Atenolol Side Effects
Brand Names: Tenormin
Please note - some side effects for Atenolol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Atenolol - for the consumer
Atenolol/Chlorthalidone
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Atenolol/Chlorthalidone:
Seek medical attention right away if any of these SEVERE side effects occur when using Atenolol/Chlorthalidone:Diarrhea; dizziness; feeling of a whirling motion; headache; lack of energy; lightheadedness; mild drowsiness; nausea; unusual tiredness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty breathing; drowsiness; dry mouth; infrequent urination; lethargy; low blood pressure; muscle pain or cramps; muscle tiredness; nausea; rapid or irregular heartbeat; restlessness; thirst; very slow heartbeat; vomiting; weakness.
Atenolol
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Atenolol: Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Atenolol:
Seek medical attention right away if any of these SEVERE side effects occur when using Atenolol:Cold fingers and toes; diarrhea; dizziness; drowsiness; nausea; tiredness or weakness.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blue fingernails, toenails, or palms; decreased sexual ability; fainting; mental or mood problems; persistent dizziness or lightheadedness; shortness of breath; sudden, unusual weight gain; swelling of hands, ankles, or feet; unusual bruising or bleeding; unusually slow heartbeat.
Atenolol Tablets
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Atenolol Tablets: Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Atenolol Tablets:
Seek medical attention right away if any of these SEVERE side effects occur when using Atenolol Tablets:Cold fingers and toes; diarrhea; dizziness; drowsiness; nausea; tiredness or weakness.
TopSevere allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blue fingernails, toenails, or palms; decreased sexual ability; fainting; mental or mood problems; persistent dizziness or lightheadedness; shortness of breath; sudden, unusual weight gain; swelling of hands, ankles, or feet; unusual bruising or bleeding; unusually slow heartbeat.
For the professional
Atenolol
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 (U.S. studies) or elicited, e.g., by checklist (foreign studies). The reported frequency of elicited adverse effects was higher for both Atenolol and placebo-treated patients than when these reactions were volunteered. Where frequency of adverse effects of Atenolol and placebo is similar, causal relationship to Atenolol is uncertain.
| Volunteered (U.S. Studies) |
Total-Volunteered and Elicited (Foreign+U.S. 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/ NEUROMUSCULAR |
||||
| 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 | ||||
| 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 (n=244) |
Conventional Therapy 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 + Major Axis Deviation | 16 (6.6%) | 28 (12%) |
| Supraventicular Trachycardia | 28 (11.5%) | 45 (19%) |
| Atrial Fibrillation | 12 (5%) | 29 (11%) |
| Atrial Flutter | 4 (1.6%) | 7 (3%) |
| Venticular Trachycardia | 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 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 Atenolol treatment, the dosage of intravenous and subsequent oral Atenolol was either discontinued or reduced for the following reasons:
| Reasons for Reduced Dosage | ||||
|---|---|---|---|---|
| IV Atenolol Reduced Dose (<5 mg)* |
Oral Partial Dose |
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*Full dosage was 10 mg and some patients received less than 10 mg but more than 5 mg. | ||||
| Hypotension/Bradycardia | 105 (1.3% ) | 1168 (14.5%) | ||
| Cardiogenic Shock | 4 (.04% ) | 35 (.44% ) | ||
| Reinfraction | 0 (0%) | 5 (.06%) | ||
| Cardiac Arrest | 5 (.06 %) | 28 (.34%) | ||
| Heart Block (> first degree) | 5 (.06 %) | 143 (1.7%) | ||
| Cardiac Failure | 1 (.01%) | 233 (2.9%) | ||
| Arrhythmias | 3 (.04 %) | 22 (.27%) | ||
| Bronchospasm | 1 (.01%) | 50 (.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.
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.
TopAtenolol Tablets
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 (U.S. studies) or elicited, e.g., by checklist (foreign studies). The reported frequency of elicited adverse effects was higher for both Atenolol and placebo-treated patients than when these reactions were volunteered. Where frequency of adverse effects of Atenolol and placebo is similar, causal relationship to Atenolol is uncertain.
| Volunteered (U.S. Studies) | Total - Volunteered and Elicited (Foreign + U.S. 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/NEUROMUSCULAR& | ||||
| Dizziness | 4 | 1 | 13 | 6 |
| Vertigo | 2 | 0.5 | 2 | 0.2 |
| Lightheadedness | 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 | ||||
| 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 (n = 244) | Conventional Therapy 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 + Major Axis 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 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 Atenolol treatment, the dosage of intravenous and subsequent oral Atenolol was either discontinued or reduced for the following reasons:
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 disturbances, 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.
TopMore resources:
Atenolol - Includes detailed dosage instructions.
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