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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

DOSTARLIMAB-GXLY: 504 Adverse Event Reports & Safety Profile

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504
Total FAERS Reports
55 (10.9%)
Deaths Reported
126
Hospitalizations
504
As Primary/Secondary Suspect
26
Life-Threatening
3
Disabilities
Prescription
Status

FDA Application: 761174 ·

First Report: 20210816 · Latest Report: 20250903

What Are the Most Common DOSTARLIMAB-GXLY Side Effects?

#1 Most Reported
Off label use
51 reports (10.1%)
#2 Most Reported
Rash
42 reports (8.3%)
#3 Most Reported
Malignant neoplasm progression
28 reports (5.6%)

All DOSTARLIMAB-GXLY Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 51 10.1% 4 6
Rash 42 8.3% 1 11
Death 28 5.6% 28 1
Malignant neoplasm progression 28 5.6% 4 2
Fatigue 22 4.4% 2 4
Neuropathy peripheral 20 4.0% 0 0
Pyrexia 20 4.0% 0 9
Product use in unapproved indication 19 3.8% 3 7
Thrombocytopenia 16 3.2% 2 7
Hypothyroidism 14 2.8% 1 3
Erythema 13 2.6% 0 0
Colitis 12 2.4% 0 5
Dyspnoea 12 2.4% 3 2
Diarrhoea 11 2.2% 1 6
Pain 11 2.2% 2 2
Acute polyneuropathy 10 2.0% 0 10
Anaemia 10 2.0% 1 6
Hyperthyroidism 10 2.0% 0 4
Abdominal pain 9 1.8% 1 7
Rash maculo-papular 9 1.8% 0 4

Who Reports DOSTARLIMAB-GXLY Side Effects? Age & Gender Data

Gender: 92.7% female, 7.3% male. Average age: 67.4 years. Most reports from: US. View detailed demographics →

Is DOSTARLIMAB-GXLY Getting Safer? Reports by Year

YearReportsDeathsHosp.
2021 5 2 4
2022 18 2 0
2023 37 2 9
2024 99 7 44
2025 82 12 32

View full timeline →

What Is DOSTARLIMAB-GXLY Used For?

IndicationReports
Endometrial cancer 191
Product used for unknown indication 134
Endometrial adenocarcinoma 33
Endometrial cancer metastatic 33
Uterine cancer 26
Rectal cancer 14
Endometrial cancer recurrent 10
Endometrial cancer stage iv 9
Endometrial neoplasm 6

DOSTARLIMAB-GXLY vs Alternatives: Which Is Safer?

DOSTARLIMAB-GXLY vs DOTATATE GALLIUM GA-68 DOSTARLIMAB-GXLY vs DOTHIEPIN DOSTARLIMAB-GXLY vs DOXAZOSIN DOSTARLIMAB-GXLY vs DOXAZOSIN\DOXAZOSIN DOSTARLIMAB-GXLY vs DOXEPIN DOSTARLIMAB-GXLY vs DOXERCALCIFEROL DOSTARLIMAB-GXLY vs DOXIFLURIDINE DOSTARLIMAB-GXLY vs DOXORUBICIN DOSTARLIMAB-GXLY vs DOXYCYCLINE DOSTARLIMAB-GXLY vs DOXYCYCLINE HYCLATE

Official FDA Label for DOSTARLIMAB-GXLY

Official prescribing information from the FDA-approved drug label.