Tenormin Side Effects
Generic name: atenolol
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 By body system
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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 |
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 |
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:
|
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 |
|
Volunteered (US Studies) |
Total − Volunteered and Elicited (Foreign + US Studies) |
|||
|
Volunteered (US Studies) |
Total − Volunteered and Elicited (Foreign + US Studies) |
|||
|
Atenolol (n=164) % |
Placebo (n=206) % |
Atenolol (n=399) % |
Placebo (n=407) % |
|
|
Atenolol (n=164) % |
Placebo (n=206) % |
Atenolol (n=399) % |
Placebo (n=407) % |
|
|
CARDIOVASCULAR |
||||
|
CARDIOVASCULAR |
||||
|
Bradycardia |
3 |
0 |
3 |
0 |
|
Bradycardia |
3 |
0 |
3 |
0 |
|
Cold Extremities |
0 |
0.5 |
12 |
5 |
|
Cold Extremities |
0 |
0.5 |
12 |
5 |
|
Postural Hypotension |
2 |
1 |
4 |
5 |
|
Postural Hypotension |
2 |
1 |
4 |
5 |
|
Leg Pain |
0 |
0.5 |
3 |
1 |
|
Leg Pain |
0 |
0.5 |
3 |
1 |
|
CENTRAL NERVOUS SYSTEM/ NEUROMUSCULAR |
||||
|
CENTRAL NERVOUS SYSTEM/ NEUROMUSCULAR |
||||
|
Dizziness |
4 |
1 |
13 |
6 |
|
Dizziness |
4 |
1 |
13 |
6 |
|
Vertigo |
2 |
0.5 |
2 |
0.2 |
|
Vertigo |
2 |
0.5 |
2 |
0.2 |
|
Light-headedness |
1 |
0 |
3 |
0.7 |
|
Light-headedness |
1 |
0 |
3 |
0.7 |
|
Tiredness |
0.6 |
0.5 |
26 |
13 |
|
Tiredness |
0.6 |
0.5 |
26 |
13 |
|
Fatigue |
3 |
1 |
6 |
5 |
|
Fatigue |
3 |
1 |
6 |
5 |
|
Lethargy |
1 |
0 |
3 |
0.7 |
|
Lethargy |
1 |
0 |
3 |
0.7 |
|
Drowsiness |
0.6 |
0 |
2 |
0.5 |
|
Drowsiness |
0.6 |
0 |
2 |
0.5 |
|
Depression |
0.6 |
0.5 |
12 |
9 |
|
Depression |
0.6 |
0.5 |
12 |
9 |
|
Dreaming |
0 |
0 |
3 |
1 |
|
Dreaming |
0 |
0 |
3 |
1 |
|
GASTROINTESTINAL |
||||
|
GASTROINTESTINAL |
||||
|
Diarrhea |
2 |
0 |
3 |
2 |
|
Diarrhea |
2 |
0 |
3 |
2 |
|
Nausea |
4 |
1 |
3 |
1 |
|
Nausea |
4 |
1 |
3 |
1 |
|
RESPIRATORY |
||||
|
RESPIRATORY |
||||
|
Wheeziness |
0 |
0 |
3 |
3 |
|
Wheeziness |
0 |
0 |
3 |
3 |
|
Dyspnea |
0.6 |
1 |
6 |
4 |
|
Dyspnea |
0.6 |
1 |
6 |
4 |
|
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.
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%) |
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:
|
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%) |
|
Conventional Therapy Plus Atenolol |
Conventional Therapy Alone |
|||
|
Conventional Therapy Plus Atenolol |
Conventional Therapy Alone |
|||
|
(n=244) |
(n=233) |
|||
|
(n=244) |
(n=233) |
|||
|
Bradycardia |
43 |
(18%) |
24 |
(10%) |
|
Bradycardia |
43 |
(18%) |
24 |
(10%) |
|
Hypotension |
60 |
(25%) |
34 |
(15%) |
|
Hypotension |
60 |
(25%) |
34 |
(15%) |
|
Bronchospasm |
3 |
(1.2%) |
2 |
(0.9%) |
|
Bronchospasm |
3 |
(1.2%) |
2 |
(0.9%) |
|
Heart Failure |
46 |
(19%) |
56 |
(24%) |
|
Heart Failure |
46 |
(19%) |
56 |
(24%) |
|
Heart Block |
11 |
(4.5%) |
10 |
(4.3%) |
|
Heart Block |
11 |
(4.5%) |
10 |
(4.3%) |
|
BBB + Major |
||||
|
BBB + Major |
||||
|
Axis Deviation |
16 |
(6.6%) |
28 |
(12%) |
|
Axis Deviation |
16 |
(6.6%) |
28 |
(12%) |
|
Supraventricular Tachycardia |
28 |
(11.5%) |
45 |
(19%) |
|
Supraventricular Tachycardia |
28 |
(11.5%) |
45 |
(19%) |
|
Atrial Fibrillation |
12 |
(5%) |
29 |
(11%) |
|
Atrial Fibrillation |
12 |
(5%) |
29 |
(11%) |
|
Atrial Flutter |
4 |
(1.6%) |
7 |
(3%) |
|
Atrial Flutter |
4 |
(1.6%) |
7 |
(3%) |
|
Ventricular Tachycardia |
39 |
(16%) |
52 |
(22%) |
|
Ventricular Tachycardia |
39 |
(16%) |
52 |
(22%) |
|
Cardiac Reinfarction |
0 |
(0%) |
6 |
(2.6%) |
|
Cardiac Reinfarction |
0 |
(0%) |
6 |
(2.6%) |
|
Total Cardiac Arrests |
4 |
(1.6%) |
16 |
(6.9%) |
|
Total Cardiac Arrests |
4 |
(1.6%) |
16 |
(6.9%) |
|
Nonfatal Cardiac Arrests |
4 |
(1.6%) |
12 |
(5.1%) |
|
Nonfatal Cardiac Arrests |
4 |
(1.6%) |
12 |
(5.1%) |
|
Deaths |
7 |
(2.9%) |
16 |
(6.9%) |
|
Deaths |
7 |
(2.9%) |
16 |
(6.9%) |
|
Cardiogenic Shock |
1 |
(0.4%) |
4 |
(1.7%) |
|
Cardiogenic Shock |
1 |
(0.4%) |
4 |
(1.7%) |
|
Development of Ventricular Septal Defect |
0 |
(0%) |
2 |
(0.9%) |
|
Development of Ventricular Septal Defect |
0 |
(0%) |
2 |
(0.9%) |
|
Development of Mitral Regurgitation |
0 |
(0%) |
2 |
(0.9%) |
|
Development of Mitral Regurgitation |
0 |
(0%) |
2 |
(0.9%) |
|
Renal Failure |
1 |
(0.4%) |
0 |
(0%) |
|
Renal Failure |
1 |
(0.4%) |
0 |
(0%) |
|
Pulmonary Emboli |
3 |
(1.2%) |
0 |
(0%) |
|
Pulmonary Emboli |
3 |
(1.2%) |
0 |
(0%) |
|
||||
|
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%) |
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.
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:
|
||||
|
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%) |
|
Reasons for Reduced Dosage |
||||
|
Reasons for Reduced Dosage |
||||
|
IV Atenolol Reduced Dose (<5 mg)* |
Oral Partial Dose |
|||
|
IV Atenolol Reduced Dose (<5 mg)* |
Oral Partial Dose |
|||
|
Hypotension/Bradycardia |
105 |
(1.3%) |
1168 |
(14.5%) |
|
Hypotension/Bradycardia |
105 |
(1.3%) |
1168 |
(14.5%) |
|
Cardiogenic Shock |
4 |
(.04%) |
35 |
(.44%) |
|
Cardiogenic Shock |
4 |
(.04%) |
35 |
(.44%) |
|
Reinfarction |
0 |
(0%) |
5 |
(.06%) |
|
Reinfarction |
0 |
(0%) |
5 |
(.06%) |
|
Cardiac Arrest |
5 |
(.06%) |
28 |
(.34%) |
|
Cardiac Arrest |
5 |
(.06%) |
28 |
(.34%) |
|
Heart Block (> first degree) |
5 |
(.06%) |
143 |
(1.7%) |
|
Heart Block (> first degree) |
5 |
(.06%) |
143 |
(1.7%) |
|
Cardiac Failure |
1 |
(.01%) |
233 |
(2.9%) |
|
Cardiac Failure |
1 |
(.01%) |
233 |
(2.9%) |
|
Arrhythmias |
3 |
(.04%) |
22 |
(.27%) |
|
Arrhythmias |
3 |
(.04%) |
22 |
(.27%) |
|
Bronchospasm |
1 |
(.01%) |
50 |
(.62%) |
|
Bronchospasm |
1 |
(.01%) |
50 |
(.62%) |
|
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.
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%) |
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:
|
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%) |
|
Conventional Therapy Plus Atenolol |
Conventional Therapy Alone |
|||
|
Conventional Therapy Plus Atenolol |
Conventional Therapy Alone |
|||
|
(n=244) |
(n=233) |
|||
|
(n=244) |
(n=233) |
|||
|
Bradycardia |
43 |
(18%) |
24 |
(10%) |
|
Bradycardia |
43 |
(18%) |
24 |
(10%) |
|
Hypotension |
60 |
(25%) |
34 |
(15%) |
|
Hypotension |
60 |
(25%) |
34 |
(15%) |
|
Bronchospasm |
3 |
(1.2%) |
2 |
(0.9%) |
|
Bronchospasm |
3 |
(1.2%) |
2 |
(0.9%) |
|
Heart Failure |
46 |
(19%) |
56 |
(24%) |
|
Heart Failure |
46 |
(19%) |
56 |
(24%) |
|
Heart Block |
11 |
(4.5%) |
10 |
(4.3%) |
|
Heart Block |
11 |
(4.5%) |
10 |
(4.3%) |
|
BBB + Major |
||||
|
BBB + Major |
||||
|
Axis Deviation |
16 |
(6.6%) |
28 |
(12%) |
|
Axis Deviation |
16 |
(6.6%) |
28 |
(12%) |
|
Supraventricular Tachycardia |
28 |
(11.5%) |
45 |
(19%) |
|
Supraventricular Tachycardia |
28 |
(11.5%) |
45 |
(19%) |
|
Atrial Fibrillation |
12 |
(5%) |
29 |
(11%) |
|
Atrial Fibrillation |
12 |
(5%) |
29 |
(11%) |
|
Atrial Flutter |
4 |
(1.6%) |
7 |
(3%) |
|
Atrial Flutter |
4 |
(1.6%) |
7 |
(3%) |
|
Ventricular Tachycardia |
39 |
(16%) |
52 |
(22%) |
|
Ventricular Tachycardia |
39 |
(16%) |
52 |
(22%) |
|
Cardiac Reinfarction |
0 |
(0%) |
6 |
(2.6%) |
|
Cardiac Reinfarction |
0 |
(0%) |
6 |
(2.6%) |
|
Total Cardiac Arrests |
4 |
(1.6%) |
16 |
(6.9%) |
|
Total Cardiac Arrests |
4 |
(1.6%) |
16 |
(6.9%) |
|
Nonfatal Cardiac Arrests |
4 |
(1.6%) |
12 |
(5.1%) |
|
Nonfatal Cardiac Arrests |
4 |
(1.6%) |
12 |
(5.1%) |
|
Deaths |
7 |
(2.9%) |
16 |
(6.9%) |
|
Deaths |
7 |
(2.9%) |
16 |
(6.9%) |
|
Cardiogenic Shock |
1 |
(0.4%) |
4 |
(1.7%) |
|
Cardiogenic Shock |
1 |
(0.4%) |
4 |
(1.7%) |
|
Development of Ventricular Septal Defect |
0 |
(0%) |
2 |
(0.9%) |
|
Development of Ventricular Septal Defect |
0 |
(0%) |
2 |
(0.9%) |
|
Development of Mitral Regurgitation |
0 |
(0%) |
2 |
(0.9%) |
|
Development of Mitral Regurgitation |
0 |
(0%) |
2 |
(0.9%) |
|
Renal Failure |
1 |
(0.4%) |
0 |
(0%) |
|
Renal Failure |
1 |
(0.4%) |
0 |
(0%) |
|
Pulmonary Emboli |
3 |
(1.2%) |
0 |
(0%) |
|
Pulmonary Emboli |
3 |
(1.2%) |
0 |
(0%) |
|
||||
|
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%) |
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.
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:
|
||||
|
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%) |
|
Reasons for Reduced Dosage |
||||
|
Reasons for Reduced Dosage |
||||
|
IV Atenolol Reduced Dose (<5 mg)* |
Oral Partial Dose |
|||
|
IV Atenolol Reduced Dose (<5 mg)* |
Oral Partial Dose |
|||
|
Hypotension/Bradycardia |
105 |
(1.3%) |
1168 |
(14.5%) |
|
Hypotension/Bradycardia |
105 |
(1.3%) |
1168 |
(14.5%) |
|
Cardiogenic Shock |
4 |
(.04%) |
35 |
(.44%) |
|
Cardiogenic Shock |
4 |
(.04%) |
35 |
(.44%) |
|
Reinfarction |
0 |
(0%) |
5 |
(.06%) |
|
Reinfarction |
0 |
(0%) |
5 |
(.06%) |
|
Cardiac Arrest |
5 |
(.06%) |
28 |
(.34%) |
|
Cardiac Arrest |
5 |
(.06%) |
28 |
(.34%) |
|
Heart Block (> first degree) |
5 |
(.06%) |
143 |
(1.7%) |
|
Heart Block (> first degree) |
5 |
(.06%) |
143 |
(1.7%) |
|
Cardiac Failure |
1 |
(.01%) |
233 |
(2.9%) |
|
Cardiac Failure |
1 |
(.01%) |
233 |
(2.9%) |
|
Arrhythmias |
3 |
(.04%) |
22 |
(.27%) |
|
Arrhythmias |
3 |
(.04%) |
22 |
(.27%) |
|
Bronchospasm |
1 |
(.01%) |
50 |
(.62%) |
|
Bronchospasm |
1 |
(.01%) |
50 |
(.62%) |
|
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.
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%) |
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:
|
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%) |
|
Conventional Therapy Plus Atenolol |
Conventional Therapy Alone |
|||
|
Conventional Therapy Plus Atenolol |
Conventional Therapy Alone |
|||
|
(n=244) |
(n=233) |
|||
|
(n=244) |
(n=233) |
|||
|
Bradycardia |
43 |
(18%) |
24 |
(10%) |
|
Bradycardia |
43 |
(18%) |
24 |
(10%) |
|
Hypotension |
60 |
(25%) |
34 |
(15%) |
|
Hypotension |
60 |
(25%) |
34 |
(15%) |
|
Bronchospasm |
3 |
(1.2%) |
2 |
(0.9%) |
|
Bronchospasm |
3 |
(1.2%) |
2 |
(0.9%) |
|
Heart Failure |
46 |
(19%) |
56 |
(24%) |
|
Heart Failure |
46 |
(19%) |
56 |
(24%) |
|
Heart Block |
11 |
(4.5%) |
10 |
(4.3%) |
|
Heart Block |
11 |
(4.5%) |
10 |
(4.3%) |
|
BBB + Major |
||||
|
BBB + Major |
||||
|
Axis Deviation |
16 |
(6.6%) |
28 |
(12%) |
|
Axis Deviation |
16 |
(6.6%) |
28 |
(12%) |
|
Supraventricular Tachycardia |
28 |
(11.5%) |
45 |
(19%) |
|
Supraventricular Tachycardia |
28 |
(11.5%) |
45 |
(19%) |
|
Atrial Fibrillation |
12 |
(5%) |
29 |
(11%) |
|
Atrial Fibrillation |
12 |
(5%) |
29 |
(11%) |
|
Atrial Flutter |
4 |
(1.6%) |
7 |
(3%) |
|
Atrial Flutter |
4 |
(1.6%) |
7 |
(3%) |
|
Ventricular Tachycardia |
39 |
(16%) |
52 |
(22%) |
|
Ventricular Tachycardia |
39 |
(16%) |
52 |
(22%) |
|
Cardiac Reinfarction |
0 |
(0%) |
6 |
(2.6%) |
|
Cardiac Reinfarction |
0 |
(0%) |
6 |
(2.6%) |
|
Total Cardiac Arrests |
4 |
(1.6%) |
16 |
(6.9%) |
|
Total Cardiac Arrests |
4 |
(1.6%) |
16 |
(6.9%) |
|
Nonfatal Cardiac Arrests |
4 |
(1.6%) |
12 |
(5.1%) |
|
Nonfatal Cardiac Arrests |
4 |
(1.6%) |
12 |
(5.1%) |
|
Deaths |
7 |
(2.9%) |
16 |
(6.9%) |
|
Deaths |
7 |
(2.9%) |
16 |
(6.9%) |
|
Cardiogenic Shock |
1 |
(0.4%) |
4 |
(1.7%) |
|
Cardiogenic Shock |
1 |
(0.4%) |
4 |
(1.7%) |
|
Development of Ventricular Septal Defect |
0 |
(0%) |
2 |
(0.9%) |
|
Development of Ventricular Septal Defect |
0 |
(0%) |
2 |
(0.9%) |
|
Development of Mitral Regurgitation |
0 |
(0%) |
2 |
(0.9%) |
|
Development of Mitral Regurgitation |
0 |
(0%) |
2 |
(0.9%) |
|
Renal Failure |
1 |
(0.4%) |
0 |
(0%) |
|
Renal Failure |
1 |
(0.4%) |
0 |
(0%) |
|
Pulmonary Emboli |
3 |
(1.2%) |
0 |
(0%) |
|
Pulmonary Emboli |
3 |
(1.2%) |
0 |
(0%) |
|
||||
|
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%) |
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.
TopBy body system
Cardiovascular side effects
Profound hypotension following atenolol administration for malignant hypertension has been reported.
Cardiovascular side effects occur in less than 3% of patients and include bradycardia, hypotension, precipitation of heart failure, and cold extremities. Less than 1% of patients report flushing symptoms. These side effects may require discontinuation of therapy or dosage reduction. The use of atenolol may be associated with reduced HDL cholesterol and increased total cholesterol. These changes may be deleterious in some patients with heart disease.
Nervous system side effects
Nervous system side effects such as complaints of sleep disturbances, depression, and headache occur in up to 4% of patients. Nervous system side effects are less common than with some beta-blockers due to the more hydrophilic properties of atenolol. A single case of organic anxiety syndrome has been associated with rapid withdrawal of atenolol therapy.
Neurologic side effects are less common with atenolol than with some other beta-blockers because it is less lipophilic and, therefore, less able to penetrate the central nervous system. At least three cases of acute central nervous system disturbances have been attributed to atenolol therapy. In one case, the ratio of the serum to CSF atenolol levels was 2:1, which is much lower than previously reported ratios of 14:,1 indicating that there was significant CSF penetration.
Gastrointestinal side effects
A 68-year-old woman with hypertension developed vomiting, abdominal pain, and progressive renal failure associated with extensive retroperitoneal fibrosis and ureteral obstruction during atenolol therapy. While the patient was also taking oral iron preparations, metoclopramide, and ibuprofen, the authors of this case report implicate atenolol due to previous associations of the retroperitoneal fibrosis with other beta-blockers.
Gastrointestinal side effects have included diarrhea and nausea in 2% and 4% of patients, respectively. Retroperitoneal fibrosis has rarely been associated with atenolol.
Hypersensitivity side effects
Hypersensitivity reactions are rare.
Hepatic side effects
A single case of reversible liver dysfunction and a single case of cholecystitis have been associated with atenolol. The mechanism of toxicity is not known, and is considered to be idiosyncratic.
Hepatic dysfunction has rarely been associated with atenolol.
Dermatologic side effects
A 71-year-old woman with unstable angina developed multiple erythematous, subcutaneous nodules over the metacarpal-phalanx and interphalanx joints of both hands. The patient also developed an increase of CD8+ T lymphocytes (cytotoxic suppressor lymphocytes) and the presence of antinuclear antibodies. The lesions resolved by 90 days after atenolol was withdrawn. Subsequent use of atenolol lead to a similar sequelae.
Dermatologic side effects are rare. A case of septal panniculitis is reported, thought to be due to an immunologic mechanism.
Endocrine side effects
Endocrine side effects including slightly decreased T3 concentrations among patients with hyperthyroidism have been reported, although T4 concentrations were not affected.
Genitourinary side effects
Genitourinary side effects have included decreased libido and at least one case of breast pain, swelling, and tenderness.
Breast pain, swelling, and tenderness developed in a 54-year-old woman after starting therapy with atenolol 25 mg daily. Symptoms resolved following discontinuation of therapy.
In one study, postmenopausal women reported a reduction in libido after receiving atenolol 50 to 100 mg daily.
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