FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25942954 Type 1
Serious
BEVACIZUMAB, ATEZOLIZUMAB, DURVALUMAB\TREMELIMUMAB
Report Version
1
Receive Date
10/21/2025
Receipt Date
10/21/2025
Transmission Date
01/18/2026
Primary Source Country
JP
Occurrence Country
JP
Reporter Country
JP
Reporter Qualification
Other Health Professional
Literature Reference
Matono T.; Tada T.; Tada F. et al.. Clinical outcomes of sequential therapy with Atezolizumab/Bevacizumab and Durvalmab/Tremelimumab for unresectable hepatocellular carcinoma. Program and abstracts of the 61st Annual Meeting of Japan Liver Cancer Associati. 2025;112
Company Number
JP-AMGEN-JPNSP2025205959
Authority Number
--
Sender Organization
AMGEN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (8)

Immune-mediated adverse reaction (v28.1) Fatal
Hepatocellular carcinoma (v28.1) Unknown
Colitis (v28.1) Unknown
Drug effective for unapproved indication (v28.1) Unknown
Rash (v28.1) Unknown
Liver disorder (v28.1) Unknown
Off label use (v28.1) Unknown
Hypertension (v28.1) Unknown

Drugs (3)

BEVACIZUMAB (BEVACIZUMAB) Suspect
Route: 065 | Dosage: UNK | Form: Unknown formulation | Indication: Hepatocellular carcinoma | Action: Not Applicable
Auth#: 761028 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
ATEZOLIZUMAB (ATEZOLIZUMAB) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Hepatocellular carcinoma | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
DURVALUMAB\TREMELIMUMAB (DURVALUMAB\TREMELIMUMAB) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Hepatocellular carcinoma | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435593b3830196fa52abf", "safetyreportid": "25942954", "authoritynumb": null, "companynumb": "JP-AMGEN-JPNSP2025205959", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "JP", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Immune-mediated adverse reaction", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hepatocellular carcinoma", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Colitis", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug effective for unapproved indication", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Rash", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Liver disorder", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Off label use", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypertension", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "BEVACIZUMAB", "drugauthorizationnumb": "761028", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown formulation", "drugadministrationroute": "065", "drugindication": "Hepatocellular carcinoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "BEVACIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ATEZOLIZUMAB", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Hepatocellular carcinoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ATEZOLIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DURVALUMAB\\TREMELIMUMAB", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Hepatocellular carcinoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DURVALUMAB\\TREMELIMUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "JP", "qualification": 3, "literaturereference": "Matono T.; Tada T.; Tada F. et al.. Clinical outcomes of sequential therapy with Atezolizumab/Bevacizumab and Durvalmab/Tremelimumab for unresectable hepatocellular carcinoma. Program and abstracts of the 61st Annual Meeting of Japan Liver Cancer Associati. 2025;112" }, "primarysourcecountry": "JP", "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": "AMGEN" }, "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" }
25942953 Type 1
Non-Serious
MYCOPHENOLATE MOFETIL, TACROLIMUS, BASILIXIMAB (+1 more)
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
Other Health Professional
Literature Reference
Genosar R, Coman M, Herold K. Reversing Diabetes with Your Own Cells: Closer to the Dream. Journal of Clinical Endocrinology and Metabolism. 2025-Oct-01;110 (10):e3522-e3523. doi:10.1210/clinem/dgae851.
Company Number
US-ROCHE-10000412669
Authority Number
--
Sender Organization
ROCHE
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)

Respiratory tract infection (v28.1) Unknown

Drugs (4)

MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Prophylaxis against transplant rejection | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TACROLIMUS (TACROLIMUS) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Prophylaxis against transplant rejection | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
BASILIXIMAB (BASILIXIMAB) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Prophylaxis against transplant rejection | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ETANERCEPT (ETANERCEPT) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Prophylaxis against transplant rejection | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435593b3830196fa52ac0", "safetyreportid": "25942953", "authoritynumb": null, "companynumb": "US-ROCHE-10000412669", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Respiratory tract infection", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "MYCOPHENOLATE MOFETIL", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Prophylaxis against transplant rejection", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "MYCOPHENOLATE MOFETIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TACROLIMUS", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Prophylaxis against transplant rejection", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TACROLIMUS" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "BASILIXIMAB", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Prophylaxis against transplant rejection", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "BASILIXIMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ETANERCEPT", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Prophylaxis against transplant rejection", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ETANERCEPT" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": "Genosar R, Coman M, Herold K. Reversing Diabetes with Your Own Cells: Closer to the Dream. Journal of Clinical Endocrinology and Metabolism. 2025-Oct-01;110 (10):e3522-e3523. doi:10.1210/clinem/dgae851." }, "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": "ROCHE" }, "serious": 2, "seriousnesscongenitalanomali": null, "seriousnessdeath": null, "seriousnessdisabling": null, "seriousnesshospitalization": null, "seriousnesslifethreatening": null, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25942951 Type 1
Non-Serious
VYKAT XR, VYKAT XR, SOMATROPIN
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-SOLENO THERAPEUTICS, INC.-SOL2025000600
Authority Number
--
Sender Organization
SOLENO THERAPEUTICS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
16.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
49.887 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Pain (v28.1) Unknown

Drugs (3)

VYKAT XR (DIAZOXIDE CHOLINE) Suspect
Route: 048 | Dosage: UNK | Form: TABLET, EXTENDED RELEASE | Indication: Prader-Willi syndrome | Action: Dose Not Changed
Auth#: 216665 | Batch#: 104690FG | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2025 | End: 01/01/2025 | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VYKAT XR (DIAZOXIDE CHOLINE) Suspect
Route: 048 | Dosage: 225 MILLIGRAM, QD (ONE 150MG TAB AND ONE 75MG TAB) | Form: TABLET, EXTENDED RELEASE | Indication: -- | Action: Dose Not Changed
Auth#: 216665 | Batch#: 104690FG | Structured Dosage: 225.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SOMATROPIN (SOMATROPIN) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250918

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435593b3830196fa52abc", "safetyreportid": "25942951", "authoritynumb": null, "companynumb": "US-SOLENO THERAPEUTICS, INC.-SOL2025000600", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 16.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 49.887, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pain", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "VYKAT XR", "drugauthorizationnumb": "216665", "drugbatchnumb": "104690FG", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "TABLET, EXTENDED RELEASE", "drugadministrationroute": "048", "drugindication": "Prader-Willi syndrome", "drugstartdateformat": "602", "drugstartdate": "2025-01-01T00:00:00", "drugenddateformat": "602", "drugenddate": "2025-01-01T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "DIAZOXIDE CHOLINE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "VYKAT XR", "drugauthorizationnumb": "216665", "drugbatchnumb": "104690FG", "drugstructuredosagenumb": 225.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "225 MILLIGRAM, QD (ONE 150MG TAB AND ONE 75MG TAB)", "drugdosageform": "TABLET, EXTENDED RELEASE", "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": "602", "drugstartdate": "2025-01-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "DIAZOXIDE CHOLINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SOMATROPIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "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": null, "actiondrug": null, "activesubstance": { "activesubstancename": "SOMATROPIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250918" }, "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": "SOLENO 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" }
25942948 Type 1
Non-Serious
DUPIXENT
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
Physician
Literature Reference
--
Company Number
US-SANOFI-02691953
Authority Number
--
Sender Organization
SANOFI AVENTIS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
65.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Abdominal discomfort (v28.1) Unknown

Drugs (1)

DUPIXENT (DUPILUMAB) Suspect
Route: -- | Dosage: 300 MG | Form: Solution for injection | Indication: Chronic obstructive pulmonary disease | Action: Unknown
Auth#: 761055 | Batch#: -- | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (1)

SANOFI: US-SANOFI-02691953

Raw JSON (click to expand)

{ "_id": "69d435593b3830196fa52aba", "safetyreportid": "25942948", "authoritynumb": null, "companynumb": "US-SANOFI-02691953", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 65.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal discomfort", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": "761055", "drugbatchnumb": null, "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "300 MG", "drugdosageform": "Solution for injection", "drugadministrationroute": null, "drugindication": "Chronic obstructive pulmonary disease", "drugstartdateformat": "602", "drugstartdate": "2025-01-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101" }, "primarysource": { "reportercountry": "US", "qualification": 1, "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": "SANOFI", "duplicatenumb": "US-SANOFI-02691953" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANOFI AVENTIS" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25942950 Type 1
Serious
ATORVASTATIN, NINTEDANIB
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
--
Authority Number
GB-MHRA-MED-202510160847332270-QTPKY
Sender Organization
MYLAN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
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
57.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Myalgia (v28.1) Recovered
Medication error (v28.1) Unknown

Drugs (2)

ATORVASTATIN (ATORVASTATIN) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Blood cholesterol increased | Action: Withdrawn
Auth#: 020702 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
NINTEDANIB (NINTEDANIB) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: Idiopathic pulmonary fibrosis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251010

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435593b3830196fa52abb", "safetyreportid": "25942950", "authoritynumb": "GB-MHRA-MED-202510160847332270-QTPKY", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "GB", "patient": { "patientonsetage": 78.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 57.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Myalgia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Medication error", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ATORVASTATIN", "drugauthorizationnumb": "020702", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Blood cholesterol increased", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "ATORVASTATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "NINTEDANIB", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Idiopathic pulmonary fibrosis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "NINTEDANIB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251010" }, "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": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "MYLAN" }, "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" }
25942949 Type 1
Non-Serious
ESOMEPRAZOLE MAGNESIUM
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-DRL-USA-USA/2025/10/015579
Authority Number
--
Sender Organization
DR REDDYS
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
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Drug ineffective (v28.1) Unknown

Drugs (1)

ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM) Suspect
Route: 065 | Dosage: -- | Form: Prolonged-release capsule | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 207198 | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435593b3830196fa52ab9", "safetyreportid": "25942949", "authoritynumb": null, "companynumb": "US-DRL-USA-USA/2025/10/015579", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ESOMEPRAZOLE MAGNESIUM", "drugauthorizationnumb": "207198", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Prolonged-release capsule", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "ESOMEPRAZOLE MAGNESIUM" }, "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": "DR REDDYS" }, "serious": 2, "seriousnesscongenitalanomali": null, "seriousnessdeath": null, "seriousnessdisabling": null, "seriousnesshospitalization": null, "seriousnesslifethreatening": null, "seriousnessother": null, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25942945 Type 1
Non-Serious
ZEPBOUND, ZEPBOUND
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-ELI_LILLY_AND_COMPANY-US202510013995
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
49.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Alopecia (v28.1) Not Recovered

Drugs (2)

ZEPBOUND (TIRZEPATIDE) Suspect
Route: 065 | Dosage: 2.5 MG, UNKNOWN | Form: -- | Indication: Weight control | Action: Dose Not Changed
Auth#: 215866 | Batch#: -- | Structured Dosage: 2.5 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/15/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ZEPBOUND (TIRZEPATIDE) Suspect
Route: 065 | Dosage: 2.5 MG, UNKNOWN | Form: -- | Indication: Weight control | Action: Dose Not Changed
Auth#: 215866 | Batch#: -- | Structured Dosage: 2.5 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/15/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250719

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435593b3830196fa52ab8", "safetyreportid": "25942945", "authoritynumb": null, "companynumb": "US-ELI_LILLY_AND_COMPANY-US202510013995", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 49.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Alopecia", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ZEPBOUND", "drugauthorizationnumb": "215866", "drugbatchnumb": null, "drugstructuredosagenumb": 2.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2.5 MG, UNKNOWN", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Weight control", "drugstartdateformat": "102", "drugstartdate": "2025-07-15T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "TIRZEPATIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ZEPBOUND", "drugauthorizationnumb": "215866", "drugbatchnumb": null, "drugstructuredosagenumb": 2.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2.5 MG, UNKNOWN", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Weight control", "drugstartdateformat": "102", "drugstartdate": "2025-07-15T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "TIRZEPATIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250719" }, "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": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25942941 Type 1
Non-Serious
DUPIXENT
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
Other Health Professional
Literature Reference
--
Company Number
US-SA-2025SA311258
Authority Number
--
Sender Organization
SANOFI AVENTIS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
2.0 yr
Patient Age Group
Child
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Eczema (v28.1) Recovered
Therapeutic response shortened (v28.1) Recovered
Inappropriate schedule of product administration (v28.1) Unknown

Drugs (1)

DUPIXENT (DUPILUMAB) Suspect
Route: 058 | Dosage: 200.000MG Q4W | Form: Solution for injection | Indication: Eczema | Action: Not Applicable
Auth#: 761055 | Batch#: -- | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 4.0 wk | Cumulative: -- (unit: --)
Start: 08/18/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250901

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435593b3830196fa52ab4", "safetyreportid": "25942941", "authoritynumb": null, "companynumb": "US-SA-2025SA311258", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 2.0, "patientonsetageunit": 801, "patientagegroup": 3, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Eczema", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Therapeutic response shortened", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Inappropriate schedule of product administration", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": "761055", "drugbatchnumb": null, "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 4.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "200.000MG Q4W", "drugdosageform": "Solution for injection", "drugadministrationroute": "058", "drugindication": "Eczema", "drugstartdateformat": "102", "drugstartdate": "2025-08-18T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250901" }, "primarysource": { "reportercountry": "US", "qualification": 3, "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": "SANOFI AVENTIS" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25942921 Type 1
Serious
ACETAMINOPHEN\CAFFEINE\CODEINE PHOSPHATE, IBUPROFEN, OLANZAPINE (+2 more)
Report Version
1
Receive Date
10/21/2025
Receipt Date
10/21/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Consumer
Literature Reference
--
Company Number
EU-GlaxoSmithKline-A0633173A
Authority Number
--
Sender Organization
GALPHARM INTERNATIONAL
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
29.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Intentional overdose (v28.1) Recovered
Vomiting (v28.1) Recovered

Drugs (5)

ACETAMINOPHEN\CAFFEINE\CODEINE PHOSPHATE (ACETAMINOPHEN\CAFFEINE\CODEINE PHOSPHATE) Suspect
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNK | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
IBUPROFEN (IBUPROFEN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: 072096 | Batch#: UNK | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
OLANZAPINE (OLANZAPINE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNK | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ALCOHOL (ALCOHOL) (ALCOHOL) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNK | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CHLORPROMAZINE (CHLORPROMAZINE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Intentional overdose | Action: Unknown
Auth#: -- | Batch#: UNK | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (2)

GlaxoSmithKline: EU-GlaxoSmithKline-A0633173A
HPRA: EU-HPRA-038763

Raw JSON (click to expand)

{ "_id": "69d435593b3830196fa52ab6", "safetyreportid": "25942921", "authoritynumb": null, "companynumb": "EU-GlaxoSmithKline-A0633173A", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 29.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Intentional overdose", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vomiting", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ACETAMINOPHEN\\CAFFEINE\\CODEINE PHOSPHATE", "drugauthorizationnumb": null, "drugbatchnumb": "UNK", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "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": "ACETAMINOPHEN\\CAFFEINE\\CODEINE PHOSPHATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "IBUPROFEN", "drugauthorizationnumb": "072096", "drugbatchnumb": "UNK", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "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": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "IBUPROFEN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "OLANZAPINE", "drugauthorizationnumb": null, "drugbatchnumb": "UNK", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "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": "OLANZAPINE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ALCOHOL (ALCOHOL)", "drugauthorizationnumb": null, "drugbatchnumb": "UNK", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "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": "ALCOHOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CHLORPROMAZINE", "drugauthorizationnumb": null, "drugbatchnumb": "UNK", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Intentional overdose", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CHLORPROMAZINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "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": "GlaxoSmithKline", "duplicatenumb": "EU-GlaxoSmithKline-A0633173A" }, { "duplicatesource": "HPRA", "duplicatenumb": "EU-HPRA-038763" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "GALPHARM INTERNATIONAL" }, "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" }
25942942 Type 1
Serious
ZOLPIDEM TARTRATE
Report Version
1
Receive Date
10/21/2025
Receipt Date
10/21/2025
Transmission Date
01/17/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CN-SA-2025SA311857
Authority Number
--
Sender Organization
SANOFI AVENTIS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
75.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Altered state of consciousness (v28.1) Recovering
Dyspnoea (v28.1) Recovering
Oxygen saturation decreased (v28.1) Recovering

Drugs (1)

ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) Suspect
Route: 048 | Dosage: 10 MG, QD | Form: Film-coated tablet | Indication: Insomnia | Action: Withdrawn
Auth#: 019908 | Batch#: LT0208 | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 10.0 (unit: 003)
Start: 10/16/2025 | End: 10/16/2025 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251016

Report Duplicates (1)

NMPACDR: 4451991004299202500377

Raw JSON (click to expand)

{ "_id": "69d435593b3830196fa52ab7", "safetyreportid": "25942942", "authoritynumb": null, "companynumb": "CN-SA-2025SA311857", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 75.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Altered state of consciousness", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Oxygen saturation decreased", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ZOLPIDEM TARTRATE", "drugauthorizationnumb": "019908", "drugbatchnumb": "LT0208", "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 10.0, "drugcumulativedosageunit": "003", "drugdosagetext": "10 MG, QD", "drugdosageform": "Film-coated tablet", "drugadministrationroute": "048", "drugindication": "Insomnia", "drugstartdateformat": "102", "drugstartdate": "2025-10-16T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-16T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "ZOLPIDEM TARTRATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251016" }, "primarysource": { "reportercountry": "CN", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CN", "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": "NMPACDR", "duplicatenumb": "4451991004299202500377" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANOFI AVENTIS" }, "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" }