PROPAFENONE HYDROCHLORIDE

N/A

Manufactured by Actavis Pharma, Inc.

4,618 FDA adverse event reports analyzed

Last updated: 2026-04-15

About PROPAFENONE HYDROCHLORIDE

PROPAFENONE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Actavis Pharma, Inc.. The most commonly reported adverse reactions for PROPAFENONE HYDROCHLORIDE include ATRIAL FIBRILLATION, DIZZINESS, DRUG INEFFECTIVE, NAUSEA, HYPOTENSION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PROPAFENONE HYDROCHLORIDE.

Top Adverse Reactions

ATRIAL FIBRILLATION217 reports
DIZZINESS148 reports
DRUG INEFFECTIVE141 reports
NAUSEA132 reports
HYPOTENSION124 reports
DYSPNOEA121 reports
FATIGUE108 reports
ASTHENIA98 reports
DRUG INTERACTION92 reports
FALL88 reports
ARRHYTHMIA85 reports
VOMITING79 reports
DIARRHOEA77 reports
BRADYCARDIA75 reports
HEADACHE75 reports
PRODUCT QUALITY ISSUE70 reports
COMPLETED SUICIDE69 reports
MALAISE69 reports
CHEST PAIN61 reports
PALPITATIONS61 reports
SYNCOPE58 reports
ELECTROCARDIOGRAM QRS COMPLEX PROLONGED56 reports
CARDIAC ARREST55 reports
OVERDOSE55 reports
PNEUMONIA54 reports
CHEST DISCOMFORT51 reports
PAIN51 reports
TOXICITY TO VARIOUS AGENTS48 reports
LOSS OF CONSCIOUSNESS47 reports
HEART RATE INCREASED45 reports
HYPERTENSION45 reports
OFF LABEL USE44 reports
WEIGHT DECREASED44 reports
ANXIETY43 reports
DECREASED APPETITE43 reports
INSOMNIA42 reports
CEREBROVASCULAR ACCIDENT41 reports
ANAEMIA40 reports
BLOOD PRESSURE INCREASED40 reports
CONDITION AGGRAVATED39 reports
FEELING ABNORMAL39 reports
HEART RATE IRREGULAR39 reports
MYOCARDIAL INFARCTION39 reports
INTERNATIONAL NORMALISED RATIO INCREASED38 reports
COUGH37 reports
DEATH37 reports
VENTRICULAR TACHYCARDIA37 reports
ARTHRALGIA36 reports
CONSTIPATION36 reports
PYREXIA36 reports
ABDOMINAL PAIN UPPER35 reports
ATRIAL FLUTTER35 reports
BLOOD PRESSURE DECREASED35 reports
ABDOMINAL PAIN34 reports
PAIN IN EXTREMITY34 reports
HYPERHIDROSIS33 reports
TACHYCARDIA33 reports
DYSPEPSIA32 reports
GAIT DISTURBANCE32 reports
GASTROINTESTINAL HAEMORRHAGE32 reports
SINUS BRADYCARDIA32 reports
BALANCE DISORDER31 reports
OEDEMA PERIPHERAL30 reports
RESPIRATORY FAILURE29 reports
TREMOR29 reports
VISION BLURRED29 reports
SUICIDE ATTEMPT28 reports
URINARY TRACT INFECTION28 reports
CARDIAC FAILURE CONGESTIVE27 reports
RASH27 reports
SOMNOLENCE27 reports
CONTUSION26 reports
DEHYDRATION26 reports
PRODUCT SUBSTITUTION ISSUE26 reports
BACK PAIN25 reports
DEPRESSION25 reports
ELECTROCARDIOGRAM QT PROLONGED25 reports
MUSCULAR WEAKNESS25 reports
HEART RATE DECREASED24 reports
RESPIRATORY DISTRESS24 reports
VERTIGO24 reports
WEIGHT INCREASED24 reports
ATRIOVENTRICULAR BLOCK FIRST DEGREE23 reports
DYSGEUSIA23 reports
FLUSHING23 reports
HAEMATURIA23 reports
INCORRECT DOSE ADMINISTERED23 reports
MYALGIA23 reports
PRURITUS23 reports
ALOPECIA22 reports
CARDIAC FAILURE22 reports
COMA22 reports
CONVULSION22 reports
INTENTIONAL OVERDOSE22 reports
BLOOD GLUCOSE INCREASED20 reports
CONFUSIONAL STATE20 reports
CARDIAC DISORDER19 reports
CARDIO RESPIRATORY ARREST19 reports
ECONOMIC PROBLEM19 reports
ISCHAEMIC STROKE19 reports

Report Outcomes

Out of 2,022 classified reports for PROPAFENONE HYDROCHLORIDE:

Serious 80.9%Non-Serious 19.1%

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

Female1,114 (59.1%)
Male764 (40.5%)
Unknown7 (0.4%)

Reports by Age

Age 7859 reports
Age 7458 reports
Age 8057 reports
Age 6652 reports
Age 7047 reports
Age 7143 reports
Age 7243 reports
Age 6842 reports
Age 6541 reports
Age 7940 reports
Age 8240 reports
Age 6938 reports
Age 7335 reports
Age 6434 reports
Age 6333 reports
Age 6732 reports
Age 7631 reports
Age 8331 reports
Age 5229 reports
Age 5829 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 PROPAFENONE HYDROCHLORIDE?

This profile reflects 4,618 FDA FAERS reports that mention PROPAFENONE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PROPAFENONE HYDROCHLORIDE?

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

Who manufactures PROPAFENONE HYDROCHLORIDE?

Labeling and FAERS entries often list Actavis Pharma, Inc. in connection with PROPAFENONE 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.