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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.

ONC-392: 27 Adverse Event Reports & Safety Profile

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27
Total FAERS Reports
1 (3.7%)
Deaths Reported
27
Hospitalizations
27
As Primary/Secondary Suspect

First Report: 20211101 · Latest Report: 20230718

What Are the Most Common ONC-392 Side Effects?

#1 Most Reported
Immune-mediated enterocolitis
8 reports (29.6%)
#2 Most Reported
Pneumonia
4 reports (14.8%)
#3 Most Reported
Colitis
4 reports (14.8%)

All ONC-392 Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Immune-mediated enterocolitis 8 29.6% 1 8

Who Reports ONC-392 Side Effects? Age & Gender Data

Gender: 42.4% female, 57.6% male. Average age: 68.1 years. Most reports from: US. View detailed demographics →

Is ONC-392 Getting Safer? Reports by Year

YearReportsDeathsHosp.
2021 1 0 1
2022 11 1 11
2023 15 0 15

View full timeline →

What Is ONC-392 Used For?

IndicationReports
Malignant melanoma 13
Non-small cell lung cancer 11

Official FDA Label for ONC-392

Official prescribing information from the FDA-approved drug label.