SOTALOL HYDROCHLORIDE

N/A

Manufactured by UNICHEM PHARMACEUTICALS (USA), INC.

29,885 FDA adverse event reports analyzed

Last updated: 2026-04-14

About SOTALOL HYDROCHLORIDE

SOTALOL HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by UNICHEM PHARMACEUTICALS (USA), INC.. The most commonly reported adverse reactions for SOTALOL HYDROCHLORIDE include ATRIAL FIBRILLATION, DRUG INEFFECTIVE, DYSPNOEA, FATIGUE, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SOTALOL HYDROCHLORIDE.

Top Adverse Reactions

ATRIAL FIBRILLATION1,178 reports
DRUG INEFFECTIVE945 reports
DYSPNOEA912 reports
FATIGUE867 reports
DIZZINESS735 reports
DIARRHOEA721 reports
NAUSEA693 reports
OFF LABEL USE656 reports
ASTHENIA625 reports
HYPOTENSION580 reports
FALL555 reports
DRUG INTERACTION504 reports
DEATH497 reports
MALAISE474 reports
HEADACHE453 reports
ELECTROCARDIOGRAM QT PROLONGED437 reports
PAIN425 reports
VOMITING423 reports
GASTROINTESTINAL HAEMORRHAGE394 reports
ARTHRALGIA389 reports
BRADYCARDIA385 reports
PNEUMONIA385 reports
COUGH369 reports
WEIGHT DECREASED359 reports
PALPITATIONS347 reports
CHEST PAIN329 reports
PRURITUS326 reports
ACUTE KIDNEY INJURY325 reports
ANAEMIA324 reports
ARRHYTHMIA319 reports
BACK PAIN306 reports
ACCIDENTAL POISONING295 reports
HEART RATE INCREASED294 reports
VENTRICULAR TACHYCARDIA292 reports
RASH287 reports
DECREASED APPETITE281 reports
FEELING ABNORMAL270 reports
INSOMNIA265 reports
CONDITION AGGRAVATED264 reports
PYREXIA263 reports
BLOOD PRESSURE INCREASED257 reports
PAIN IN EXTREMITY256 reports
CARDIAC FAILURE CONGESTIVE250 reports
HYPERTENSION247 reports
URINARY TRACT INFECTION243 reports
SYNCOPE242 reports
TOXICITY TO VARIOUS AGENTS241 reports
GAIT DISTURBANCE236 reports
ANXIETY230 reports
PERIPHERAL SWELLING230 reports
SOMNOLENCE229 reports
CARDIAC ARREST228 reports
MYOCARDIAL INFARCTION228 reports
CARDIAC DISORDER226 reports
RENAL FAILURE226 reports
ABDOMINAL DISCOMFORT224 reports
CONSTIPATION224 reports
OEDEMA PERIPHERAL223 reports
DEHYDRATION222 reports
LOSS OF CONSCIOUSNESS219 reports
ABDOMINAL PAIN UPPER218 reports
WEIGHT INCREASED216 reports
TORSADE DE POINTES209 reports
EPISTAXIS203 reports
ALOPECIA197 reports
TACHYCARDIA195 reports
CEREBROVASCULAR ACCIDENT194 reports
CARDIAC FAILURE188 reports
ABDOMINAL PAIN187 reports
BLOOD GLUCOSE INCREASED185 reports
CONFUSIONAL STATE182 reports
INTERNATIONAL NORMALISED RATIO INCREASED178 reports
HYPERHIDROSIS177 reports
MEMORY IMPAIRMENT177 reports
MUSCULAR WEAKNESS173 reports
CONTUSION170 reports
VISUAL IMPAIRMENT160 reports
BLOOD PRESSURE DECREASED158 reports
MYALGIA157 reports
COVID 19156 reports
HEART RATE DECREASED154 reports
DRUG HYPERSENSITIVITY151 reports
RECTAL HAEMORRHAGE150 reports
CHEST DISCOMFORT148 reports
HAEMOGLOBIN DECREASED147 reports
TRANSIENT ISCHAEMIC ATTACK147 reports
OVERDOSE144 reports
PRODUCT USE IN UNAPPROVED INDICATION142 reports
HAEMORRHAGE141 reports
MUSCLE SPASMS141 reports
FOETAL EXPOSURE DURING PREGNANCY139 reports
DEPRESSION133 reports
HYPONATRAEMIA132 reports
INCORRECT DOSE ADMINISTERED132 reports
PLEURAL EFFUSION131 reports
SEPSIS130 reports
NEUTROPENIA129 reports
VISION BLURRED129 reports
COMPLETED SUICIDE128 reports
ERYTHEMA128 reports

Report Outcomes

Out of 16,057 classified reports for SOTALOL HYDROCHLORIDE:

Serious 78.7%Non-Serious 21.3%

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

Female7,412 (50.3%)
Male7,288 (49.5%)
Unknown21 (0.1%)

Reports by Age

Age 73430 reports
Age 75417 reports
Age 78409 reports
Age 72406 reports
Age 79395 reports
Age 74384 reports
Age 77376 reports
Age 71371 reports
Age 70369 reports
Age 80369 reports
Age 76367 reports
Age 69355 reports
Age 68349 reports
Age 81344 reports
Age 82333 reports
Age 83325 reports
Age 67317 reports
Age 66301 reports
Age 65276 reports
Age 62261 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 SOTALOL HYDROCHLORIDE?

This profile reflects 29,885 FDA FAERS reports that mention SOTALOL HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for SOTALOL HYDROCHLORIDE?

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

Who manufactures SOTALOL HYDROCHLORIDE?

Labeling and FAERS entries often list UNICHEM PHARMACEUTICALS (USA), INC. in connection with SOTALOL 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.