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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.

CLOMETHIAZOLE: 229 Adverse Event Reports & Safety Profile

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Boost Your Brain
229
Total FAERS Reports
46 (20.1%)
Deaths Reported
154
Hospitalizations
229
As Primary/Secondary Suspect
77
Life-Threatening
17
Disabilities

First Report: 19991208 · Latest Report: 20250426

What Are the Most Common CLOMETHIAZOLE Side Effects?

#1 Most Reported
Abdominal pain
29 reports (12.7%)
#2 Most Reported
Fall
27 reports (11.8%)
#3 Most Reported
Nausea
26 reports (11.4%)

All CLOMETHIAZOLE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Abdominal pain 29 12.7% 24 27
Fall 27 11.8% 3 25
Nausea 26 11.4% 25 25
Abdominal distension 25 10.9% 25 24
White blood cell count increased 23 10.0% 21 20
Dementia 22 9.6% 21 20
Subileus 22 9.6% 22 21
Abdominal tenderness 21 9.2% 21 20
Faecaloma 21 9.2% 21 21
Gastrointestinal sounds abnormal 21 9.2% 21 20
Ileus 21 9.2% 21 20
Pancreatitis 21 9.2% 21 20
Vascular encephalopathy 21 9.2% 21 20
Intentional overdose 20 8.7% 0 14
Bladder disorder 18 7.9% 18 17
Intentional self-injury 18 7.9% 0 13
General physical health deterioration 17 7.4% 5 14
Toxic epidermal necrolysis 17 7.4% 0 13
Toxicity to various agents 16 7.0% 1 13
Agitation 13 5.7% 0 3

Who Reports CLOMETHIAZOLE Side Effects? Age & Gender Data

Gender: 52.7% female, 47.3% male. Average age: 66.2 years. Most reports from: DE. View detailed demographics →

Is CLOMETHIAZOLE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2005 8 0 8
2008 1 0 1
2009 23 23 22
2012 3 0 3
2013 4 0 4
2014 7 1 5
2015 7 0 3
2016 3 0 3
2017 31 3 26
2018 19 0 6
2019 11 3 7
2020 13 0 8
2021 17 3 7
2022 3 0 1
2023 3 0 1
2024 13 0 12
2025 10 1 10

View full timeline →

What Is CLOMETHIAZOLE Used For?

IndicationReports
Product used for unknown indication 101
Anxiety 16
Sleep disorder 13
Premedication 12
Alcohol withdrawal syndrome 8
Bipolar disorder 8
Insomnia 7
Schizophrenia 6

CLOMETHIAZOLE vs Alternatives: Which Is Safer?

CLOMETHIAZOLE vs CLOMIPHENE CLOMETHIAZOLE vs CLOMIPRAMINE CLOMETHIAZOLE vs CLONAZEPAM CLOMETHIAZOLE vs CLONIDINE CLOMETHIAZOLE vs CLOPIDOGREL CLOMETHIAZOLE vs CLOPIDOGREL BESILATE CLOMETHIAZOLE vs CLOPIDOGREL BISULFATE CLOMETHIAZOLE vs CLORAZEPATE CLOMETHIAZOLE vs CLOSTRIDIUM TETANI TOXOID ANTIGEN CLOMETHIAZOLE vs CLOTHIAPINE

Official FDA Label for CLOMETHIAZOLE

Official prescribing information from the FDA-approved drug label.