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Side Effects > Tenormin

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).


For the consumer

For the professional

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:

Cold fingers and toes; diarrhea; dizziness; drowsiness; nausea; tiredness or weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Tenormin:

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:

Cold fingers and toes; diarrhea; dizziness; drowsiness; nausea; tiredness or weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Tenormin Tablets:

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.

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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:

*
Full dosage was 10 mg and some patients received less than 10 mg but more than 5 mg.

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.

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Tenormin 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:

*
Full dosage was 10 mg and some patients received less than 10 mg but more than 5 mg.

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.

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More resources:

Drugs.com Tenormin

PDR Tenormin

MedFacts Tenormin

Micromedex Tenormin - Includes detailed dosage instructions.

FDA Tenormin

Facts & Comparisons Atenolol

FDA Atenolol

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