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lacosamide Side Effects

Also known as: Vimpat

Analysis of 35,350 adverse event reports submitted to the FDA from 2007 to 2025.

Total Reports

35,350

Death-Related

3,025

8.6% of reports

Hospitalizations

12,020

34.0% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

SEIZURE
6,507
DRUG INEFFECTIVE
3,936
OFF LABEL USE
3,757
DIZZINESS
1,612
SOMNOLENCE
1,404
FATIGUE
1,376
FALL
1,337
EPILEPSY
1,336
STATUS EPILEPTICUS
1,220
OVERDOSE
1,207
GENERALISED TONIC-CLONIC SEIZURE
1,123
DEATH
1,047
HEADACHE
1,028
DRUG INTERACTION
956
CONVULSION
937
NAUSEA
913
VOMITING
881
MULTIPLE-DRUG RESISTANCE
782
TREMOR
702
CONDITION AGGRAVATED
696

Who Reports Side Effects

Gender Distribution

Female 16,238 (55%)
Male 13,350 (45%)
Unknown 162

Age Distribution

0-17 3,577 (17%)
18-44 7,367 (35%)
45-64 5,496 (26%)
65-74 2,556 (12%)
75+ 2,150 (10%)

Reporting Trend by Year

2007 2025

Reactions in Death Reports

Top reactions reported in 3,025 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 1,046
OFF LABEL USE 374
DRUG INEFFECTIVE 298
SEIZURE 253
TOXICITY TO VARIOUS AGENTS 177
CARDIAC ARREST 172
STATUS EPILEPTICUS 170
COMPLETED SUICIDE 150
PNEUMONIA 122
CARDIO-RESPIRATORY ARREST 109
SUDDEN UNEXPLAINED DEATH IN EPILEPSY 101
MULTIPLE-DRUG RESISTANCE 84
OVERDOSE 82
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION 81
EPILEPSY 81
GENERAL PHYSICAL HEALTH DETERIORATION 77
SEPSIS 77
METABOLIC ACIDOSIS 75
FALL 73
PNEUMONIA ASPIRATION 73

Reactions in Hospitalization Reports

Top reactions in 12,020 reports where hospitalization was an outcome.

Reaction Reports
SEIZURE 2,541
DRUG INEFFECTIVE 1,445
OFF LABEL USE 1,392
STATUS EPILEPTICUS 728
FALL 713
EPILEPSY 519
HOSPITALISATION 497
OVERDOSE 497
SOMNOLENCE 481
DRUG INTERACTION 466
PNEUMONIA 457
VOMITING 453
DIZZINESS 440
GENERALISED TONIC-CLONIC SEIZURE 420
FATIGUE 405
CONVULSION 393
PYREXIA 367
TOXICITY TO VARIOUS AGENTS 351
HEADACHE 342
NAUSEA 325

Nearby — Related Medications

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What the FAERS Data Reveals About lacosamide Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 35,350 voluntary reports linked to lacosamide and its brand equivalents (Vimpat), spanning 2007 through 2025. Of those, 3,025 (8.6%) listed death as an outcome and 12,020 (34.0%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 55% were female and 45% male; age distribution skews toward 18-44, with 7,367 reports in that bracket. The single most reported reaction is seizure with 6,507 submissions, followed by drug ineffective 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.