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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.

NIROGACESTAT HYDROBROMIDE: 166 Adverse Event Reports & Safety Profile

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166
Total FAERS Reports
0
Deaths Reported
18
Hospitalizations
166
As Primary/Secondary Suspect
10
Disabilities
Apr 4, 2024
FDA Approved
Prescription
Status

FDA Application: 217677 ·

Patent Expires: Sep 8, 2042 · First Report: 20180101 · Latest Report: 20250819

What Are the Most Common NIROGACESTAT HYDROBROMIDE Side Effects?

#1 Most Reported
Diarrhoea
32 reports (19.3%)
#2 Most Reported
Rash
25 reports (15.1%)
#3 Most Reported
Nausea
21 reports (12.7%)

All NIROGACESTAT HYDROBROMIDE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Diarrhoea 32 19.3% 0 6
Rash 25 15.1% 0 2
Nausea 21 12.7% 0 3
Fatigue 20 12.1% 0 2
Epistaxis 12 7.2% 0 0
Stomatitis 10 6.0% 0 0
Vomiting 10 6.0% 0 4
Headache 9 5.4% 0 0
Hidradenitis 9 5.4% 0 0
Hypophosphataemia 7 4.2% 0 0
Intentional underdose 7 4.2% 0 0
Off label use 7 4.2% 0 3
Epiphyseal fracture 6 3.6% 0 2
Femur fracture 6 3.6% 0 1
Hot flush 6 3.6% 0 0
Pruritus 6 3.6% 0 0
Alopecia 5 3.0% 0 0
Cough 5 3.0% 0 0
Photopsia 5 3.0% 0 0
Scoliosis 5 3.0% 0 2

Who Reports NIROGACESTAT HYDROBROMIDE Side Effects? Age & Gender Data

Gender: 63.0% female, 37.0% male. Average age: 46.8 years. Most reports from: US. View detailed demographics →

Is NIROGACESTAT HYDROBROMIDE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2018 1 0 0
2022 2 0 0
2023 2 0 0
2024 35 0 3
2025 14 0 5

View full timeline →

What Is NIROGACESTAT HYDROBROMIDE Used For?

IndicationReports
Desmoid tumour 82
Product used for unknown indication 76

NIROGACESTAT HYDROBROMIDE vs Alternatives: Which Is Safer?

NIROGACESTAT HYDROBROMIDE vs NIRSEVIMAB NIROGACESTAT HYDROBROMIDE vs NIRSEVIMAB-ALIP NIROGACESTAT HYDROBROMIDE vs NITAZOXANIDE NIROGACESTAT HYDROBROMIDE vs NITISINONE NIROGACESTAT HYDROBROMIDE vs NITRAZEPAM NIROGACESTAT HYDROBROMIDE vs NITRENDIPINE NIROGACESTAT HYDROBROMIDE vs NITRIC NIROGACESTAT HYDROBROMIDE vs NITROFURANTOIN NIROGACESTAT HYDROBROMIDE vs NITROFURANTOIN\NITROFURANTOIN NIROGACESTAT HYDROBROMIDE vs NITROFURAZONE

Official FDA Label for NIROGACESTAT HYDROBROMIDE

Official prescribing information from the FDA-approved drug label.