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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.

STIRIPENTOL: 1,350 Adverse Event Reports & Safety Profile

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1,350
Total FAERS Reports
65 (4.8%)
Deaths Reported
437
Hospitalizations
1,350
As Primary/Secondary Suspect
33
Life-Threatening
6
Disabilities
Aug 20, 2018
FDA Approved
Prescription
Status

FDA Application: 206709 ·

First Report: 19850101 · Latest Report: 20250909

What Are the Most Common STIRIPENTOL Side Effects?

#1 Most Reported
Seizure
586 reports (43.4%)
#2 Most Reported
Product use in unapproved indication
343 reports (25.4%)
#3 Most Reported
Drug ineffective
193 reports (14.3%)

All STIRIPENTOL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Seizure 586 43.4% 8 223
Product use in unapproved indication 343 25.4% 12 137
Drug ineffective 193 14.3% 16 43
Product dose omission issue 157 11.6% 3 65
Decreased appetite 147 10.9% 1 46
Somnolence 139 10.3% 3 40
Product preparation issue 129 9.6% 3 52
Off label use 107 7.9% 7 36
Fatigue 95 7.0% 0 22
Hospitalisation 63 4.7% 1 62
Pyrexia 61 4.5% 6 28
Pneumonia 56 4.2% 2 44
Weight decreased 54 4.0% 0 16
Condition aggravated 50 3.7% 0 15
Change in seizure presentation 47 3.5% 4 10
Fall 46 3.4% 1 13
Vomiting 44 3.3% 1 25
No adverse event 43 3.2% 0 7
Sleep disorder 40 3.0% 0 6
Behaviour disorder 38 2.8% 0 9

Who Reports STIRIPENTOL Side Effects? Age & Gender Data

Gender: 50.2% female, 49.8% male. Average age: 12.2 years. Most reports from: US. View detailed demographics →

Is STIRIPENTOL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2007 1 0 1
2008 3 0 3
2009 3 0 1
2010 2 0 1
2011 1 0 1
2013 1 0 1
2014 2 0 2
2015 6 1 3
2016 2 0 1
2017 12 0 5
2018 27 1 11
2019 114 5 42
2020 39 1 21
2021 50 3 26
2022 53 5 25
2023 64 2 23
2024 48 0 19
2025 25 2 9

View full timeline →

What Is STIRIPENTOL Used For?

IndicationReports
Severe myoclonic epilepsy of infancy 850
Epilepsy 199
Product used for unknown indication 134
Lennox-gastaut syndrome 46
Seizure 46
Status epilepticus 36
Idiopathic generalised epilepsy 34
Partial seizures 23
Generalised tonic-clonic seizure 15
Epileptic encephalopathy 13

STIRIPENTOL vs Alternatives: Which Is Safer?

STIRIPENTOL vs STIVARGA STIRIPENTOL vs STRATTERA STIRIPENTOL vs STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN\STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN\STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN\STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN\STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE A STIRIPENTOL vs STREPTOMYCIN STIRIPENTOL vs STREPTOMYCIN\STREPTOMYCIN STIRIPENTOL vs STREPTOZOCIN STIRIPENTOL vs STRIBILD STIRIPENTOL vs SUBOXONE STIRIPENTOL vs SUBUTEX STIRIPENTOL vs SUCCINYLCHOLINE

Official FDA Label for STIRIPENTOL

Official prescribing information from the FDA-approved drug label.