Atenolol (Page 4 of 5)

Acute Myocardial Infarction

In a series of investigations in the treatment of acute myocardial infarction, bradycardia and hypotension occurred more commonly, as expected for any beta-blocker, in atenolol-treated patients than in control patients. However, these usually responded to atropine and/or to withholding further dosage of atenolol. The incidence of heart failure was not increased by atenolol. Inotropic agents were infrequently used. The reported frequency of these and other events occurring during these investigations is given in the following table.

In a study of 477 patients, the following adverse events were reported during either intravenous and/or oral atenolol administration:

Conventional TherapyPlus Atenolol (n = 244) ConventionalTherapy Alone (n = 233)
Bradycardia 43 (18%) 24 (10%)
Hypotension 60 (25%) 34 (15%)
Bronchospasm 3 (1.2%) 2 (0.9%)
Heart Failure 46 (19%) 56 (24%)
Heart Block 11 (4.5%) 10 (4.3%)
BBB + MajorAxis Deviation 16 (6.6%) 28 (12%)
Supraventricular Tachycardia 28 (11.5%) 45 (19%)
Atrial Fibrillation 12 (5%) 29 (11%)
Atrial Flutter 4 (1.6%) 7 (3%)
Ventricular Tachycardia 39 (16%) 52 (22%)
Cardiac Reinfarction 0 (0%) 6 (2.6%)
Total Cardiac Arrests 4 (1.6%) 16 (6.9%)
Nonfatal Cardiac Arrests 4 (1.6%) 12 (5.1%)
Deaths 7 (2.9%) 16 (6.9%)
Cardiogenic Shock 1 (0.4%) 4 (1.7%)
Development of Ventricular Septal Defect 0 (0%) 2 (0.9%)
Development of MitralRegurgitation 0 (0%) 2 (0.9%)
Renal Failure 1 (0.4%) 0 (0%)
Pulmonary Emboli 3 (1.2%) 0 (0%)

In the subsequent International Study of Infarct Survival (ISIS-1) including over 16,000 patients of whom 8,037 were randomized to receive atenolol treatment, the dosage of intravenous and subsequent oral atenolol was either discontinued or reduced for the following reasons:

*
Full dosage was 10 mg and some patients received less than 10 mg but more than 5 mg.
Reasons for Reduced Dosage
IV AtenololReduced Dose(< 5 mg)* Oral Partial Dose
Hypotension/Bradycardia 105 (1.3%) 1168 (14.5%)
Cardiogenic Shock 4 (0.04%) 35 (0.44%)
Reinfarction 0 (0%) 5 (0.06%)
Cardiac Arrest 5 (0.06%) 28 (0.34%)
Heart Block (> first degree) 5 (0.06%) 143 (1.7%)
Cardiac Failure 1 (0.01%) 233 (2.9%)
Arrhythmias 3 (0.04%) 22 (0.27%)
Bronchospasm 1 (0.01%) 50 (0.62%)

During postmarketing experience with atenolol, the following have been reported in temporal relationship to the use of the drug: elevated liver enzymes and/or bilirubin, hallucinations, headache, impotence, Peyronie’s disease, postural hypotension which may be associated with syncope, psoriasiform rash or exacerbation of psoriasis, psychoses, purpura, reversible alopecia, thrombocytopenia, visual disturbance, sick sinus syndrome, and dry mouth. Atenolol, like other beta-blockers, has been associated with the development of antinuclear antibodies (ANA), lupus syndrome, and Raynaud’s phenomenon.

POTENTIAL ADVERSE EFFECTS

In addition, a variety of adverse effects have been reported with other beta-adrenergic blocking agents, and may be considered potential adverse effects of atenolol.

Hematologic: Agranulocytosis.

Allergic: Fever, combined with aching and sore throat, laryngospasm, and respiratory distress.

Central Nervous System: Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation of time and place; short-term memory loss; emotional lability with slightly clouded sensorium; and, decreased performance on neuropsychometrics.

Gastrointestinal: Mesenteric arterial thrombosis, ischemic colitis.

Other: Erythematous rash.

Miscellaneous: There have been reports of skin rashes and/or dry eyes associated with the use of beta-adrenergic blocking drugs. The reported incidence is small, and in most cases, the symptoms have cleared when treatment was withdrawn. Discontinuance of the drug should be considered if any such reaction is not otherwise explicable. Patients should be closely monitored following cessation of therapy (see INDICATIONS AND USAGE).

The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with atenolol. Furthermore, a number of patients who had previously demonstrated established practolol reactions were transferred to atenolol therapy with subsequent resolution or quiescence of the reaction.

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