Is Propranolol registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 8 valid registrations of Propranolol, including INDERAL TABLETS 10 MG. (10 mg, Tablet, SAR 20.00); INDERAL TABLETS 40 MG. (40 mg, Tablet, SAR 40.00); INDICARDIN 10 mg tablet (10 mg, Tablet, SAR 7.00); INDICARDIN 40 mg tablet (40 mg, Tablet, SAR 15.00); PROTENSE 40 mg/5 ml oral solution (8 mg/ml, Oral solution, SAR 110.00).

Is Propranolol approved by the US FDA?

Drugs@FDA lists 132 application product lines for Propranolol, including INDERAL LA (Prescription); PROPRANOLOL HYDROCHLORIDE (Prescription); PROPRANOLOL HYDROCHLORIDE (Prescription); PROPRANOLOL HYDROCHLORIDE (Prescription); PROPRANOLOL HYDROCHLORIDE (Prescription).

Is Propranolol authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Propranolol: Hemangiol.

Is Propranolol on the WHO Model List of Essential Medicines?

Yes — 5.1.5.2. Medicines for migraine prophylaxis (core list): Migraine.

Are there safety signals or safety updates for Propranolol?

EMA PRAC: 2 entries; US FDA: 3 entries (latest 2023-12-22).

Active substance

Propranolol

SFDA 10
US FDA 132
EMA 1
Health Canada 17
US price lines 12
NHS prices 10
WHO EML 1
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
INDERAL TABLETS 10 MG.	10 mg	Tablet · Oral use	50 Tablet Container	SAR 20.00	NCE · Prescription	Atnahs Pharma UK Limited	Valid
INDERAL TABLETS 40 MG.	40 mg	Tablet · Oral use	50 Tablet Container	SAR 40.00	NCE · Prescription	Atnahs Pharma UK Limited	Valid
INDICARDIN 10 mg tablet	10 mg	Tablet · Oral use	50 Blister	SAR 7.00	Generic · Prescription	APM	Valid
INDICARDIN 40 mg tablet	40 mg	Tablet · Oral use	50 Blister	SAR 15.00	Generic · Prescription	APM	Valid
PROTENSE 40 mg/5 ml oral solution	8 mg/ml	Oral solution · Oral use	1 Bottle	SAR 110.00	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Properal	80 mg	Tablet · Oral use	60 Blister	SAR 43.20	Generic · Prescription	Saudi Amarox	Valid
Properal	60 mg	Tablet · Oral use	60 Blister	SAR 43.20	Generic · Prescription	Saudi Amarox	Valid
Properal	10 mg	Tablet · Oral use	60 Blister	SAR 21.60	Generic · Prescription	Saudi Amarox	Valid
INDERAL AMPULES 1MG-ML	1 mg/ml	Solution · Intravenous use	10 Ampoule	SAR 15.85	NCE · Prescription	AstraZeneca	Invalid · Not Marketed
INDERAL TABLETS 80 MG.	80 mg	Tablet · Oral use	100 Tablet Container	SAR 59.10	NCE · Prescription	AstraZeneca	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ARRHYTHMIA; ATRIAL FIBRILLATION; BURN MANAGEMENT; CORONARY ARTERY DISEASE; HYPERTENSION; HYPERTHYROIDISM; INFANTILE HEMANGIOMA; LIVER CIRRHOSIS; MIGRAINE/ HEADACHE; NON-ST WAVE ELEVATED MYOCARDIAL INFARCTION (NSTEMI); SCHIZOPHRENIA; ST-WAVE ELEVATED MYOCARDIAL INFARCTION (STEMI); SUPRAVENTRICULAR TACHYCARDIA; TRANSIENT FACIAL ERYTHEMA (FLUSHING); VENTRICULAR TACHYCARDIA

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
INDERAL LA	160MG; 80MG; 120MG; 60MG	capsule, extended release · oral	ANI PHARMS	Prescription	19 Apr 1983
PROPRANOLOL HYDROCHLORIDE	40MG; 10MG; 20MG; 80MG; 60MG	tablet · oral	MYLAN	Prescription	19 Nov 1985
PROPRANOLOL HYDROCHLORIDE	80MG; 10MG; 20MG; 40MG; 60MG	tablet · oral	PH HEALTH	Prescription	14 Apr 1986
PROPRANOLOL HYDROCHLORIDE	10MG	tablet · oral	WATSON LABS	Prescription	13 May 1986
PROPRANOLOL HYDROCHLORIDE	20MG	tablet · oral	WATSON LABS	Prescription	13 May 1986
PROPRANOLOL HYDROCHLORIDE	40MG	tablet · oral	WATSON LABS	Prescription	13 May 1986
PROPRANOLOL HYDROCHLORIDE	80MG	tablet · oral	WATSON LABS	Prescription	13 May 1986
PROPRANOLOL HYDROCHLORIDE	40MG	tablet · oral	VINTAGE PHARMS	Prescription	1 Aug 1986
PROPRANOLOL HYDROCHLORIDE	80MG; 10MG; 20MG; 40MG; 60MG	tablet · oral	INNOGENIX	Prescription	4 Aug 1986
PROPRANOLOL HYDROCHLORIDE	40MG/5ML; 20MG/5ML	solution · oral	HIKMA PHARMS	Prescription	15 May 1987
PROPRANOLOL HYDROCHLORIDE	10MG; 20MG; 40MG	tablet · oral	IMPAX LABS INC	Prescription	6 Apr 1988
PROPRANOLOL HYDROCHLORIDE	80MG; 60MG	tablet · oral	IMPAX LABS INC	Prescription	6 Apr 1988
PROPRANOLOL HYDROCHLORIDE	1MG/ML	injectable · injection	FRESENIUS KABI USA	Prescription	31 Aug 2001
INNOPRAN XL	80MG; 120MG	capsule, extended release · oral	ANI PHARMS	Prescription	12 Mar 2003
PROPRANOLOL HYDROCHLORIDE	60MG; 80MG; 120MG; 160MG	capsule, extended release · oral	ANDA REPOSITORY	Prescription	26 Jan 2007
PROPRANOLOL HYDROCHLORIDE	60MG; 80MG; 120MG; 160MG	capsule, extended release · oral	ACTAVIS ELIZABETH	Prescription	10 Aug 2007
PROPRANOLOL HYDROCHLORIDE	1MG/ML	injectable · injection	HIKMA FARMACEUTICA	Prescription	31 Jan 2008
PROPRANOLOL HYDROCHLORIDE	10MG; 20MG; 40MG; 60MG; 80MG	tablet · oral	IPCA LABS LTD	Prescription	2 Jun 2008
PROPRANOLOL HYDROCHLORIDE	60MG; 80MG; 120MG; 160MG	capsule, extended release · oral	ZYDUS PHARMS USA INC	Prescription	25 Mar 2011
PROPRANOLOL HYDROCHLORIDE	60MG; 80MG; 120MG; 160MG	capsule, extended release · oral	ADARE PHARMS INC	Prescription	15 Jul 2011
HEMANGEOL	4.28MG/ML	solution · oral	ETON	Prescription	14 Mar 2014
PROPRANOLOL HYDROCHLORIDE	60MG; 80MG; 120MG; 160MG	capsule, extended release · oral	AMTA	Prescription	6 Jan 2020
PROPRANOLOL HYDROCHLORIDE	10MG; 20MG; 40MG; 60MG; 80MG	tablet · oral	MANKIND PHARMA	Prescription	27 Jan 2026
PROPRANOLOL HYDROCHLORIDE	60MG; 80MG; 120MG; 160MG	capsule, extended release · oral	IPCA LABS LTD	Prescription	1 May 2026
PROPRANOLOL HYDROCHLORIDE	20MG/5ML	solution · oral	PAI HOLDINGS	Prescription	10 Jun 2026

107 more — full table

EMA European Union — centrally authorised medicines

Hemangiol Pierre Fabre Medicament · Authorised · authorised 23 Apr 2014 · ATC C07AA05

Therapeutic indication (EMA)

Hemangiol is indicated in the treatment of proliferating infantile haemangioma requiring systemic therapy: Life- or function-threatening haemangioma, Ulcerated haemangioma with pain and/or lack of response to simple wound care measures, Haemangioma with a risk of permanent scars or disfigurement. It is to be initiated in infants aged 5 weeks to 5 months.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
HEMANGIOL	02457857	3.75 MG / ML	SOLUTION · ORAL	PIERRE FABRE DERMO-COSMETIQUE CANADA INC
JAMP PROPRANOLOL	02563053	10 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP PROPRANOLOL	02563061	20 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP PROPRANOLOL	02563088	40 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP PROPRANOLOL	02563096	80 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
LUPIN-PROPRANOLOL LA	02491893	60 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	LUPIN PHARMA CANADA LIMITED
LUPIN-PROPRANOLOL LA	02491907	80 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	LUPIN PHARMA CANADA LIMITED
LUPIN-PROPRANOLOL LA	02491915	120 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	LUPIN PHARMA CANADA LIMITED
LUPIN-PROPRANOLOL LA	02491923	160 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	LUPIN PHARMA CANADA LIMITED
PROPRANOLOL HYDROCHLORIDE INJECTION USP	02225883	1 MG / ML	SOLUTION · INTRAVENOUS	SANDOZ CANADA INCORPORATED
PRZ-PROPRANOLOL	02550814	20 MG	TABLET · ORAL	PHARMARIS CANADA INC
PRZ-PROPRANOLOL	02550822	40 MG	TABLET · ORAL	PHARMARIS CANADA INC
PRZ-PROPRANOLOL	02550830	80 MG	TABLET · ORAL	PHARMARIS CANADA INC
TEVA-PROPRANOLOL	00496480	10 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-PROPRANOLOL	00496499	40 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-PROPRANOLOL	00496502	80 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-PROPRANOLOL	00740675	20 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	INDERAL XL 80 MG CAPSULE	$68.70376	per EA	23 Sep 2026
US NADAC	PROPRANOLOL 10 MG TABLET	$0.04657	per EA	23 Sep 2026
US NADAC	PROPRANOLOL 20 MG TABLET	$0.0493	per EA	23 Sep 2026
US NADAC	PROPRANOLOL 20 MG/5 ML SOLN	$0.09221	per ML	23 Sep 2026
US NADAC	PROPRANOLOL 40 MG TABLET	$0.07658	per EA	30 Sep 2026
US NADAC	PROPRANOLOL 40 MG/5 ML SOLN	$0.13316	per ML	22 Apr 2026
US NADAC	PROPRANOLOL 60 MG TABLET	$0.15881	per EA	23 Sep 2026
US NADAC	PROPRANOLOL 80 MG TABLET	$0.15905	per EA	23 Sep 2026
US NADAC	PROPRANOLOL ER 120 MG CAPSULE	$0.19561	per EA	23 Sep 2026
US NADAC	PROPRANOLOL ER 160 MG CAPSULE	$0.305	per EA	23 Sep 2026
US NADAC	PROPRANOLOL ER 60 MG CAPSULE	$0.17007	per EA	23 Sep 2026
US NADAC	PROPRANOLOL ER 80 MG CAPSULE	$0.19078	per EA	23 Sep 2026
NHS Drug Tariff	Propranolol 10mg tablets	£0.71	28 tablet	1 Oct 2026
NHS Drug Tariff	Propranolol 10mg/5ml oral solution sugar free	£18.38	150 ml	1 Oct 2026
NHS Drug Tariff	Propranolol 160mg modified-release capsules	£4.88	28 capsule	1 Oct 2026
NHS Drug Tariff	Propranolol 160mg tablets	£5.87	56 tablet	1 Oct 2026
NHS Drug Tariff	Propranolol 40mg tablets	£0.96	28 tablet	1 Oct 2026
NHS Drug Tariff	Propranolol 40mg/5ml oral solution sugar free	£21.35	150 ml	1 Oct 2026
NHS Drug Tariff	Propranolol 50mg/5ml oral solution sugar free	£23.20	150 ml	1 Oct 2026
NHS Drug Tariff	Propranolol 5mg/5ml oral solution sugar free	£15.01	150 ml	1 Oct 2026
NHS Drug Tariff	Propranolol 80mg modified-release capsules	£4.95	28 capsule	1 Oct 2026
NHS Drug Tariff	Propranolol 80mg tablets	£2.14	56 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

5.1.5.2. Medicines for migraine prophylaxis · core
Migraine
Oral > Solid > tablet: 40 mg (hydrochloride); 10 mg (hydrochloride) (EMLc)

Safety signals and safety-related labeling changes

US FDA 22 Dec 2023 INNOPRAN XL — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 7 Nov 2023 INDERAL LA — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 22 Jun 2021 HEMANGEOL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 29 Nov 2018 PRAC signal: Increased risk of Parkinson’s disease
Action for MAH: update of the product information: No
EMA PRAC 12 Jul 2018 PRAC signal: Increased risk of Parkinson’s disease
Action for MAH: update of the product information: No

All safety entries for propranolol →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.