FDA FAERS Adverse Event Reports

111000

Total Reports

60668

Serious Reports

108

Reporter Countries

25940926 Type 1

Serious

ROPIVACAINE, ROPIVACAINE

Report Version

Receive Date

10/20/2025

Receipt Date

10/20/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Aknouche F, Maruejouls C, Trebuchet C, Fargeot K, Valancony C. Fatal overdose of ropivacaine during surgery. Toxicologie Analytique et Clinique. 2025;1-3. doi:10.1016/j.toxac.2025.09.002.

Company Number

EU-FreseniusKabi-FK202514127

Authority Number

Sender Organization

FRESENIUS KABI

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

69.0 yr

Patient Age Group

Elderly

Patient Sex

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Overdose (v28.1) Fatal

Pulmonary embolism (v28.1) Fatal

Arrhythmia (v28.1) Fatal

Drugs (2)

ROPIVACAINE (ROPIVACAINE) Suspect

Route: -- | Dosage: -- | Form: -- | Indication: Local anaesthesia | Action: Not Applicable

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

Recurrences: --

ROPIVACAINE (ROPIVACAINE) Suspect

Route: -- | Dosage: -- | Form: -- | Indication: Ankle operation | Action: Not Applicable

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d4354e3b3830196fa5222a",
  "safetyreportid": "25940926",
  "authoritynumb": null,
  "companynumb": "EU-FreseniusKabi-FK202514127",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": 69.0,
    "patientonsetageunit": 801,
    "patientagegroup": 6,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Overdose",
        "reactionoutcome": 5
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Pulmonary embolism",
        "reactionoutcome": 5
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Arrhythmia",
        "reactionoutcome": 5
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ROPIVACAINE",
        "drugauthorizationnumb": "020533",
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Local anaesthesia",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "ROPIVACAINE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ROPIVACAINE",
        "drugauthorizationnumb": "020533",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Ankle operation",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "ROPIVACAINE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 3,
    "literaturereference": "Aknouche F, Maruejouls C, Trebuchet C, Fargeot K, Valancony C. Fatal overdose of ropivacaine during surgery. Toxicologie Analytique et Clinique. 2025;1-3. doi:10.1016/j.toxac.2025.09.002."
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-20T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-20T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "FRESENIUS KABI"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 1,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25940927 Type 3

Serious

DEXAMETHASONE, POMALIDOMIDE, CYCLOPHOSPHAMIDE

Report Version

Receive Date

10/20/2025

Receipt Date

10/20/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Kim JS, Song Y, Jen W, Chim CS, Lee J, Yoon S, Ng SC, Gan GG, Handa H, Lee JH, Kim K, Ito S, Huang JS, Min CK, Ming MOG, de Mel S, Soekojo C, Li X, Awasthi N, Pokharkar Y, Durie BGM, Chng W. Randomized Phase 3 study of pomalidomide cyclophosphamide dexamethasone versus pomalidomide dexamethasone in relapse or refractory myeloma: an Asian Myeloma Network study (AMN003). Blood Cancer Journal. 2025;155(15): 1-9. doi:10.1038/s41408-025-01356-z.

Company Number

KR-Prasco Laboratories-PRAS20250359

Authority Number

Sender Organization

PRASCO

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

Patient Age Group

Patient Sex

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Infection (v28.1) Fatal

Drugs (3)

DEXAMETHASONE (DEXAMETHASONE) Suspect

Route: 048 | Dosage: 40 MG ONCE A WEEK | Form: -- | Indication: Plasma cell myeloma refractory | Action: Not Applicable

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

Recurrences: --

POMALIDOMIDE (POMALIDOMIDE) Suspect

Route: 048 | Dosage: DAYS 1-21 | Form: -- | Indication: Plasma cell myeloma refractory | Action: Not Applicable

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

Recurrences: --

CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) Suspect

Route: 048 | Dosage: 400 MG ONCE WEEKLY FOR THREE WEEKS ON DAYS 1, 8 AND 15 | Form: -- | Indication: Plasma cell myeloma refractory | Action: Not Applicable

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d4354e3b3830196fa5222b",
  "safetyreportid": "25940927",
  "authoritynumb": null,
  "companynumb": "KR-Prasco Laboratories-PRAS20250359",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "KR",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": null,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Infection",
        "reactionoutcome": 5
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "DEXAMETHASONE",
        "drugauthorizationnumb": "080399",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 40.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "40 MG ONCE A WEEK",
        "drugdosageform": null,
        "drugadministrationroute": "048",
        "drugindication": "Plasma cell myeloma refractory",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "DEXAMETHASONE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "POMALIDOMIDE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 4.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "DAYS 1-21",
        "drugdosageform": null,
        "drugadministrationroute": "048",
        "drugindication": "Plasma cell myeloma refractory",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "POMALIDOMIDE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CYCLOPHOSPHAMIDE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 400.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "400 MG ONCE WEEKLY FOR THREE WEEKS ON DAYS 1, 8 AND 15",
        "drugdosageform": null,
        "drugadministrationroute": "048",
        "drugindication": "Plasma cell myeloma refractory",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "CYCLOPHOSPHAMIDE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "KR",
    "qualification": 3,
    "literaturereference": "Kim JS, Song Y, Jen W, Chim CS, Lee J, Yoon S, Ng SC, Gan GG, Handa H, Lee JH, Kim K, Ito S, Huang JS, Min CK, Ming MOG, de Mel S, Soekojo C, Li X, Awasthi N, Pokharkar Y, Durie BGM, Chng W. Randomized Phase 3 study of pomalidomide cyclophosphamide dexamethasone versus pomalidomide dexamethasone in relapse or refractory myeloma: an Asian Myeloma Network study (AMN003). Blood Cancer Journal. 2025;155(15): 1-9. doi:10.1038/s41408-025-01356-z."
  },
  "primarysourcecountry": "KR",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-20T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-20T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 3,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "PRASCO"
  },
  "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"
}
                        

25940928 Type 1

Non-Serious

WIXELA INHUB

Report Version

Receive Date

10/20/2025

Receipt Date

10/20/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

US-MYLANLABS-2025M1085274

Authority Number

Sender Organization

MYLAN

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

Patient Age Group

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Inappropriate schedule of product administration (v28.1) Unknown

Circumstance or information capable of leading to medication error (v28.1) Unknown

Device issue (v28.1) Unknown

Drugs (1)

WIXELA INHUB (FLUTICASONE PROPIONATE\SALMETEROL XINAFOATE) Suspect

Route: -- | Dosage: 100/50 MICROGRAM, AM (1 PUFF IN MORNING) | Form: -- | Indication: Asthma | Action: Not Applicable

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d4354e3b3830196fa5222c",
  "safetyreportid": "25940928",
  "authoritynumb": null,
  "companynumb": "US-MYLANLABS-2025M1085274",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Inappropriate schedule of product administration",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Circumstance or information capable of leading to medication error",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Device issue",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "WIXELA INHUB",
        "drugauthorizationnumb": "208891",
        "drugbatchnumb": "62005445",
        "drugstructuredosagenumb": 100.0,
        "drugstructuredosageunit": "004",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "100/50 MICROGRAM, AM (1 PUFF IN MORNING)",
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Asthma",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "FLUTICASONE PROPIONATE\\SALMETEROL XINAFOATE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-20T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-20T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "MYLAN"
  },
  "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"
}
                        

25940925 Type 1

Serious

ICATIBANT ACETATE, ICATIBANT ACETATE

Report Version

Receive Date

10/20/2025

Receipt Date

10/20/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Other Health Professional

Literature Reference

Company Number

Authority Number

EU-AFSSAPS-PP2025001090

Sender Organization

TAKEDA

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

42.0 yr

Patient Age Group

Patient Sex

Female

Patient Weight

88.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Drug ineffective (v28.1) Not Recovered

Drugs (2)

ICATIBANT ACETATE (ICATIBANT ACETATE) Suspect

Route: -- | Dosage: UNK | Form: -- | Indication: Hereditary angioedema with normal C1 esterase inhibitor | Action: Unknown

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

Recurrences: --

ICATIBANT ACETATE (ICATIBANT ACETATE) Suspect

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

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20241213

Report Duplicates (1)

AFSSAPS: EU-AFSSAPS-PP2025001090

Raw JSON (click to expand)

                            {
  "_id": "69d4354e3b3830196fa52228",
  "safetyreportid": "25940925",
  "authoritynumb": "EU-AFSSAPS-PP2025001090",
  "companynumb": null,
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "EU",
  "patient": {
    "patientonsetage": 42.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": 88.0,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Drug ineffective",
        "reactionoutcome": 3
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ICATIBANT ACETATE",
        "drugauthorizationnumb": "22150",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Hereditary angioedema with normal C1 esterase inhibitor",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "ICATIBANT ACETATE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "ICATIBANT ACETATE",
        "drugauthorizationnumb": "22150",
        "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": 3,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "ICATIBANT ACETATE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20241213"
  },
  "primarysource": {
    "reportercountry": "EU",
    "qualification": 3,
    "literaturereference": null
  },
  "primarysourcecountry": "EU",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-20T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-20T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "AFSSAPS",
      "duplicatenumb": "EU-AFSSAPS-PP2025001090"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "TAKEDA"
  },
  "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"
}
                        

25940916 Type 1

Non-Serious

BREZTRI, SYMBICORT

Report Version

Receive Date

10/20/2025

Receipt Date

10/20/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

US-AstraZeneca-CH-00972065AP

Authority Number

Sender Organization

ALEXION PHARMACEUTICALS

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

Patient Age Group

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (7)

Device delivery system issue (v28.1) Unknown

Product use issue (v28.1) Unknown

Mood altered (v28.1) Unknown

Cough (v28.1) Unknown

Wheezing (v28.1) Unknown

Dyspnoea (v28.1) Unknown

Wrong technique in product usage process (v28.1) Unknown

Drugs (2)

BREZTRI (BUDESONIDE\FORMOTEROL\GLYCOPYRROLATE) Suspect

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

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

Recurrences: --

SYMBICORT (BUDESONIDE\FORMOTEROL FUMARATE DIHYDRATE) Suspect

Route: 065 | Dosage: -- | Form: -- | Indication: -- | Action: Withdrawn

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d4354e3b3830196fa52220",
  "safetyreportid": "25940916",
  "authoritynumb": null,
  "companynumb": "US-AstraZeneca-CH-00972065AP",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Device delivery system issue",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Product use issue",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Mood altered",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Cough",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Wheezing",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dyspnoea",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Wrong technique in product usage process",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "BREZTRI",
        "drugauthorizationnumb": "212122",
        "drugbatchnumb": "6103790B00",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "BUDESONIDE\\FORMOTEROL\\GLYCOPYRROLATE"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "SYMBICORT",
        "drugauthorizationnumb": "21929",
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": null,
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": null,
        "actiondrug": 1,
        "activesubstance": {
          "activesubstancename": "BUDESONIDE\\FORMOTEROL FUMARATE DIHYDRATE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-20T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-20T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ALEXION PHARMACEUTICALS"
  },
  "serious": 2,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 2,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25940918 Type 2

Serious

VEDOLIZUMAB, VEDOLIZUMAB

Report Version

Receive Date

10/20/2025

Receipt Date

10/20/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

GB-TAKEDA-2025TUS091298

Authority Number

Sender Organization

TAKEDA

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

78.0 yr

Patient Age Group

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Colitis ulcerative (v28.1) Unknown

Drug ineffective (v28.1) Unknown

Influenza like illness (v28.1) Unknown

Drugs (2)

VEDOLIZUMAB (VEDOLIZUMAB) Suspect

Route: -- | Dosage: 108 MILLIGRAM, Q2WEEKS | Form: Solution for injection | Indication: Colitis ulcerative | Action: Dose Not Changed

Start: 09/30/2025 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --

Recurrences: --

VEDOLIZUMAB (VEDOLIZUMAB) Suspect

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

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d4354e3b3830196fa5221f",
  "safetyreportid": "25940918",
  "authoritynumb": null,
  "companynumb": "GB-TAKEDA-2025TUS091298",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "GB",
  "patient": {
    "patientonsetage": 78.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Colitis ulcerative",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Drug ineffective",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Influenza like illness",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "VEDOLIZUMAB",
        "drugauthorizationnumb": "125476",
        "drugbatchnumb": "12910418",
        "drugstructuredosagenumb": 108.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 2.0,
        "drugintervaldosagedefinition": 803,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "108 MILLIGRAM, Q2WEEKS",
        "drugdosageform": "Solution for injection",
        "drugadministrationroute": null,
        "drugindication": "Colitis ulcerative",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-09-30T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "VEDOLIZUMAB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "VEDOLIZUMAB",
        "drugauthorizationnumb": "125476",
        "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": 3,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "VEDOLIZUMAB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "GB",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "GB",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-20T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-20T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 2,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "TAKEDA"
  },
  "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"
}
                        

25940915 Type 2

Serious

MEPOLIZUMAB

Report Version

Receive Date

10/20/2025

Receipt Date

10/20/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Physician

Literature Reference

Company Number

US-GSK-US2025135029

Authority Number

Sender Organization

GLAXOSMITHKLINE

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

Patient Age Group

Patient Sex

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Death (v28.1) Fatal

Drugs (1)

MEPOLIZUMAB (MEPOLIZUMAB) Suspect

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

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d4354e3b3830196fa5221c",
  "safetyreportid": "25940915",
  "authoritynumb": null,
  "companynumb": "US-GSK-US2025135029",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Death",
        "reactionoutcome": 5
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "MEPOLIZUMAB",
        "drugauthorizationnumb": "125526",
        "drugbatchnumb": "UNK",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": null,
        "drugadministrationroute": null,
        "drugindication": "Product used for unknown indication",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "MEPOLIZUMAB"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 1,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-20T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-20T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 2,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "GLAXOSMITHKLINE"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 1,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25940913 Type 1

Non-Serious

VENTOLIN HFA

Report Version

Receive Date

10/20/2025

Receipt Date

10/20/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

US-GSK-US2025123374

Authority Number

Sender Organization

GLAXOSMITHKLINE

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

Patient Age Group

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Wrong technique in device usage process (v28.1) Unknown

Drugs (1)

VENTOLIN HFA (ALBUTEROL SULFATE) Suspect

Route: -- | Dosage: UNK | Form: Inhaler | Indication: Asthma | Action: Dose Not Changed

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

Recurrences: --

Clinical Narrative

Report Duplicates (0)

Raw JSON (click to expand)

                            {
  "_id": "69d4354e3b3830196fa5221d",
  "safetyreportid": "25940913",
  "authoritynumb": null,
  "companynumb": "US-GSK-US2025123374",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Wrong technique in device usage process",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "VENTOLIN HFA",
        "drugauthorizationnumb": "020983",
        "drugbatchnumb": "UNK",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": "Inhaler",
        "drugadministrationroute": null,
        "drugindication": "Asthma",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "ALBUTEROL SULFATE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-20T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-20T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "GLAXOSMITHKLINE"
  },
  "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"
}
                        

25940911 Type 1

Serious

YESCARTA

Report Version

Receive Date

10/20/2025

Receipt Date

10/20/2025

Transmission Date

01/18/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

US-GILEAD-2025-0732351

Authority Number

Sender Organization

GILEAD

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

60.0 yr

Patient Age Group

Adult

Patient Sex

Male

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Mental impairment (v28.1) Unknown

Drugs (1)

YESCARTA (AXICABTAGENE CILOLEUCEL) Suspect

Route: 065 | Dosage: UNK | Form: Suspension | 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": "69d4354e3b3830196fa52219",
  "safetyreportid": "25940911",
  "authoritynumb": null,
  "companynumb": "US-GILEAD-2025-0732351",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 60.0,
    "patientonsetageunit": 801,
    "patientagegroup": 5,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Mental impairment",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "YESCARTA",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "Unknown",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": "Suspension",
        "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": "AXICABTAGENE CILOLEUCEL"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-20T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-20T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "GILEAD"
  },
  "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"
}
                        

25940886 Type 1

Serious

TYMLOS, TOPAMAX, PREDNISONE (+18 more)

Report Version

Receive Date

10/20/2025

Receipt Date

10/20/2025

Transmission Date

01/17/2026

Primary Source Country

Occurrence Country

Reporter Country

Reporter Qualification

Consumer

Literature Reference

Company Number

US-RADIUS HEALTH INC.-US-RADIUS-25054732

Authority Number

Sender Organization

RADIUS PHARM

Sender Type

Receiver Organization

FDA

Receiver Type

Expedite Criteria

Yes

Duplicate

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

Patient Age Group

Patient Sex

Female

Patient Weight

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Neoplasm malignant (v28.1) Recovered

Product use in unapproved indication (v28.1) Unknown

Drugs (21)

TYMLOS (ABALOPARATIDE) Suspect

Route: 065 | Dosage: 3120MCG 1.56ML | Form: Sub-cutaneous injection | Indication: Type V hyperlipidaemia | Action: Withdrawn

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

Recurrences: --

TOPAMAX (TOPIRAMATE) Concomitant

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