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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.

EPILIM: 93 Adverse Event Reports & Safety Profile

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93
Total FAERS Reports
11 (11.8%)
Deaths Reported
45
Hospitalizations
93
As Primary/Secondary Suspect
10
Life-Threatening
12
Disabilities

First Report: 19870726 · Latest Report: 20140501

What Are the Most Common EPILIM Side Effects?

#1 Most Reported
Convulsion
28 reports (30.1%)
#2 Most Reported
Foetal exposure during pregnancy
21 reports (22.6%)
#3 Most Reported
Somnolence
15 reports (16.1%)

All EPILIM Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Convulsion 28 30.1% 1 15
Foetal exposure during pregnancy 21 22.6% 9 2
Somnolence 15 16.1% 0 14
Asthenia 9 9.7% 0 9
Confusional state 9 9.7% 0 9
Hyponatraemia 9 9.7% 0 9
Accidental overdose 8 8.6% 0 8
Blood ketone body increased 8 8.6% 0 8
Cerebral haemorrhage 8 8.6% 0 8
Dehydration 8 8.6% 0 8
Disturbance in attention 8 8.6% 0 7
Fall 8 8.6% 0 8
Pyrexia 8 8.6% 0 8
Urinary tract infection 8 8.6% 0 8
Ataxia 7 7.5% 0 6
Overdose 7 7.5% 0 7
Reaction to drug excipients 7 7.5% 0 7
Sedation 7 7.5% 0 7
Drug administered to patient of inappropriate age 6 6.5% 0 6
Drug interaction 6 6.5% 0 0

Who Reports EPILIM Side Effects? Age & Gender Data

Average age: 51.8 years. Most reports from: GB. View detailed demographics →

Is EPILIM Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 0
2003 6 0 6
2004 1 0 1
2006 3 0 1
2007 1 0 0
2012 4 2 2
2013 5 0 4
2014 16 0 10

View full timeline →

What Is EPILIM Used For?

IndicationReports
Product used for unknown indication 35
Maternal exposure timing unspecified 18
Epilepsy 14
Mood altered 9

Official FDA Label for EPILIM

Official prescribing information from the FDA-approved drug label.