Pindolol Side Effects

ADVERSE REACTIONS Most adverse reactions have been mild.

The incidences listed in the following table are derived from 12-week comparative double-blind, parallel design trials in hypertensive patients given pindolol as monotherapy, given various active control drugs as monotherapy, or given placebo.

Data for pindolol and the positive controls were pooled from several trials because no striking differences were seen in the individual studies, with one exception.

When considering all adverse reactions reported, the frequency of edema was noticeably higher in positive control trials (16% pindolol vs.

9% positive control) than in placebo controlled trials (6% pindolol vs.

3% placebo).

The table includes adverse reactions either volunteered or elicited, and at least possibly drug-related, which were reported in greater than 2% of pindolol patients and other selected important reactions.

ADVERSE REACTIONS WHICH WERE VOLUNTEERED OR ELICITED (and at least possibly drug-related) Body System/ Adverse Reactions Pindolol (N = 322) % Central Nervous System Bizarre or Many Dreams 5 Dizziness 9 Fatigue 8 Hallucinations < 1 Insomnia 10 Nervousness 7 Weakness 4 Autonomic Nervous System Paresthesia 3 Cardiovascular Dyspnea 5 Edema 6 Heart Failure < 1 Palpitations < 1 Musculoskeletal Chest Pain 3 Joint Pain 7 Muscle Cramps 3 Muscle Pain 10 Gastrointestinal Abdominal Discomfort 4 Nausea 5 Skin Pruritus 1 Rash < 1 Body System/ Adverse Reactions Active Controls Active Controls: Patients received either propranolol, α-methyldopa or a diuretic (hydrochlorothiazide or chlorthalidone).

(N = 188) % Central Nervous System Bizarre or Many Dreams 0 Dizziness 11 Fatigue 4 Hallucinations 0 Insomnia 3 Nervousness 3 Weakness 2 Autonomic Nervous System Paresthesia 1 Cardiovascular Dyspnea 4 Edema 3 Heart Failure < 1 Palpitations 1 Musculoskeletal Chest Pain 1 Joint Pain 4 Muscle Cramps 1 Muscle Pain 9 Gastrointestinal Abdominal Discomfort 4 Nausea 2 Skin Pruritus < 1 Rash < 1 Body System/ Adverse Reactions Placebo (N = 78) % Central Nervous System Bizarre or Many Dreams 6 Dizziness 1 Fatigue 4 Hallucinations 0 Insomnia 10 Nervousness 5 Weakness 1 Autonomic Nervous System Paresthesia 6 Cardiovascular Dyspnea 6 Edema 1 Heart Failure 0 Palpitations 0 Musculoskeletal Chest Pain 3 Joint Pain 4 Muscle Cramps 0 Muscle Pain 8 Gastrointestinal Abdominal Discomfort 5 Nausea 1 Skin Pruritus 0 Rash 1 The following selected (potentially important) adverse reactions were seen in 2% or fewer patients and their relationship to pindolol is uncertain.

CENTRAL NERVOUS SYSTEM: anxiety, lethargy;