FDA-Approved Indications for Propranolol
Propranolol is FDA-approved for hypertension, angina pectoris due to coronary atherosclerosis, migraine prophylaxis, and hypertrophic subaortic stenosis 1.
Primary FDA-Approved Indications
Based on the official FDA drug label, propranolol hydrochloride extended-release capsules are indicated for:
Cardiovascular Indications
- Hypertension: May be used alone or in combination with other antihypertensive agents (particularly thiazide diuretics). Not indicated for hypertensive emergencies 1.
- Angina Pectoris Due to Coronary Atherosclerosis: Decreases angina frequency and increases exercise tolerance 1.
- Hypertrophic Subaortic Stenosis: Improves NYHA functional class in symptomatic patients 1.
Neurological Indication
- Migraine Prophylaxis: Indicated for prevention of common migraine headache. Important caveat: Propranolol is NOT effective for treating an acute migraine attack that has already started 1. This is specifically mentioned in the FDA labeling 2.
Additional Context from Guidelines
While not part of the core FDA question, recent guidelines identify propranolol as particularly useful for:
- Essential Tremor: Used for over 40 years with established efficacy 2
- Thyrotoxicosis/Hyperthyroidism: Most widely studied nonselective beta-blocker for managing tachycardia and tremor in thyroid storm, also inhibits peripheral T4 to T3 conversion 2
Critical Contraindications
Propranolol is absolutely contraindicated in 1:
- Cardiogenic shock
- Sinus bradycardia and greater than first-degree heart block
- Bronchial asthma
- Known hypersensitivity to propranolol hydrochloride
Orphan Drug Designation
Propranolol received FDA orphan drug approval for infantile hemangioma (IH) in infants less than 5 months of age requiring systemic therapy 3, 4. This represents a distinct indication with specific dosing protocols and monitoring requirements 5.