FDA FAERS Adverse Event Reports

25945431 Type 1

Non-Serious

SERTRALINE

Report Version

1

Receive Date

10/21/2025

Receipt Date

10/21/2025

Transmission Date

01/18/2026

Primary Source Country

US

Occurrence Country

--

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

--

Authority Number

782905

Sender Organization

FDA-CTU

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

3

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)

Treatment failure (v28.1) --

Drugs (1)

SERTRALINE (SERTRALINE HYDROCHLORIDE) Suspect

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

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

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435653b3830196fa53525",
  "safetyreportid": "25945431",
  "authoritynumb": "782905",
  "companynumb": null,
  "duplicate": null,
  "fulfillexpeditecriteria": 3,
  "occurcountry": null,
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": null,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Treatment failure",
        "reactionoutcome": null
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "SERTRALINE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "SERTRALINE HYDROCHLORIDE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-21T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-21T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "FDA-CTU"
  },
  "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"
}
                        

25945429 Type 1

Serious

ABILIFY, ABILIFY, DIVALPROEX SODIUM

Report Version

1

Receive Date

10/21/2025

Receipt Date

10/21/2025

Transmission Date

01/18/2026

Primary Source Country

CA

Occurrence Country

CA

Reporter Country

CA

Reporter Qualification

Consumer

Literature Reference

--

Company Number

CA-MMM-Otsuka-ZTAY074J

Authority Number

--

Sender Organization

OTSUKA

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

1

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

38.0 yr

Patient Age Group

--

Patient Sex

Female

Patient Weight

27.21 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (18)

Arrhythmia (v28.1) Unknown

Loss of consciousness (v28.1) Recovering

Tardive dyskinesia (v28.1) Unknown

Neuroleptic malignant syndrome (v28.1) Unknown

Mental disorder (v28.1) Unknown

Confusional state (v28.1) Unknown

Heart rate increased (v28.1) Unknown

Malaise (v28.1) Unknown

Aggression (v28.1) Unknown

Body temperature increased (v28.1) Unknown

Jaundice (v28.1) Unknown

Gambling disorder (v28.1) Unknown

Hyperhidrosis (v28.1) Unknown

Weight increased (v28.1) Unknown

Drug interaction (v28.1) Unknown

Therapy interrupted (v28.1) Unknown

Overdose (v28.1) Unknown

Contraindicated product administered (v28.1) Unknown

Drugs (3)

ABILIFY (ARIPIPRAZOLE) Interacting

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

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

Recurrences: --

ABILIFY (ARIPIPRAZOLE) Interacting

Route: 065 | Dosage: 20 MG | Form: -- | Indication: -- | Action: Unknown

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

Recurrences: --

DIVALPROEX SODIUM (DIVALPROEX SODIUM) Interacting

Route: 065 | Dosage: 1500 MG, DAILY (THREE RED PILLS, EACH 500 MG) | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

Clinical Narrative

--

Report Duplicates (2)

MMM: CA-MMM-Otsuka-ZTAY074J

Raw JSON (click to expand)

                            {
  "_id": "69d435653b3830196fa53523",
  "safetyreportid": "25945429",
  "authoritynumb": null,
  "companynumb": "CA-MMM-Otsuka-ZTAY074J",
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "CA",
  "patient": {
    "patientonsetage": 38.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": 27.21,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Arrhythmia",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Loss of consciousness",
        "reactionoutcome": 2
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Tardive dyskinesia",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Neuroleptic malignant syndrome",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Mental disorder",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Confusional state",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Heart rate increased",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Malaise",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Aggression",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Body temperature increased",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Jaundice",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Gambling disorder",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Hyperhidrosis",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Weight increased",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Drug interaction",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Therapy interrupted",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Overdose",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Contraindicated product administered",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 3,
        "medicinalproduct": "ABILIFY",
        "drugauthorizationnumb": "021436",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": "Schizophrenia",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "ARIPIPRAZOLE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 3,
        "medicinalproduct": "ABILIFY",
        "drugauthorizationnumb": "021436",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 20.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "20 MG",
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "ARIPIPRAZOLE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 3,
        "medicinalproduct": "DIVALPROEX SODIUM",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 1500.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "1500 MG, DAILY (THREE RED PILLS, EACH 500 MG)",
        "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": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "DIVALPROEX SODIUM"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "CA",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "CA",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-21T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-21T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "MMM",
      "duplicatenumb": "CA-MMM-Otsuka-ZTAY074J"
    },
    {
      "duplicatesource": "MMM",
      "duplicatenumb": "CA-MMM-Otsuka-ZTAY074J"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "OTSUKA"
  },
  "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"
}
                        

25945426 Type 1

Non-Serious

REPATHA

Report Version

1

Receive Date

10/21/2025

Receipt Date

10/21/2025

Transmission Date

01/17/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-AMGEN-USASP2025203413

Authority Number

--

Sender Organization

AMGEN

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

No

Duplicate

1

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

76.0 yr

Patient Age Group

Elderly

Patient Sex

Female

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Injury associated with device (v28.1) Unknown

Device use error (v28.1) Unknown

Drug dose omission by device (v28.1) Unknown

Drugs (1)

REPATHA (EVOLOCUMAB) Suspect

Route: 058 | Dosage: 140 MILLIGRAM, Q2WK | Form: Solution for injection | Indication: Type IIa hyperlipidaemia | Action: Dose Not Changed

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251012

Report Duplicates (1)

AMGEN INC: US-AMGEN INC-25-0283845-SR-01

Raw JSON (click to expand)

                            {
  "_id": "69d435653b3830196fa5351f",
  "safetyreportid": "25945426",
  "authoritynumb": null,
  "companynumb": "US-AMGEN-USASP2025203413",
  "duplicate": 1,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 76.0,
    "patientonsetageunit": 801,
    "patientagegroup": 6,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Injury associated with device",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Device use error",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Drug dose omission by device",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "REPATHA",
        "drugauthorizationnumb": "125522",
        "drugbatchnumb": "1191042",
        "drugstructuredosagenumb": 140.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 2.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "140 MILLIGRAM, Q2WK",
        "drugdosageform": "Solution for injection",
        "drugadministrationroute": "058",
        "drugindication": "Type IIa hyperlipidaemia",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "EVOLOCUMAB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251012"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-21T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-21T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "AMGEN INC",
      "duplicatenumb": "US-AMGEN INC-25-0283845-SR-01"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "AMGEN"
  },
  "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"
}
                        

25945428 Type 1

Serious

LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

Report Version

1

Receive Date

10/21/2025

Receipt Date

10/21/2025

Transmission Date

01/19/2026

Primary Source Country

EU

Occurrence Country

EU

Reporter Country

EU

Reporter Qualification

Other Health Professional

Literature Reference

Moser J. Talazoparib plus Enzalutamid beim mCRPC PARPi/ARPi-Kombination mit Uberlebensvorteil [Talazoparib plus enzalutamide in mCRPC PARPi/ARPi combination with survival advantage]. CONGRESS. 2025;68-70

Company Number

EU-002147023-NVSC2025AT159426

Authority Number

--

Sender Organization

NOVARTIS

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

58.0 yr

Patient Age Group

--

Patient Sex

Male

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

TP53 gene mutation (v28.1) Unknown

Gene mutation (v28.1) Unknown

Pain (v28.1) Unknown

General physical health deterioration (v28.1) Unknown

Gait disturbance (v28.1) Unknown

Drugs (1)

LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) Suspect

Route: 065 | Dosage: UNK, CYCLIC (SIX CYCLE) | Form: Solution for injection/infusion | Indication: Prostate cancer | Action: Unknown

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

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435653b3830196fa53520",
  "safetyreportid": "25945428",
  "authoritynumb": null,
  "companynumb": "EU-002147023-NVSC2025AT159426",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": 58.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "TP53 gene mutation",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Gene mutation",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Pain",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "General physical health deterioration",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Gait disturbance",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN",
        "drugauthorizationnumb": "215833",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK, CYCLIC (SIX CYCLE)",
        "drugdosageform": "Solution for injection/infusion",
        "drugadministrationroute": "065",
        "drugindication": "Prostate cancer",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 3,
    "literaturereference": "Moser J. Talazoparib plus Enzalutamid beim mCRPC PARPi/ARPi-Kombination mit Uberlebensvorteil [Talazoparib plus enzalutamide in mCRPC PARPi/ARPi combination with survival advantage]. CONGRESS. 2025;68-70"
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-21T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-21T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "NOVARTIS"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-19T00:00:00",
  "transmissiondateformat": "102"
}
                        

25945418 Type 1

Non-Serious

ZEPBOUND

Report Version

1

Receive Date

10/21/2025

Receipt Date

10/21/2025

Transmission Date

01/18/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-ELI_LILLY_AND_COMPANY-US202510012215

Authority Number

--

Sender Organization

ELI LILLY AND COMPANY

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

No

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

71.0 yr

Patient Age Group

Elderly

Patient Sex

Female

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (9)

Headache (v28.1) Recovered

Rhinorrhoea (v28.1) Unknown

Thirst (v28.1) Unknown

Postmenopausal haemorrhage (v28.1) Unknown

Vaginal discharge (v28.1) Unknown

Muscle strain (v28.1) Unknown

Dry mouth (v28.1) Unknown

Abdominal pain lower (v28.1) Unknown

Dizziness (v28.1) Unknown

Drugs (1)

ZEPBOUND (TIRZEPATIDE) Suspect

Route: 065 | Dosage: 2.5 MG, UNKNOWN | Form: Solution for injection | Indication: Weight control | Action: Unknown

Start: 09/24/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251005

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435653b3830196fa53519",
  "safetyreportid": "25945418",
  "authoritynumb": null,
  "companynumb": "US-ELI_LILLY_AND_COMPANY-US202510012215",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 71.0,
    "patientonsetageunit": 801,
    "patientagegroup": 6,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Headache",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Rhinorrhoea",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Thirst",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Postmenopausal haemorrhage",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Vaginal discharge",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Muscle strain",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dry mouth",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Abdominal pain lower",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dizziness",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ZEPBOUND",
        "drugauthorizationnumb": "215866",
        "drugbatchnumb": "2172155",
        "drugstructuredosagenumb": 2.5,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "2.5 MG, UNKNOWN",
        "drugdosageform": "Solution for injection",
        "drugadministrationroute": "065",
        "drugindication": "Weight control",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-09-24T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "TIRZEPATIDE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251005"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-21T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-21T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ELI LILLY AND COMPANY"
  },
  "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"
}
                        

25945421 Type 1

Serious

MOUNJARO

Report Version

1

Receive Date

10/21/2025

Receipt Date

10/21/2025

Transmission Date

01/18/2026

Primary Source Country

GB

Occurrence Country

GB

Reporter Country

GB

Reporter Qualification

Consumer

Literature Reference

--

Company Number

--

Authority Number

GB-MHRA-MED-202510151253539560-DQYZV

Sender Organization

ELI LILLY AND COMPANY

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

1

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

--

Patient Age Group

--

Patient Sex

Male

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Nephrolithiasis (v28.1) Not Recovered

Drugs (1)

MOUNJARO (TIRZEPATIDE) Suspect

Route: 065 | Dosage: UNK UNK, UNKNOWN | Form: -- | Indication: Product used for unknown indication | Action: Unknown

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

Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

MHRA: GB-MHRA-MED-202510151253539560-DQYZV

Raw JSON (click to expand)

                            {
  "_id": "69d435653b3830196fa5351c",
  "safetyreportid": "25945421",
  "authoritynumb": "GB-MHRA-MED-202510151253539560-DQYZV",
  "companynumb": null,
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "GB",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Nephrolithiasis",
        "reactionoutcome": 3
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "MOUNJARO",
        "drugauthorizationnumb": "215866",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK UNK, UNKNOWN",
        "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": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "TIRZEPATIDE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "GB",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "GB",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-21T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-21T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "MHRA",
      "duplicatenumb": "GB-MHRA-MED-202510151253539560-DQYZV"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ELI LILLY AND COMPANY"
  },
  "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"
}
                        

25945419 Type 1

Serious

TIRZEPATIDE, TIRZEPATIDE, METAMIZOLE

Report Version

1

Receive Date

10/21/2025

Receipt Date

10/21/2025

Transmission Date

01/17/2026

Primary Source Country

EU

Occurrence Country

EU

Reporter Country

EU

Reporter Qualification

Consumer

Literature Reference

--

Company Number

--

Authority Number

EU-CADRBFARM-2025339008

Sender Organization

ELI LILLY AND COMPANY

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

1

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

45.0 yr

Patient Age Group

Adult

Patient Sex

Female

Patient Weight

61.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Leukopenia (v28.1) Not Recovered

Drugs (3)

TIRZEPATIDE (TIRZEPATIDE) Suspect

Route: 058 | Dosage: 5 MG, UNKNOWN | Form: -- | Indication: Obesity | Action: Unknown

Start: 09/25/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown

Recurrences: --

TIRZEPATIDE (TIRZEPATIDE) Suspect

Route: 058 | Dosage: 5 MG, UNKNOWN | Form: -- | Indication: Obesity | Action: Unknown

Start: 09/25/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown

Recurrences: --

METAMIZOLE (METAMIZOLE) Concomitant

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

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250326

Report Duplicates (2)

BFARM: EU-BFARM-25007172

CADRBFARM: EU-CADRBFARM-2025339008

Raw JSON (click to expand)

                            {
  "_id": "69d435653b3830196fa5351a",
  "safetyreportid": "25945419",
  "authoritynumb": "EU-CADRBFARM-2025339008",
  "companynumb": null,
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": 45.0,
    "patientonsetageunit": 801,
    "patientagegroup": 5,
    "patientweight": 61.0,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Leukopenia",
        "reactionoutcome": 3
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "TIRZEPATIDE",
        "drugauthorizationnumb": "215866",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 5.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "5 MG, UNKNOWN",
        "drugdosageform": null,
        "drugadministrationroute": "058",
        "drugindication": "Obesity",
        "drugstartdateformat": "102",
        "drugstartdate": "2024-09-25T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "TIRZEPATIDE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "TIRZEPATIDE",
        "drugauthorizationnumb": "215866",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 5.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "5 MG, UNKNOWN",
        "drugdosageform": null,
        "drugadministrationroute": "058",
        "drugindication": "Obesity",
        "drugstartdateformat": "102",
        "drugstartdate": "2024-09-25T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "TIRZEPATIDE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "METAMIZOLE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK UNK, PRN",
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": null,
        "activesubstance": {
          "activesubstancename": "METAMIZOLE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250326"
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-21T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-21T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "BFARM",
      "duplicatenumb": "EU-BFARM-25007172"
    },
    {
      "duplicatesource": "CADRBFARM",
      "duplicatenumb": "EU-CADRBFARM-2025339008"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ELI LILLY AND COMPANY"
  },
  "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"
}
                        

25945425 Type 2

Serious

ENHERTU

Report Version

1

Receive Date

10/21/2025

Receipt Date

10/21/2025

Transmission Date

01/18/2026

Primary Source Country

MY

Occurrence Country

MY

Reporter Country

MY

Reporter Qualification

Pharmacist

Literature Reference

--

Company Number

MY-AstraZeneca-CH-00973518A

Authority Number

--

Sender Organization

DAIICHI

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

1

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

--

Patient Age Group

Adult

Patient Sex

Female

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Death (v28.1) Fatal

Drugs (1)

ENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) Suspect

Route: 042 | Dosage: 200 MG | Form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | Indication: HER2 positive breast cancer | Action: Unknown

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

Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

ASTRAZENECA: MY-ASTRAZENECA-202510ASI014878MY

Raw JSON (click to expand)

                            {
  "_id": "69d435653b3830196fa5351e",
  "safetyreportid": "25945425",
  "authoritynumb": null,
  "companynumb": "MY-AstraZeneca-CH-00973518A",
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "MY",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": 5,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Death",
        "reactionoutcome": 5
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ENHERTU",
        "drugauthorizationnumb": "761139",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 200.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "200 MG",
        "drugdosageform": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
        "drugadministrationroute": "042",
        "drugindication": "HER2 positive breast cancer",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "FAM-TRASTUZUMAB DERUXTECAN-NXKI"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "MY",
    "qualification": 2,
    "literaturereference": null
  },
  "primarysourcecountry": "MY",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-21T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-21T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "ASTRAZENECA",
      "duplicatenumb": "MY-ASTRAZENECA-202510ASI014878MY"
    }
  ],
  "reporttype": 2,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "DAIICHI"
  },
  "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"
}
                        

25945427 Type 2

Serious

RINVOQ

Report Version

1

Receive Date

10/21/2025

Receipt Date

10/21/2025

Transmission Date

01/17/2026

Primary Source Country

GB

Occurrence Country

GB

Reporter Country

GB

Reporter Qualification

Consumer

Literature Reference

--

Company Number

GB-ABBVIE-6508839

Authority Number

--

Sender Organization

ABBVIE

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

Elderly

Patient Sex

Male

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Knee operation (v28.1) Unknown

Drugs (1)

RINVOQ (UPADACITINIB) Suspect

Route: 048 | Dosage: -- | Form: Tablet | Indication: Rheumatoid arthritis | Action: Withdrawn

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

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435653b3830196fa53522",
  "safetyreportid": "25945427",
  "authoritynumb": null,
  "companynumb": "GB-ABBVIE-6508839",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "GB",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": 6,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Knee operation",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "RINVOQ",
        "drugauthorizationnumb": "211675",
        "drugbatchnumb": "Not Available",
        "drugstructuredosagenumb": 15.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Tablet",
        "drugadministrationroute": "048",
        "drugindication": "Rheumatoid arthritis",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "UPADACITINIB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "GB",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "GB",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-21T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-21T00:00:00",
  "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": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25945416 Type 1

Serious

TRULICITY

Report Version

1

Receive Date

10/21/2025

Receipt Date

10/21/2025

Transmission Date

01/17/2026

Primary Source Country

EU

Occurrence Country

EU

Reporter Country

EU

Reporter Qualification

Consumer

Literature Reference

--

Company Number

--

Authority Number

EU-AFSSAPS-BX2025001572

Sender Organization

ELI LILLY AND COMPANY

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

1

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

56.0 yr

Patient Age Group

Adult

Patient Sex

Male

Patient Weight

105.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Glaucoma (v28.1) Recovering

Drugs (1)

TRULICITY (DULAGLUTIDE) Suspect

Route: 058 | Dosage: 1.5 MG, UNKNOWN | Form: Solution for injection in pre-filled pen | Indication: Diabetes mellitus | Action: Withdrawn

Start: 07/03/2025 | End: 09/04/2025 | Duration: 63.0 day | Rechallenge: Unknown | Additional: Yes

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250904

Report Duplicates (1)

AFSSAPS: EU-AFSSAPS-BX2025001572

Raw JSON (click to expand)

                            {
  "_id": "69d435653b3830196fa53518",
  "safetyreportid": "25945416",
  "authoritynumb": "EU-AFSSAPS-BX2025001572",
  "companynumb": null,
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": 56.0,
    "patientonsetageunit": 801,
    "patientagegroup": 5,
    "patientweight": 105.0,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Glaucoma",
        "reactionoutcome": 2
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "TRULICITY",
        "drugauthorizationnumb": "125469",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 1.5,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "1.5 MG, UNKNOWN",
        "drugdosageform": "Solution for injection in pre-filled pen",
        "drugadministrationroute": "058",
        "drugindication": "Diabetes mellitus",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-07-03T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-09-04T00:00:00",
        "drugtreatmentduration": 63.0,
        "drugtreatmentdurationunit": 804,
        "drugrecurreadministration": 3,
        "drugadditional": 1,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "DULAGLUTIDE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250904"
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-21T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-21T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "AFSSAPS",
      "duplicatenumb": "EU-AFSSAPS-BX2025001572"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ELI LILLY AND COMPANY"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 1,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 2,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        