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ethosuximide Side Effects

Also known as: Zarontin

Analysis of 2,415 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

2,415

Death-Related

62

2.6% of reports

Hospitalizations

568

23.5% of reports

Top Indication

Epilepsy

Most Reported Adverse Reactions

DRUG INEFFECTIVE
498
SEIZURE
347
OFF LABEL USE
225
SOMNOLENCE
146
GENERALISED TONIC-CLONIC SEIZURE
140
PETIT MAL EPILEPSY
117
TREATMENT FAILURE
114
DRUG INTERACTION
113
FATIGUE
109
EPILEPSY
105
MULTIPLE-DRUG RESISTANCE
101
CONDITION AGGRAVATED
99
VOMITING
95
STATUS EPILEPTICUS
89
DECREASED APPETITE
81
AGGRESSION
75
CONVULSION
74
ATAXIA
73
HEADACHE
70
NAUSEA
69

Who Reports Side Effects

Gender Distribution

Female 1,173 (58%)
Male 846 (42%)
Unknown 11

Age Distribution

0-17 969 (61%)
18-44 417 (26%)
45-64 131 (8%)
65-74 40 (3%)
75+ 28 (2%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 62 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
SEIZURE 13
OFF LABEL USE 11
DEATH 10
SOMNOLENCE 10
ABNORMAL WEIGHT GAIN 9
COLON CANCER 9
DYSKINESIA 9
DYSPNOEA 9
FEELING HOT 9
GYNAECOMASTIA 9
HYPERHIDROSIS 9
POLLAKIURIA 9
RESPIRATORY FAILURE 9
HYPOTENSION 8
INSOMNIA 8
LUNG NEOPLASM MALIGNANT 8
PRODUCT USE IN UNAPPROVED INDICATION 8
RASH PRURITIC 8
VOMITING 8
INCREASED APPETITE 7

Reactions in Hospitalization Reports

Top reactions in 568 reports where hospitalization was an outcome.

Reaction Reports
SEIZURE 92
DRUG INEFFECTIVE 84
OFF LABEL USE 54
DRUG INTERACTION 39
SOMNOLENCE 38
VOMITING 38
EPILEPSY 32
GENERALISED TONIC-CLONIC SEIZURE 31
STATUS EPILEPTICUS 29
PETIT MAL EPILEPSY 28
NAUSEA 25
PYREXIA 24
DECREASED APPETITE 23
DEPRESSED LEVEL OF CONSCIOUSNESS 22
DIZZINESS 19
FALL 19
PNEUMONIA 19
ATAXIA 18
CONVULSION 18
PRODUCT USE IN UNAPPROVED INDICATION 18

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What the FAERS Data Reveals About ethosuximide Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 2,415 voluntary reports linked to ethosuximide and its brand equivalents (Zarontin), spanning 2004 through 2025. Of those, 62 (2.6%) listed death as an outcome and 568 (23.5%) involved hospitalization. The most common indication reported alongside adverse events was Epilepsy.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 58% were female and 42% male; age distribution skews toward 0-17, with 969 reports in that bracket. The single most reported reaction is drug ineffective with 498 submissions, followed by seizure and off label use.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.