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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.

PRAZEPAM: 1,721 Adverse Event Reports & Safety Profile

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1,721
Total FAERS Reports
154 (8.9%)
Deaths Reported
1,080
Hospitalizations
1,721
As Primary/Secondary Suspect
237
Life-Threatening
41
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
Yes
Generic Available

FDA Application: 017415 ·

First Report: 1980 · Latest Report: 20250902

What Are the Most Common PRAZEPAM Side Effects?

#1 Most Reported
Coma
273 reports (15.9%)
#2 Most Reported
Somnolence
249 reports (14.5%)
#3 Most Reported
Toxicity to various agents
196 reports (11.4%)

All PRAZEPAM Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Coma 273 15.9% 28 169
Somnolence 249 14.5% 14 196
Toxicity to various agents 196 11.4% 39 144
Poisoning deliberate 190 11.0% 13 145
Drug abuse 180 10.5% 17 103
Hypotension 133 7.7% 5 115
Intentional overdose 115 6.7% 13 92
Fall 99 5.8% 7 88
Altered state of consciousness 93 5.4% 2 78
Confusional state 92 5.4% 8 78
Suicide attempt 82 4.8% 2 61
Miosis 74 4.3% 0 62
Drug dependence 73 4.2% 0 26
Drug use disorder 70 4.1% 0 31
Overdose 69 4.0% 19 54
Pneumonia aspiration 65 3.8% 5 40
Vomiting 64 3.7% 0 36
Tachycardia 60 3.5% 2 50
Intentional product misuse 59 3.4% 9 34
Loss of consciousness 56 3.3% 5 42

Who Reports PRAZEPAM Side Effects? Age & Gender Data

Gender: 63.2% female, 36.8% male. Average age: 48.9 years. Most reports from: FR. View detailed demographics →

Is PRAZEPAM Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 4 0 4
2005 2 0 2
2006 8 0 5
2007 1 0 0
2008 2 0 2
2009 9 0 4
2010 3 0 1
2011 7 0 6
2012 23 3 17
2013 23 0 18
2014 48 3 40
2015 73 9 63
2016 103 20 78
2017 192 8 136
2018 169 10 121
2019 155 22 91
2020 154 6 106
2021 150 8 64
2022 120 7 68
2023 98 11 53
2024 85 3 60
2025 47 0 25

View full timeline →

What Is PRAZEPAM Used For?

IndicationReports
Product used for unknown indication 712
Anxiety 291
Depression 112
Toxicity to various agents 71
Poisoning deliberate 66
Suicide attempt 51
Intentional overdose 36
Psychotic disorder 22
Mixed anxiety and depressive disorder 21
Mental disorder 17

PRAZEPAM vs Alternatives: Which Is Safer?

PRAZEPAM vs PRAZIQUANTEL PRAZEPAM vs PRAZOSIN PRAZEPAM vs PREDNICARBATE PRAZEPAM vs PREDNISOLONE PRAZEPAM vs PREDNISOLONE METAZOATE PRAZEPAM vs PREDNISOLONE\PREDNISOLONE\PREDNISOLONE PRAZEPAM vs PREDNISONE PRAZEPAM vs PREGABALIN PRAZEPAM vs PREMARIN PRAZEPAM vs PREMPRO

Official FDA Label for PRAZEPAM

Official prescribing information from the FDA-approved drug label.