Tenormin Side Effects
Generic Name: Atenolol
Please note - some side effects for Tenormin 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 Tenormin - for the consumer
Tenormin
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 Tenormin: Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Tenormin:
Seek medical attention right away if any of these SEVERE side effects occur when using Tenormin: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.
Tenormin 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 Tenormin Tablets: Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Tenormin Tablets:
Seek medical attention right away if any of these SEVERE side effects occur when using Tenormin 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
Tenormin
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 and placebo-treated patients than when these reactions were volunteered. Where frequency of adverse effects of Tenormin and placebo is similar, causal relationship to Tenormin 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/ 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 |
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 |
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 Tenormin treatment, the dosage of intravenous and subsequent oral Tenormin 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 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 Tenormin, 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, like other beta blockers, has been associated with the development of antinuclear antibodies (ANA), lupus syndrome, and Raynaud’s phenomenon.
TopTenormin Injection
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 and placebo-treated patients than when these reactions were volunteered. Where frequency of adverse effects of Tenormin and placebo is similar, causal relationship to Tenormin 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/ 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%) |
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 Tenormin treatment, the dosage of intravenous and subsequent oral Tenormin was either discontinued or reduced for the following reasons:
| ||||
Reasons for Reduced Dosage | ||||
|
IV Atenolol Reduced Dose (<5mg)* |
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 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 Tenormin, 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. Tenormin, like other beta blockers, has been associated with the development of antinuclear antibodies (ANA), lupus syndrome, and Raynaud’s phenomenon.
TopMore resources:
Tenormin - Includes detailed dosage instructions.
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