AMIODARONE HYDROCHLORIDE

N/A

Manufactured by Upsher-Smith Laboratories, LLC

29,334 FDA adverse event reports analyzed

Last updated: 2026-04-14

About AMIODARONE HYDROCHLORIDE

AMIODARONE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Upsher-Smith Laboratories, LLC. The most commonly reported adverse reactions for AMIODARONE HYDROCHLORIDE include DYSPNOEA, ASTHENIA, FATIGUE, OFF LABEL USE, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AMIODARONE HYDROCHLORIDE.

Top Adverse Reactions

DYSPNOEA1,158 reports
ASTHENIA976 reports
FATIGUE894 reports
OFF LABEL USE852 reports
DRUG INEFFECTIVE719 reports
PRODUCT USE IN UNAPPROVED INDICATION664 reports
NAUSEA606 reports
COUGH597 reports
ATRIAL FIBRILLATION595 reports
DIZZINESS572 reports
PNEUMONIA540 reports
HYPOTENSION477 reports
VOMITING466 reports
DRUG INTERACTION453 reports
PULMONARY TOXICITY407 reports
DEATH392 reports
PULMONARY FIBROSIS389 reports
ANAEMIA380 reports
CHEST PAIN374 reports
CONDITION AGGRAVATED364 reports
GAIT DISTURBANCE351 reports
HYPERTHYROIDISM351 reports
FALL350 reports
CARDIAC FAILURE CONGESTIVE349 reports
RESPIRATORY FAILURE338 reports
DIARRHOEA332 reports
BLINDNESS328 reports
GENERAL PHYSICAL HEALTH DETERIORATION328 reports
WHEEZING327 reports
CONSTIPATION325 reports
HEADACHE323 reports
HYPONATRAEMIA319 reports
ABDOMINAL PAIN316 reports
SEPSIS307 reports
ACUTE KIDNEY INJURY303 reports
WEIGHT DECREASED298 reports
CARDIAC FAILURE282 reports
CARDIOGENIC SHOCK280 reports
PAIN270 reports
UNEVALUABLE EVENT269 reports
INTERSTITIAL LUNG DISEASE267 reports
BRADYCARDIA262 reports
TOXICITY TO VARIOUS AGENTS261 reports
VENTRICULAR FIBRILLATION260 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME259 reports
SOMNOLENCE246 reports
ABDOMINAL DISTENSION238 reports
ASCITES236 reports
GASTROINTESTINAL HAEMORRHAGE233 reports
TREMOR233 reports
DECREASED APPETITE228 reports
RENAL FAILURE228 reports
ELECTROCARDIOGRAM QT PROLONGED226 reports
HYPERTENSION222 reports
STRESS215 reports
DRUG HYPERSENSITIVITY214 reports
OEDEMA PERIPHERAL212 reports
VENTRICULAR TACHYCARDIA210 reports
DEPRESSION207 reports
OEDEMA204 reports
SYNCOPE204 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE203 reports
HYPOTHYROIDISM201 reports
MALAISE197 reports
LUNG DISORDER196 reports
APPENDICITIS184 reports
PYREXIA184 reports
ARRHYTHMIA182 reports
PLEURAL EFFUSION180 reports
ANXIETY178 reports
APPENDICOLITH178 reports
CARDIAC ARREST175 reports
MYOCARDIAL INFARCTION172 reports
URINARY TRACT INFECTION171 reports
THROMBOSIS168 reports
DRUG INTOLERANCE167 reports
ARTHRALGIA165 reports
VISION BLURRED160 reports
DEHYDRATION158 reports
DRY MOUTH157 reports
PULMONARY EMBOLISM157 reports
DIABETES MELLITUS156 reports
WEIGHT INCREASED156 reports
VISUAL IMPAIRMENT155 reports
CONFUSIONAL STATE152 reports
HAEMORRHAGE149 reports
INSOMNIA149 reports
SWELLING146 reports
DYSPNOEA EXERTIONAL144 reports
PAIN IN EXTREMITY142 reports
INTENTIONAL PRODUCT MISUSE141 reports
CORONARY ARTERY DISEASE140 reports
RENAL IMPAIRMENT140 reports
HEART RATE INCREASED139 reports
RASH138 reports
TORSADE DE POINTES138 reports
BACK PAIN134 reports
BLOOD CREATININE INCREASED134 reports
PULMONARY HYPERTENSION132 reports
PALPITATIONS130 reports

Report Outcomes

Out of 10,677 classified reports for AMIODARONE HYDROCHLORIDE:

Serious 85.9%Non-Serious 14.1%

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

Male5,982 (60.7%)
Female3,870 (39.3%)
Unknown7 (0.1%)

Reports by Age

Age 80460 reports
Age 75335 reports
Age 77275 reports
Age 76252 reports
Age 73236 reports
Age 78236 reports
Age 70231 reports
Age 82227 reports
Age 69226 reports
Age 72224 reports
Age 74219 reports
Age 79219 reports
Age 81211 reports
Age 71202 reports
Age 67200 reports
Age 68199 reports
Age 83189 reports
Age 66180 reports
Age 64169 reports
Age 86152 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 AMIODARONE HYDROCHLORIDE?

This profile reflects 29,334 FDA FAERS reports that mention AMIODARONE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for AMIODARONE HYDROCHLORIDE?

Frequently reported terms in FAERS include DYSPNOEA, ASTHENIA, FATIGUE, OFF LABEL USE, DRUG INEFFECTIVE, PRODUCT USE IN UNAPPROVED INDICATION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures AMIODARONE HYDROCHLORIDE?

Labeling and FAERS entries often list Upsher-Smith Laboratories, LLC in connection with AMIODARONE 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.