ESMOLOL HYDROCHLORIDE

N/A

Manufactured by Baxter Healthcare Corporation

539 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ESMOLOL HYDROCHLORIDE

ESMOLOL HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Baxter Healthcare Corporation. The most commonly reported adverse reactions for ESMOLOL HYDROCHLORIDE include DRUG INEFFECTIVE, CARDIAC ARREST, HYPOTENSION, BRADYCARDIA, PRODUCT USE ISSUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ESMOLOL HYDROCHLORIDE.

Top Adverse Reactions

DRUG INEFFECTIVE35 reports
CARDIAC ARREST21 reports
HYPOTENSION19 reports
BRADYCARDIA17 reports
PRODUCT USE ISSUE15 reports
PRODUCT USE IN UNAPPROVED INDICATION12 reports
RENAL FAILURE11 reports
ATRIAL FIBRILLATION9 reports
HYPERTENSION9 reports
VENTRICULAR FIBRILLATION9 reports
HEPATOTOXICITY8 reports
HYPERBILIRUBINAEMIA8 reports
PULMONARY OEDEMA8 reports
RESPIRATORY FAILURE8 reports
CONDITION AGGRAVATED7 reports
DEATH7 reports
MULTI ORGAN FAILURE7 reports
PYREXIA7 reports
RESPIRATORY ARREST7 reports
ACUTE KIDNEY INJURY6 reports
ANXIETY6 reports
BLOOD PRESSURE DECREASED6 reports
CARDIOGENIC SHOCK6 reports
CEREBROVASCULAR ACCIDENT6 reports
OVERDOSE6 reports
PAIN6 reports
RENAL IMPAIRMENT6 reports
SEPSIS6 reports
ALANINE AMINOTRANSFERASE INCREASED5 reports
ANAEMIA5 reports
ANHEDONIA5 reports
ASPARTATE AMINOTRANSFERASE INCREASED5 reports
COAGULOPATHY5 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION5 reports
DYSPNOEA5 reports
HAEMODYNAMIC INSTABILITY5 reports
HEPATIC FUNCTION ABNORMAL5 reports
HEPATOMEGALY5 reports
INJURY5 reports
INTERSTITIAL LUNG DISEASE5 reports
OFF LABEL USE5 reports
PULSELESS ELECTRICAL ACTIVITY5 reports
TACHYCARDIA5 reports
TOXICITY TO VARIOUS AGENTS5 reports
UNEVALUABLE EVENT5 reports
CONGESTIVE CARDIOMYOPATHY4 reports
COUGH4 reports
DELIRIUM4 reports
DIARRHOEA4 reports
DRUG ERUPTION4 reports
EMOTIONAL DISTRESS4 reports
EXPOSURE DURING PREGNANCY4 reports
FEAR4 reports
HEART RATE INCREASED4 reports
INFUSION SITE EXTRAVASATION4 reports
NEUROTOXICITY4 reports
NEUTROPHIL COUNT DECREASED4 reports
PNEUMONIA4 reports
RENAL INJURY4 reports
SEIZURE4 reports
STRESS4 reports
THROMBOCYTOPENIA4 reports
VENTRICULAR ARRHYTHMIA4 reports
AGITATION3 reports
ATRIOVENTRICULAR BLOCK3 reports
ATRIOVENTRICULAR BLOCK COMPLETE3 reports
BRAIN OEDEMA3 reports
CARDIAC FAILURE3 reports
CARDIOMYOPATHY3 reports
COMA3 reports
EXTRAVASATION3 reports
HAEMOPTYSIS3 reports
HYPERHIDROSIS3 reports
HYPONATRAEMIA3 reports
HYPOXIA3 reports
JUNCTIONAL ECTOPIC TACHYCARDIA3 reports
LACTIC ACIDOSIS3 reports
LEUKOPENIA3 reports
MATERNAL EXPOSURE DURING PREGNANCY3 reports
NAUSEA3 reports
OCCUPATIONAL EXPOSURE TO PRODUCT3 reports
OROPHARYNGEAL DISCOMFORT3 reports
PLEURAL EFFUSION3 reports
PNEUMONIA ASPIRATION3 reports
POST PROCEDURAL COMPLICATION3 reports
RASH GENERALISED3 reports
RHABDOMYOLYSIS3 reports
SHOCK3 reports
SUPRAVENTRICULAR TACHYCARDIA3 reports
THERAPEUTIC RESPONSE DECREASED3 reports
VENTRICULAR DYSFUNCTION3 reports
VENTRICULAR TACHYCARDIA3 reports
WHITE BLOOD CELL COUNT DECREASED3 reports
ABDOMINAL PAIN2 reports
ACUTE HEPATIC FAILURE2 reports
ACUTE LEFT VENTRICULAR FAILURE2 reports
ACUTE PULMONARY OEDEMA2 reports
ACUTE RESPIRATORY FAILURE2 reports
ADMINISTRATION SITE EXTRAVASATION2 reports
APHASIA2 reports

Report Outcomes

Out of 258 classified reports for ESMOLOL HYDROCHLORIDE:

Serious 93.8%Non-Serious 6.2%

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

Male111 (53.6%)
Female93 (44.9%)
Unknown3 (1.4%)

Reports by Age

Age 58 reports
Age 537 reports
Age 346 reports
Age 676 reports
Age 686 reports
Age 716 reports
Age 585 reports
Age 605 reports
Age 645 reports
Age 785 reports
Age 64 reports
Age 164 reports
Age 474 reports
Age 524 reports
Age 704 reports
Age 283 reports
Age 293 reports
Age 303 reports
Age 323 reports
Age 333 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 ESMOLOL HYDROCHLORIDE?

This profile reflects 539 FDA FAERS reports that mention ESMOLOL HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ESMOLOL HYDROCHLORIDE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, CARDIAC ARREST, HYPOTENSION, BRADYCARDIA, PRODUCT USE ISSUE, PRODUCT USE IN UNAPPROVED INDICATION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ESMOLOL HYDROCHLORIDE?

Labeling and FAERS entries often list Baxter Healthcare Corporation in connection with ESMOLOL 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.