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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.

BREXANOLONE: 261 Adverse Event Reports & Safety Profile

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261
Total FAERS Reports
1 (0.4%)
Deaths Reported
12
Hospitalizations
261
As Primary/Secondary Suspect
4
Life-Threatening
2
Disabilities
Jun 17, 2019
FDA Approved
Discontinued
Status

FDA Application: 211371 ·

Patent Expires: Nov 27, 2033 · First Report: 201503 · Latest Report: 20241111

What Are the Most Common BREXANOLONE Side Effects?

#1 Most Reported
Product administration error
36 reports (13.8%)
#2 Most Reported
Anxiety
34 reports (13.0%)
#3 Most Reported
Drug ineffective
26 reports (10.0%)

All BREXANOLONE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Product administration error 36 13.8% 0 1
Anxiety 34 13.0% 0 0
Drug ineffective 26 10.0% 1 4
Off label use 24 9.2% 0 1
Drug monitoring procedure incorrectly performed 19 7.3% 0 0
Fatigue 17 6.5% 0 1
Dizziness 16 6.1% 0 0
Perinatal depression 15 5.8% 0 1
Crying 14 5.4% 0 0
Product administration interrupted 14 5.4% 0 1
Feeling abnormal 13 5.0% 0 0
Incorrect product administration duration 12 4.6% 0 1
Therapeutic product effect incomplete 12 4.6% 0 0
Headache 11 4.2% 0 0
Somnolence 11 4.2% 0 0
Depression 10 3.8% 0 0
Medication error 10 3.8% 0 0
Product use in unapproved indication 10 3.8% 0 0
Suicidal ideation 10 3.8% 0 0
Insomnia 8 3.1% 0 1

Who Reports BREXANOLONE Side Effects? Age & Gender Data

Gender: 96.0% female, 4.0% male. Average age: 29.5 years. Most reports from: US. View detailed demographics →

Is BREXANOLONE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2015 3 0 3
2016 1 0 1
2017 1 0 0
2019 32 0 1
2020 53 0 2
2021 42 0 1
2022 30 0 0
2023 33 0 1
2024 8 0 0

View full timeline →

What Is BREXANOLONE Used For?

IndicationReports
Perinatal depression 216
Product used for unknown indication 10
Status epilepticus 10
Seizure 7
Major depression 5

BREXANOLONE vs Alternatives: Which Is Safer?

BREXANOLONE vs BREXPIPRAZOLE BREXANOLONE vs BREXUCABTAGENE AUTOLEUCEL BREXANOLONE vs BRIGATINIB BREXANOLONE vs BRILINTA BREXANOLONE vs BRILIQUE BREXANOLONE vs BRIMONIDINE BREXANOLONE vs BRIMONIDINE\BRINZOLAMIDE BREXANOLONE vs BRIMONIDINE\TIMOLOL BREXANOLONE vs BRINTELLIX BREXANOLONE vs BRINZOLAMIDE

Official FDA Label for BREXANOLONE

Official prescribing information from the FDA-approved drug label.