DRONEDARONE

N/A

Manufactured by Sanofi-Aventis U.S. LLC

17,724 FDA adverse event reports analyzed

Last updated: 2026-04-14

About DRONEDARONE

DRONEDARONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Sanofi-Aventis U.S. LLC. The most commonly reported adverse reactions for DRONEDARONE include ATRIAL FIBRILLATION, DYSPNOEA, FATIGUE, DIARRHOEA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DRONEDARONE.

Top Adverse Reactions

ATRIAL FIBRILLATION1,420 reports
DYSPNOEA838 reports
FATIGUE616 reports
DIARRHOEA476 reports
NAUSEA472 reports
DRUG INTERACTION467 reports
DIZZINESS448 reports
OFF LABEL USE430 reports
GASTROINTESTINAL HAEMORRHAGE420 reports
ASTHENIA380 reports
DRUG INEFFECTIVE329 reports
BLOOD CREATININE INCREASED312 reports
HEADACHE225 reports
CARDIAC FAILURE224 reports
MALAISE218 reports
OEDEMA PERIPHERAL218 reports
COUGH215 reports
PALPITATIONS211 reports
RASH210 reports
CARDIAC FAILURE CONGESTIVE208 reports
DEATH196 reports
ANAEMIA195 reports
WEIGHT INCREASED194 reports
PNEUMONIA192 reports
INTERNATIONAL NORMALISED RATIO INCREASED190 reports
RENAL FAILURE189 reports
HYPOTENSION185 reports
VOMITING183 reports
CONDITION AGGRAVATED179 reports
WEIGHT DECREASED178 reports
HEART RATE INCREASED175 reports
PRURITUS173 reports
FALL170 reports
ARRHYTHMIA169 reports
PAIN168 reports
FEELING ABNORMAL159 reports
BRADYCARDIA158 reports
ARTHRALGIA155 reports
HEART RATE DECREASED149 reports
ABDOMINAL DISCOMFORT141 reports
CHEST PAIN138 reports
DECREASED APPETITE137 reports
GAIT DISTURBANCE136 reports
HAEMORRHAGE135 reports
ABDOMINAL PAIN UPPER134 reports
RENAL FAILURE ACUTE131 reports
TREMOR124 reports
ABDOMINAL PAIN122 reports
INSOMNIA122 reports
PAIN IN EXTREMITY122 reports
EPISTAXIS119 reports
CONTUSION117 reports
ACUTE KIDNEY INJURY116 reports
ALANINE AMINOTRANSFERASE INCREASED115 reports
VENTRICULAR TACHYCARDIA114 reports
RECTAL HAEMORRHAGE113 reports
SYNCOPE111 reports
PYREXIA110 reports
PERIPHERAL SWELLING108 reports
ATRIAL FLUTTER105 reports
CHEST DISCOMFORT102 reports
HYPERTENSION101 reports
MUSCLE SPASMS101 reports
ASPARTATE AMINOTRANSFERASE INCREASED98 reports
ALOPECIA97 reports
ANXIETY96 reports
BACK PAIN96 reports
MYALGIA96 reports
CEREBROVASCULAR ACCIDENT95 reports
TACHYCARDIA95 reports
CONSTIPATION93 reports
HEPATIC ENZYME INCREASED93 reports
URINARY TRACT INFECTION93 reports
CARDIAC DISORDER91 reports
BLOOD PRESSURE INCREASED90 reports
CARDIAC ARREST90 reports
ELECTROCARDIOGRAM QT PROLONGED90 reports
HAEMATURIA90 reports
JOINT SWELLING89 reports
DYSPEPSIA88 reports
BLOOD PRESSURE DECREASED85 reports
DYSPHAGIA85 reports
ERYTHEMA85 reports
RENAL IMPAIRMENT84 reports
UPPER GASTROINTESTINAL HAEMORRHAGE83 reports
HAEMOGLOBIN DECREASED82 reports
HAEMORRHAGIC ANAEMIA81 reports
HEART RATE IRREGULAR81 reports
MUSCULAR WEAKNESS80 reports
INCORRECT DOSE ADMINISTERED79 reports
COAGULOPATHY78 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS78 reports
PLEURAL EFFUSION77 reports
UNDERDOSE77 reports
OEDEMA75 reports
VISION BLURRED75 reports
VISUAL IMPAIRMENT74 reports
LIVER FUNCTION TEST ABNORMAL73 reports
LOSS OF CONSCIOUSNESS72 reports
SOMNOLENCE72 reports

Report Outcomes

Out of 9,903 classified reports for DRONEDARONE:

Serious 71.7%Non-Serious 28.3%

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

Female4,813 (52.9%)
Male4,229 (46.5%)
Unknown59 (0.6%)

Reports by Age

Age 78303 reports
Age 70295 reports
Age 80278 reports
Age 77277 reports
Age 72271 reports
Age 75268 reports
Age 74267 reports
Age 76262 reports
Age 73261 reports
Age 68259 reports
Age 69242 reports
Age 71237 reports
Age 79228 reports
Age 67226 reports
Age 81226 reports
Age 82199 reports
Age 65181 reports
Age 66178 reports
Age 83177 reports
Age 85164 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 DRONEDARONE?

This profile reflects 17,724 FDA FAERS reports that mention DRONEDARONE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DRONEDARONE?

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

Who manufactures DRONEDARONE?

Labeling and FAERS entries often list Sanofi-Aventis U.S. LLC in connection with DRONEDARONE. 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.