FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25939856 Type 1
Non-Serious
TYLENOL 8HR, TYLENOL 8HR
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-KENVUE-20250911832
Authority Number
--
Sender Organization
Kenvue
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Incorrect dose administered (v28.1) Unknown
Inappropriate schedule of product administration (v28.1) Unknown

Drugs (2)

TYLENOL 8HR (ACETAMINOPHEN) Suspect
Route: 065 | Dosage: 1 DOSAGE FORM, TWICE A DAY | Form: Tablet | Indication: Arthritis | Action: Dose Not Changed
Auth#: 019872 | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 2.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
TYLENOL 8HR (ACETAMINOPHEN) Suspect
Route: -- | Dosage: -- | Form: Tablet | Indication: Tendon injury | Action: Dose Not Changed
Auth#: 019872 | 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": "69d435493b3830196fa51e2f", "safetyreportid": "25939856", "authoritynumb": null, "companynumb": "US-KENVUE-20250911832", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Incorrect dose administered", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Inappropriate schedule of product administration", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TYLENOL 8HR", "drugauthorizationnumb": "019872", "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 2.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 DOSAGE FORM, TWICE A DAY", "drugdosageform": "Tablet", "drugadministrationroute": "065", "drugindication": "Arthritis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TYLENOL 8HR", "drugauthorizationnumb": "019872", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": null, "drugindication": "Tendon injury", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "Kenvue" }, "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" }
25939857 Type 1
Serious
CYCLOPHOSPHAMIDE, FLUDARABINE, ALFENTA (+50 more)
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Physician
Literature Reference
--
Company Number
US-002147023-NVSC2020US322533
Authority Number
--
Sender Organization
SANDOZ
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
18.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
48.9 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Cytokine release syndrome (v28.1) Recovered
Neutropenia (v28.1) Recovered

Drugs (53)

CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) Suspect
Route: 042 | Dosage: 184 MG | Form: Unknown | Indication: Chemotherapy | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 184.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/26/2021 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
FLUDARABINE (FLUDARABINE PHOSPHATE) Suspect
Route: 042 | Dosage: 182 MG | Form: Unknown | Indication: Chemotherapy | Action: Unknown
Auth#: 22137 | Batch#: -- | Structured Dosage: 182.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/05/2020 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ALFENTA (ALFENTANIL HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Surgery | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/09/2020 | End: 11/09/2020 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
ALFENTA (ALFENTANIL HYDROCHLORIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Pain | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ALOXI (PALONOSETRON HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: 125 MCG/ML | Form: -- | Indication: Antiemetic supportive care | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/05/2020 | End: 11/05/2020 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
BACTRIM DS (SULFAMETHOXAZOLE\TRIMETHOPRIM) Concomitant
Route: 048 | Dosage: 160 MG, BID SAT/SUN | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 320.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 2880.0 (unit: 003)
Start: 02/27/2021 | End: 03/07/2021 | Duration: 9.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
BACTRIM DS (SULFAMETHOXAZOLE\TRIMETHOPRIM) Concomitant
Route: 065 | Dosage: BID | Form: -- | Indication: Infection prophylaxis | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 2880.0 (unit: 003)
Start: 08/08/2020 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
BACTRIM DS (SULFAMETHOXAZOLE\TRIMETHOPRIM) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: General physical condition | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 2880.0 (unit: 003)
Start: 11/28/2020 | End: 12/05/2020 | Duration: 8.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
BACTRIM DS (SULFAMETHOXAZOLE\TRIMETHOPRIM) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 2880.0 (unit: 003)
Start: 11/07/2020 | End: 11/23/2020 | Duration: 17.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Nausea | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/03/2021 | End: 03/03/2021 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Premedication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/27/2021 | End: 02/27/2021 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Prophylaxis of nausea and vomiting | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/27/2020 | End: 12/05/2020 | Duration: 9.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Vomiting | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CHLORHEXIDINE (CHLORHEXIDINE) Concomitant
Route: 048 | Dosage: 12 %, QD | Form: -- | Indication: Fatigue | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 12.0 (unit: 030) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 11/27/2020 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
COLACE (DOCUSATE SODIUM) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Constipation | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/23/2020 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CYPROHEPTADINE (CYPROHEPTADINE) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Decreased appetite | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/06/2020 | End: 04/29/2021 | Duration: 206.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
DIPRIVAN (PROPOFOL) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Prophylaxis | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/09/2020 | End: 11/09/2020 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
Ela-max (--) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Hypoaesthesia | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/20/2020 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
Ela-max (--) Concomitant
Route: 065 | Dosage: APPLY TO SKIN, PRN | Form: -- | Indication: Anaesthesia oral | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/04/2020 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EMEND (APREPITANT) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Prophylaxis | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 02/27/2021 | End: 02/28/2021 | Duration: 2.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
EMEND (APREPITANT) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Nausea | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
HYDROCORTISONE (HYDROCORTISONE) Concomitant
Route: 061 | Dosage: 1 %, TID | Form: Cream | Indication: Hypoaesthesia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 3.0 (unit: 030) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/06/2020 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
HYDROCORTISONE (HYDROCORTISONE) Concomitant
Route: 065 | Dosage: UNK | Form: Cream | Indication: Rash | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/07/2020 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
KYTRIL (GRANISETRON HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: 1000 MCG/ML | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/28/2020 | End: 12/05/2020 | Duration: 8.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
KYTRIL (GRANISETRON HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Prophylaxis of nausea and vomiting | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/06/2020 | End: 11/09/2020 | Duration: 4.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
KYTRIL (GRANISETRON HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/07/2020 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
LEVAQUIN (LEVOFLOXACIN) Concomitant
Route: 048 | Dosage: 500 MG, QD | Form: -- | Indication: Prophylaxis | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 2500.0 (unit: 003)
Start: 03/03/2021 | End: 03/07/2021 | Duration: 5.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
LEVAQUIN (LEVOFLOXACIN) Concomitant
Route: 048 | Dosage: 500 MG, ONCE DAILY | Form: -- | Indication: General physical condition | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 2500.0 (unit: 003)
Start: 11/23/2020 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
LEVAQUIN (LEVOFLOXACIN) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Antibiotic prophylaxis | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 2500.0 (unit: 003)
Start: 11/10/2020 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
LEVAQUIN (LEVOFLOXACIN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Infection prophylaxis | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 2500.0 (unit: 003)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
MARINOL (DRONABINOL) Concomitant
Route: 048 | Dosage: UNK | Form: -- | Indication: Prophylaxis of nausea and vomiting | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/17/2020 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
MARINOL (DRONABINOL) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Nausea | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/03/2020 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
MAXIPIME (CEFEPIME HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Antibiotic prophylaxis | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/26/2020 | End: 12/05/2020 | Duration: 10.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
MELATONIN (MELATONIN) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Sleep disorder | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/29/2020 | End: 12/05/2020 | Duration: 7.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
MERCAPTOPURINE (MERCAPTOPURINE) Concomitant
Route: 065 | Dosage: 300 MG, QD | Form: -- | Indication: Nausea | Action: --
Auth#: -- | Batch#: oral use | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 11/19/2020 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MEROPENEM (MEROPENEM) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Pyrexia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/15/2020 | End: 11/23/2020 | Duration: 9.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
MEROPENEM (MEROPENEM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Cytokine release syndrome | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
METHOTREXATE (METHOTREXATE) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Premedication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/27/2020 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
METHOTREXATE SODIUM (METHOTREXATE SODIUM) Concomitant
Route: 065 | Dosage: UNK | Form: Solution | Indication: Nausea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/28/2020 | End: 11/29/2020 | Duration: 2.0 day | Rechallenge: -- | Additional: --
Recurrences: --
NOXAFIL (POSACONAZOLE) Concomitant
Route: 048 | Dosage: 300 MG, DAILY | Form: -- | Indication: Infection prophylaxis | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/19/2020 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
NOXAFIL (POSACONAZOLE) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Prophylaxis | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/18/2020 | End: 11/23/2020 | Duration: 6.0 day | Rechallenge: -- | Additional: --
Recurrences: --
NOXAFIL (POSACONAZOLE) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/27/2020 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PERIACTIN (CYPROHEPTADINE HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Decreased appetite | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/06/2020 | End: 04/29/2021 | Duration: 206.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Nausea | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/01/2021 | End: 03/01/2021 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Prophylaxis of nausea and vomiting | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/29/2020 | End: 12/01/2020 | Duration: 3.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Vomiting | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SENNA S (DOCUSATE SODIUM\SENNOSIDES) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Constipation | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 05/21/2020 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TYLENOL (ACETAMINOPHEN) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Premedication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/03/2021 | End: 03/03/2021 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
TYLENOL (ACETAMINOPHEN) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/10/2020 | End: 11/10/2020 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
VANCOCIN (VANCOMYCIN HYDROCHLORIDE) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Cytokine release syndrome | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/29/2020 | End: 12/01/2020 | Duration: 3.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
VANCOCIN (VANCOMYCIN HYDROCHLORIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Febrile neutropenia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
VINCRISTINE (VINCRISTINE) Concomitant
Route: 065 | Dosage: UNK | Form: Solution | Indication: Vomiting | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/29/2020 | End: 12/01/2020 | Duration: 3.0 day | Rechallenge: -- | Additional: --
Recurrences: --
VITAMIN D3 (CHOLECALCIFEROL) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: General physical condition | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/15/2020 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20210308

Report Duplicates (0)

--

Raw JSON (click to expand)

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null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Hypoaesthesia", "drugstartdateformat": "102", "drugstartdate": "2020-05-20T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "Ela-max", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, 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"drugcharacterization": 2, "medicinalproduct": "HYDROCORTISONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Cream", "drugadministrationroute": "065", "drugindication": "Rash", "drugstartdateformat": "102", "drugstartdate": "2020-10-07T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "HYDROCORTISONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "KYTRIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, 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"summary_narrativeincludeclinical": "CASE EVENT DATE: 20210308" }, "primarysource": { "reportercountry": "US", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANDOZ" }, "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" }
25939854 Type 2
Serious
DURVALUMAB
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
CA
Occurrence Country
CA
Reporter Country
CA
Reporter Qualification
Consumer
Literature Reference
--
Company Number
CA-AstraZeneca-CH-00972831A
Authority Number
--
Sender Organization
ALEXION PHARMACEUTICALS
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
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Thrombosis (v28.1) Recovering
Pain in extremity (v28.1) Recovering

Drugs (1)

DURVALUMAB (DURVALUMAB) Suspect
Route: 065 | Dosage: 1500 MILLIGRAM, Q4W | Form: -- | Indication: Bladder cancer | Action: Unknown
Auth#: 761069 | Batch#: BCAW | Structured Dosage: 1500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 4.0 wk | Cumulative: -- (unit: --)
Start: 08/14/2025 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435493b3830196fa51e2b", "safetyreportid": "25939854", "authoritynumb": null, "companynumb": "CA-AstraZeneca-CH-00972831A", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CA", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Thrombosis", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pain in extremity", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DURVALUMAB", "drugauthorizationnumb": "761069", "drugbatchnumb": "BCAW", "drugstructuredosagenumb": 1500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 4.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1500 MILLIGRAM, Q4W", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Bladder cancer", "drugstartdateformat": "102", "drugstartdate": "2025-08-14T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DURVALUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CA", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "CA", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ALEXION PHARMACEUTICALS" }, "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" }
25939852 Type 2
Serious
XYWAV, XYWAV, XYWAV (+3 more)
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-JAZZ PHARMACEUTICALS-2025-US-024164
Authority Number
--
Sender Organization
JAZZ
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
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Surgery (v28.1) Unknown

Drugs (6)

XYWAV (CALCIUM OXYBATE\MAGNESIUM OXYBATE\POTASSIUM OXYBATE\SODIUM OXYBATE) Suspect
Route: -- | Dosage: -- | Form: Oral solution | Indication: Narcolepsy | Action: Withdrawn
Auth#: 212690 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
XYWAV (CALCIUM OXYBATE\MAGNESIUM OXYBATE\POTASSIUM OXYBATE\SODIUM OXYBATE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Cataplexy | Action: Withdrawn
Auth#: 212690 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
XYWAV (CALCIUM OXYBATE\MAGNESIUM OXYBATE\POTASSIUM OXYBATE\SODIUM OXYBATE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Somnolence | Action: Withdrawn
Auth#: 212690 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --
ZYRTEC (CETIRIZINE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: UNK | Form: Gel | 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: --
MAGNESIUM GLUCEPTATE (MAGNESIUM GLUCEPTATE) Concomitant
Route: -- | Dosage: 0000 | Form: Tablet | 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: --
NALTREXONE (NALTREXONE) 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": "69d435493b3830196fa51e2a", "safetyreportid": "25939852", "authoritynumb": null, "companynumb": "US-JAZZ PHARMACEUTICALS-2025-US-024164", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Surgery", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "XYWAV", "drugauthorizationnumb": "212690", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Oral solution", "drugadministrationroute": null, "drugindication": "Narcolepsy", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "CALCIUM OXYBATE\\MAGNESIUM OXYBATE\\POTASSIUM OXYBATE\\SODIUM OXYBATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "XYWAV", "drugauthorizationnumb": "212690", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Cataplexy", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "CALCIUM OXYBATE\\MAGNESIUM OXYBATE\\POTASSIUM OXYBATE\\SODIUM OXYBATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "XYWAV", "drugauthorizationnumb": "212690", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Somnolence", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "CALCIUM OXYBATE\\MAGNESIUM OXYBATE\\POTASSIUM OXYBATE\\SODIUM OXYBATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ZYRTEC", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Gel", "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": "CETIRIZINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MAGNESIUM GLUCEPTATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "0000", "drugdosageform": "Tablet", "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": "MAGNESIUM GLUCEPTATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "NALTREXONE", "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": "NALTREXONE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "JAZZ" }, "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" }
25939853 Type 1
Serious
OCREVUS
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-ROCHE-10000411354
Authority Number
--
Sender Organization
ROCHE
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
Adult
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Pneumonia (v28.1) Unknown
Relapsing-remitting multiple sclerosis (v28.1) Unknown

Drugs (1)

OCREVUS (OCRELIZUMAB) Suspect
Route: 042 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435493b3830196fa51e29", "safetyreportid": "25939853", "authoritynumb": null, "companynumb": "EU-ROCHE-10000411354", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 5, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pneumonia", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Relapsing-remitting multiple sclerosis", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "OCREVUS", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 600.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "042", "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": "OCRELIZUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ROCHE" }, "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" }
25939849 Type 1
Serious
ETOPOSIDE, METHOTREXATE, CYTARABINE (+4 more)
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/19/2026
Primary Source Country
MX
Occurrence Country
MX
Reporter Country
MX
Reporter Qualification
Physician
Literature Reference
Abdala Mendoza FY, Ancona Castro C. Grade 4 Mucositis Secondary to Methotrexate Use in a Pediatric Patient With Stage IV Burkitt Lymphoma: A Case Report. Cureus. 2025 Aug 25;17(8):e90944. doi: 10.7759/cureus.90944.
Company Number
MX-Accord-508919
Authority Number
--
Sender Organization
ACCORD
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
11.0 yr
Patient Age Group
Child
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Mucosal inflammation (v28.1) Recovered
Dermatosis (v28.1) Recovered
Ascites (v28.1) Unknown
Pleural effusion (v28.1) Unknown
Renal injury (v28.1) Unknown

Drugs (7)

ETOPOSIDE (ETOPOSIDE) Suspect
Route: -- | Dosage: FIRST CYCLE, 100 MG/M2/DAY X2 DOSES | Form: -- | Indication: Burkitt^s lymphoma stage IV | Action: Unknown
Auth#: 074513 | Batch#: -- | Structured Dosage: 100.0 (unit: 009) | Separate Dosage#: -- | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
METHOTREXATE (METHOTREXATE) Suspect
Route: -- | Dosage: 5G/M2 FIRST CYCLE | Form: -- | Indication: Burkitt^s lymphoma stage IV | Action: Withdrawn
Auth#: 040716 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
CYTARABINE (CYTARABINE) Suspect
Route: -- | Dosage: FIRST CYCLE, 150 MG/M2/DAY X2 DOSES | Form: -- | Indication: Burkitt^s lymphoma stage IV | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 150.0 (unit: 009) | Separate Dosage#: -- | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
LEUCOVORIN (LEUCOVORIN\LEUCOVORIN CALCIUM) Suspect
Route: -- | Dosage: FIRST CYCLE | Form: -- | Indication: Burkitt^s lymphoma stage IV | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 15.0 (unit: 009) | Separate Dosage#: -- | Interval: 6.0 hr | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
IFOSFAMIDE (IFOSFAMIDE) Suspect
Route: -- | Dosage: FIRST CYCLE | Form: -- | Indication: Burkitt^s lymphoma stage IV | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 800.0 (unit: 009) | Separate Dosage#: -- | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
MESNA (MESNA) Suspect
Route: -- | Dosage: FIRST CYCLE | Form: -- | Indication: Burkitt^s lymphoma stage IV | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
VINCRISTINE (VINCRISTINE) Suspect
Route: -- | Dosage: FIRST CYCLE | Form: -- | Indication: Burkitt^s lymphoma stage IV | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 1.5 (unit: 009) | Separate Dosage#: -- | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (3)

MLM: MX-MLMSERVICE-20251001-PI664930-00218-1
MLM Service Tracking number: PI664930-00140
MLM Service Tracking number: PI664930-00158

Raw JSON (click to expand)

{ "_id": "69d435493b3830196fa51e27", "safetyreportid": "25939849", "authoritynumb": null, "companynumb": "MX-Accord-508919", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "MX", "patient": { "patientonsetage": 11.0, "patientonsetageunit": 801, "patientagegroup": 3, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Mucosal inflammation", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dermatosis", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Ascites", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pleural effusion", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Renal injury", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ETOPOSIDE", "drugauthorizationnumb": "074513", "drugbatchnumb": null, "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FIRST CYCLE, 100 MG/M2/DAY X2 DOSES", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Burkitt^s lymphoma stage IV", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ETOPOSIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METHOTREXATE", "drugauthorizationnumb": "040716", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5G/M2 FIRST CYCLE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Burkitt^s lymphoma stage IV", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "METHOTREXATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CYTARABINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 150.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FIRST CYCLE, 150 MG/M2/DAY X2 DOSES", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Burkitt^s lymphoma stage IV", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CYTARABINE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "LEUCOVORIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 15.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": 6.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FIRST CYCLE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Burkitt^s lymphoma stage IV", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "LEUCOVORIN\\LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "IFOSFAMIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 800.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FIRST CYCLE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Burkitt^s lymphoma stage IV", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "IFOSFAMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "MESNA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FIRST CYCLE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Burkitt^s lymphoma stage IV", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "MESNA" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "VINCRISTINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.5, "drugstructuredosageunit": "009", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FIRST CYCLE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Burkitt^s lymphoma stage IV", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "VINCRISTINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "MX", "qualification": 1, "literaturereference": "Abdala Mendoza FY, Ancona Castro C. Grade 4 Mucositis Secondary to Methotrexate Use in a Pediatric Patient With Stage IV Burkitt Lymphoma: A Case Report. Cureus. 2025 Aug 25;17(8):e90944. doi: 10.7759/cureus.90944." }, "primarysourcecountry": "MX", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "MLM", "duplicatenumb": "MX-MLMSERVICE-20251001-PI664930-00218-1" }, { "duplicatesource": "MLM Service Tracking number", "duplicatenumb": "PI664930-00140" }, { "duplicatesource": "MLM Service Tracking number", "duplicatenumb": "PI664930-00158" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ACCORD" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 1, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-19T00:00:00", "transmissiondateformat": "102" }
25939850 Type 1
Serious
GOSERELIN, ZOLADEX, TAMSULOSIN
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
GB
Occurrence Country
GB
Reporter Country
GB
Reporter Qualification
Physician
Literature Reference
--
Company Number
--
Authority Number
GB-MHRA-MED-202510141107023500-BMRGK
Sender Organization
TERSERA THERAPEUTICS
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 (1)

Interstitial lung disease (v28.1) Not Recovered

Drugs (3)

GOSERELIN (GOSERELIN) Suspect
Route: 065 | Dosage: 10.8MG EVERY 3 MONTHS | Form: Implant | Indication: Adverse drug reaction | Action: Unknown
Auth#: 20578 | Batch#: NA | Structured Dosage: 10.8 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
ZOLADEX (GOSERELIN ACETATE) Suspect
Route: 065 | Dosage: UNK | Form: Prefilled Syringe | Indication: Adverse drug reaction | Action: Unknown
Auth#: -- | Batch#: NA | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
TAMSULOSIN (TAMSULOSIN) Concomitant
Route: 065 | Dosage: UNK | Form: -- | Indication: Lower urinary tract symptoms | Action: Unknown
Auth#: -- | Batch#: ASKU | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20240406

Report Duplicates (2)

MHRA: GB-MHRA-MED-202510141107023500-BMRGK
ASTRAZENECA: GB-ASTRAZENECA-202510GLO011774GB

Raw JSON (click to expand)

{ "_id": "69d435493b3830196fa51e26", "safetyreportid": "25939850", "authoritynumb": "GB-MHRA-MED-202510141107023500-BMRGK", "companynumb": null, "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "GB", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Interstitial lung disease", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "GOSERELIN", "drugauthorizationnumb": "20578", "drugbatchnumb": "NA", "drugstructuredosagenumb": 10.8, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10.8MG EVERY 3 MONTHS", "drugdosageform": "Implant", "drugadministrationroute": "065", "drugindication": "Adverse drug reaction", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "GOSERELIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ZOLADEX", "drugauthorizationnumb": null, "drugbatchnumb": "NA", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Prefilled Syringe", "drugadministrationroute": "065", "drugindication": "Adverse drug reaction", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "GOSERELIN ACETATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TAMSULOSIN", "drugauthorizationnumb": null, "drugbatchnumb": "ASKU", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Lower urinary tract symptoms", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TAMSULOSIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20240406" }, "primarysource": { "reportercountry": "GB", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "GB", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "MHRA", "duplicatenumb": "GB-MHRA-MED-202510141107023500-BMRGK" }, { "duplicatesource": "ASTRAZENECA", "duplicatenumb": "GB-ASTRAZENECA-202510GLO011774GB" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "TERSERA THERAPEUTICS" }, "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" }
25939851 Type 1
Non-Serious
BEVACIZUMAB
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Physician
Literature Reference
Grassmeyer J, Campbell J, Thanos A. Choroidal Neovascularization in Peripapillary Persistent Fetal Vasculature Syndrome: A Possible Sequela of Nonsurgical Management. Ophthalmic Surgery Lasers and Imaging Retina. 2025-Sep-01;56 (9):566-8. doi:10.3928/23258160-20250604-01.
Company Number
US-ROCHE-10000412030
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
2.0 yr
Patient Age Group
Child
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Off label use (v28.1) Unknown
No adverse event (v28.1) Unknown
Off label use (v28.1) Unknown

Drugs (1)

BEVACIZUMAB (BEVACIZUMAB) Suspect
Route: 050 | Dosage: -- | Form: Injection | Indication: Choroidal neovascularisation | Action: Not Applicable
Auth#: -- | Batch#: Asked But Unknown | Structured Dosage: 1.25 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435493b3830196fa51e25", "safetyreportid": "25939851", "authoritynumb": null, "companynumb": "US-ROCHE-10000412030", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 2.0, "patientonsetageunit": 801, "patientagegroup": 3, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Off label use", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "No adverse event", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Off label use", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "BEVACIZUMAB", "drugauthorizationnumb": null, "drugbatchnumb": "Asked But Unknown", "drugstructuredosagenumb": 1.25, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Injection", "drugadministrationroute": "050", "drugindication": "Choroidal neovascularisation", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "BEVACIZUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 1, "literaturereference": "Grassmeyer J, Campbell J, Thanos A. Choroidal Neovascularization in Peripapillary Persistent Fetal Vasculature Syndrome: A Possible Sequela of Nonsurgical Management. Ophthalmic Surgery Lasers and Imaging Retina. 2025-Sep-01;56 (9):566-8. doi:10.3928/23258160-20250604-01." }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ROCHE" }, "serious": 2, "seriousnesscongenitalanomali": null, "seriousnessdeath": null, "seriousnessdisabling": null, "seriousnesshospitalization": null, "seriousnesslifethreatening": null, "seriousnessother": null, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25939848 Type 2
Serious
ISOTRETINOIN, ISOTRETINOIN
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Physician
Literature Reference
--
Company Number
US-UPSHER-SMITH LABORATORIES, LLC-20251001309
Authority Number
--
Sender Organization
UPSHER SMITH LABORATORIES
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
95.238 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Hepatic cirrhosis (v28.1) Unknown
Depression (v28.1) Unknown
Myalgia (v28.1) Unknown

Drugs (2)

ISOTRETINOIN (ISOTRETINOIN) Suspect
Route: 065 | Dosage: 30 MG, BID | Form: Capsule | Indication: Acne | Action: Withdrawn
Auth#: 076485 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/12/2025 | End: 10/10/2025 | Duration: 60.0 day | Rechallenge: -- | Additional: --
Recurrences: --
ISOTRETINOIN (ISOTRETINOIN) Suspect
Route: 065 | Dosage: 40 MG | Form: Capsule | Indication: -- | Action: Withdrawn
Auth#: 076485 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435493b3830196fa51e24", "safetyreportid": "25939848", "authoritynumb": null, "companynumb": "US-UPSHER-SMITH LABORATORIES, LLC-20251001309", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": 95.238, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hepatic cirrhosis", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Depression", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Myalgia", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ISOTRETINOIN", "drugauthorizationnumb": "076485", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "30 MG, BID", "drugdosageform": "Capsule", "drugadministrationroute": "065", "drugindication": "Acne", "drugstartdateformat": "102", "drugstartdate": "2025-08-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-10T00:00:00", "drugtreatmentduration": 60.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "ISOTRETINOIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ISOTRETINOIN", "drugauthorizationnumb": "076485", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "40 MG", "drugdosageform": "Capsule", "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "ISOTRETINOIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101" }, "primarysource": { "reportercountry": "US", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "UPSHER SMITH LABORATORIES" }, "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" }
25939847 Type 2
Serious
DURVALUMAB
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
IN
Occurrence Country
IN
Reporter Country
IN
Reporter Qualification
Consumer
Literature Reference
--
Company Number
IN-AstraZeneca-CH-00972710A
Authority Number
--
Sender Organization
ALEXION PHARMACEUTICALS
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
Male
Patient Weight
98.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Disease progression (v28.1) Unknown

Drugs (1)

DURVALUMAB (DURVALUMAB) Suspect
Route: -- | Dosage: 1500 MILLIGRAM, Q3W | Form: -- | Indication: Non-small cell lung cancer | Action: Withdrawn
Auth#: 761069 | Batch#: Unknown | Structured Dosage: 1500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

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Report Duplicates (0)

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Raw JSON (click to expand)

{ "_id": "69d435493b3830196fa51e22", "safetyreportid": "25939847", "authoritynumb": null, "companynumb": "IN-AstraZeneca-CH-00972710A", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "IN", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": 98.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Disease progression", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DURVALUMAB", "drugauthorizationnumb": "761069", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 1500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1500 MILLIGRAM, Q3W", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Non-small cell lung cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "DURVALUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "IN", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "IN", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ALEXION PHARMACEUTICALS" }, "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" }