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Propranolol side effects: what the label and studies report

The prescribing information for propranolol hydrochloride tablets lists adverse events by body system. For immediate-release formulations, it says fatigue, lethargy, and vivid dreams appear dose-related; the passage gives no dose and no percentage. Single-dose and situational studies report differing results, and this guide reports each one as written.

What the label lists

The label introduces its adverse reactions list by saying the following adverse events were observed and have been reported in patients using propranolol. The passages cited here are lists of events and give no percentages.

Body systemEvents the label lists
CardiovascularBradycardia; congestive heart failure; intensification of AV block; hypotension; paresthesia of hands; thrombocytopenic purpura; arterial insufficiency, usually of the Raynaud type
Central nervous systemLight-headedness, mental depression manifested by insomnia, lassitude, weakness, fatigue; catatonia; visual disturbances; hallucinations; vivid dreams; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics
GastrointestinalNausea, vomiting, epigastric distress, abdominal cramping, diarrhea, constipation, mesenteric arterial thrombosis, ischemic colitis
AllergicHypersensitivity reactions, including anaphylactic/anaphylactoid reactions, pharyngitis and agranulocytosis; erythematous rash, fever combined with aching and sore throat; laryngospasm, and respiratory distress
RespiratoryBronchospasm
HematologicAgranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura

What an FDA page says about side effects

A general FDA consumer page, which is not about propranolol, says to note any changes and write them down so that you can remember to tell your doctor, pharmacist, or other health care professional, and to know when to notify your doctor.

A review of fatigue and depressive symptoms

A 2002 quantitative review in JAMA covered randomized trials of beta-blockers in myocardial infarction, heart failure, and hypertension. It reports on beta-blockers as a group, and the passages used here do not break results out for propranolol. It concluded that there is no significant increased risk of depressive symptoms and only small increased risks of fatigue and sexual dysfunction. It reported a small significant annual increase in risk of reported fatigue (18 per 1000 patients; 95% CI, 5-30), equivalent to 1 additional report of fatigue for every 57 patients treated per year with beta-blockers.

Single-dose studies in healthy volunteers

A double-blind, single-dose, parallel-group study gave 55 healthy volunteers (mean age, 28 years) single oral doses of placebo, atenolol (50 mg), propranolol (40 mg), or lorazepam (2 mg). It reported that, in contrast to lorazepam, atenolol and propranolol produced at most small changes in self-ratings and observer ratings and did not alter DSST performance (the abstract's abbreviation) or memory.

In a double-blind study in healthy volunteers, a single oral dose of 80 mg propranolol reduced the stress-induced increase in heart rate and systolic blood pressure to 49.9 per cent and 8.3 per cent respectively, compared to 61.0 per cent and 17.4 per cent with placebo. The abstract also says the subjects' self-rating of anxiety, alertness and concentration was unaffected by propranolol. The number of volunteers is not given in the passages used here.

A double-blind, randomized, placebo controlled crossover study in healthy volunteers tested propranolol and metoprolol-Oros. It reported that neither beta-adrenoceptor blocker had significant effects in a battery of tests after single or 3 days dosing. Doses and group size are not stated in the passage used here.

A randomized study of single doses in healthy volunteers, titled a preliminary report, reported that single doses of atenolol and propranolol produced significant impairment of psychomotor performance. Doses and size are not stated in the passage used here.

Studies of exams, surgery and speaking

A 1985 double-blind cross-over study of acute propranolol in medical students taking examinations measured exam scores. The abstract does not state the dose. It reported an improvement in total score of 9.2 +/- 3.9 marks (P less than 0.05), an improvement in mental arithmetic score of 5.6 +/- 2.3 marks (P less than 0.05) and an improvement in verbal reasoning score of 3.6 +/- 2.4 marks (NS).

A 1983 abstract of a study of beta blockers and speakers' performance and memory reports that propranolol impaired recall of difficult items in the memory of anxious subjects. The passage used here gives no dose, group size or design.

A randomized, double-masked, crossover study had 5 third-year ophthalmology residents take a capsule containing either propranolol, 40 mg, or placebo 1 hour prior to performing ophthalmic microsurgery. Its abstract states there were no side effects reported or observed in any of the surgeons.

What this does not tell you

This guide cannot say how often any listed event occurs, because the label passages give no percentages. The 2002 review covered people with myocardial infarction, heart failure or hypertension, and the passages used here give no figures for other groups. The studies above are mostly single-dose, several are older, and some do not state dose or size. A study of 5 residents that reports no side effects cannot show that others would have none.

None of these sources tells you what to do about a symptom. The FDA consumer page says to know when to notify your doctor, and a licensed provider decides what is right for an individual.

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