FDA FAERS Adverse Event Reports

25949791 Type 1

Serious

RIVAROXABAN, ACETAMINOPHEN, PREGABALIN (+7 more)

Report Version

1

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/18/2026

Primary Source Country

GB

Occurrence Country

GB

Reporter Country

GB

Reporter Qualification

Pharmacist

Literature Reference

--

Company Number

GB-MHRA-MIDB-73d62089-2d13-403b-b535-7a2d3a6f7fb5

Authority Number

--

Sender Organization

CIPLA

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

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 (1)

Haemoglobin decreased (v28.1) Unknown

Drugs (10)

RIVAROXABAN (RIVAROXABAN) Suspect

Route: 065 | Dosage: 15 MILLIGRAM, QD (TABLETS) | Form: NON COMPANY FORMULATION | Indication: Product used for unknown indication | Action: Withdrawn

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

Recurrences: --

ACETAMINOPHEN (ACETAMINOPHEN) Concomitant

Route: 065 | Dosage: 500 MILLIGRAMS, QID(ONE TO BE TAKEN EVERY 4-6 HOURS UP TO FOUR TIMES A DAY ) | Form: Tablet | Indication: Product used for unknown indication | Action: Not Applicable

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

Recurrences: --

PREGABALIN (PREGABALIN) Concomitant

Route: 065 | Dosage: 50 MILLIGRAM, BID (ONE TO BE TAKEN TWICE A DAY ) (EVERY 12 HOURS) | Form: Capsule | Indication: Product used for unknown indication | Action: Not Applicable

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

Recurrences: --

THIAMINE (THIAMINE) Concomitant

Route: 065 | Dosage: 100 MILLIGRAM, TID (ONE TO BE TAKEN THREE TIMES A DAY) (EVERY 8 HOURS) | Form: Tablet | Indication: Product used for unknown indication | Action: Not Applicable

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

Recurrences: --

OMEPRAZOLE (OMEPRAZOLE) Concomitant

Route: 065 | Dosage: 20 MILLIGRAM, QD (ONE TO BE TAKEN EACH DAY ) | Form: Gastro-resistant capsule | Indication: Product used for unknown indication | Action: Not Applicable

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

Recurrences: --

ACIDEX ADVANCE (--) Concomitant

Route: 065 | Dosage: 5 MILLILITER, BID (EVERY 12 HOURS) ANISEED TWO 5 MLS SPOONFUL^S | Form: Oral suspension | Indication: Dyspepsia | Action: Not Applicable

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

Recurrences: --

HYLO CARE (--) Concomitant

Route: 065 | Dosage: 1 DOSAGE FORM, QID (EVERY 6 HOURS) (PRESERVATIVE FREE USE ONE DROP FOUR TIMES A DAY) | Form: Eye drops | Indication: Product used for unknown indication | Action: Not Applicable

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

Recurrences: --

MIRABEGRON (MIRABEGRON) Concomitant

Route: 065 | Dosage: 25 MILLIGRAM, QD | Form: Modified-release tablet | Indication: Product used for unknown indication | Action: Not Applicable

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

Recurrences: --

ALLOPURINOL (ALLOPURINOL) Concomitant

Route: 065 | Dosage: 100 MILLIGRAM, QD (ONE TO BE TAKEN DAILY) | Form: Tablet | Indication: Product used for unknown indication | Action: Not Applicable

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

Recurrences: --

VENTOLIN (ALBUTEROL SULFATE) Concomitant

Route: 065 | Dosage: 1 MILLIGRAM (STRENGTH:100 MICROGRAMS / DOSE) | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable

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

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d4357b3b3830196fa546d5",
  "safetyreportid": "25949791",
  "authoritynumb": null,
  "companynumb": "GB-MHRA-MIDB-73d62089-2d13-403b-b535-7a2d3a6f7fb5",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "GB",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": null,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Haemoglobin decreased",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "RIVAROXABAN",
        "drugauthorizationnumb": "208543",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 15.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "15 MILLIGRAM, QD (TABLETS)",
        "drugdosageform": "NON COMPANY FORMULATION",
        "drugadministrationroute": "065",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
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        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": null,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "RIVAROXABAN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "ACETAMINOPHEN",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 500.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 6.0,
        "drugintervaldosagedefinition": 805,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "500 MILLIGRAMS, QID(ONE TO BE TAKEN EVERY 4-6 HOURS UP TO FOUR TIMES A DAY )",
        "drugdosageform": "Tablet",
        "drugadministrationroute": "065",
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
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        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "ACETAMINOPHEN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "PREGABALIN",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 50.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 2.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "50 MILLIGRAM, BID (ONE TO BE TAKEN TWICE A DAY ) (EVERY 12 HOURS)",
        "drugdosageform": "Capsule",
        "drugadministrationroute": "065",
        "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": "PREGABALIN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "THIAMINE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 100.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 3.0,
        "drugintervaldosageunitnumb": 3.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "100 MILLIGRAM, TID (ONE TO BE TAKEN THREE TIMES A DAY) (EVERY 8 HOURS)",
        "drugdosageform": "Tablet",
        "drugadministrationroute": "065",
        "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": "THIAMINE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "OMEPRAZOLE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 20.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "20 MILLIGRAM, QD (ONE TO BE TAKEN EACH DAY )",
        "drugdosageform": "Gastro-resistant capsule",
        "drugadministrationroute": "065",
        "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": "OMEPRAZOLE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "ACIDEX ADVANCE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 5.0,
        "drugstructuredosageunit": "012",
        "drugseparatedosagenumb": 2.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "5 MILLILITER, BID (EVERY 12 HOURS) ANISEED TWO 5 MLS SPOONFUL^S",
        "drugdosageform": "Oral suspension",
        "drugadministrationroute": "065",
        "drugindication": "Dyspepsia",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": null,
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "HYLO CARE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 1.0,
        "drugstructuredosageunit": "032",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 6.0,
        "drugintervaldosagedefinition": 805,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "1 DOSAGE FORM, QID (EVERY 6 HOURS) (PRESERVATIVE FREE USE ONE DROP FOUR TIMES A DAY)",
        "drugdosageform": "Eye drops",
        "drugadministrationroute": "065",
        "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": null,
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "MIRABEGRON",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 25.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "25 MILLIGRAM, QD",
        "drugdosageform": "Modified-release tablet",
        "drugadministrationroute": "065",
        "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": "MIRABEGRON"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "ALLOPURINOL",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 100.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "100 MILLIGRAM, QD (ONE TO BE TAKEN DAILY)",
        "drugdosageform": "Tablet",
        "drugadministrationroute": "065",
        "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": "ALLOPURINOL"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "VENTOLIN",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 1.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "1 MILLIGRAM (STRENGTH:100 MICROGRAMS / DOSE)",
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "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": "ALBUTEROL SULFATE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "GB",
    "qualification": 2,
    "literaturereference": null
  },
  "primarysourcecountry": "GB",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-22T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-22T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "CIPLA"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 1,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 2,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25949786 Type 1

Non-Serious

DUPIXENT

Report Version

1

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/17/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-SA-2025SA313871

Authority Number

--

Sender Organization

SANOFI AVENTIS

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

No

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

--

Patient Age Group

Child

Patient Sex

Male

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Rash (v28.1) Recovered

Therapeutic response shortened (v28.1) Recovered

Drugs (1)

DUPIXENT (DUPILUMAB) Suspect

Route: 058 | Dosage: 300 MG, Q4W | Form: Solution for injection | Indication: Dermatitis atopic | Action: Unknown

Start: 11/01/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d4357b3b3830196fa546cf",
  "safetyreportid": "25949786",
  "authoritynumb": null,
  "companynumb": "US-SA-2025SA313871",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": 3,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Rash",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Therapeutic response shortened",
        "reactionoutcome": 1
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "DUPIXENT",
        "drugauthorizationnumb": "761055",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 300.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 4.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "300 MG, Q4W",
        "drugdosageform": "Solution for injection",
        "drugadministrationroute": "058",
        "drugindication": "Dermatitis atopic",
        "drugstartdateformat": "610",
        "drugstartdate": "2022-11-01T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "DUPILUMAB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-22T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-22T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "SANOFI AVENTIS"
  },
  "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"
}
                        

25949784 Type 1

Serious

OZEMPIC, WEGOVY

Report Version

1

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/17/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-NOVOPROD-1542014

Authority Number

--

Sender Organization

NOVO NORDISK

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

45.0 yr

Patient Age Group

--

Patient Sex

--

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Intestinal obstruction (v28.1) Not Recovered

Ileus (v28.1) Not Recovered

Emotional distress (v28.1) Not Recovered

Off label use (v28.1) Unknown

Drugs (2)

OZEMPIC (SEMAGLUTIDE) Suspect

Route: -- | Dosage: UNK | Form: Solution for injection | Indication: Weight control | Action: Unknown

Start: 09/01/2022 | End: 06/01/2023 | Duration: -- -- | Rechallenge: -- | Additional: Unknown

Recurrences: --

WEGOVY (SEMAGLUTIDE) Suspect

Route: -- | Dosage: UNK | Form: Solution for injection | Indication: Weight control | Action: Unknown

Start: 08/01/2022 | End: 09/01/2022 | Duration: -- -- | Rechallenge: -- | Additional: Unknown

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20220901

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d4357b3b3830196fa546cb",
  "safetyreportid": "25949784",
  "authoritynumb": null,
  "companynumb": "US-NOVOPROD-1542014",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 45.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": null,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Intestinal obstruction",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Ileus",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Emotional distress",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Off label use",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "OZEMPIC",
        "drugauthorizationnumb": "209637",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": "Solution for injection",
        "drugadministrationroute": null,
        "drugindication": "Weight control",
        "drugstartdateformat": "610",
        "drugstartdate": "2022-09-01T00:00:00",
        "drugenddateformat": "610",
        "drugenddate": "2023-06-01T00:00:00",
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "SEMAGLUTIDE"
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        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "WEGOVY",
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          "activesubstancename": "SEMAGLUTIDE"
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    ],
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  },
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    "qualification": 5,
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  },
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}
                        

25949785 Type 1

Serious

OZEMPIC

Report Version

1

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/17/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-NOVOPROD-1541976

Authority Number

--

Sender Organization

NOVO NORDISK

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

--

Patient Age Group

--

Patient Sex

--

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Blindness (v28.1) Recovered

Intestinal obstruction (v28.1) Recovered

Impaired gastric emptying (v28.1) Recovered

Ileus (v28.1) Recovered

Drugs (1)

OZEMPIC (SEMAGLUTIDE) Suspect

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

Start: 01/01/2023 | End: 01/01/2024 | Duration: -- -- | Rechallenge: -- | Additional: Unknown

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230601

Report Duplicates (0)

--

Raw JSON (click to expand)

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  "_id": "69d4357b3b3830196fa546cd",
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25949789 Type 1

Serious

ESOMEPRAZOLE, VENLAFAXIN MEDICAL VALLEY, LEVOTHYROXINE SODIUM (+4 more)

Report Version

1

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/18/2026

Primary Source Country

EU

Occurrence Country

EU

Reporter Country

EU

Reporter Qualification

Consumer

Literature Reference

--

Company Number

EU-SEMPA-2025-008422

Authority Number

--

Sender Organization

CIPLA

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

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 (1)

Diplopia (v28.1) Recovered

Drugs (7)

ESOMEPRAZOLE (ESOMEPRAZOLE) Suspect

Route: 065 | Dosage: 20 MILLIGRAM, QD, GASTRO-RESISTANT CAPSULE, HARD | Form: NON COMPANY FORMULATION | Indication: Gastritis | Action: Withdrawn

Start: 09/13/2025 | End: 09/18/2025 | Duration: 5.0 day | Rechallenge: Unknown | Additional: Yes

Recurrences: --

VENLAFAXIN MEDICAL VALLEY (--) Concomitant

Route: 065 | Dosage: UNK | Form: Prolonged-release tablet | Indication: Product used for unknown indication | Action: Not Applicable

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

Recurrences: --

LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM) Concomitant

Route: 065 | Dosage: UNK | Form: Tablet | Indication: Product used for unknown indication | Action: Not Applicable

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

Recurrences: --

FOLSYRA VITABALANS (--) Concomitant

Route: 065 | Dosage: UNK | Form: Tablet | Indication: Product used for unknown indication | Action: Not Applicable

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

Recurrences: --

KALCIUM/KOLEKALCIFEROL EVOLAN (--) Concomitant

Route: 065 | Dosage: UNK | Form: Film Coated Tablets | Indication: Product used for unknown indication | Action: Not Applicable

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

Recurrences: --

ALENDRONAT (ALENDRONATE SODIUM) Concomitant

Route: 065 | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable

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

Recurrences: --

BETOLVAN (--) Concomitant

Route: 065 | Dosage: UNK | Form: Film Coated Tablets | Indication: Product used for unknown indication | Action: Not Applicable

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250917

Report Duplicates (0)

--

Raw JSON (click to expand)

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      },
      {
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        "actiondrug": 6,
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      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "ALENDRONAT",
        "drugauthorizationnumb": null,
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          "activesubstancename": "ALENDRONATE SODIUM"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
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    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250917"
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-22T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-22T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
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  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25949778 Type 1

Serious

OZEMPIC, OZEMPIC

Report Version

1

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/17/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-NOVOPROD-1541453

Authority Number

--

Sender Organization

NOVO NORDISK

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

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 (3)

Intestinal obstruction (v28.1) Not Recovered

Impaired gastric emptying (v28.1) Not Recovered

Ileus (v28.1) Not Recovered

Drugs (2)

OZEMPIC (SEMAGLUTIDE) Suspect

Route: -- | Dosage: UNK | Form: Solution for injection | Indication: -- | Action: Unknown

Start: 12/01/2021 | End: 12/01/2023 | Duration: -- -- | Rechallenge: -- | Additional: Unknown

Recurrences: --

OZEMPIC (SEMAGLUTIDE) Suspect

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

Start: 10/01/2018 | End: 08/18/2019 | Duration: -- -- | Rechallenge: -- | Additional: Unknown

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20231012

Report Duplicates (0)

--

Raw JSON (click to expand)

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  "_id": "69d4357b3b3830196fa546c6",
  "safetyreportid": "25949778",
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        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Intestinal obstruction",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Impaired gastric emptying",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Ileus",
        "reactionoutcome": 3
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    "drug": [
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        "drugstartdateformat": "610",
        "drugstartdate": "2021-12-01T00:00:00",
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        "drugstartdateformat": "610",
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        "drugenddate": "2019-08-18T00:00:00",
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        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20231012"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-22T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-22T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "NOVO NORDISK"
  },
  "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"
}
                        

25949780 Type 2

Serious

IDELALISIB, ACETAMINOPHEN, ALBUTEROL (+5 more)

Report Version

1

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/17/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-GILEAD-2025-0733483

Authority Number

--

Sender Organization

GILEAD

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

59.0 yr

Patient Age Group

Adult

Patient Sex

Male

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Death (v28.1) Fatal

Drugs (8)

IDELALISIB (IDELALISIB) Suspect

Route: 048 | Dosage: 1 DOSAGE FORM, QD | Form: Tablet | Indication: Chronic lymphocytic leukaemia | Action: Not Applicable

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

Recurrences: --

ACETAMINOPHEN (ACETAMINOPHEN) Concomitant

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

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

Recurrences: --

ALBUTEROL (ALBUTEROL) Concomitant

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

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

Recurrences: --

DEXTROSE (DEXTROSE MONOHYDRATE) Concomitant

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

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

Recurrences: --

DIPHENHYDRAMINE (DIPHENHYDRAMINE) Concomitant

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

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

Recurrences: --

ESCITALOPRAM (ESCITALOPRAM OXALATE) Concomitant

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

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

Recurrences: --

IMMUNE GLOBULIN (--) Concomitant

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

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

Recurrences: --

LEVOTHYROXINE (LEVOTHYROXINE) Concomitant

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

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

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d4357b3b3830196fa546c7",
  "safetyreportid": "25949780",
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  "companynumb": "US-GILEAD-2025-0733483",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
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  "patient": {
    "patientonsetage": 59.0,
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      {
        "reactionmeddraversionpt": "28.1",
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      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "IDELALISIB",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": 1.0,
        "drugstructuredosageunit": "032",
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        "drugintervaldosagedefinition": 804,
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        "drugdosagetext": "1 DOSAGE FORM, QD",
        "drugdosageform": "Tablet",
        "drugadministrationroute": "048",
        "drugindication": "Chronic lymphocytic leukaemia",
        "drugstartdateformat": null,
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        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "IDELALISIB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "ACETAMINOPHEN",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
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          "activesubstancename": "ACETAMINOPHEN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "ALBUTEROL",
        "drugauthorizationnumb": null,
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        "activesubstance": {
          "activesubstancename": "ALBUTEROL"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "DEXTROSE",
        "drugauthorizationnumb": null,
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        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "DEXTROSE MONOHYDRATE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "DIPHENHYDRAMINE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
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        "drugdosagetext": null,
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        "activesubstance": {
          "activesubstancename": "DIPHENHYDRAMINE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "ESCITALOPRAM",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
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        "drugindication": null,
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        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "ESCITALOPRAM OXALATE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "IMMUNE GLOBULIN",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
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        "drugindication": null,
        "drugstartdateformat": null,
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        "drugenddateformat": null,
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        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": null,
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "LEVOTHYROXINE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
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        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
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        "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": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-22T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-22T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 2,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "GILEAD"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 1,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25949783 Type 1

Non-Serious

SIROLIMUS, SIROLIMUS

Report Version

1

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/18/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Other Health Professional

Literature Reference

Meluskey H, Blowey B, O^Brien AB, O^Byrne ML, Rome JJ, Frank DB et.al. Systemic Sirolimus Monitoring in Pediatric Pulmonary Vein Stenosis. Pediatric Cardiology. 2025

Company Number

US-APOTEX-2025AP031200

Authority Number

--

Sender Organization

APOTEX

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

No

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

--

Patient Age Group

Child

Patient Sex

--

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Drug level above therapeutic (v28.1) Unknown

Stomatitis (v28.1) Unknown

Drugs (2)

SIROLIMUS (SIROLIMUS) Suspect

Route: 065 | Dosage: UNK | Form: -- | Indication: Pulmonary vein stenosis | Action: Unknown

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

Recurrences: --

SIROLIMUS (SIROLIMUS) Suspect

Route: -- | Dosage: -- | Form: -- | Indication: Vascular stent stenosis | Action: Unknown

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

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d4357b3b3830196fa546ca",
  "safetyreportid": "25949783",
  "authoritynumb": null,
  "companynumb": "US-APOTEX-2025AP031200",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": 3,
    "patientweight": null,
    "patientsex": null,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Drug level above therapeutic",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Stomatitis",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "SIROLIMUS",
        "drugauthorizationnumb": "211406",
        "drugbatchnumb": null,
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        "drugstructuredosageunit": null,
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        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": "Pulmonary vein stenosis",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "SIROLIMUS"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "SIROLIMUS",
        "drugauthorizationnumb": "211406",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
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        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Vascular stent stenosis",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
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        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "SIROLIMUS"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 3,
    "literaturereference": "Meluskey H, Blowey B, O^Brien AB, O^Byrne ML, Rome JJ, Frank DB et.al. Systemic Sirolimus Monitoring in Pediatric Pulmonary Vein Stenosis. Pediatric Cardiology. 2025"
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-22T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-22T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "APOTEX"
  },
  "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"
}
                        

25949781 Type 1

Serious

OZEMPIC

Report Version

1

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/18/2026

Primary Source Country

EU

Occurrence Country

EU

Reporter Country

EU

Reporter Qualification

Physician

Literature Reference

--

Company Number

EU-NOVOPROD-1541635

Authority Number

--

Sender Organization

NOVO NORDISK

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

--

Patient Age Group

Adult

Patient Sex

Male

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Colitis (v28.1) Unknown

Drugs (1)

OZEMPIC (SEMAGLUTIDE) Suspect

Route: -- | Dosage: UNK | Form: Solution for injection | Indication: Product used for unknown indication | Action: Withdrawn

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

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d4357b3b3830196fa546c8",
  "safetyreportid": "25949781",
  "authoritynumb": null,
  "companynumb": "EU-NOVOPROD-1541635",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": 5,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Colitis",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "OZEMPIC",
        "drugauthorizationnumb": "209637",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
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        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": "Solution for injection",
        "drugadministrationroute": null,
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
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        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "SEMAGLUTIDE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 1,
    "literaturereference": null
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-22T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-22T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "NOVO NORDISK"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 1,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 2,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25949782 Type 1

Non-Serious

DUPIXENT

Report Version

1

Receive Date

10/22/2025

Receipt Date

10/22/2025

Transmission Date

01/18/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Other Health Professional

Literature Reference

--

Company Number

US-SA-2025SA311501

Authority Number

--

Sender Organization

SANOFI AVENTIS

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

No

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

57.0 yr

Patient Age Group

Adult

Patient Sex

Male

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Rash macular (v28.1) Unknown

Pruritus (v28.1) Unknown

Skin burning sensation (v28.1) Unknown

Condition aggravated (v28.1) Unknown

Drugs (1)

DUPIXENT (DUPILUMAB) Suspect

Route: 058 | Dosage: 300 MG, QOW | Form: Solution for injection | Indication: Dermatitis atopic | Action: Unknown

Start: 08/01/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250901

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d4357b3b3830196fa546c9",
  "safetyreportid": "25949782",
  "authoritynumb": null,
  "companynumb": "US-SA-2025SA311501",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 57.0,
    "patientonsetageunit": 801,
    "patientagegroup": 5,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Rash macular",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Pruritus",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Skin burning sensation",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Condition aggravated",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "DUPIXENT",
        "drugauthorizationnumb": "761055",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 300.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 2.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "300 MG, QOW",
        "drugdosageform": "Solution for injection",
        "drugadministrationroute": "058",
        "drugindication": "Dermatitis atopic",
        "drugstartdateformat": "610",
        "drugstartdate": "2021-08-01T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "DUPILUMAB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250901"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 3,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-22T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-22T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "SANOFI AVENTIS"
  },
  "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"
}
                        