FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25946517 Type 1
Serious
PACLITAXEL, PACLITAXEL
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
--
Authority Number
EU-URPL-DML-MLP.4401.1.2356.2023
Sender Organization
TEVA
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
61.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
109.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Anaphylactic reaction (v28.1) Recovering

Drugs (2)

PACLITAXEL (PACLITAXEL) Suspect
Route: 042 | Dosage: -- | Form: -- | Indication: Ovarian cancer | Action: Unknown
Auth#: 075297 | Batch#: 87220472AB | Structured Dosage: 319.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/20/2023 | End: 12/20/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PACLITAXEL (PACLITAXEL) Suspect
Route: 042 | Dosage: -- | Form: -- | Indication: Ovarian cancer | Action: Unknown
Auth#: 075297 | Batch#: 87230032AA | Structured Dosage: 319.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/20/2023 | End: 12/20/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

URPLWEBP: EU-URPL-DML-MLP.4401.1.2356.2023

Raw JSON (click to expand)

{ "_id": "69d4356a3b3830196fa53951", "safetyreportid": "25946517", "authoritynumb": "EU-URPL-DML-MLP.4401.1.2356.2023", "companynumb": null, "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 61.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 109.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Anaphylactic reaction", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "PACLITAXEL", "drugauthorizationnumb": "075297", "drugbatchnumb": "87220472AB", "drugstructuredosagenumb": 319.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Ovarian cancer", "drugstartdateformat": "102", "drugstartdate": "2023-12-20T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-12-20T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PACLITAXEL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PACLITAXEL", "drugauthorizationnumb": "075297", "drugbatchnumb": "87230032AA", "drugstructuredosagenumb": 319.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Ovarian cancer", "drugstartdateformat": "102", "drugstartdate": "2023-12-20T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-12-20T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PACLITAXEL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "URPLWEBP", "duplicatenumb": "EU-URPL-DML-MLP.4401.1.2356.2023" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "TEVA" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 1, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25946518 Type 1
Non-Serious
ORENCIA
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-BRISTOL-MYERS SQUIBB COMPANY-2025-143128
Authority Number
--
Sender Organization
BRISTOL-MYERS SQUIBB COMPANY
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
41.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Arthralgia (v28.1) Unknown
Joint swelling (v28.1) Unknown

Drugs (1)

ORENCIA (ABATACEPT) Suspect
Route: -- | Dosage: CODE UNIT: 125 MG/ML | Form: Solution for injection in pre-filled syringe | Indication: Rheumatoid arthritis | Action: Dose Not Changed
Auth#: 125118 | Batch#: BCXJ27A | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 7.0 day | Cumulative: -- (unit: --)
Start: 11/01/2021 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4356a3b3830196fa53950", "safetyreportid": "25946518", "authoritynumb": null, "companynumb": "US-BRISTOL-MYERS SQUIBB COMPANY-2025-143128", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 41.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Arthralgia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Joint swelling", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ORENCIA", "drugauthorizationnumb": "125118", "drugbatchnumb": "BCXJ27A", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 7.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "CODE UNIT: 125 MG/ML", "drugdosageform": "Solution for injection in pre-filled syringe", "drugadministrationroute": null, "drugindication": "Rheumatoid arthritis", "drugstartdateformat": "610", "drugstartdate": "2021-11-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "ABATACEPT" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BRISTOL-MYERS SQUIBB COMPANY" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25946516 Type 1
Serious
CAMZYOS
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/18/2026
Primary Source Country
MO
Occurrence Country
MO
Reporter Country
MO
Reporter Qualification
Physician
Literature Reference
--
Company Number
MO-BRISTOL-MYERS SQUIBB COMPANY-2025-143635
Authority Number
--
Sender Organization
BRISTOL-MYERS SQUIBB COMPANY
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Blood pressure decreased (v28.1) Unknown

Drugs (1)

CAMZYOS (MAVACAMTEN) Suspect
Route: -- | Dosage: -- | Form: Capsule | Indication: Product used for unknown indication | Action: Withdrawn
Auth#: 214998 | Batch#: -- | Structured Dosage: 2.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/01/2025 | End: 10/13/2025 | Duration: 74.0 day | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4356a3b3830196fa5394f", "safetyreportid": "25946516", "authoritynumb": null, "companynumb": "MO-BRISTOL-MYERS SQUIBB COMPANY-2025-143635", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "MO", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blood pressure decreased", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "CAMZYOS", "drugauthorizationnumb": "214998", "drugbatchnumb": null, "drugstructuredosagenumb": 2.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Capsule", "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": "610", "drugstartdate": "2025-08-01T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-13T00:00:00", "drugtreatmentduration": 74.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "MAVACAMTEN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "MO", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "MO", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BRISTOL-MYERS SQUIBB COMPANY" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 1, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25946514 Type 1
Serious
FABRAZYME, ELIQUIS, LYRICA (+23 more)
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-SA-2025SA303163
Authority Number
--
Sender Organization
SANOFI AVENTIS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
31.0 yr
Patient Age Group
Adult
Patient Sex
Male
Patient Weight
52.2 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (20)

Splenic infarction (v28.1) Unknown
Intracardiac mass (v28.1) Unknown
Aspergilloma (v28.1) Unknown
Pyrexia (v28.1) Unknown
Pneumonia bacterial (v28.1) Unknown
Pericardial effusion (v28.1) Unknown
Hypothermia (v28.1) Unknown
Acute respiratory failure (v28.1) Unknown
Aortic valve incompetence (v28.1) Unknown
Thrombocytopenia (v28.1) Unknown
Night sweats (v28.1) Unknown
Influenza (v28.1) Unknown
Abdominal tenderness (v28.1) Unknown
Fibrin D dimer increased (v28.1) Unknown
Pleural effusion (v28.1) Unknown
Weight decreased (v28.1) Unknown
Thoracic operation (v28.1) Unknown
Abdominal pain (v28.1) Unknown
Pain (v28.1) Unknown
Oedema peripheral (v28.1) Unknown

Drugs (26)

FABRAZYME (AGALSIDASE BETA) Suspect
Route: 042 | Dosage: UNK UNK, QOW | Form: Powder for concentrate for solution for infusion | Indication: -- | Action: Unknown
Auth#: 103979 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ELIQUIS (APIXABAN) Concomitant
Route: 048 | Dosage: 1 DF, BID | Form: Tablet | Indication: Splenic infarction | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 12.0 hr | Cumulative: -- (unit: --)
Start: 02/14/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
LYRICA (PREGABALIN) Concomitant
Route: 048 | Dosage: 1 DF, BID | Form: Capsule | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 12.0 hr | Cumulative: -- (unit: --)
Start: 02/14/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
PROGRAF (TACROLIMUS) Concomitant
Route: 048 | Dosage: 1 DF, Q12H | Form: Capsule | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 12.0 hr | Cumulative: -- (unit: --)
Start: 02/14/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DELTASONE (PREDNISONE) Concomitant
Route: 048 | Dosage: 1 DF, QD | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/15/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SENOKOT-S (DOCUSATE SODIUM\SENNOSIDES) Concomitant
Route: 048 | Dosage: 2 DF, QD | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/14/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CRESEMBA (ISAVUCONAZONIUM SULFATE) Concomitant
Route: 048 | Dosage: 2 DF, QD | Form: Capsule | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/17/2023 | End: 03/19/2023 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
LOMOTIL (ATROPINE SULFATE\DIPHENOXYLATE HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: 1 DF, TID | Form: Tablet | Indication: Diarrhoea | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 8.0 hr | Cumulative: -- (unit: --)
Start: 12/31/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
LEVOTHYROXINE (LEVOTHYROXINE) Concomitant
Route: 048 | Dosage: 175 UG, QD | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 175.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 01/02/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ZOLOFT (SERTRALINE HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: 25 MG, QD | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 25.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 11/07/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SEROQUEL (QUETIAPINE FUMARATE) Concomitant
Route: 048 | Dosage: 50 MG, BID | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 12.0 hr | Cumulative: -- (unit: --)
Start: 01/02/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TESSALON (BENZONATATE) Concomitant
Route: 048 | Dosage: 1 DF, TID | Form: Capsule | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 8.0 hr | Cumulative: -- (unit: --)
Start: 01/17/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRILOSEC (OMEPRAZOLE MAGNESIUM) Concomitant
Route: 048 | Dosage: 20 MG, QD | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ROXICODONE (OXYCODONE HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: 1 DF, Q6H | Form: Tablet | Indication: Pain | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 6.0 hr | Cumulative: -- (unit: --)
Start: 02/14/2023 | End: 02/21/2023 | Duration: 7.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
TYLENOL (ACETAMINOPHEN) Concomitant
Route: 048 | Dosage: 1 DF, TID | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 8.0 hr | Cumulative: -- (unit: --)
Start: 02/14/2023 | End: 02/28/2023 | Duration: 14.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
NEURONTIN (GABAPENTIN) Concomitant
Route: 048 | Dosage: 1 DF, TID | Form: Capsule | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 8.0 hr | Cumulative: -- (unit: --)
Start: 02/14/2023 | End: 02/28/2023 | Duration: 14.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
LASIX (FUROSEMIDE) Concomitant
Route: 048 | Dosage: 1 DF, QD | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/14/2023 | End: 02/21/2023 | Duration: 7.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
ROBAXIN (METHOCARBAMOL) Concomitant
Route: 048 | Dosage: 1 DF, Q6H | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: 6.0 hr | Cumulative: -- (unit: --)
Start: 02/14/2023 | End: 02/28/2023 | Duration: 14.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
MYFORTIC (MYCOPHENOLATE SODIUM) Concomitant
Route: -- | Dosage: UNK | Form: Prolonged-release tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TEGRETOL (CARBAMAZEPINE) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CELLCEPT (MYCOPHENOLATE MOFETIL) Concomitant
Route: -- | Dosage: UNK | Form: Capsule | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ZOFRAN (ONDANSETRON HYDROCHLORIDE) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
GLYCOLAX (POLYETHYLENE GLYCOL 3350) Concomitant
Route: 048 | Dosage: 17 G, QD | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 17.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/14/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
MIRALAX (POLYETHYLENE GLYCOL 3350) Concomitant
Route: 048 | Dosage: 17 G, QD | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 17.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 02/14/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
PRINIVIL (LISINOPRIL) Concomitant
Route: -- | Dosage: UNK | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ZESTRIL (LISINOPRIL) Concomitant
Route: -- | Dosage: UNK | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230101

Report Duplicates (0)

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"drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "POLYETHYLENE GLYCOL 3350" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PRINIVIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Tablet", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LISINOPRIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ZESTRIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Tablet", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LISINOPRIL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230101" }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANOFI AVENTIS" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25946513 Type 1
Serious
INFLIXIMAB, INFLIXIMAB, INFLIXIMAB (+17 more)
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/17/2026
Primary Source Country
CA
Occurrence Country
CA
Reporter Country
CA
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CA-PFIZER INC-202400274679
Authority Number
--
Sender Organization
CELLTRION
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Pain in extremity (v28.1) Not Recovered
Pneumonia (v28.1) Not Recovered
Arthralgia (v28.1) Not Recovered
Overdose (v28.1) Unknown

Drugs (20)

INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 5 MG/KG | Form: Powder for solution for infusion | Indication: Crohn^s disease | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 210.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 5 MG/KG | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 5 MG/KG | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 5 MG/KG | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 565 MG | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 565.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 5 MG/KG | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 5 MG/KG | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 570 MG | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 570.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 565 MG | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 565.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 550 MG | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: Unknown | Structured Dosage: 550.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 5 MG/KG, 0, 2, 6 THEN EVERY 8 WEEKS | Form: Powder for injection | Indication: Crohn^s disease | Action: Dose Not Changed
Auth#: 125544 | Batch#: Unknown | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/19/2021 | End: 10/14/2021 | Duration: 210.0 day | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 5 MG/KG, EVERY 4 WEEKS | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: Unknown | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/23/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 5 MG/KG, EVERY 4 WEEKS | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: HR4778 | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/11/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 5 MG/KG, EVERY 4 WEEKS | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: Unknown | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/09/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 550 MG (5 MG/KG), EVERY 4 WEEKS | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: HN1567 | Structured Dosage: 550.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/06/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 5 MG/KG, EVERY 4 WEEKS | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: hn1567 | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/02/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 570 MG, AFTER 4 WEEKS (5 MG/KG, EVERY 4 WEEKS) | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: hx6360 | Structured Dosage: 570.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/29/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 565 MG, EVERY 4 WEEKS (5MG/KG) | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: Unknown | Structured Dosage: 565.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/26/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 5 MG/KG, EVERY 4 WEEK | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: LG5355 | Structured Dosage: 5.0 (unit: 007) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/26/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INFLECTRA (INFLIXIMAB-DYYB) Suspect
Route: 042 | Dosage: 565 MG, EVERY 4 WEEK (5 MG/KG, EVERY 4 WEEK) | Form: Powder for injection | Indication: -- | Action: Dose Not Changed
Auth#: 125544 | Batch#: LL2938 | Structured Dosage: 565.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 04/23/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20241001

Report Duplicates (5)

PFIZER INC: CA-PFIZER INC-202400274679
PFIZER INC: CA-PFIZER INC-202400274679
PFIZER INC: CA-PFIZER INC-202400274679
PFIZER INC: CA-PFIZER INC-202400274679
PFIZER INC: CA-PFIZER INC-202400274679

Raw JSON (click to expand)

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"activesubstancename": "INFLIXIMAB-DYYB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "INFLECTRA", "drugauthorizationnumb": "125544", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "007", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG/KG, EVERY 4 WEEKS", "drugdosageform": "Powder for injection", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2021-12-23T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "INFLIXIMAB-DYYB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "INFLECTRA", "drugauthorizationnumb": "125544", "drugbatchnumb": "HR4778", "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "007", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG/KG, EVERY 4 WEEKS", "drugdosageform": "Powder for injection", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2024-09-11T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "INFLIXIMAB-DYYB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "INFLECTRA", "drugauthorizationnumb": "125544", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "007", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG/KG, EVERY 4 WEEKS", "drugdosageform": "Powder for injection", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2024-10-09T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "INFLIXIMAB-DYYB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "INFLECTRA", "drugauthorizationnumb": "125544", "drugbatchnumb": "HN1567", "drugstructuredosagenumb": 550.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "550 MG (5 MG/KG), EVERY 4 WEEKS", "drugdosageform": "Powder for injection", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2024-11-06T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "INFLIXIMAB-DYYB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "INFLECTRA", "drugauthorizationnumb": "125544", "drugbatchnumb": "hn1567", "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "007", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG/KG, EVERY 4 WEEKS", "drugdosageform": "Powder for injection", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-01-02T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "INFLIXIMAB-DYYB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "INFLECTRA", "drugauthorizationnumb": "125544", "drugbatchnumb": "hx6360", "drugstructuredosagenumb": 570.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "570 MG, AFTER 4 WEEKS (5 MG/KG, EVERY 4 WEEKS)", "drugdosageform": "Powder for injection", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-01-29T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "INFLIXIMAB-DYYB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "INFLECTRA", "drugauthorizationnumb": "125544", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 565.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "565 MG, EVERY 4 WEEKS (5MG/KG)", "drugdosageform": "Powder for injection", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-02-26T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "INFLIXIMAB-DYYB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "INFLECTRA", "drugauthorizationnumb": "125544", "drugbatchnumb": "LG5355", "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "007", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG/KG, EVERY 4 WEEK", "drugdosageform": "Powder for injection", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-03-26T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "INFLIXIMAB-DYYB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "INFLECTRA", "drugauthorizationnumb": "125544", "drugbatchnumb": "LL2938", "drugstructuredosagenumb": 565.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "565 MG, EVERY 4 WEEK (5 MG/KG, EVERY 4 WEEK)", "drugdosageform": "Powder for injection", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-04-23T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "INFLIXIMAB-DYYB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20241001" }, "primarysource": { "reportercountry": "CA", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CA", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "PFIZER INC", "duplicatenumb": "CA-PFIZER INC-202400274679" }, { "duplicatesource": "PFIZER INC", "duplicatenumb": "CA-PFIZER INC-202400274679" }, { "duplicatesource": "PFIZER INC", "duplicatenumb": "CA-PFIZER INC-202400274679" }, { "duplicatesource": "PFIZER INC", "duplicatenumb": "CA-PFIZER INC-202400274679" }, { "duplicatesource": "PFIZER INC", "duplicatenumb": "CA-PFIZER INC-202400274679" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "CELLTRION" }, "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" }
25946512 Type 1
Serious
TISLELIZUMAB, TISLELIZUMAB, TISLELIZUMAB (+3 more)
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
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-BEIGENE-BGN-2025-017861
Authority Number
--
Sender Organization
BEIGENE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
72.0 yr
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Myelosuppression (v28.1) Recovering

Drugs (6)

TISLELIZUMAB (TISLELIZUMAB) Suspect
Route: -- | Dosage: 200 MILLIGRAM | Form: -- | Indication: Salivary gland cancer | Action: Unknown
Auth#: 761232 | Batch#: G202501001 | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
TISLELIZUMAB (TISLELIZUMAB) Suspect
Route: 041 | Dosage: 200 MILLIGRAM | Form: -- | Indication: -- | Action: Unknown
Auth#: 761232 | Batch#: G202501001 | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
TISLELIZUMAB (TISLELIZUMAB) Suspect
Route: 041 | Dosage: 200 MILLIGRAM | Form: -- | Indication: -- | Action: Unknown
Auth#: 761232 | Batch#: G202501001 | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
TISLELIZUMAB (TISLELIZUMAB) Suspect
Route: -- | Dosage: 200 MILLIGRAM | Form: -- | Indication: -- | Action: Unknown
Auth#: 761232 | Batch#: G202501001 | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) Suspect
Route: 041 | Dosage: 600 MILLIGRAM | Form: -- | Indication: Salivary gland cancer | Action: Unknown
Auth#: -- | Batch#: 5A718A | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) Suspect
Route: -- | Dosage: 600 MILLIGRAM | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 5A718A | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

NMPACDR: 3101151031449202500161

Raw JSON (click to expand)

{ "_id": "69d4356a3b3830196fa5394b", "safetyreportid": "25946512", "authoritynumb": null, "companynumb": "CN-BEIGENE-BGN-2025-017861", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 72.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Myelosuppression", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TISLELIZUMAB", "drugauthorizationnumb": "761232", "drugbatchnumb": "G202501001", "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "200 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Salivary gland cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TISLELIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TISLELIZUMAB", "drugauthorizationnumb": "761232", "drugbatchnumb": "G202501001", "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "200 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": "041", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TISLELIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TISLELIZUMAB", "drugauthorizationnumb": "761232", "drugbatchnumb": "G202501001", "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "200 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": "041", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TISLELIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TISLELIZUMAB", "drugauthorizationnumb": "761232", "drugbatchnumb": "G202501001", "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "200 MILLIGRAM", "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": "TISLELIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CYCLOPHOSPHAMIDE", "drugauthorizationnumb": null, "drugbatchnumb": "5A718A", "drugstructuredosagenumb": 600.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "600 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": "041", "drugindication": "Salivary gland cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CYCLOPHOSPHAMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CYCLOPHOSPHAMIDE", "drugauthorizationnumb": null, "drugbatchnumb": "5A718A", "drugstructuredosagenumb": 600.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "600 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CYCLOPHOSPHAMIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CN", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CN", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "NMPACDR", "duplicatenumb": "3101151031449202500161" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BEIGENE" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25946510 Type 2
Serious
RESTASIS
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-ABBVIE-6509329
Authority Number
--
Sender Organization
ABBVIE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
91.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Blindness (v28.1) Not Recovered
Eye disorder (v28.1) Unknown

Drugs (1)

RESTASIS (CYCLOSPORINE) Suspect
Route: 047 | Dosage: 1 DROP IN EACH EYE | Form: Eye drops, solution | Indication: Product used for unknown indication | Action: Unknown
Auth#: 050790 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 0.5 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4356a3b3830196fa5394a", "safetyreportid": "25946510", "authoritynumb": null, "companynumb": "US-ABBVIE-6509329", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 91.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blindness", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Eye disorder", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "RESTASIS", "drugauthorizationnumb": "050790", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.5, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DROP IN EACH EYE", "drugdosageform": "Eye drops, solution", "drugadministrationroute": "047", "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": "CYCLOSPORINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ABBVIE" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25946509 Type 1
Non-Serious
GENOSYL
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-VEROBIOTECH-2025USVEROSPO00290
Authority Number
--
Sender Organization
VERO BIOTECH
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
5
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 (2)

Device malfunction (v28.1) Unknown
Device issue (v28.1) Unknown

Drugs (1)

GENOSYL (NITRIC OXIDE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 202860 | Batch#: -- | 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": "69d4356a3b3830196fa53949", "safetyreportid": "25946509", "authoritynumb": null, "companynumb": "US-VEROBIOTECH-2025USVEROSPO00290", "duplicate": null, "fulfillexpeditecriteria": 5, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Device malfunction", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Device issue", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "GENOSYL", "drugauthorizationnumb": "202860", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "NITRIC OXIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "VERO BIOTECH" }, "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" }
25946508 Type 1
Non-Serious
PLUVICTO
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-002147023-NVSC2025US158942
Authority Number
--
Sender Organization
NOVARTIS
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)

General physical health deterioration (v28.1) Unknown

Drugs (1)

PLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) Suspect
Route: 065 | Dosage: UNK | Form: Solution for injection/infusion | Indication: Product used for unknown indication | Action: Unknown
Auth#: 215833 | Batch#: -- | 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": "69d4356a3b3830196fa53948", "safetyreportid": "25946508", "authoritynumb": null, "companynumb": "US-002147023-NVSC2025US158942", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "General physical health deterioration", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "PLUVICTO", "drugauthorizationnumb": "215833", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Solution for injection/infusion", "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": "LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "NOVARTIS" }, "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" }
25946511 Type 1
Serious
ORENITRAM, ORENITRAM, ORENITRAM (+17 more)
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-UNITED THERAPEUTICS-UNT-2025-035578
Authority Number
--
Sender Organization
UNITED THERAPEUTICS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Female
Patient Weight
78.912 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Pleural effusion (v28.1) Unknown

Drugs (20)

ORENITRAM (TREPROSTINIL) Suspect
Route: -- | Dosage: 2.5 MG (1 TABLET OF 2.5 MG), Q12H | Form: -- | Indication: Pulmonary arterial hypertension | Action: Unknown
Auth#: 203496 | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ORENITRAM (TREPROSTINIL) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: Unknown
Auth#: 203496 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ORENITRAM (TREPROSTINIL) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Pulmonary arterial hypertension | Action: Unknown
Auth#: 203496 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
MELATONIN (MELATONIN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
IMODIUM (LOPERAMIDE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ELIQUIS (APIXABAN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
JARDIANCE (EMPAGLIFLOZIN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
XOPENEX (LEVALBUTEROL HYDROCHLORIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CALCIUM\VITAMIN D (CALCIUM\VITAMIN D) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
TYLENOL ARTHRITIS PAIN (ACETAMINOPHEN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LEVALBUTEROL TARTRATE (LEVALBUTEROL TARTRATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
BIOFREEZE (MENTHOL) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OPSUMIT (MACITENTAN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OXYGEN (OXYGEN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FOLIC ACID (FOLIC ACID) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
TRAZODONE HCL (TRAZODONE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VITAMIN D3 (CHOLECALCIFEROL) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4356a3b3830196fa53947", "safetyreportid": "25946511", "authoritynumb": null, "companynumb": "US-UNITED THERAPEUTICS-UNT-2025-035578", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": 78.912, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pleural effusion", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ORENITRAM", "drugauthorizationnumb": "203496", "drugbatchnumb": null, "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2.5 MG (1 TABLET OF 2.5 MG), Q12H", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pulmonary arterial hypertension", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TREPROSTINIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ORENITRAM", "drugauthorizationnumb": "203496", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TREPROSTINIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ORENITRAM", "drugauthorizationnumb": "203496", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pulmonary arterial hypertension", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TREPROSTINIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MELATONIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "MELATONIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "IMODIUM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LOPERAMIDE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ELIQUIS", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "APIXABAN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TYLENOL EXTRA STRENGTH", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "JARDIANCE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "EMPAGLIFLOZIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "XOPENEX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LEVALBUTEROL HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CALCIUM\\VITAMIN D", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CALCIUM\\VITAMIN D" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TYLENOL ARTHRITIS PAIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, 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"transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }