MEXILETINE HYDROCHLORIDE

N/A

Manufactured by ANI Pharmaceuticals, Inc.

1,120 FDA adverse event reports analyzed

Last updated: 2026-04-15

About MEXILETINE HYDROCHLORIDE

MEXILETINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. The most commonly reported adverse reactions for MEXILETINE HYDROCHLORIDE include DRUG INEFFECTIVE, FATIGUE, VENTRICULAR TACHYCARDIA, DYSPNOEA, POOR QUALITY SLEEP. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MEXILETINE HYDROCHLORIDE.

Top Adverse Reactions

DRUG INEFFECTIVE42 reports
FATIGUE31 reports
VENTRICULAR TACHYCARDIA31 reports
DYSPNOEA26 reports
POOR QUALITY SLEEP24 reports
IMPAIRED WORK ABILITY23 reports
NAUSEA23 reports
IMPAIRED QUALITY OF LIFE22 reports
PYREXIA22 reports
CARDIAC FAILURE18 reports
HYPERTENSION18 reports
PNEUMONIA18 reports
CONTUSION15 reports
ALANINE AMINOTRANSFERASE INCREASED14 reports
CARDIAC FAILURE CONGESTIVE14 reports
DIARRHOEA14 reports
HERPES ZOSTER14 reports
RESPIRATORY FAILURE14 reports
CATARACT13 reports
DIZZINESS13 reports
GAMMA GLUTAMYLTRANSFERASE INCREASED13 reports
HEPATIC FUNCTION ABNORMAL13 reports
INSOMNIA13 reports
PAIN13 reports
RASH13 reports
WEIGHT INCREASED13 reports
FALL12 reports
HYPERLIPIDAEMIA12 reports
HYPOTENSION12 reports
OFF LABEL USE12 reports
ASTHENIA11 reports
BLOOD PRESSURE DECREASED11 reports
CELLULITIS11 reports
ELECTROCARDIOGRAM QT PROLONGED11 reports
GLUCOSE TOLERANCE IMPAIRED11 reports
PLEURAL EFFUSION11 reports
RENAL IMPAIRMENT11 reports
VOMITING11 reports
ANAEMIA10 reports
ANXIETY10 reports
ASPARTATE AMINOTRANSFERASE INCREASED10 reports
BLOOD ALKALINE PHOSPHATASE INCREASED10 reports
BODY TINEA10 reports
BONE DENSITY DECREASED10 reports
DEATH10 reports
DRUG ERUPTION10 reports
HYPERKALAEMIA10 reports
INFECTION SUSCEPTIBILITY INCREASED10 reports
INHIBITORY DRUG INTERACTION10 reports
ORAL HERPES10 reports
PURPURA10 reports
SKIN DISORDER10 reports
WEIGHT DECREASED10 reports
BACK PAIN9 reports
CARDIAC ARREST9 reports
DECREASED APPETITE9 reports
ERYTHEMA9 reports
LEUKOCYTOSIS9 reports
LIVER DISORDER9 reports
LOSS OF CONSCIOUSNESS9 reports
MYOCARDIAL INFARCTION9 reports
NEUROPATHY PERIPHERAL9 reports
PRURITUS9 reports
RENAL FAILURE9 reports
ARRHYTHMIA8 reports
CONDITION AGGRAVATED8 reports
DRUG INTERACTION8 reports
DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS8 reports
GENERAL PHYSICAL HEALTH DETERIORATION8 reports
HEADACHE8 reports
HYPOKALAEMIA8 reports
PAIN IN EXTREMITY8 reports
VENTRICULAR FIBRILLATION8 reports
WHITE BLOOD CELL COUNT INCREASED8 reports
ALTERED STATE OF CONSCIOUSNESS7 reports
C REACTIVE PROTEIN INCREASED7 reports
CONVULSION7 reports
DIABETES MELLITUS7 reports
HYPONATRAEMIA7 reports
INJURY7 reports
INTERSTITIAL LUNG DISEASE7 reports
JAUNDICE7 reports
NEUTROPENIA7 reports
SEPSIS7 reports
THROMBOCYTOPENIA7 reports
WHITE BLOOD CELL COUNT DECREASED7 reports
BLOOD CREATININE INCREASED6 reports
BLOOD LACTATE DEHYDROGENASE INCREASED6 reports
BLOOD PRESSURE INCREASED6 reports
DEPRESSION6 reports
DISEASE RECURRENCE6 reports
DRUG HYPERSENSITIVITY6 reports
DYSARTHRIA6 reports
ECONOMIC PROBLEM6 reports
EXTRASYSTOLES6 reports
GASTROINTESTINAL HAEMORRHAGE6 reports
HYPOAESTHESIA6 reports
MALAISE6 reports
OEDEMA PERIPHERAL6 reports
OVERDOSE6 reports

Report Outcomes

Out of 408 classified reports for MEXILETINE HYDROCHLORIDE:

Serious 92.2%Non-Serious 7.8%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male230 (59.1%)
Female158 (40.6%)
Unknown1 (0.3%)

Reports by Age

Age 5022 reports
Age 7213 reports
Age 8213 reports
Age 6412 reports
Age 6911 reports
Age 7911 reports
Age 8511 reports
Age 5610 reports
Age 7410 reports
Age 7810 reports
Age 709 reports
Age 769 reports
Age 718 reports
Age 738 reports
Age 667 reports
Age 777 reports
Age 807 reports
Age 817 reports
Age 847 reports
Age 496 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with MEXILETINE HYDROCHLORIDE?

This profile reflects 1,120 FDA FAERS reports that mention MEXILETINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for MEXILETINE HYDROCHLORIDE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, FATIGUE, VENTRICULAR TACHYCARDIA, DYSPNOEA, POOR QUALITY SLEEP, IMPAIRED WORK ABILITY. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures MEXILETINE HYDROCHLORIDE?

Labeling and FAERS entries often list ANI Pharmaceuticals, Inc. in connection with MEXILETINE HYDROCHLORIDE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.