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Most adverse effects have been mild and transient.

The frequency estimates in the following table were derived from controlled studies in hypertensive patients in which adverse reactions were either volunteered by the patient (US studies) or elicited, eg, by checklist (foreign studies). The reported frequency of elicited adverse effects was higher for both TENORMIN (atenolol tablets) and placebo-treated patients than when these reactions were volunteered. Where frequency of adverse effects of TENORMIN (atenolol tablets) and placebo is similar, causal relationship to TENORMIN (atenolol tablets) is uncertain.

  Volunteered
(US Studies)
Total -Volunteered and Elicited
(Foreign+ US Studies)
Atenolol
(n=164)
%
Placebo
(n=206)
%
Atenolol
(n=399)
%
Placebo
(n=407)
%
CARDIOVASCULAR
  Bradycardia 3 0 3 0
  Cold Extremities 0 0.5 12 5
  Postural Hypotension 2 1 4 5
  Leg Pain 0 0.5 3 1
CENTRAL NERVOUS SYSTEM/NEURO MUSCULAR
  Dizziness 4 1 13 6
  Vertigo 2 0.5 2 0.2
  Light-headedness 1 0 3 0.7
  Tiredness 0.6 0.5 26 13
  Fatigue 3 1 6 5
  Lethargy 1 0 3 0.7
  Drowsiness 0.6 0 2 0.5
  Depression 0.6 0.5 12 9
  Dreaming 0 0 3 1
GASTROINTESTINAL
  Diarrhea 2 0 3 2
  Nausea 4 1 3 1
RESPIRATORY see WARNINGS)
  Wheeziness 0 0 3 3
  Dyspnea 0.6 1 6 4

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 Therapy Plus Atenolol Conventional Therapy Alone

(n=244)

(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 BBB + Major 11 (4.5%) 10 (4.3%)
Axis Deviation Supraventricular 16 (6.6%) 28 (12%)
Tachycardia 28 (11.5%) 45 (19%)
Atrial Fibrillation 12 (5%) 29 (11%)
Atrial Flutter Ventricular 4 (1.6%) 7 (3%)
Tachycardia 39 (16%) 52 (22%)
Cardiac Reinfarction 0 (0%) 6 (2.6%)
Total Cardiac Arrests Nonfatal Cardiac 4 (1.6%) 16 (6.9%)
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 Mitral Regurgitation 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 TENORMIN (atenolol tablets) treatment, the dosage of intravenous and subsequent oral TENORMIN (atenolol tablets) was either discontinued or reduced for the following reasons:

  Reasons for Reduced Dosage
IV Atenolol Reduced Dose (<5 mg)* Oral Partial Dose
Hypotension/Bradycardia 105 (1.3%) 1168 (14.5%)
Cardiogenic Shock 4 (.04%) 35 (.44%)
Reinfarction 0 (0%) 5 (.06%)
Cardiac Arrest 5 (.06%) 28 (.34%)
Heart Block (> first 5 (.06%) 143 (1.7%)
degree)        
Cardiac Failure 1 (.01%) 233 (2.9%)
Arrhythmias 3 (.04%) 22 (.27%)
Bronchospasm 1 (.01%) 50 (.62%)
*Full dosage was 10 mg and some patients received less than 10 mg but more than 5 mg.

During postmarketing experience with TENORMIN (atenolol tablets) , 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. TENORMIN (atenolol tablets) , 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 TENORMIN (atenolol tablets) .

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.)

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