Propranolol

FDA prescribing information

DailyMed, U.S. National Library of Medicine. Propranolol hydrochloride immediate-release oral tablets (Par label), prescribing information, label version effective 26 August 2026. Set ID 0d74bb04-8227-4afa-b523-ce1556150e07.

The label approves propranolol hydrochloride tablets for hypertension (alone or with other agents, particularly a thiazide), angina, ventricular rate control in atrial fibrillation, reducing cardiovascular mortality after myocardial infarction, migraine prophylaxis, familial or hereditary essential tremor (reducing amplitude, not frequency), hypertrophic subaortic stenosis, and as an adjunct to alpha blockade in pheochromocytoma. Anxiety, insomnia and stimulant effects are not labeled indications. Its pharmacology section says clinical studies show benefit in exaggerated physiological and essential tremor. Propranolol is highly lipophilic and almost completely absorbed, but high first-pass metabolism leaves about 25% reaching the circulation; peak levels come 1 to 4 hours after a dose, protein-rich food raises bioavailability by about 50%, and it crosses the blood-brain barrier. The label advises caution with drugs that affect CYP2D6, 1A2 or 2C19 pathways; plasma half-life is 3 to 6 hours. It is a racemate whose S(-) enantiomer is about 100 times as potent at beta receptors as the R(+) enantiomer. It is contraindicated in cardiogenic shock, sinus bradycardia and greater than first-degree block, bronchial asthma, and hypersensitivity. The label warns that abrupt discontinuation has been followed by worsening angina and, in some cases, myocardial infarction; that patients with bronchospastic lung disease should in general not receive beta blockers, because propranolol can provoke an asthma attack by blocking bronchodilation from endogenous and exogenous catecholamines; that it is a competitive inhibitor of beta-receptor agonists; that it can mask signs of hypoglycemia and of hyperthyroidism (abrupt withdrawal may be followed by thyroid storm), and hypoglycemia has been reported after prolonged physical exertion; and that patients on long-term propranolol may develop uncontrolled hypertension if given epinephrine, from unopposed alpha stimulation. Central nervous system adverse reactions include light-headedness, depression manifested by insomnia, lassitude, weakness and fatigue, hallucinations, and vivid dreams; with immediate-release forms, fatigue, lethargy and vivid dreams appear dose-related. Male impotence is listed.

Participants / model

Patients with the labeled conditions; label PK participants; patients in labeled uses and postmarketing reports

Treatment

Propranolol hydrochloride immediate-release oral tablets (Par label)

Follow-up

Label version effective 26 August 2026

Study design

FDA prescribing information

Funding

not stated in the source

Label-level statements. The page does not reproduce label dosing or the label's schedule for stopping the drug.

Regulatory record

U.S. Food and Drug Administration. Drugs@FDA application records for propranolol, including INDERAL LA (NDA 018553), HEMANGEOL (NDA 205410) and generic propranolol hydrochloride (ANDA 070213). Dates read from the openFDA Drugs@FDA records.

openFDA Drugs@FDA records include INDERAL LA, NDA 018553, approved 19 April 1983; HEMANGEOL, NDA 205410, approved 14 March 2014; and generic propranolol hydrochloride, the earliest among the records returned being ANDA 070213 on 19 November 1985. The original immediate-release INDERAL tablet application was not among the records returned.

Participants / model

Not a clinical population

Treatment

Drug applications

Follow-up

Approvals from 1983 to 2014 in the records returned

Study design

FDA application records

Funding

not stated in the source

The original immediate-release INDERAL application was not returned, so the first U.S. approval date is not established. The generic date is the earliest among the records returned.

Chemical identity record

National Library of Medicine. PubChem compound records CID 4946 (propranolol) and CID 62882 (propranolol hydrochloride).

Propranolol free base: C16H21NO2, 259.34 g/mol, CAS 525-66-6. Propranolol hydrochloride, the salt in US tablets: CID 62882, C16H22ClNO2, 295.80 g/mol, CAS 318-98-9; the label gives a molecular weight of 295.80 and describes a racemic mixture.

Participants / model

Chemical identity, not a clinical population

Treatment

Defined molecule and salt

Follow-up

Not applicable

Study design

NLM chemical record

Funding

not stated in the source

Identity record only; it says nothing about efficacy or safety.

Randomized controlled trial

JAMA. 1982;247(12):1707-14. PMID 7038157.

Stopped 9 months early, it found total mortality of 7.2% versus 9.8% over an average 24 months, and sudden cardiac death of 3.3% versus 4.6%. Hypotension, gastrointestinal problems, tiredness, bronchospasm, and cold hands and feet were more frequent on propranolol.

Participants / model

3,837 men and women aged 30 to 69, 5 to 21 days after myocardial infarction

Treatment

Oral propranolol hydrochloride 180 or 240 mg/day depending on serum levels, or placebo

Follow-up

Average 24 months; stopped 9 months early

Study design

Randomized placebo-controlled trial

Funding

not stated in the source

People after myocardial infarction; the result supports the labeled mortality indication and does not apply to the supplier's uses.

FDA prescribing information

DailyMed, U.S. National Library of Medicine. Propranolol hydrochloride immediate-release oral tablets (Par label), prescribing information, label version effective 26 August 2026. Set ID 0d74bb04-8227-4afa-b523-ce1556150e07.

The label approves propranolol hydrochloride tablets for hypertension (alone or with other agents, particularly a thiazide), angina, ventricular rate control in atrial fibrillation, reducing cardiovascular mortality after myocardial infarction, migraine prophylaxis, familial or hereditary essential tremor (reducing amplitude, not frequency), hypertrophic subaortic stenosis, and as an adjunct to alpha blockade in pheochromocytoma. Anxiety, insomnia and stimulant effects are not labeled indications. Its pharmacology section says clinical studies show benefit in exaggerated physiological and essential tremor. Propranolol is highly lipophilic and almost completely absorbed, but high first-pass metabolism leaves about 25% reaching the circulation; peak levels come 1 to 4 hours after a dose, protein-rich food raises bioavailability by about 50%, and it crosses the blood-brain barrier. The label advises caution with drugs that affect CYP2D6, 1A2 or 2C19 pathways; plasma half-life is 3 to 6 hours. It is a racemate whose S(-) enantiomer is about 100 times as potent at beta receptors as the R(+) enantiomer. It is contraindicated in cardiogenic shock, sinus bradycardia and greater than first-degree block, bronchial asthma, and hypersensitivity. The label warns that abrupt discontinuation has been followed by worsening angina and, in some cases, myocardial infarction; that patients with bronchospastic lung disease should in general not receive beta blockers, because propranolol can provoke an asthma attack by blocking bronchodilation from endogenous and exogenous catecholamines; that it is a competitive inhibitor of beta-receptor agonists; that it can mask signs of hypoglycemia and of hyperthyroidism (abrupt withdrawal may be followed by thyroid storm), and hypoglycemia has been reported after prolonged physical exertion; and that patients on long-term propranolol may develop uncontrolled hypertension if given epinephrine, from unopposed alpha stimulation. Central nervous system adverse reactions include light-headedness, depression manifested by insomnia, lassitude, weakness and fatigue, hallucinations, and vivid dreams; with immediate-release forms, fatigue, lethargy and vivid dreams appear dose-related. Male impotence is listed.

Participants / model

Patients with the labeled conditions; label PK participants; patients in labeled uses and postmarketing reports

Treatment

Propranolol hydrochloride immediate-release oral tablets (Par label)

Follow-up

Label version effective 26 August 2026

Study design

FDA prescribing information

Funding

not stated in the source

Label-level statements. The page does not reproduce label dosing or the label's schedule for stopping the drug.

PubMed search record

PubMed search run on 9 October 2026: propranolol[tiab] AND clenbuterol[tiab] AND humans[mh]. 27 records returned. A second search, propranolol[tiab] AND (stimulant*[tiab] OR caffeine[tiab] OR amphetamine*[tiab] OR clenbuterol[tiab] OR ephedrine[tiab]) AND (sleep[tiab] OR insomnia[tiab]), returned 15 records.

The first search returned 27 records. None was a trial or cohort of propranolol for resting tachycardia in people taking clenbuterol or albuterol for body composition. Two were case reports of acute clenbuterol poisoning treated in hospital with intravenous propranolol and potassium (a bodybuilder, and a father and daughter who ate contaminated liver); the rest covered receptor and cell pharmacology, doping-control and analytical methods, and reviews. The second search returned 15 records, none testing propranolol for stimulant-driven sleep problems; they covered headache, migraine and narcolepsy papers, a review of sleep disturbance with antihypertensives, surgeon tremor and dexterity studies, animal and toxicology studies, reviews of beta blockers in heart failure and of caffeine exposure, a test-anxiety survey, and a 2026 survey of Jordanian medical students in which most of 23 current beta-blocker users (78.3% propranolol, 56.5% non-prescribed) reported night waking and nightmares.

Participants / model

Records returned, not a population

Treatment

Not applicable

Follow-up

Searches run on 9 October 2026

Study design

Literature search

Funding

not stated in the source

A search result shows what PubMed returned on that date. It is not proof that no unindexed study exists. The link opens the first search.

FDA prescribing information

DailyMed, U.S. National Library of Medicine. Propranolol hydrochloride immediate-release oral tablets (Par label), prescribing information, label version effective 26 August 2026. Set ID 0d74bb04-8227-4afa-b523-ce1556150e07.

The label approves propranolol hydrochloride tablets for hypertension (alone or with other agents, particularly a thiazide), angina, ventricular rate control in atrial fibrillation, reducing cardiovascular mortality after myocardial infarction, migraine prophylaxis, familial or hereditary essential tremor (reducing amplitude, not frequency), hypertrophic subaortic stenosis, and as an adjunct to alpha blockade in pheochromocytoma. Anxiety, insomnia and stimulant effects are not labeled indications. Its pharmacology section says clinical studies show benefit in exaggerated physiological and essential tremor. Propranolol is highly lipophilic and almost completely absorbed, but high first-pass metabolism leaves about 25% reaching the circulation; peak levels come 1 to 4 hours after a dose, protein-rich food raises bioavailability by about 50%, and it crosses the blood-brain barrier. The label advises caution with drugs that affect CYP2D6, 1A2 or 2C19 pathways; plasma half-life is 3 to 6 hours. It is a racemate whose S(-) enantiomer is about 100 times as potent at beta receptors as the R(+) enantiomer. It is contraindicated in cardiogenic shock, sinus bradycardia and greater than first-degree block, bronchial asthma, and hypersensitivity. The label warns that abrupt discontinuation has been followed by worsening angina and, in some cases, myocardial infarction; that patients with bronchospastic lung disease should in general not receive beta blockers, because propranolol can provoke an asthma attack by blocking bronchodilation from endogenous and exogenous catecholamines; that it is a competitive inhibitor of beta-receptor agonists; that it can mask signs of hypoglycemia and of hyperthyroidism (abrupt withdrawal may be followed by thyroid storm), and hypoglycemia has been reported after prolonged physical exertion; and that patients on long-term propranolol may develop uncontrolled hypertension if given epinephrine, from unopposed alpha stimulation. Central nervous system adverse reactions include light-headedness, depression manifested by insomnia, lassitude, weakness and fatigue, hallucinations, and vivid dreams; with immediate-release forms, fatigue, lethargy and vivid dreams appear dose-related. Male impotence is listed.

Participants / model

Patients with the labeled conditions; label PK participants; patients in labeled uses and postmarketing reports

Treatment

Propranolol hydrochloride immediate-release oral tablets (Par label)

Follow-up

Label version effective 26 August 2026

Study design

FDA prescribing information

Funding

not stated in the source

Label-level statements. The page does not reproduce label dosing or the label's schedule for stopping the drug.

Human study

Hoffman RS et al. Ann Emerg Med. 2008;52(5):548-53. PMID 18501476.

Five poison centers identified 34 probable or confirmed emergency department cases over 6 months (13 confirmed). Patients had tachycardia, hypotension, hyperglycemia, hypokalemia and raised lactate; 6 showed biochemical myocardial injury. Ten received beta-adrenergic antagonists without adverse effect.

Participants / model

34 emergency department patients after clenbuterol-adulterated heroin

Treatment

Unintended clenbuterol exposure; beta blockers given in hospital

Follow-up

6 months

Study design

Descriptive case series

Funding

not stated in the source

Acute poisoning treated in hospital, not self-directed use to lower resting heart rate.

Human study

Brett J et al. Med J Aust. 2014;200(4):219-21. PMID 24580525.

The centre recorded 63 clenbuterol exposures, rising from 3 in 2008 to 27 in 2012, and at least 53 (84%) required hospitalization. Bodybuilding and slimming were the commonest reasons for use. Tachycardia (24 patients), gastrointestinal disturbance (16) and tremor (11) were most common, and one 21-year-old man had a cardiac arrest.

Participants / model

63 people exposed to clenbuterol, Australia

Treatment

Clenbuterol, mostly self-administered

Follow-up

Calls from 2004 to 2012

Study design

Retrospective poison center case series

Funding

not stated in the source

Describes clenbuterol toxicity; it does not test propranolol.

Systematic review and meta-analysis

Steenen SA et al. J Psychopharmacol. 2016;30(2):128-39. PMID 26487439.

The review found 8 studies: panic disorder (4 studies, total n = 130), specific phobia (2, n = 37), social phobia (1, n = 16) and PTSD (1, n = 19). Pooled panic-disorder data showed no significant difference from benzodiazepines for short-term treatment, and no effect on PTSD symptom severity was found. The authors judged the evidence insufficient to support routine use of propranolol for any anxiety disorder.

Participants / model

Patients with anxiety disorders: panic disorder, specific phobia, social phobia and PTSD

Treatment

Oral propranolol

Follow-up

Pooled short-term studies

Study design

Systematic review of randomized trials, with pooled panic-disorder data

Funding

not stated in the source

The review dates from 2016; later trials were not reviewed.

Randomized controlled trial

Danjou P et al. Int Clin Psychopharmacol. 1987;2(2):135-40. PMID 3298418.

Propranolol showed no hypnotic effect and even increased insomnia, which the authors relate to the sleep disturbance seen when beta-blocker treatment begins.

Participants / model

37 adults with chronic insomnia previously treated with hypnotics, mostly benzodiazepines

Treatment

Oral propranolol 80 mg or placebo

Follow-up

not stated in the source

Study design

Double-blind placebo-controlled crossover trial

Funding

not stated in the source

Adults with chronic insomnia after long-term hypnotic use, not people with stimulant-driven sleep problems.

Randomized controlled trial

Betts TA et al. Eur J Clin Pharmacol. 1985;28 Suppl:65-8. PMID 2865152.

The lipophilic beta blockers propranolol, metoprolol and pindolol increased awakening and remembered dreaming, with increased waking confirmed on overnight recordings, while REM sleep was reduced. Hydrophilic atenolol had no effect on subjective sleep.

Participants / model

10 female volunteers

Treatment

Oral propranolol, metoprolol, pindolol or atenolol, or placebo

Follow-up

not stated in the source

Study design

Placebo-controlled crossover trial

Funding

not stated in the source

Healthy female volunteers; the effect on sleep is a class property of lipophilic beta blockers in this study.

FDA prescribing information

DailyMed, U.S. National Library of Medicine. Propranolol hydrochloride immediate-release oral tablets (Par label), prescribing information, label version effective 26 August 2026. Set ID 0d74bb04-8227-4afa-b523-ce1556150e07.

The label approves propranolol hydrochloride tablets for hypertension (alone or with other agents, particularly a thiazide), angina, ventricular rate control in atrial fibrillation, reducing cardiovascular mortality after myocardial infarction, migraine prophylaxis, familial or hereditary essential tremor (reducing amplitude, not frequency), hypertrophic subaortic stenosis, and as an adjunct to alpha blockade in pheochromocytoma. Anxiety, insomnia and stimulant effects are not labeled indications. Its pharmacology section says clinical studies show benefit in exaggerated physiological and essential tremor. Propranolol is highly lipophilic and almost completely absorbed, but high first-pass metabolism leaves about 25% reaching the circulation; peak levels come 1 to 4 hours after a dose, protein-rich food raises bioavailability by about 50%, and it crosses the blood-brain barrier. The label advises caution with drugs that affect CYP2D6, 1A2 or 2C19 pathways; plasma half-life is 3 to 6 hours. It is a racemate whose S(-) enantiomer is about 100 times as potent at beta receptors as the R(+) enantiomer. It is contraindicated in cardiogenic shock, sinus bradycardia and greater than first-degree block, bronchial asthma, and hypersensitivity. The label warns that abrupt discontinuation has been followed by worsening angina and, in some cases, myocardial infarction; that patients with bronchospastic lung disease should in general not receive beta blockers, because propranolol can provoke an asthma attack by blocking bronchodilation from endogenous and exogenous catecholamines; that it is a competitive inhibitor of beta-receptor agonists; that it can mask signs of hypoglycemia and of hyperthyroidism (abrupt withdrawal may be followed by thyroid storm), and hypoglycemia has been reported after prolonged physical exertion; and that patients on long-term propranolol may develop uncontrolled hypertension if given epinephrine, from unopposed alpha stimulation. Central nervous system adverse reactions include light-headedness, depression manifested by insomnia, lassitude, weakness and fatigue, hallucinations, and vivid dreams; with immediate-release forms, fatigue, lethargy and vivid dreams appear dose-related. Male impotence is listed.

Participants / model

Patients with the labeled conditions; label PK participants; patients in labeled uses and postmarketing reports

Treatment

Propranolol hydrochloride immediate-release oral tablets (Par label)

Follow-up

Label version effective 26 August 2026

Study design

FDA prescribing information

Funding

not stated in the source

Label-level statements. The page does not reproduce label dosing or the label's schedule for stopping the drug.

Systematic review and meta-analysis

Morales DR et al. Chest. 2014;145(4):779-786. PMID 24202435.

Nonselective beta blockers lowered FEV1 by 10.2% (95% CI -14.7 to -5.6), caused a fall of 20% or more in 1 in 9 patients, and attenuated the response to beta2-agonist rescue therapy by 20.0% (95% CI -29.4 to -10.7). Selective agents were better tolerated but not risk-free.

Participants / model

People with asthma in randomized blinded placebo-controlled trials

Treatment

Acute beta-blocker exposure (routes not stated in the abstract)

Follow-up

Acute exposure

Study design

Systematic review and meta-analysis

Funding

not stated in the source

Albuterol is a beta2-agonist, so in a person who uses it for asthma, propranolol both risks bronchospasm and blunts the rescue drug.

FDA prescribing information

DailyMed, U.S. National Library of Medicine. Propranolol hydrochloride immediate-release oral tablets (Par label), prescribing information, label version effective 26 August 2026. Set ID 0d74bb04-8227-4afa-b523-ce1556150e07.

The label approves propranolol hydrochloride tablets for hypertension (alone or with other agents, particularly a thiazide), angina, ventricular rate control in atrial fibrillation, reducing cardiovascular mortality after myocardial infarction, migraine prophylaxis, familial or hereditary essential tremor (reducing amplitude, not frequency), hypertrophic subaortic stenosis, and as an adjunct to alpha blockade in pheochromocytoma. Anxiety, insomnia and stimulant effects are not labeled indications. Its pharmacology section says clinical studies show benefit in exaggerated physiological and essential tremor. Propranolol is highly lipophilic and almost completely absorbed, but high first-pass metabolism leaves about 25% reaching the circulation; peak levels come 1 to 4 hours after a dose, protein-rich food raises bioavailability by about 50%, and it crosses the blood-brain barrier. The label advises caution with drugs that affect CYP2D6, 1A2 or 2C19 pathways; plasma half-life is 3 to 6 hours. It is a racemate whose S(-) enantiomer is about 100 times as potent at beta receptors as the R(+) enantiomer. It is contraindicated in cardiogenic shock, sinus bradycardia and greater than first-degree block, bronchial asthma, and hypersensitivity. The label warns that abrupt discontinuation has been followed by worsening angina and, in some cases, myocardial infarction; that patients with bronchospastic lung disease should in general not receive beta blockers, because propranolol can provoke an asthma attack by blocking bronchodilation from endogenous and exogenous catecholamines; that it is a competitive inhibitor of beta-receptor agonists; that it can mask signs of hypoglycemia and of hyperthyroidism (abrupt withdrawal may be followed by thyroid storm), and hypoglycemia has been reported after prolonged physical exertion; and that patients on long-term propranolol may develop uncontrolled hypertension if given epinephrine, from unopposed alpha stimulation. Central nervous system adverse reactions include light-headedness, depression manifested by insomnia, lassitude, weakness and fatigue, hallucinations, and vivid dreams; with immediate-release forms, fatigue, lethargy and vivid dreams appear dose-related. Male impotence is listed.

Participants / model

Patients with the labeled conditions; label PK participants; patients in labeled uses and postmarketing reports

Treatment

Propranolol hydrochloride immediate-release oral tablets (Par label)

Follow-up

Label version effective 26 August 2026

Study design

FDA prescribing information

Funding

not stated in the source

Label-level statements. The page does not reproduce label dosing or the label's schedule for stopping the drug.

FDA prescribing information

DailyMed, U.S. National Library of Medicine. Propranolol hydrochloride immediate-release oral tablets (Par label), prescribing information, label version effective 26 August 2026. Set ID 0d74bb04-8227-4afa-b523-ce1556150e07.

The label approves propranolol hydrochloride tablets for hypertension (alone or with other agents, particularly a thiazide), angina, ventricular rate control in atrial fibrillation, reducing cardiovascular mortality after myocardial infarction, migraine prophylaxis, familial or hereditary essential tremor (reducing amplitude, not frequency), hypertrophic subaortic stenosis, and as an adjunct to alpha blockade in pheochromocytoma. Anxiety, insomnia and stimulant effects are not labeled indications. Its pharmacology section says clinical studies show benefit in exaggerated physiological and essential tremor. Propranolol is highly lipophilic and almost completely absorbed, but high first-pass metabolism leaves about 25% reaching the circulation; peak levels come 1 to 4 hours after a dose, protein-rich food raises bioavailability by about 50%, and it crosses the blood-brain barrier. The label advises caution with drugs that affect CYP2D6, 1A2 or 2C19 pathways; plasma half-life is 3 to 6 hours. It is a racemate whose S(-) enantiomer is about 100 times as potent at beta receptors as the R(+) enantiomer. It is contraindicated in cardiogenic shock, sinus bradycardia and greater than first-degree block, bronchial asthma, and hypersensitivity. The label warns that abrupt discontinuation has been followed by worsening angina and, in some cases, myocardial infarction; that patients with bronchospastic lung disease should in general not receive beta blockers, because propranolol can provoke an asthma attack by blocking bronchodilation from endogenous and exogenous catecholamines; that it is a competitive inhibitor of beta-receptor agonists; that it can mask signs of hypoglycemia and of hyperthyroidism (abrupt withdrawal may be followed by thyroid storm), and hypoglycemia has been reported after prolonged physical exertion; and that patients on long-term propranolol may develop uncontrolled hypertension if given epinephrine, from unopposed alpha stimulation. Central nervous system adverse reactions include light-headedness, depression manifested by insomnia, lassitude, weakness and fatigue, hallucinations, and vivid dreams; with immediate-release forms, fatigue, lethargy and vivid dreams appear dose-related. Male impotence is listed.

Participants / model

Patients with the labeled conditions; label PK participants; patients in labeled uses and postmarketing reports

Treatment

Propranolol hydrochloride immediate-release oral tablets (Par label)

Follow-up

Label version effective 26 August 2026

Study design

FDA prescribing information

Funding

not stated in the source

Label-level statements. The page does not reproduce label dosing or the label's schedule for stopping the drug.

Human study

Reith DM et al. J Toxicol Clin Toxicol. 1996;34(3):273-8. PMID 8667464.

Propranolol was the only beta blocker associated with seizures and with death; two thirds of people who took more than 2 g of propranolol had a seizure, and a QRS duration above 100 ms was associated with seizure risk. All toxicity appeared within 6 hours. The authors advise avoiding propranolol in people at risk of self-poisoning.

Participants / model

58 hospital presentations of beta-blocker self-poisoning and 2 coroner-investigated deaths, Newcastle and Lake Macquarie, Australia

Treatment

Oral beta-blocker overdose

Follow-up

1987 to 1995

Study design

Prospective clinical database study

Funding

not stated in the source

Overdose series. A larger series found no overall severity difference among beta blockers.

Human study

Lauterbach M. Basic Clin Pharmacol Toxicol. 2019;125(2):178-186. PMID 30916882.

There were more seizures with propranolol but no significant difference in poisoning severity among beta blockers, and no deaths after single-substance exposure. One patient died after combined bisoprolol and verapamil, and the author flags co-exposure with other antihypertensives, sedatives or alcohol.

Participants / model

2,967 adults with beta-blocker exposure reported to the Mainz Poison Center, Germany (697 single-substance)

Treatment

Oral beta-blocker overdose

Follow-up

10-year review

Study design

Retrospective poison center study

Funding

not stated in the source

Tempers the Newcastle series without removing the propranolol seizure signal.

FDA prescribing information

DailyMed, U.S. National Library of Medicine. Propranolol hydrochloride immediate-release oral tablets (Par label), prescribing information, label version effective 26 August 2026. Set ID 0d74bb04-8227-4afa-b523-ce1556150e07.

The label approves propranolol hydrochloride tablets for hypertension (alone or with other agents, particularly a thiazide), angina, ventricular rate control in atrial fibrillation, reducing cardiovascular mortality after myocardial infarction, migraine prophylaxis, familial or hereditary essential tremor (reducing amplitude, not frequency), hypertrophic subaortic stenosis, and as an adjunct to alpha blockade in pheochromocytoma. Anxiety, insomnia and stimulant effects are not labeled indications. Its pharmacology section says clinical studies show benefit in exaggerated physiological and essential tremor. Propranolol is highly lipophilic and almost completely absorbed, but high first-pass metabolism leaves about 25% reaching the circulation; peak levels come 1 to 4 hours after a dose, protein-rich food raises bioavailability by about 50%, and it crosses the blood-brain barrier. The label advises caution with drugs that affect CYP2D6, 1A2 or 2C19 pathways; plasma half-life is 3 to 6 hours. It is a racemate whose S(-) enantiomer is about 100 times as potent at beta receptors as the R(+) enantiomer. It is contraindicated in cardiogenic shock, sinus bradycardia and greater than first-degree block, bronchial asthma, and hypersensitivity. The label warns that abrupt discontinuation has been followed by worsening angina and, in some cases, myocardial infarction; that patients with bronchospastic lung disease should in general not receive beta blockers, because propranolol can provoke an asthma attack by blocking bronchodilation from endogenous and exogenous catecholamines; that it is a competitive inhibitor of beta-receptor agonists; that it can mask signs of hypoglycemia and of hyperthyroidism (abrupt withdrawal may be followed by thyroid storm), and hypoglycemia has been reported after prolonged physical exertion; and that patients on long-term propranolol may develop uncontrolled hypertension if given epinephrine, from unopposed alpha stimulation. Central nervous system adverse reactions include light-headedness, depression manifested by insomnia, lassitude, weakness and fatigue, hallucinations, and vivid dreams; with immediate-release forms, fatigue, lethargy and vivid dreams appear dose-related. Male impotence is listed.

Participants / model

Patients with the labeled conditions; label PK participants; patients in labeled uses and postmarketing reports

Treatment

Propranolol hydrochloride immediate-release oral tablets (Par label)

Follow-up

Label version effective 26 August 2026

Study design

FDA prescribing information

Funding

not stated in the source

Label-level statements. The page does not reproduce label dosing or the label's schedule for stopping the drug.

Regulatory record

U.S. Food and Drug Administration. Drugs@FDA application records for propranolol, including INDERAL LA (NDA 018553), HEMANGEOL (NDA 205410) and generic propranolol hydrochloride (ANDA 070213). Dates read from the openFDA Drugs@FDA records.

openFDA Drugs@FDA records include INDERAL LA, NDA 018553, approved 19 April 1983; HEMANGEOL, NDA 205410, approved 14 March 2014; and generic propranolol hydrochloride, the earliest among the records returned being ANDA 070213 on 19 November 1985. The original immediate-release INDERAL tablet application was not among the records returned.

Participants / model

Not a clinical population

Treatment

Drug applications

Follow-up

Approvals from 1983 to 2014 in the records returned

Study design

FDA application records

Funding

not stated in the source

The original immediate-release INDERAL application was not returned, so the first U.S. approval date is not established. The generic date is the earliest among the records returned.

Randomized controlled trial

JAMA. 1982;247(12):1707-14. PMID 7038157.

Stopped 9 months early, it found total mortality of 7.2% versus 9.8% over an average 24 months, and sudden cardiac death of 3.3% versus 4.6%. Hypotension, gastrointestinal problems, tiredness, bronchospasm, and cold hands and feet were more frequent on propranolol.

Participants / model

3,837 men and women aged 30 to 69, 5 to 21 days after myocardial infarction

Treatment

Oral propranolol hydrochloride 180 or 240 mg/day depending on serum levels, or placebo

Follow-up

Average 24 months; stopped 9 months early

Study design

Randomized placebo-controlled trial

Funding

not stated in the source

People after myocardial infarction; the result supports the labeled mortality indication and does not apply to the supplier's uses.

Systematic review and meta-analysis

Steenen SA et al. J Psychopharmacol. 2016;30(2):128-39. PMID 26487439.

The review found 8 studies: panic disorder (4 studies, total n = 130), specific phobia (2, n = 37), social phobia (1, n = 16) and PTSD (1, n = 19). Pooled panic-disorder data showed no significant difference from benzodiazepines for short-term treatment, and no effect on PTSD symptom severity was found. The authors judged the evidence insufficient to support routine use of propranolol for any anxiety disorder.

Participants / model

Patients with anxiety disorders: panic disorder, specific phobia, social phobia and PTSD

Treatment

Oral propranolol

Follow-up

Pooled short-term studies

Study design

Systematic review of randomized trials, with pooled panic-disorder data

Funding

not stated in the source

The review dates from 2016; later trials were not reviewed.

Randomized controlled trial

Danjou P et al. Int Clin Psychopharmacol. 1987;2(2):135-40. PMID 3298418.

Propranolol showed no hypnotic effect and even increased insomnia, which the authors relate to the sleep disturbance seen when beta-blocker treatment begins.

Participants / model

37 adults with chronic insomnia previously treated with hypnotics, mostly benzodiazepines

Treatment

Oral propranolol 80 mg or placebo

Follow-up

not stated in the source

Study design

Double-blind placebo-controlled crossover trial

Funding

not stated in the source

Adults with chronic insomnia after long-term hypnotic use, not people with stimulant-driven sleep problems.

Randomized controlled trial

Betts TA et al. Eur J Clin Pharmacol. 1985;28 Suppl:65-8. PMID 2865152.

The lipophilic beta blockers propranolol, metoprolol and pindolol increased awakening and remembered dreaming, with increased waking confirmed on overnight recordings, while REM sleep was reduced. Hydrophilic atenolol had no effect on subjective sleep.

Participants / model

10 female volunteers

Treatment

Oral propranolol, metoprolol, pindolol or atenolol, or placebo

Follow-up

not stated in the source

Study design

Placebo-controlled crossover trial

Funding

not stated in the source

Healthy female volunteers; the effect on sleep is a class property of lipophilic beta blockers in this study.

Systematic review and meta-analysis

Morales DR et al. Chest. 2014;145(4):779-786. PMID 24202435.

Nonselective beta blockers lowered FEV1 by 10.2% (95% CI -14.7 to -5.6), caused a fall of 20% or more in 1 in 9 patients, and attenuated the response to beta2-agonist rescue therapy by 20.0% (95% CI -29.4 to -10.7). Selective agents were better tolerated but not risk-free.

Participants / model

People with asthma in randomized blinded placebo-controlled trials

Treatment

Acute beta-blocker exposure (routes not stated in the abstract)

Follow-up

Acute exposure

Study design

Systematic review and meta-analysis

Funding

not stated in the source

Albuterol is a beta2-agonist, so in a person who uses it for asthma, propranolol both risks bronchospasm and blunts the rescue drug.

Human study

Hoffman RS et al. Ann Emerg Med. 2008;52(5):548-53. PMID 18501476.

Five poison centers identified 34 probable or confirmed emergency department cases over 6 months (13 confirmed). Patients had tachycardia, hypotension, hyperglycemia, hypokalemia and raised lactate; 6 showed biochemical myocardial injury. Ten received beta-adrenergic antagonists without adverse effect.

Participants / model

34 emergency department patients after clenbuterol-adulterated heroin

Treatment

Unintended clenbuterol exposure; beta blockers given in hospital

Follow-up

6 months

Study design

Descriptive case series

Funding

not stated in the source

Acute poisoning treated in hospital, not self-directed use to lower resting heart rate.

Human study

Reith DM et al. J Toxicol Clin Toxicol. 1996;34(3):273-8. PMID 8667464.

Propranolol was the only beta blocker associated with seizures and with death; two thirds of people who took more than 2 g of propranolol had a seizure, and a QRS duration above 100 ms was associated with seizure risk. All toxicity appeared within 6 hours. The authors advise avoiding propranolol in people at risk of self-poisoning.

Participants / model

58 hospital presentations of beta-blocker self-poisoning and 2 coroner-investigated deaths, Newcastle and Lake Macquarie, Australia

Treatment

Oral beta-blocker overdose

Follow-up

1987 to 1995

Study design

Prospective clinical database study

Funding

not stated in the source

Overdose series. A larger series found no overall severity difference among beta blockers.

Human study

Lauterbach M. Basic Clin Pharmacol Toxicol. 2019;125(2):178-186. PMID 30916882.

There were more seizures with propranolol but no significant difference in poisoning severity among beta blockers, and no deaths after single-substance exposure. One patient died after combined bisoprolol and verapamil, and the author flags co-exposure with other antihypertensives, sedatives or alcohol.

Participants / model

2,967 adults with beta-blocker exposure reported to the Mainz Poison Center, Germany (697 single-substance)

Treatment

Oral beta-blocker overdose

Follow-up

10-year review

Study design

Retrospective poison center study

Funding

not stated in the source

Tempers the Newcastle series without removing the propranolol seizure signal.

PubMed search record

PubMed search run on 9 October 2026: propranolol[tiab] AND clenbuterol[tiab] AND humans[mh]. 27 records returned. A second search, propranolol[tiab] AND (stimulant*[tiab] OR caffeine[tiab] OR amphetamine*[tiab] OR clenbuterol[tiab] OR ephedrine[tiab]) AND (sleep[tiab] OR insomnia[tiab]), returned 15 records.

The first search returned 27 records. None was a trial or cohort of propranolol for resting tachycardia in people taking clenbuterol or albuterol for body composition. Two were case reports of acute clenbuterol poisoning treated in hospital with intravenous propranolol and potassium (a bodybuilder, and a father and daughter who ate contaminated liver); the rest covered receptor and cell pharmacology, doping-control and analytical methods, and reviews. The second search returned 15 records, none testing propranolol for stimulant-driven sleep problems; they covered headache, migraine and narcolepsy papers, a review of sleep disturbance with antihypertensives, surgeon tremor and dexterity studies, animal and toxicology studies, reviews of beta blockers in heart failure and of caffeine exposure, a test-anxiety survey, and a 2026 survey of Jordanian medical students in which most of 23 current beta-blocker users (78.3% propranolol, 56.5% non-prescribed) reported night waking and nightmares.

Participants / model

Records returned, not a population

Treatment

Not applicable

Follow-up

Searches run on 9 October 2026

Study design

Literature search

Funding

not stated in the source

A search result shows what PubMed returned on that date. It is not proof that no unindexed study exists. The link opens the first search.

FDA prescribing information

DailyMed, U.S. National Library of Medicine. Propranolol hydrochloride immediate-release oral tablets (Par label), prescribing information, label version effective 26 August 2026. Set ID 0d74bb04-8227-4afa-b523-ce1556150e07.

The label approves propranolol hydrochloride tablets for hypertension (alone or with other agents, particularly a thiazide), angina, ventricular rate control in atrial fibrillation, reducing cardiovascular mortality after myocardial infarction, migraine prophylaxis, familial or hereditary essential tremor (reducing amplitude, not frequency), hypertrophic subaortic stenosis, and as an adjunct to alpha blockade in pheochromocytoma. Anxiety, insomnia and stimulant effects are not labeled indications. Its pharmacology section says clinical studies show benefit in exaggerated physiological and essential tremor. Propranolol is highly lipophilic and almost completely absorbed, but high first-pass metabolism leaves about 25% reaching the circulation; peak levels come 1 to 4 hours after a dose, protein-rich food raises bioavailability by about 50%, and it crosses the blood-brain barrier. The label advises caution with drugs that affect CYP2D6, 1A2 or 2C19 pathways; plasma half-life is 3 to 6 hours. It is a racemate whose S(-) enantiomer is about 100 times as potent at beta receptors as the R(+) enantiomer. It is contraindicated in cardiogenic shock, sinus bradycardia and greater than first-degree block, bronchial asthma, and hypersensitivity. The label warns that abrupt discontinuation has been followed by worsening angina and, in some cases, myocardial infarction; that patients with bronchospastic lung disease should in general not receive beta blockers, because propranolol can provoke an asthma attack by blocking bronchodilation from endogenous and exogenous catecholamines; that it is a competitive inhibitor of beta-receptor agonists; that it can mask signs of hypoglycemia and of hyperthyroidism (abrupt withdrawal may be followed by thyroid storm), and hypoglycemia has been reported after prolonged physical exertion; and that patients on long-term propranolol may develop uncontrolled hypertension if given epinephrine, from unopposed alpha stimulation. Central nervous system adverse reactions include light-headedness, depression manifested by insomnia, lassitude, weakness and fatigue, hallucinations, and vivid dreams; with immediate-release forms, fatigue, lethargy and vivid dreams appear dose-related. Male impotence is listed.

Participants / model

Patients with the labeled conditions; label PK participants; patients in labeled uses and postmarketing reports

Treatment

Propranolol hydrochloride immediate-release oral tablets (Par label)

Follow-up

Label version effective 26 August 2026

Study design

FDA prescribing information

Funding

not stated in the source

Label-level statements. The page does not reproduce label dosing or the label's schedule for stopping the drug.

Regulatory record

U.S. Food and Drug Administration. Drugs@FDA application records for propranolol, including INDERAL LA (NDA 018553), HEMANGEOL (NDA 205410) and generic propranolol hydrochloride (ANDA 070213). Dates read from the openFDA Drugs@FDA records.

openFDA Drugs@FDA records include INDERAL LA, NDA 018553, approved 19 April 1983; HEMANGEOL, NDA 205410, approved 14 March 2014; and generic propranolol hydrochloride, the earliest among the records returned being ANDA 070213 on 19 November 1985. The original immediate-release INDERAL tablet application was not among the records returned.

Participants / model

Not a clinical population

Treatment

Drug applications

Follow-up

Approvals from 1983 to 2014 in the records returned

Study design

FDA application records

Funding

not stated in the source

The original immediate-release INDERAL application was not returned, so the first U.S. approval date is not established. The generic date is the earliest among the records returned.

Randomized controlled trial

JAMA. 1982;247(12):1707-14. PMID 7038157.

Stopped 9 months early, it found total mortality of 7.2% versus 9.8% over an average 24 months, and sudden cardiac death of 3.3% versus 4.6%. Hypotension, gastrointestinal problems, tiredness, bronchospasm, and cold hands and feet were more frequent on propranolol.

Participants / model

3,837 men and women aged 30 to 69, 5 to 21 days after myocardial infarction

Treatment

Oral propranolol hydrochloride 180 or 240 mg/day depending on serum levels, or placebo

Follow-up

Average 24 months; stopped 9 months early

Study design

Randomized placebo-controlled trial

Funding

not stated in the source

People after myocardial infarction; the result supports the labeled mortality indication and does not apply to the supplier's uses.

Systematic review and meta-analysis

Steenen SA et al. J Psychopharmacol. 2016;30(2):128-39. PMID 26487439.

The review found 8 studies: panic disorder (4 studies, total n = 130), specific phobia (2, n = 37), social phobia (1, n = 16) and PTSD (1, n = 19). Pooled panic-disorder data showed no significant difference from benzodiazepines for short-term treatment, and no effect on PTSD symptom severity was found. The authors judged the evidence insufficient to support routine use of propranolol for any anxiety disorder.

Participants / model

Patients with anxiety disorders: panic disorder, specific phobia, social phobia and PTSD

Treatment

Oral propranolol

Follow-up

Pooled short-term studies

Study design

Systematic review of randomized trials, with pooled panic-disorder data

Funding

not stated in the source

The review dates from 2016; later trials were not reviewed.

Randomized controlled trial

Danjou P et al. Int Clin Psychopharmacol. 1987;2(2):135-40. PMID 3298418.

Propranolol showed no hypnotic effect and even increased insomnia, which the authors relate to the sleep disturbance seen when beta-blocker treatment begins.

Participants / model

37 adults with chronic insomnia previously treated with hypnotics, mostly benzodiazepines

Treatment

Oral propranolol 80 mg or placebo

Follow-up

not stated in the source

Study design

Double-blind placebo-controlled crossover trial

Funding

not stated in the source

Adults with chronic insomnia after long-term hypnotic use, not people with stimulant-driven sleep problems.

Randomized controlled trial

Betts TA et al. Eur J Clin Pharmacol. 1985;28 Suppl:65-8. PMID 2865152.

The lipophilic beta blockers propranolol, metoprolol and pindolol increased awakening and remembered dreaming, with increased waking confirmed on overnight recordings, while REM sleep was reduced. Hydrophilic atenolol had no effect on subjective sleep.

Participants / model

10 female volunteers

Treatment

Oral propranolol, metoprolol, pindolol or atenolol, or placebo

Follow-up

not stated in the source

Study design

Placebo-controlled crossover trial

Funding

not stated in the source

Healthy female volunteers; the effect on sleep is a class property of lipophilic beta blockers in this study.

Systematic review and meta-analysis

Morales DR et al. Chest. 2014;145(4):779-786. PMID 24202435.

Nonselective beta blockers lowered FEV1 by 10.2% (95% CI -14.7 to -5.6), caused a fall of 20% or more in 1 in 9 patients, and attenuated the response to beta2-agonist rescue therapy by 20.0% (95% CI -29.4 to -10.7). Selective agents were better tolerated but not risk-free.

Participants / model

People with asthma in randomized blinded placebo-controlled trials

Treatment

Acute beta-blocker exposure (routes not stated in the abstract)

Follow-up

Acute exposure

Study design

Systematic review and meta-analysis

Funding

not stated in the source

Albuterol is a beta2-agonist, so in a person who uses it for asthma, propranolol both risks bronchospasm and blunts the rescue drug.

Human study

Hoffman RS et al. Ann Emerg Med. 2008;52(5):548-53. PMID 18501476.

Five poison centers identified 34 probable or confirmed emergency department cases over 6 months (13 confirmed). Patients had tachycardia, hypotension, hyperglycemia, hypokalemia and raised lactate; 6 showed biochemical myocardial injury. Ten received beta-adrenergic antagonists without adverse effect.

Participants / model

34 emergency department patients after clenbuterol-adulterated heroin

Treatment

Unintended clenbuterol exposure; beta blockers given in hospital

Follow-up

6 months

Study design

Descriptive case series

Funding

not stated in the source

Acute poisoning treated in hospital, not self-directed use to lower resting heart rate.

Human study

Brett J et al. Med J Aust. 2014;200(4):219-21. PMID 24580525.

The centre recorded 63 clenbuterol exposures, rising from 3 in 2008 to 27 in 2012, and at least 53 (84%) required hospitalization. Bodybuilding and slimming were the commonest reasons for use. Tachycardia (24 patients), gastrointestinal disturbance (16) and tremor (11) were most common, and one 21-year-old man had a cardiac arrest.

Participants / model

63 people exposed to clenbuterol, Australia

Treatment

Clenbuterol, mostly self-administered

Follow-up

Calls from 2004 to 2012

Study design

Retrospective poison center case series

Funding

not stated in the source

Describes clenbuterol toxicity; it does not test propranolol.

Human study

Reith DM et al. J Toxicol Clin Toxicol. 1996;34(3):273-8. PMID 8667464.

Propranolol was the only beta blocker associated with seizures and with death; two thirds of people who took more than 2 g of propranolol had a seizure, and a QRS duration above 100 ms was associated with seizure risk. All toxicity appeared within 6 hours. The authors advise avoiding propranolol in people at risk of self-poisoning.

Participants / model

58 hospital presentations of beta-blocker self-poisoning and 2 coroner-investigated deaths, Newcastle and Lake Macquarie, Australia

Treatment

Oral beta-blocker overdose

Follow-up

1987 to 1995

Study design

Prospective clinical database study

Funding

not stated in the source

Overdose series. A larger series found no overall severity difference among beta blockers.

Human study

Lauterbach M. Basic Clin Pharmacol Toxicol. 2019;125(2):178-186. PMID 30916882.

There were more seizures with propranolol but no significant difference in poisoning severity among beta blockers, and no deaths after single-substance exposure. One patient died after combined bisoprolol and verapamil, and the author flags co-exposure with other antihypertensives, sedatives or alcohol.

Participants / model

2,967 adults with beta-blocker exposure reported to the Mainz Poison Center, Germany (697 single-substance)

Treatment

Oral beta-blocker overdose

Follow-up

10-year review

Study design

Retrospective poison center study

Funding

not stated in the source

Tempers the Newcastle series without removing the propranolol seizure signal.

PubMed search record

PubMed search run on 9 October 2026: propranolol[tiab] AND clenbuterol[tiab] AND humans[mh]. 27 records returned. A second search, propranolol[tiab] AND (stimulant*[tiab] OR caffeine[tiab] OR amphetamine*[tiab] OR clenbuterol[tiab] OR ephedrine[tiab]) AND (sleep[tiab] OR insomnia[tiab]), returned 15 records.

The first search returned 27 records. None was a trial or cohort of propranolol for resting tachycardia in people taking clenbuterol or albuterol for body composition. Two were case reports of acute clenbuterol poisoning treated in hospital with intravenous propranolol and potassium (a bodybuilder, and a father and daughter who ate contaminated liver); the rest covered receptor and cell pharmacology, doping-control and analytical methods, and reviews. The second search returned 15 records, none testing propranolol for stimulant-driven sleep problems; they covered headache, migraine and narcolepsy papers, a review of sleep disturbance with antihypertensives, surgeon tremor and dexterity studies, animal and toxicology studies, reviews of beta blockers in heart failure and of caffeine exposure, a test-anxiety survey, and a 2026 survey of Jordanian medical students in which most of 23 current beta-blocker users (78.3% propranolol, 56.5% non-prescribed) reported night waking and nightmares.

Participants / model

Records returned, not a population

Treatment

Not applicable

Follow-up

Searches run on 9 October 2026

Study design

Literature search

Funding

not stated in the source

A search result shows what PubMed returned on that date. It is not proof that no unindexed study exists. The link opens the first search.

Chemical identity record

National Library of Medicine. PubChem compound records CID 4946 (propranolol) and CID 62882 (propranolol hydrochloride).

Propranolol free base: C16H21NO2, 259.34 g/mol, CAS 525-66-6. Propranolol hydrochloride, the salt in US tablets: CID 62882, C16H22ClNO2, 295.80 g/mol, CAS 318-98-9; the label gives a molecular weight of 295.80 and describes a racemic mixture.

Participants / model

Chemical identity, not a clinical population

Treatment

Defined molecule and salt

Follow-up

Not applicable

Study design

NLM chemical record

Funding

not stated in the source

Identity record only; it says nothing about efficacy or safety.