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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.

CLOTIAZEPAM: 323 Adverse Event Reports & Safety Profile

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323
Total FAERS Reports
41 (12.7%)
Deaths Reported
207
Hospitalizations
323
As Primary/Secondary Suspect
47
Life-Threatening
10
Disabilities

First Report: 200610 · Latest Report: 20250830

What Are the Most Common CLOTIAZEPAM Side Effects?

#1 Most Reported
Coma
65 reports (20.1%)
#2 Most Reported
Toxicity to various agents
54 reports (16.7%)
#3 Most Reported
Somnolence
52 reports (16.1%)

All CLOTIAZEPAM Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Coma 65 20.1% 16 46
Toxicity to various agents 54 16.7% 16 34
Somnolence 52 16.1% 16 32
Suicide attempt 31 9.6% 0 29
Fall 25 7.7% 0 21
Poisoning 24 7.4% 0 18
Confusional state 21 6.5% 13 12
Dizziness 19 5.9% 0 15
Hypotension 19 5.9% 4 18
Drug use disorder 17 5.3% 5 4
Intentional overdose 17 5.3% 0 14
Cardio-respiratory arrest 16 5.0% 16 6
Cardiomyopathy 16 5.0% 16 6
Encephalopathy 16 5.0% 9 13
Hepatic cytolysis 16 5.0% 16 6
Myocarditis 16 5.0% 16 6
Overdose 16 5.0% 9 14
Vomiting 16 5.0% 0 11
Hyperglycaemia 15 4.6% 14 7
Hepatocellular injury 14 4.3% 0 12

Who Reports CLOTIAZEPAM Side Effects? Age & Gender Data

Gender: 59.2% female, 40.8% male. Average age: 50.5 years. Most reports from: FR. View detailed demographics →

Is CLOTIAZEPAM Getting Safer? Reports by Year

YearReportsDeathsHosp.
2006 5 5 0
2009 6 1 0
2012 9 5 4
2013 4 0 3
2014 5 0 5
2015 6 0 5
2016 39 10 33
2017 18 1 9
2018 32 1 30
2019 43 2 28
2020 20 1 14
2021 7 1 4
2022 13 0 4
2023 11 0 2
2024 8 0 8
2025 8 0 7

View full timeline →

What Is CLOTIAZEPAM Used For?

IndicationReports
Product used for unknown indication 133
Anxiety 38
Suicide attempt 21
Depression 15
Agitation 7
Mixed anxiety and depressive disorder 6
Seizure 6
Skin test 6
Sedation 5

CLOTIAZEPAM vs Alternatives: Which Is Safer?

CLOTIAZEPAM vs CLOTRIMAZOLE CLOTIAZEPAM vs CLOXACILLIN CLOTIAZEPAM vs CLOXAZOLAM CLOTIAZEPAM vs CLOZAPINE CLOTIAZEPAM vs CLOZARIL CLOTIAZEPAM vs COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTEIN C\PROTEIN S HUMAN\PROTHROMBIN CLOTIAZEPAM vs COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN CLOTIAZEPAM vs COAGULATION FACTOR IX RECOMBINANT HUMAN CLOTIAZEPAM vs COAGULATION FACTOR IX RECOMBINANT HUMAN\ISOPROPYL ALCOHOL CLOTIAZEPAM vs COAGULATION FACTOR VIIA RECOMBINANT HUMAN

Official FDA Label for CLOTIAZEPAM

Official prescribing information from the FDA-approved drug label.