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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.

CLOTHIAPINE: 499 Adverse Event Reports & Safety Profile

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499
Total FAERS Reports
83 (16.6%)
Deaths Reported
276
Hospitalizations
499
As Primary/Secondary Suspect
48
Life-Threatening
1
Disabilities

First Report: 20070101 · Latest Report: 20250302

What Are the Most Common CLOTHIAPINE Side Effects?

#1 Most Reported
Drug abuse
92 reports (18.4%)
#2 Most Reported
Toxicity to various agents
77 reports (15.4%)
#3 Most Reported
Sopor
74 reports (14.8%)

All CLOTHIAPINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug abuse 92 18.4% 6 67
Toxicity to various agents 77 15.4% 56 25
Sopor 74 14.8% 0 51
Intentional self-injury 57 11.4% 0 23
Intentional overdose 53 10.6% 4 29
Suicide attempt 50 10.0% 0 49
Depressed level of consciousness 42 8.4% 12 38
Coma 34 6.8% 0 24
Sudden death 29 5.8% 29 2
Off label use 25 5.0% 1 13
Agitation 24 4.8% 1 19
Neuroleptic malignant syndrome 21 4.2% 2 17
Tremor 21 4.2% 0 14
Drug interaction 18 3.6% 7 14
Confusional state 17 3.4% 0 5
Drug ineffective 17 3.4% 5 13
Hyperhidrosis 17 3.4% 0 15
Hyponatraemia 17 3.4% 0 15
Overdose 17 3.4% 3 9
Intentional product misuse 16 3.2% 0 2

Who Reports CLOTHIAPINE Side Effects? Age & Gender Data

Gender: 41.2% female, 58.8% male. Average age: 43.7 years. Most reports from: IT. View detailed demographics →

Is CLOTHIAPINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2007 2 0 1
2009 2 0 0
2011 1 0 1
2012 5 0 4
2014 12 0 6
2015 24 0 22
2016 30 2 14
2017 8 0 2
2018 49 0 20
2019 53 1 31
2020 13 0 12
2021 8 0 7
2022 24 0 20
2023 18 0 16
2024 22 0 16
2025 8 0 8

View full timeline →

What Is CLOTHIAPINE Used For?

IndicationReports
Product used for unknown indication 202
Suicide attempt 24
Psychotic disorder 23
Schizophrenia 23
Depression 19
Mental disorder 18
Bipolar disorder 16
Intentional self-injury 16
Affective disorder 11
Drug abuse 7

CLOTHIAPINE vs Alternatives: Which Is Safer?

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

Official FDA Label for CLOTHIAPINE

Official prescribing information from the FDA-approved drug label.