Propranolol

ATC code

C07AA05

Therapeutic class

Non-selective beta-blocking agent · Non-selective beta-blocking agents

Forms

oral tablet, oral solution

Brand names

Propranolol Hydrochloride (US) · Inderal (US) · Hemangiol (EU) · PROPRANOLOL TEVA (FR)

Overall confidence

high

Regulatory sources consulted

openfda-label-0e14f176-3801-4c34-8bbf-b321c95c3d1d
ema-epars-EMEA/H/C/002621
ansm-rcp-67954061
aemps-cima-114919001
PubMed PMID:37159031 ↗
PubMed PMID:36174643 ↗
PubMed PMID:34764294 ↗
PubMed PMID:35057977 ↗
PubMed PMID:36847017 ↗
CredibleMeds.org
OpenFDA · C07AA05
RxNorm rxcui 8787 ↗

Approved indications

Hypertension. It may be used alone or in combination with other antihypertensive agents.
Angina pectoris due to coronary atherosclerosis, to decrease angina frequency and increase exercise tolerance.
Control of ventricular rate in patients with atrial fibrillation and a rapid ventricular response.
To reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable.
Prophylaxis of common migraine headache.
Management of familial or hereditary essential tremor.
Treatment of proliferating infantile haemangioma requiring systemic therapy. It is to be initiated in infants aged 5 weeks to 5 months.
Primary prophylaxis of variceal hemorrhage in patients with cirrhosis and clinically significant portal hypertension. · off-label

Contraindications

Absolute

Bronchial asthma or chronic obstructive pulmonary disease.
Uncontrolled heart failure.
Cardiogenic shock.
Second- and third-degree atrioventricular (AV) block not treated with a pacemaker.
Sinus bradycardia (<50-55 bpm).
Untreated pheochromocytoma (requires prior alpha-blockade).
Known hypersensitivity to propranolol.

Clinical warnings

Boxed warning · Abrupt Discontinuation of Therapy: There have been reports of exacerbation of angina and, in some cases, myocardial infarction, following abrupt discontinuance of propranolol therapy. The dosage should be gradually reduced over at least a few weeks. — FDA
Major warning · Cardiac Failure: Sympathetic stimulation may be a vital component supporting circulatory function in patients with congestive heart failure, and its inhibition by beta blockade may precipitate more severe failure. — FDA
Major warning · Diabetes and Hypoglycemia: Beta-blockers may mask the signs and symptoms of acute hypoglycemia (especially tachycardia). — ANSM

Drug interactions

HighVerapamilC08DA01
Mechanism: Additive depressant effects on myocardial contractility, automaticity (bradycardia, sinus arrest), and AV conduction.
Recommendation: Association not recommended. Risk of severe bradycardia, heart failure, and cardiovascular collapse. Requires close clinical and ECG monitoring if unavoidable.
ANSM RCPFDA label
HighFingolimodL04AE01
Mechanism: Potentiation of bradycardic effects which can have fatal consequences. Beta-blockers prevent adrenergic compensation mechanisms.
Recommendation: Association not recommended. If co-administered, continuous clinical and ECG monitoring is required for 24 hours after the first dose of fingolimod.
ANSM RCP
ModerateFluvoxamineN06AB08
Mechanism: Increased plasma concentrations of propranolol due to inhibition of its hepatic metabolism (CYP1A2).
Recommendation: Clinical monitoring and, if necessary, adjustment of propranolol dosage during treatment with fluvoxamine and after its discontinuation.
ANSM RCP

Adverse events

Common (≥1%)

fatigue · bradycardia · dizziness · insomnia · vivid dreams · nausea · cold extremities

Rare but serious

congestive heart failure · complete AV block · severe bronchospasm · anaphylactic reactions · Stevens-Johnson syndrome · agranulocytosis · severe depression

Pregnancy and lactation

FDA category: C (historical)

There are no adequate and well-controlled studies in pregnant women. May cause intrauterine growth retardation, bradycardia, and respiratory problems in the neonate. However, it is considered relatively safe for treating maternal arrhythmias when necessary. Generally not recommended during lactation.

Recent literature (PubMed)

Diagnosis and Management of Cirrhosis and Its Complications: A Review.
Tapper EB, et al. · JAMA · 2023 · Relevance 5/5
Revisión sobre el manejo de la cirrosis. Menciona un ensayo clínico aleatorizado que demostró que los betabloqueantes no selectivos (carvedilol o propranolol) redujeron el riesgo de descompensación o muerte en comparación con placebo (16% vs 27%) en pacientes con hipertensión portal.
Endoscopic diagnosis and management of esophagogastric variceal hemorrhage: European Society of Gastrointestinal Endoscopy (ESGE) Guideline.
Gralnek IM, et al. · Endoscopy · 2022 · Relevance 5/5
Guía de práctica clínica de la ESGE que recomienda el uso de betabloqueantes no selectivos (preferiblemente carvedilol, también propranolol) en pacientes con enfermedad hepática crónica avanzada compensada e hipertensión portal clínicamente significativa para prevenir la hemorragia por varices.
Essential tremor.
Welton T, et al. · Nat Rev Dis Primers · 2021 · Relevance 4/5
Revisión exhaustiva sobre el temblor esencial que posiciona al propranolol y la primidona como los medicamentos de primera línea comúnmente prescritos para su tratamiento.
Arrhythmias in Pregnancy.
Tamirisa KP, et al. · JACC Clin Electrophysiol · 2022 · Relevance 4/5
Revisión sobre el manejo de arritmias en el embarazo. Destaca que los betabloqueantes, especialmente propranolol y metoprolol, pueden usarse de forma segura para tratar taquiarritmias en pacientes embarazadas sin cardiopatía estructural.
Pharmacological Treatment of Tremor in Parkinson's Disease Revisited.
Pirker W, et al. · J Parkinsons Dis · 2023 · Relevance 3/5
Revisión del tratamiento del temblor en la enfermedad de Parkinson. Sugiere que el propranolol puede considerarse como un tratamiento adyuvante para mejorar el temblor de reposo y de acción en pacientes con respuesta insuficiente a la levodopa.