The following adverse reaction rates are based on use of Esmolol HCl in clinical trials involving 369 patients with supraventricular tachycardia and over 600 intraoperative and postoperative patients enrolled in clinical trials. Most adverse effects observed in controlled clinical trial settings have been mild and transient. The most important adverse effect has been hypotension (see Warnings). Deaths have been reported in post-marketing experience occurring during complex clinical states where Esmolol HCl was presumably being used simply to control ventricular rate (see Cardiac Failure under Warnings).
Cardiovascular: Symptomatic hypotension (diaphoresis, dizziness) occurred in 12% of patients, and therapy was discontinued in about 11% about half of whom were symptomatic. Asymptomatic hypotension occurred in about 25% of patients. Hypotension resolved during Esmolol HCl infusion in 63% of these patients and within 30 minutes after discontinuation of infusion in 80% of the remaining patients.
Diaphoresis accompanied hypotension in 10% of patients. Peripheral ischemia occurred in approximately 1% of patients. Pallor, flushing, bradycardia (heart rate less than 50 beats per minute), chest pain, syncope, pulmonary edema and heart block have each been reported in less than 1% of patients. In two patients without supraventricular tachycardia but with serious coronary artery disease (post inferior myocardial infarction or unstable angina, severe bradycardia/sinus pause/asystole) has developed, reversible in both cases with discontinuation of treatment.
Central Nervous System: Dizziness has occurred in 3% of patients; somnolence in 3%; confusion, headache, and agitation in about 2%; and fatigue in about 1% of patients. Paresthesia, asthenia, depression, abnormal thinking, anxiety, anorexia, and lightheadedness were reported in less than 1% of patients. Seizures were also reported in less than 1% of patients, with one death.
Respiratory: Bronchospasm, wheezing, dyspnea, nasal congestion, rhonchi and rales have each been reported in less than 1% of patients.
Gastrointestinal: Nausea was reported in 7% of patients. Vomiting has occurred in about 1% of patients. Dyspepsia, constipation, dry mouth and abdominal discomfort have each occurred in less than 1% of patients. Taste perversion has also been reported.
Skin (infusion site): Infusion site reactions including inflammation and induration were reported in about 8% of patients. Edema, erythema, skin discoloration burning at the infusion site, thrombophlebitis and local skin necrosis from extravasation have each occurred in less than 1% of patients.
Miscellaneous: Each of the following has been reported in less than 1% of patients: Urinary retention, speech disorder, abnormal vision, midscapular pain, rigors and fever.