FDA FAERS Adverse Event Reports

25959617 Type 1

Non-Serious

FILSPARI

Report Version

1

Receive Date

10/26/2025

Receipt Date

10/26/2025

Transmission Date

01/17/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-TRAVERE-2025TVT01743

Authority Number

--

Sender Organization

TRAVERE THERAPEUTICS

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

No

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

--

Patient Age Group

--

Patient Sex

Female

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Nausea (v28.1) Recovered

Dizziness (v28.1) Recovered

Drugs (1)

FILSPARI (SPARSENTAN) Suspect

Route: 048 | Dosage: -- | Form: Tablet | Indication: IgA nephropathy | Action: Dose Not Changed

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

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435aa3b3830196fa5703c",
  "safetyreportid": "25959617",
  "authoritynumb": null,
  "companynumb": "US-TRAVERE-2025TVT01743",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Nausea",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dizziness",
        "reactionoutcome": 1
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "FILSPARI",
        "drugauthorizationnumb": "216403",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 200.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Tablet",
        "drugadministrationroute": "048",
        "drugindication": "IgA nephropathy",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": null,
        "actiondrug": 4,
        "activesubstance": {
          "activesubstancename": "SPARSENTAN"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-26T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-26T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "TRAVERE THERAPEUTICS"
  },
  "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"
}
                        

25959615 Type 1

Serious

SIMVASTATIN

Report Version

1

Receive Date

10/26/2025

Receipt Date

10/26/2025

Transmission Date

01/18/2026

Primary Source Country

CA

Occurrence Country

--

Reporter Country

CA

Reporter Qualification

Other Health Professional

Literature Reference

Unknown. Unknown. Unknown

Company Number

CA-ORGANON-O2510CAN001758

Authority Number

--

Sender Organization

ORGANON

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

64.0 yr

Patient Age Group

--

Patient Sex

Male

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Chronic lymphocytic leukaemia (v28.1) Unknown

Drugs (1)

SIMVASTATIN (SIMVASTATIN) Suspect

Route: 065 | Dosage: UNK | Form: -- | Indication: Low density lipoprotein increased | Action: Unknown

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

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435aa3b3830196fa5703b",
  "safetyreportid": "25959615",
  "authoritynumb": null,
  "companynumb": "CA-ORGANON-O2510CAN001758",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": null,
  "patient": {
    "patientonsetage": 64.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Chronic lymphocytic leukaemia",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "SIMVASTATIN",
        "drugauthorizationnumb": "19766",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": "Low density lipoprotein increased",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "SIMVASTATIN"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "CA",
    "qualification": 3,
    "literaturereference": "Unknown. Unknown. Unknown"
  },
  "primarysourcecountry": "CA",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-26T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-26T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ORGANON"
  },
  "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"
}
                        

25959613 Type 1

Serious

SIMVASTATIN

Report Version

1

Receive Date

10/26/2025

Receipt Date

10/26/2025

Transmission Date

01/17/2026

Primary Source Country

CA

Occurrence Country

--

Reporter Country

CA

Reporter Qualification

Other Health Professional

Literature Reference

Unknown. Unknown. Unknown

Company Number

CA-ORGANON-O2510CAN001714

Authority Number

--

Sender Organization

ORGANON

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

84.0 yr

Patient Age Group

--

Patient Sex

Female

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Chronic lymphocytic leukaemia (v28.1) Unknown

Drugs (1)

SIMVASTATIN (SIMVASTATIN) Suspect

Route: 065 | Dosage: UNK | Form: -- | Indication: Low density lipoprotein increased | Action: Unknown

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

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435aa3b3830196fa5703a",
  "safetyreportid": "25959613",
  "authoritynumb": null,
  "companynumb": "CA-ORGANON-O2510CAN001714",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": null,
  "patient": {
    "patientonsetage": 84.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Chronic lymphocytic leukaemia",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "SIMVASTATIN",
        "drugauthorizationnumb": "19766",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": "Low density lipoprotein increased",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "SIMVASTATIN"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "CA",
    "qualification": 3,
    "literaturereference": "Unknown. Unknown. Unknown"
  },
  "primarysourcecountry": "CA",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-26T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-26T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ORGANON"
  },
  "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"
}
                        

25959614 Type 1

Serious

SIMVASTATIN

Report Version

1

Receive Date

10/26/2025

Receipt Date

10/26/2025

Transmission Date

01/17/2026

Primary Source Country

CA

Occurrence Country

--

Reporter Country

CA

Reporter Qualification

Other Health Professional

Literature Reference

Unknown. Unknown. Unknown

Company Number

CA-ORGANON-O2510CAN001707

Authority Number

--

Sender Organization

ORGANON

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

66.0 yr

Patient Age Group

--

Patient Sex

Male

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Chronic lymphocytic leukaemia (v28.1) Unknown

Drugs (1)

SIMVASTATIN (SIMVASTATIN) Suspect

Route: 065 | Dosage: UNK | Form: -- | Indication: Low density lipoprotein increased | Action: Unknown

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

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435aa3b3830196fa57039",
  "safetyreportid": "25959614",
  "authoritynumb": null,
  "companynumb": "CA-ORGANON-O2510CAN001707",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": null,
  "patient": {
    "patientonsetage": 66.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Chronic lymphocytic leukaemia",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "SIMVASTATIN",
        "drugauthorizationnumb": "19766",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": "Low density lipoprotein increased",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "SIMVASTATIN"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "CA",
    "qualification": 3,
    "literaturereference": "Unknown. Unknown. Unknown"
  },
  "primarysourcecountry": "CA",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-26T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-26T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ORGANON"
  },
  "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"
}
                        

25959612 Type 3

Non-Serious

FILSPARI, FAMOTIDINE

Report Version

1

Receive Date

10/26/2025

Receipt Date

10/26/2025

Transmission Date

01/18/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-TRAVERE-2025TVT01726

Authority Number

--

Sender Organization

TRAVERE THERAPEUTICS

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

No

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

43.0 yr

Patient Age Group

Adult

Patient Sex

Female

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Somnolence (v28.1) Recovered

Fatigue (v28.1) Recovered

Drugs (2)

FILSPARI (SPARSENTAN) Suspect

Route: 048 | Dosage: -- | Form: Tablet | Indication: IgA nephropathy | Action: Unknown

Start: 09/18/2025 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown

Recurrences: --

FAMOTIDINE (FAMOTIDINE) Concomitant

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

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

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250918

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435aa3b3830196fa57036",
  "safetyreportid": "25959612",
  "authoritynumb": null,
  "companynumb": "US-TRAVERE-2025TVT01726",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 43.0,
    "patientonsetageunit": 801,
    "patientagegroup": 5,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Somnolence",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Fatigue",
        "reactionoutcome": 1
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "FILSPARI",
        "drugauthorizationnumb": "216403",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 200.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Tablet",
        "drugadministrationroute": "048",
        "drugindication": "IgA nephropathy",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-09-18T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "SPARSENTAN"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 2,
        "medicinalproduct": "FAMOTIDINE",
        "drugauthorizationnumb": null,
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 0.5,
        "drugintervaldosagedefinition": 804,
        "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": "FAMOTIDINE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250918"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-26T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-26T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 3,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "TRAVERE THERAPEUTICS"
  },
  "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"
}
                        

25959611 Type 1

Non-Serious

FILSPARI

Report Version

1

Receive Date

10/26/2025

Receipt Date

10/26/2025

Transmission Date

01/17/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-TRAVERE-2025TVT01731

Authority Number

--

Sender Organization

TRAVERE THERAPEUTICS

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

No

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

53.0 yr

Patient Age Group

Adult

Patient Sex

Female

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Chromaturia (v28.1) --

Drugs (1)

FILSPARI (SPARSENTAN) Suspect

Route: 048 | Dosage: -- | Form: Tablet | Indication: IgA nephropathy | Action: Unknown

Start: 05/21/2025 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250920

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435aa3b3830196fa57035",
  "safetyreportid": "25959611",
  "authoritynumb": null,
  "companynumb": "US-TRAVERE-2025TVT01731",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 53.0,
    "patientonsetageunit": 801,
    "patientagegroup": 5,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Chromaturia",
        "reactionoutcome": null
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "FILSPARI",
        "drugauthorizationnumb": "216403",
        "drugbatchnumb": "1979025",
        "drugstructuredosagenumb": 400.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Tablet",
        "drugadministrationroute": "048",
        "drugindication": "IgA nephropathy",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-05-21T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "SPARSENTAN"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250920"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-26T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-26T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "TRAVERE THERAPEUTICS"
  },
  "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"
}
                        

25959609 Type 1

Non-Serious

FILSPARI

Report Version

1

Receive Date

10/26/2025

Receipt Date

10/26/2025

Transmission Date

01/17/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-TRAVERE-2025TVT01732

Authority Number

--

Sender Organization

TRAVERE THERAPEUTICS

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

No

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

--

Patient Age Group

--

Patient Sex

Female

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Kidney infection (v28.1) Unknown

Drugs (1)

FILSPARI (SPARSENTAN) Suspect

Route: 048 | Dosage: -- | Form: Tablet | Indication: IgA nephropathy | Action: Unknown

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

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435aa3b3830196fa57034",
  "safetyreportid": "25959609",
  "authoritynumb": null,
  "companynumb": "US-TRAVERE-2025TVT01732",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Kidney infection",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "FILSPARI",
        "drugauthorizationnumb": "216403",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 400.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Tablet",
        "drugadministrationroute": "048",
        "drugindication": "IgA nephropathy",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "SPARSENTAN"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-26T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-26T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "TRAVERE THERAPEUTICS"
  },
  "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"
}
                        

25959605 Type 1

Serious

SIMVASTATIN

Report Version

1

Receive Date

10/26/2025

Receipt Date

10/26/2025

Transmission Date

01/19/2026

Primary Source Country

CA

Occurrence Country

--

Reporter Country

CA

Reporter Qualification

Other Health Professional

Literature Reference

Unknown. Unknown. Unknown

Company Number

CA-ORGANON-O2510CAN001745

Authority Number

--

Sender Organization

ORGANON

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

68.0 yr

Patient Age Group

--

Patient Sex

Female

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Chronic lymphocytic leukaemia (v28.1) Unknown

Drugs (1)

SIMVASTATIN (SIMVASTATIN) Suspect

Route: 065 | Dosage: UNK | Form: -- | Indication: Low density lipoprotein increased | Action: Unknown

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

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435aa3b3830196fa57033",
  "safetyreportid": "25959605",
  "authoritynumb": null,
  "companynumb": "CA-ORGANON-O2510CAN001745",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": null,
  "patient": {
    "patientonsetage": 68.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Chronic lymphocytic leukaemia",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "SIMVASTATIN",
        "drugauthorizationnumb": "19766",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": "Low density lipoprotein increased",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "SIMVASTATIN"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "CA",
    "qualification": 3,
    "literaturereference": "Unknown. Unknown. Unknown"
  },
  "primarysourcecountry": "CA",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-26T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-26T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ORGANON"
  },
  "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"
}
                        

25959606 Type 1

Serious

SIMVASTATIN

Report Version

1

Receive Date

10/26/2025

Receipt Date

10/26/2025

Transmission Date

01/17/2026

Primary Source Country

CA

Occurrence Country

--

Reporter Country

CA

Reporter Qualification

Other Health Professional

Literature Reference

Unknown. Unknown. Unknown

Company Number

CA-ORGANON-O2510CAN001767

Authority Number

--

Sender Organization

ORGANON

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

57.0 yr

Patient Age Group

--

Patient Sex

Male

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Chronic lymphocytic leukaemia (v28.1) Unknown

Drugs (1)

SIMVASTATIN (SIMVASTATIN) Suspect

Route: 065 | Dosage: UNK | Form: -- | Indication: Low density lipoprotein increased | Action: Unknown

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

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435aa3b3830196fa57032",
  "safetyreportid": "25959606",
  "authoritynumb": null,
  "companynumb": "CA-ORGANON-O2510CAN001767",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": null,
  "patient": {
    "patientonsetage": 57.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 1,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Chronic lymphocytic leukaemia",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "SIMVASTATIN",
        "drugauthorizationnumb": "19766",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": null,
        "drugadministrationroute": "065",
        "drugindication": "Low density lipoprotein increased",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "SIMVASTATIN"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "CA",
    "qualification": 3,
    "literaturereference": "Unknown. Unknown. Unknown"
  },
  "primarysourcecountry": "CA",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-26T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-26T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ORGANON"
  },
  "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"
}
                        

25959602 Type 1

Non-Serious

FILSPARI

Report Version

1

Receive Date

10/26/2025

Receipt Date

10/26/2025

Transmission Date

01/17/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-TRAVERE-2025TVT01728

Authority Number

--

Sender Organization

TRAVERE THERAPEUTICS

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

No

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

--

Patient Age Group

--

Patient Sex

Female

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Hypotension (v28.1) Unknown

Somnolence (v28.1) Unknown

Drugs (1)

FILSPARI (SPARSENTAN) Suspect

Route: 048 | Dosage: -- | Form: Tablet | Indication: IgA nephropathy | Action: Unknown

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

Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69d435aa3b3830196fa5702e",
  "safetyreportid": "25959602",
  "authoritynumb": null,
  "companynumb": "US-TRAVERE-2025TVT01728",
  "duplicate": null,
  "fulfillexpeditecriteria": 2,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Hypotension",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Somnolence",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "FILSPARI",
        "drugauthorizationnumb": "216403",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": 200.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Tablet",
        "drugadministrationroute": "048",
        "drugindication": "IgA nephropathy",
        "drugstartdateformat": null,
        "drugstartdate": null,
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "SPARSENTAN"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": null
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-26T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-26T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "TRAVERE THERAPEUTICS"
  },
  "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"
}
                        