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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.

THIOPENTAL: 1,048 Adverse Event Reports & Safety Profile

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1,048
Total FAERS Reports
211 (20.1%)
Deaths Reported
428
Hospitalizations
1,048
As Primary/Secondary Suspect
187
Life-Threatening
33
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status

FDA Application: 011679 ·

First Report: 19740706 · Latest Report: 20250716

What Are the Most Common THIOPENTAL Side Effects?

#1 Most Reported
Drug ineffective
266 reports (25.4%)
#2 Most Reported
Off label use
150 reports (14.3%)
#3 Most Reported
Status epilepticus
93 reports (8.9%)

All THIOPENTAL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 266 25.4% 57 168
Off label use 150 14.3% 52 93
Status epilepticus 93 8.9% 44 54
Hypotension 82 7.8% 16 35
Maternal exposure during pregnancy 74 7.1% 17 26
Foetal exposure during pregnancy 70 6.7% 28 10
Exposure during pregnancy 64 6.1% 7 26
Product use in unapproved indication 63 6.0% 24 37
Diabetes insipidus 55 5.3% 29 18
Drug hypersensitivity 45 4.3% 0 13
Loss of consciousness 44 4.2% 15 28
Seizure 44 4.2% 18 29
Multiple-drug resistance 43 4.1% 12 23
Intensive care unit acquired weakness 41 3.9% 14 41
Foetal death 40 3.8% 14 17
Drug ineffective for unapproved indication 39 3.7% 17 23
Infection 38 3.6% 14 36
Renal impairment 38 3.6% 14 16
Left ventricular dysfunction 37 3.5% 13 16
Multiple organ dysfunction syndrome 37 3.5% 26 30

Who Reports THIOPENTAL Side Effects? Age & Gender Data

Gender: 58.5% female, 41.5% male. Average age: 31.5 years. Most reports from: CA. View detailed demographics →

Is THIOPENTAL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2001 8 0 4
2006 2 0 0
2007 2 0 1
2008 2 2 1
2009 2 1 0
2011 2 0 0
2012 9 0 5
2013 1 0 0
2014 20 2 11
2015 12 1 5
2016 11 1 7
2017 10 1 2
2018 21 1 3
2019 23 5 9
2020 6 2 4
2021 11 1 2
2022 4 0 4
2023 6 0 0
2024 9 9 0
2025 6 0 4

View full timeline →

What Is THIOPENTAL Used For?

IndicationReports
Status epilepticus 223
Induction of anaesthesia 163
Product used for unknown indication 114
Anaesthesia 105
Seizure 88
Endotracheal intubation 68
General anaesthesia 56
Epilepsy 37
Foetal exposure during pregnancy 29
Sedation 29

THIOPENTAL vs Alternatives: Which Is Safer?

THIOPENTAL vs THIORIDAZINE THIOPENTAL vs THIOTEPA THIOPENTAL vs THIOTHIXENE THIOPENTAL vs THROMBIN THIOPENTAL vs THROMBIN HUMAN THIOPENTAL vs THYMOCYTE IMMUNE GLOBULIN NOS THIOPENTAL vs THYMOGLOBULINE THIOPENTAL vs THYMOL THIOPENTAL vs THYROID, PORCINE THIOPENTAL vs THYROID, PORCINE\THYROID, UNSPECIFIED

Official FDA Label for THIOPENTAL

Official prescribing information from the FDA-approved drug label.