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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.

SULTHIAME: 250 Adverse Event Reports & Safety Profile

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250
Total FAERS Reports
10 (4.0%)
Deaths Reported
78
Hospitalizations
250
As Primary/Secondary Suspect
25
Life-Threatening
6
Disabilities

First Report: 1968 · Latest Report: 20240101

What Are the Most Common SULTHIAME Side Effects?

#1 Most Reported
Drug ineffective
119 reports (47.6%)
#2 Most Reported
Epilepsy
69 reports (27.6%)
#3 Most Reported
Off label use
63 reports (25.2%)

All SULTHIAME Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 119 47.6% 0 40
Epilepsy 69 27.6% 0 34
Off label use 63 25.2% 1 23
Seizure 58 23.2% 0 10
Aggression 44 17.6% 8 16
Fatigue 34 13.6% 8 12
Generalised tonic-clonic seizure 32 12.8% 0 1
Multiple-drug resistance 31 12.4% 0 3
Suicidal ideation 24 9.6% 0 1
Electroencephalogram abnormal 23 9.2% 0 2
General physical health deterioration 23 9.2% 0 0
Gait disturbance 22 8.8% 0 5
Tremor 21 8.4% 0 0
Cognitive disorder 20 8.0% 0 0
Rash 20 8.0% 0 0
Behaviour disorder 19 7.6% 0 0
Status epilepticus 19 7.6% 0 0
Depression 18 7.2% 0 0
Nightmare 18 7.2% 0 0
Panic attack 18 7.2% 0 0

Who Reports SULTHIAME Side Effects? Age & Gender Data

Gender: 67.1% female, 32.9% male. Average age: 11.6 years. Most reports from: DE. View detailed demographics →

Is SULTHIAME Getting Safer? Reports by Year

YearReportsDeathsHosp.
2011 11 0 0
2012 1 0 1
2013 2 0 0
2014 1 0 1
2015 2 1 0
2016 35 0 12
2017 9 0 3
2018 24 8 20
2019 1 0 1
2020 2 0 1
2022 5 0 5
2024 2 0 2

View full timeline →

What Is SULTHIAME Used For?

IndicationReports
Epilepsy 96
Seizure 35
Partial seizures 26
Generalised tonic-clonic seizure 24
Product used for unknown indication 21
Occipital lobe epilepsy 18
Status epilepticus 10
Csws syndrome 5

SULTHIAME vs Alternatives: Which Is Safer?

SULTHIAME vs SUMATRIPTAN SULTHIAME vs SUMATRIPTAN\SUMATRIPTAN SULTHIAME vs SUMAVEL DOSEPRO SULTHIAME vs SUNITINIB SULTHIAME vs SUNITINIB MALATE SULTHIAME vs SUTENT SULTHIAME vs SUTIMLIMAB-JOME SULTHIAME vs SUVOREXANT SULTHIAME vs SUZETRIGINE SULTHIAME vs SYMBICORT

Official FDA Label for SULTHIAME

Official prescribing information from the FDA-approved drug label.