

Receipt Date

10/29/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

EU-ABBVIE-6523650

Authority Number

Sender Organization

ABBVIE

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

71.0 yr

Patient Age Group

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Post procedural complication (v28.1) Fatal

Nephrolithiasis (v28.1) Unknown

Drugs (15)

FOSCARBIDOPA\FOSLEVODOPA (FOSCARBIDOPA\FOSLEVODOPA) Suspect

Route: 058 | Dosage: CR 0.30ML/H; CR HIGH 0.33ML/H; CR LOW 0.22ML/H; ED 0.20ML | Form: Solution for infusion | Indication: Parkinson^s disease | Action: Not Applicable

Start: 01/07/2025 | End: 10/25/2025 | Duration: -- -- | Rechallenge: -- | Additional: 4

Recurrences: --

Maxi Kalz (--) Concomitant

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