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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.

BROTIZOLAM: 676 Adverse Event Reports & Safety Profile

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676
Total FAERS Reports
95 (14.1%)
Deaths Reported
386
Hospitalizations
676
As Primary/Secondary Suspect
87
Life-Threatening
21
Disabilities

First Report: 19970305 · Latest Report: 20250110

What Are the Most Common BROTIZOLAM Side Effects?

#1 Most Reported
Suicide attempt
81 reports (12.0%)
#2 Most Reported
Overdose
74 reports (10.9%)
#3 Most Reported
Intentional overdose
72 reports (10.7%)

All BROTIZOLAM Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Suicide attempt 81 12.0% 5 60
Overdose 74 11.0% 12 57
Drug abuse 72 10.7% 2 46
Intentional overdose 72 10.7% 4 62
Toxicity to various agents 61 9.0% 10 49
Fall 48 7.1% 3 38
Off label use 45 6.7% 2 28
Altered state of consciousness 44 6.5% 1 38
Somnolence 40 5.9% 3 18
Sopor 40 5.9% 0 23
Insomnia 34 5.0% 4 17
Nausea 31 4.6% 0 15
Dysphagia 26 3.9% 2 18
Loss of consciousness 26 3.9% 1 22
Vomiting 26 3.9% 0 15
Pneumonia 24 3.6% 6 19
Stevens-johnson syndrome 23 3.4% 16 2
Delirium 20 3.0% 2 8
Pruritus 20 3.0% 14 0
Rhabdomyolysis 20 3.0% 2 17

Who Reports BROTIZOLAM Side Effects? Age & Gender Data

Gender: 58.7% female, 41.3% male. Average age: 57.1 years. Most reports from: JP. View detailed demographics →

Is BROTIZOLAM Getting Safer? Reports by Year

YearReportsDeathsHosp.
2002 1 0 1
2003 1 0 1
2004 16 15 1
2008 2 0 0
2009 2 0 0
2010 2 0 0
2011 3 1 2
2012 12 4 7
2013 15 3 6
2014 41 2 28
2015 53 10 28
2016 44 10 24
2017 49 5 29
2018 53 5 22
2019 30 2 21
2020 24 4 9
2021 21 1 14
2022 17 0 11
2023 20 7 15
2024 2 0 2
2025 1 0 0

View full timeline →

What Is BROTIZOLAM Used For?

IndicationReports
Product used for unknown indication 250
Insomnia 129
Depression 28
Schizophrenia 28
Sleep disorder 25
Bipolar disorder 19
Drug abuse 17
Suicide attempt 13
Bipolar ii disorder 7
Anxiety 6

BROTIZOLAM vs Alternatives: Which Is Safer?

BROTIZOLAM vs BUCILLAMINE BROTIZOLAM vs BUDESONIDE BROTIZOLAM vs BUDESONIDE\FORMOTEROL BROTIZOLAM vs BUDESONIDE\FORMOTEROL\GLYCOPYRROLATE BROTIZOLAM vs BUDESONIDE\FORMOTEROL\GLYCOPYRRONIUM BROTIZOLAM vs BUMETANIDE BROTIZOLAM vs BUPIVACAINE BROTIZOLAM vs BUPIVACAINE\BUPIVACAINE ANHYDROUS BROTIZOLAM vs BUPIVACAINE\EPINEPHRINE BROTIZOLAM vs BUPIVACAINE\MELOXICAM

Official FDA Label for BROTIZOLAM

Official prescribing information from the FDA-approved drug label.