mexiletine Side Effects
Also known as: Mexitil
Analysis of 408 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
408
Death-Related
75
18.4% of reports
Hospitalizations
253
62.0% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 75 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| PNEUMONIA | 11 |
| DEATH | 10 |
| CARDIAC ARREST | 8 |
| CARDIAC FAILURE | 8 |
| NAUSEA | 8 |
| CARDIAC FAILURE CONGESTIVE | 7 |
| PAIN | 7 |
| DYSPNOEA | 6 |
| RENAL FAILURE | 6 |
| THROMBOCYTOPENIA | 6 |
| VOMITING | 6 |
| ANAEMIA | 5 |
| ANXIETY | 5 |
| ECONOMIC PROBLEM | 5 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 5 |
| RESPIRATORY FAILURE | 5 |
| VENTRICULAR TACHYCARDIA | 5 |
| ASTHENIA | 4 |
| HEADACHE | 4 |
| HYPERTENSION | 4 |
Reactions in Hospitalization Reports
Top reactions in 253 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| FATIGUE | 31 |
| DRUG INEFFECTIVE | 29 |
| POOR QUALITY SLEEP | 24 |
| IMPAIRED WORK ABILITY | 23 |
| IMPAIRED QUALITY OF LIFE | 22 |
| DYSPNOEA | 20 |
| VENTRICULAR TACHYCARDIA | 20 |
| PYREXIA | 18 |
| HYPERTENSION | 17 |
| PNEUMONIA | 15 |
| CONTUSION | 13 |
| HERPES ZOSTER | 13 |
| NAUSEA | 13 |
| CARDIAC FAILURE | 12 |
| CARDIAC FAILURE CONGESTIVE | 12 |
| CATARACT | 12 |
| INSOMNIA | 12 |
| RESPIRATORY FAILURE | 12 |
| WEIGHT INCREASED | 12 |
| ALANINE AMINOTRANSFERASE INCREASED | 11 |
Nearby — Related Medications
What the FAERS Data Reveals About mexiletine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 408 voluntary reports linked to mexiletine and its brand equivalents (Mexitil), spanning 2004 through 2025. Of those, 75 (18.4%) listed death as an outcome and 253 (62.0%) 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, 41% were female and 59% male; age distribution skews toward 75+, with 107 reports in that bracket. The single most reported reaction is drug ineffective with 42 submissions, followed by fatigue and ventricular tachycardia.
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.
Read our methodology — how this data is sourced, computed, and verified.