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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.

AVUTOMETINIB\DEFACTINIB: 76 Adverse Event Reports & Safety Profile

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76
Total FAERS Reports
3 (3.9%)
Deaths Reported
5
Hospitalizations
76
As Primary/Secondary Suspect

Active Ingredient: AVUTOMETINIB POTASSIUM\DEFACTINIB HYDROCHLORIDE ·

First Report: 20250602 · Latest Report: 20250812

What Are the Most Common AVUTOMETINIB\DEFACTINIB Side Effects?

#1 Most Reported
Nausea
17 reports (22.4%)
#2 Most Reported
Fatigue
13 reports (17.1%)
#3 Most Reported
Diarrhoea
10 reports (13.2%)

All AVUTOMETINIB\DEFACTINIB Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Nausea 17 22.4% 0 3
Fatigue 13 17.1% 0 1
Diarrhoea 10 13.2% 0 0
Off label use 9 11.8% 0 0
Vomiting 9 11.8% 0 1
Visual impairment 8 10.5% 0 0
Product dose omission issue 7 9.2% 0 0
Vision blurred 7 9.2% 0 0
Blood creatine phosphokinase increased 6 7.9% 0 1
Peripheral swelling 5 6.6% 0 0

Who Reports AVUTOMETINIB\DEFACTINIB Side Effects? Age & Gender Data

Most reports from: US. View detailed demographics →

Is AVUTOMETINIB\DEFACTINIB Getting Safer? Reports by Year

YearReportsDeathsHosp.
2025 26 2 2

View full timeline →

What Is AVUTOMETINIB\DEFACTINIB Used For?

IndicationReports
Ovarian cancer 57
Product used for unknown indication 6

Official FDA Label for AVUTOMETINIB\DEFACTINIB

Official prescribing information from the FDA-approved drug label.