FDA FAERS Adverse Event Reports

111000

Total Reports

60668

Serious Reports

108

Reporter Countries

25975065 Type 2

Serious

CREON, CREON, CREON

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

US-ABBVIE-5878753

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

46.0 yr

Patient Age Group

Patient Sex

Female

Patient Weight

81.646 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (13)

Endovenous ablation (v28.1) Unknown

Abdominal distension (v28.1) Not Recovered

Feeling abnormal (v28.1) Not Recovered

Alopecia (v28.1) Not Recovered

Dyspepsia (v28.1) Not Recovered

Constipation (v28.1) Not Recovered

Malnutrition (v28.1) Not Recovered

Abnormal faeces (v28.1) Not Recovered

Abdominal pain (v28.1) Not Recovered

Amylase decreased (v28.1) Unknown

Swelling (v28.1) Not Recovered

Rash (v28.1) Unknown

Urticaria (v28.1) Unknown

Drugs (3)

CREON (PANCRELIPASE AMYLASE\PANCRELIPASE LIPASE\PANCRELIPASE PROTEASE) Suspect

Route: 048 | Dosage: UNKNOWN | Form: Capsule | Indication: Pancreatic failure | Action: Not Applicable

Start: 02/01/2024 | End: 02/01/2024 | Duration: -- -- | Rechallenge: -- | Additional: 4

Recurrences: --

CREON (PANCRELIPASE AMYLASE\PANCRELIPASE LIPASE\PANCRELIPASE PROTEASE) Suspect

Route: 048 | Dosage: UNKNOWN | Form: Capsule | Indication: Pancreatic failure | Action: Not Applicable

Start: 02/01/2024 | End: 03/01/2024 | Duration: -- -- | Rechallenge: -- | Additional: 4

Recurrences: --

CREON (PANCRELIPASE AMYLASE\PANCRELIPASE LIPASE\PANCRELIPASE PROTEASE) Suspect

Route: 048 | Dosage: -- | Form: Capsule | Indication: Pancreatic failure | Action: Not Applicable

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20240101

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69e7691e5eb43a53b3ff21c0",
  "safetyreportid": "25975065",
  "authoritynumb": null,
  "companynumb": "US-ABBVIE-5878753",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 46.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": 81.646,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Endovenous ablation",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Abdominal distension",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Feeling abnormal",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Alopecia",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dyspepsia",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Constipation",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Malnutrition",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Abnormal faeces",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Abdominal pain",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Amylase decreased",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Swelling",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Rash",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Urticaria",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CREON",
        "drugauthorizationnumb": "020725",
        "drugbatchnumb": "Not Available",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 0.25,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNKNOWN",
        "drugdosageform": "Capsule",
        "drugadministrationroute": "048",
        "drugindication": "Pancreatic failure",
        "drugstartdateformat": "610",
        "drugstartdate": "2024-02-01T00:00:00",
        "drugenddateformat": "610",
        "drugenddate": "2024-02-01T00:00:00",
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "PANCRELIPASE AMYLASE\\PANCRELIPASE LIPASE\\PANCRELIPASE PROTEASE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CREON",
        "drugauthorizationnumb": "020725",
        "drugbatchnumb": "Not Available",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 0.25,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNKNOWN",
        "drugdosageform": "Capsule",
        "drugadministrationroute": "048",
        "drugindication": "Pancreatic failure",
        "drugstartdateformat": "610",
        "drugstartdate": "2024-02-01T00:00:00",
        "drugenddateformat": "610",
        "drugenddate": "2024-03-01T00:00:00",
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "PANCRELIPASE AMYLASE\\PANCRELIPASE LIPASE\\PANCRELIPASE PROTEASE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CREON",
        "drugauthorizationnumb": "020725",
        "drugbatchnumb": "Not available",
        "drugstructuredosagenumb": 24000.0,
        "drugstructuredosageunit": "032",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 3.0,
        "drugintervaldosagedefinition": 805,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Capsule",
        "drugadministrationroute": "048",
        "drugindication": "Pancreatic failure",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "PANCRELIPASE AMYLASE\\PANCRELIPASE LIPASE\\PANCRELIPASE PROTEASE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20240101"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "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": 2,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ABBVIE"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25975062 Type 1

Serious

SABRIL

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

Consumer

Literature Reference

Company Number

CA-LUNDBECK-DKLU4021089

Authority Number

Sender Organization

LUNDBECK

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

11.0 yr

Patient Age Group

Child

Patient Sex

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Disease complication (v28.1) Fatal

Drugs (1)

SABRIL (VIGABATRIN) Suspect

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

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20240901

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69e7691e5eb43a53b3ff21bf",
  "safetyreportid": "25975062",
  "authoritynumb": null,
  "companynumb": "CA-LUNDBECK-DKLU4021089",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "CA",
  "patient": {
    "patientonsetage": 11.0,
    "patientonsetageunit": 801,
    "patientagegroup": 3,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Disease complication",
        "reactionoutcome": 5
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "SABRIL",
        "drugauthorizationnumb": "22006",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Powder for oral solution",
        "drugadministrationroute": null,
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "VIGABATRIN"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20240901"
  },
  "primarysource": {
    "reportercountry": "CA",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "CA",
  "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": "LUNDBECK"
  },
  "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"
}
                        

25975032 Type 1

Non-Serious

BIMZELX, BIMZELX, PEPCID (+9 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

Other Health Professional

Literature Reference

Company Number

US-UCBSA-2025050296

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 (2)

Injection site pain (v28.1) Recovered

Off label use (v28.1) Unknown

Drugs (12)

BIMZELX (BIMEKIZUMAB-BKZX) Suspect

Route: -- | Dosage: 320 MILLIGRAM, EV 8 WEEKS | Form: Solution for injection in pre-filled pen | Indication: Acne | Action: Unknown

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

Recurrences: --

BIMZELX (BIMEKIZUMAB-BKZX) Suspect

Route: -- | Dosage: -- | Form: -- | Indication: Off label use | Action: Unknown

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

Recurrences: --

PEPCID (FAMOTIDINE) Concomitant

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