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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.

NITRAZEPAM: 1,165 Adverse Event Reports & Safety Profile

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1,165
Total FAERS Reports
365 (31.3%)
Deaths Reported
466
Hospitalizations
1,165
As Primary/Secondary Suspect
92
Life-Threatening
34
Disabilities

First Report: 1971 · Latest Report: 20250313

What Are the Most Common NITRAZEPAM Side Effects?

#1 Most Reported
Toxicity to various agents
228 reports (19.6%)
#2 Most Reported
Suicide attempt
105 reports (9.0%)
#3 Most Reported
Intentional overdose
102 reports (8.8%)

All NITRAZEPAM Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Toxicity to various agents 228 19.6% 170 53
Suicide attempt 105 9.0% 4 44
Chest discomfort 102 8.8% 80 22
Intentional overdose 102 8.8% 14 51
Drug ineffective 101 8.7% 5 31
Fall 95 8.2% 15 73
Somnolence 93 8.0% 12 28
Drug abuse 86 7.4% 42 34
Overdose 74 6.4% 33 47
Off label use 70 6.0% 7 28
Fatigue 59 5.1% 1 26
Loss of consciousness 53 4.6% 16 36
Pulmonary oedema 50 4.3% 18 33
Weight increased 48 4.1% 0 25
Dyspnoea 47 4.0% 1 25
Myocardial infarction 43 3.7% 13 29
Tachycardia 41 3.5% 0 34
Asthma 40 3.4% 0 38
Dizziness 40 3.4% 1 26
Memory impairment 39 3.4% 0 7

Who Reports NITRAZEPAM Side Effects? Age & Gender Data

Gender: 54.1% female, 45.9% male. Average age: 51.2 years. Most reports from: JP. View detailed demographics →

Is NITRAZEPAM Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 1
2002 1 0 1
2004 1 1 0
2006 2 2 0
2007 2 1 0
2008 6 0 0
2009 6 1 4
2010 5 0 4
2011 4 3 2
2012 8 1 5
2013 10 2 3
2014 34 13 16
2015 23 7 15
2016 39 4 31
2017 40 10 17
2018 79 7 70
2019 33 15 13
2020 54 6 24
2021 40 6 21
2022 33 10 18
2023 4 0 1
2024 15 0 3
2025 3 0 1

View full timeline →

What Is NITRAZEPAM Used For?

IndicationReports
Product used for unknown indication 573
Insomnia 86
Epilepsy 41
Sleep disorder 37
Depression 32
Seizure 22
Myoclonic epilepsy 17
Pain 17
Lennox-gastaut syndrome 16
Partial seizures 15

NITRAZEPAM vs Alternatives: Which Is Safer?

NITRAZEPAM vs NITRENDIPINE NITRAZEPAM vs NITRIC NITRAZEPAM vs NITROFURANTOIN NITRAZEPAM vs NITROFURANTOIN\NITROFURANTOIN NITRAZEPAM vs NITROFURAZONE NITRAZEPAM vs NITROGLYCERIN NITRAZEPAM vs NITROUS NITRAZEPAM vs NITROUS\OXYGEN NITRAZEPAM vs NIVOLUMAB NITRAZEPAM vs NIVOLUMAB\RELATLIMAB-RMBW

Official FDA Label for NITRAZEPAM

Official prescribing information from the FDA-approved drug label.