FLECAINIDE ACETATE

N/A

Manufactured by ANI Pharmaceuticals, Inc.

9,204 FDA adverse event reports analyzed

Last updated: 2026-04-15

About FLECAINIDE ACETATE

FLECAINIDE ACETATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. The most commonly reported adverse reactions for FLECAINIDE ACETATE include ATRIAL FIBRILLATION, FATIGUE, DYSPNOEA, DIZZINESS, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FLECAINIDE ACETATE.

Top Adverse Reactions

ATRIAL FIBRILLATION337 reports
FATIGUE275 reports
DYSPNOEA270 reports
DIZZINESS255 reports
NAUSEA244 reports
DRUG INEFFECTIVE214 reports
HEADACHE210 reports
DIARRHOEA205 reports
ASTHENIA198 reports
FALL179 reports
DRUG INTERACTION169 reports
TOXICITY TO VARIOUS AGENTS169 reports
HYPOTENSION168 reports
MALAISE163 reports
COUGH130 reports
VOMITING126 reports
ARTHRALGIA120 reports
PAIN116 reports
RASH116 reports
OFF LABEL USE114 reports
PRURITUS111 reports
BRADYCARDIA109 reports
PYREXIA108 reports
PALPITATIONS105 reports
ELECTROCARDIOGRAM QRS COMPLEX PROLONGED104 reports
SYNCOPE103 reports
LOSS OF CONSCIOUSNESS101 reports
DEATH99 reports
ARRHYTHMIA96 reports
BACK PAIN96 reports
ABDOMINAL PAIN95 reports
WEIGHT DECREASED95 reports
CARDIAC ARREST94 reports
PNEUMONIA93 reports
VENTRICULAR TACHYCARDIA93 reports
TACHYCARDIA92 reports
PAIN IN EXTREMITY90 reports
ANAEMIA88 reports
FEELING ABNORMAL88 reports
ELECTROCARDIOGRAM QT PROLONGED87 reports
HYPONATRAEMIA86 reports
CONDITION AGGRAVATED85 reports
HYPERTENSION82 reports
OVERDOSE82 reports
CONSTIPATION81 reports
ABDOMINAL DISCOMFORT80 reports
HEART RATE INCREASED80 reports
URINARY TRACT INFECTION78 reports
BLOOD PRESSURE INCREASED77 reports
ABDOMINAL PAIN UPPER76 reports
DECREASED APPETITE73 reports
CHEST PAIN72 reports
ATRIAL FLUTTER71 reports
PRODUCT DOSE OMISSION ISSUE71 reports
CONFUSIONAL STATE70 reports
RENAL FAILURE70 reports
GAIT DISTURBANCE68 reports
SOMNOLENCE66 reports
ACUTE KIDNEY INJURY65 reports
MUSCULAR WEAKNESS63 reports
VISION BLURRED62 reports
DEHYDRATION60 reports
INSOMNIA60 reports
THROMBOCYTOPENIA60 reports
COVID 1959 reports
TREMOR58 reports
HEART RATE DECREASED57 reports
MYALGIA57 reports
ERYTHEMA56 reports
ANXIETY55 reports
INTERNATIONAL NORMALISED RATIO INCREASED54 reports
HEART RATE IRREGULAR52 reports
CARDIAC DISORDER51 reports
COMPLETED SUICIDE51 reports
HYPERHIDROSIS51 reports
CARDIAC FAILURE50 reports
HAEMOGLOBIN DECREASED50 reports
INTENTIONAL OVERDOSE49 reports
INTERSTITIAL LUNG DISEASE49 reports
CARDIO RESPIRATORY ARREST48 reports
CHEST DISCOMFORT48 reports
CONTUSION48 reports
HYPERSENSITIVITY47 reports
WEIGHT INCREASED47 reports
DRUG HYPERSENSITIVITY46 reports
FLUSHING46 reports
VISUAL IMPAIRMENT46 reports
ALOPECIA45 reports
EPISTAXIS45 reports
BRONCHITIS44 reports
GASTROINTESTINAL DISORDER44 reports
ILLNESS44 reports
NASOPHARYNGITIS44 reports
PERIPHERAL SWELLING44 reports
JOINT SWELLING43 reports
OEDEMA PERIPHERAL43 reports
RENAL FAILURE ACUTE43 reports
URTICARIA43 reports
BALANCE DISORDER42 reports
DEPRESSION42 reports

Report Outcomes

Out of 4,983 classified reports for FLECAINIDE ACETATE:

Serious 74.9%Non-Serious 25.1%

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

Female2,717 (58.0%)
Male1,961 (41.9%)
Unknown7 (0.1%)

Reports by Age

Age 70138 reports
Age 72136 reports
Age 77133 reports
Age 76123 reports
Age 75121 reports
Age 71120 reports
Age 74113 reports
Age 69107 reports
Age 73107 reports
Age 80104 reports
Age 68101 reports
Age 6495 reports
Age 6594 reports
Age 7991 reports
Age 7887 reports
Age 6686 reports
Age 6783 reports
Age 6278 reports
Age 6377 reports
Age 8171 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 FLECAINIDE ACETATE?

This profile reflects 9,204 FDA FAERS reports that mention FLECAINIDE ACETATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for FLECAINIDE ACETATE?

Frequently reported terms in FAERS include ATRIAL FIBRILLATION, FATIGUE, DYSPNOEA, DIZZINESS, NAUSEA, DRUG INEFFECTIVE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures FLECAINIDE ACETATE?

Labeling and FAERS entries often list ANI Pharmaceuticals, Inc. in connection with FLECAINIDE ACETATE. 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.