Atenolol (Page 4 of 7)

ADVERSE REACTIONS

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 tablets and placebo-treated patients than when these reactions were volunteered. Where frequency of adverse effects of atenolol tablets and placebo is similar, causal relationship to atenolol tablets 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 (see WARNINGS)

Wheeziness

0

0

3

3

Dyspnea

0.6

1

6

4

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