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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.

FLUNITRAZEPAM: 944 Adverse Event Reports & Safety Profile

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944
Total FAERS Reports
285 (30.2%)
Deaths Reported
442
Hospitalizations
944
As Primary/Secondary Suspect
110
Life-Threatening
26
Disabilities

First Report: 19920901 · Latest Report: 20250717

What Are the Most Common FLUNITRAZEPAM Side Effects?

#1 Most Reported
Toxicity to various agents
177 reports (18.8%)
#2 Most Reported
Overdose
141 reports (14.9%)
#3 Most Reported
Intentional overdose
96 reports (10.2%)

All FLUNITRAZEPAM Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Toxicity to various agents 177 18.8% 113 48
Overdose 141 14.9% 56 77
Intentional overdose 96 10.2% 27 58
Suicide attempt 67 7.1% 4 50
Altered state of consciousness 65 6.9% 0 53
Off label use 58 6.1% 15 27
Neuroleptic malignant syndrome 55 5.8% 5 42
Drug interaction 41 4.3% 29 9
Somnolence 41 4.3% 7 23
Completed suicide 40 4.2% 40 2
Drug ineffective 39 4.1% 2 20
Drug abuse 36 3.8% 21 14
Loss of consciousness 36 3.8% 10 23
Pneumonia aspiration 36 3.8% 4 29
Rhabdomyolysis 36 3.8% 4 31
Death 33 3.5% 33 5
Pneumonia 33 3.5% 20 14
Pyrexia 33 3.5% 9 21
Suicidal ideation 32 3.4% 4 21
Fatigue 30 3.2% 0 16

Who Reports FLUNITRAZEPAM Side Effects? Age & Gender Data

Gender: 51.9% female, 48.1% male. Average age: 47.9 years. Most reports from: JP. View detailed demographics →

Is FLUNITRAZEPAM Getting Safer? Reports by Year

YearReportsDeathsHosp.
2002 1 0 0
2003 2 2 1
2004 4 3 1
2005 1 0 1
2006 4 2 2
2007 11 7 2
2008 4 0 1
2009 5 1 4
2010 4 0 2
2011 5 1 3
2012 10 1 4
2013 29 8 8
2014 41 3 33
2015 34 5 24
2016 61 8 35
2017 35 4 22
2018 38 10 21
2019 18 3 7
2020 10 1 9
2021 15 1 9
2022 12 4 5
2023 10 1 6
2024 5 1 4
2025 3 1 1

View full timeline →

What Is FLUNITRAZEPAM Used For?

IndicationReports
Product used for unknown indication 427
Insomnia 113
Schizophrenia 54
Depression 41
Sleep disorder 26
Anxiolytic therapy 17
Suicide attempt 15
Sedation 10
Affective disorder 7
Agitation 6

FLUNITRAZEPAM vs Alternatives: Which Is Safer?

FLUNITRAZEPAM vs FLUOCINOLONE FLUNITRAZEPAM vs FLUOCINOLONE ACETONIDE FLUNITRAZEPAM vs FLUOCINOLONE ACETONIDE\HYDROQUINONE\TRETINOIN FLUNITRAZEPAM vs FLUOCINONIDE FLUNITRAZEPAM vs FLUORESCEIN FLUNITRAZEPAM vs FLUOROMETHOLONE FLUNITRAZEPAM vs FLUOROURACIL FLUNITRAZEPAM vs FLUOROURACIL\IRINOTECAN\LEUCOVORIN FLUNITRAZEPAM vs FLUOROURACIL\IRINOTECAN\LEUCOVORIN\OXALIPLATIN FLUNITRAZEPAM vs FLUOROURACIL\LEUCOVORIN\OXALIPLATIN

Official FDA Label for FLUNITRAZEPAM

Official prescribing information from the FDA-approved drug label.