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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.

NELVUTAMIG: 277 Adverse Event Reports & Safety Profile

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277
Total FAERS Reports
34 (12.3%)
Deaths Reported
109
Hospitalizations
277
As Primary/Secondary Suspect
36
Life-Threatening
5
Disabilities

First Report: 20180923 · Latest Report: 20250828

What Are the Most Common NELVUTAMIG Side Effects?

#1 Most Reported
Off label use
29 reports (10.5%)
#2 Most Reported
Immune-mediated hepatitis
18 reports (6.5%)
#3 Most Reported
Hypothyroidism
17 reports (6.1%)

All NELVUTAMIG Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 29 10.5% 6 12
Immune-mediated hepatitis 18 6.5% 2 12
Hypothyroidism 17 6.1% 0 6
Immune-mediated enterocolitis 16 5.8% 5 6
Malignant neoplasm progression 16 5.8% 3 6
Colitis 15 5.4% 1 3
Drug ineffective 14 5.1% 3 0
Immune-mediated hepatic disorder 14 5.1% 0 2
Fatigue 13 4.7% 0 3
Immune-mediated myocarditis 11 4.0% 1 8
Diarrhoea 10 3.6% 0 4
Rash 10 3.6% 0 4
Hepatitis 9 3.3% 0 2
Immune-mediated hypophysitis 9 3.3% 0 4
Immune thrombocytopenia 9 3.3% 0 2
Nausea 9 3.3% 0 0
Vitiligo 9 3.3% 0 2
Adrenal insufficiency 7 2.5% 0 1
Asthenia 7 2.5% 0 5
Hyperthyroidism 7 2.5% 1 2

Who Reports NELVUTAMIG Side Effects? Age & Gender Data

Gender: 41.0% female, 59.0% male. Average age: 59.8 years. Most reports from: EU. View detailed demographics →

Is NELVUTAMIG Getting Safer? Reports by Year

YearReportsDeathsHosp.
2018 1 0 1
2019 2 0 2
2020 3 0 0
2021 2 0 0
2022 7 1 2
2023 13 1 11
2024 15 4 7
2025 43 0 32

View full timeline →

What Is NELVUTAMIG Used For?

IndicationReports
Malignant melanoma 61
Metastatic malignant melanoma 40
Clear cell renal cell carcinoma 15
Non-small cell lung cancer 14
Product used for unknown indication 14
Hepatocellular carcinoma 13
Non-small cell lung cancer metastatic 11
Lung adenocarcinoma 7
Renal cell carcinoma 7
Metastatic renal cell carcinoma 6

NELVUTAMIG vs Alternatives: Which Is Safer?

NELVUTAMIG vs NEMOLIZUMAB NELVUTAMIG vs NEMOLIZUMAB-ILTO NELVUTAMIG vs NEOMYCIN NELVUTAMIG vs NEORAL NELVUTAMIG vs NEOSTIGMINE NELVUTAMIG vs NEOSTIGMINE METHYLSULFATE NELVUTAMIG vs NEPAFENAC NELVUTAMIG vs NERATINIB NELVUTAMIG vs NETARSUDIL NELVUTAMIG vs NETUPITANT\PALONOSETRON

Official FDA Label for NELVUTAMIG

Official prescribing information from the FDA-approved drug label.