Is Alprostadil registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Alprostadil, including CAVERJECT 20MCG VIAL (20 µg, Powder and solvent for solution for injection, SAR 44.55); PROSTIN VR AMP (0.5 mg/ml, Concentrate for solution for infusion, SAR 1325.65); VITAROS 3MG/GM CREAM (3 mg/g, Cream, SAR 300.00).

Is Alprostadil approved by the US FDA?

Drugs@FDA lists 10 application product lines for Alprostadil, including PROSTIN VR PEDIATRIC (Prescription); CAVERJECT (Prescription); EDEX (Prescription); ALPROSTADIL (Prescription); ALPROSTADIL (Prescription).

Is Alprostadil on the WHO Model List of Essential Medicines?

Yes — 22.7. Medicines administered to the neonate [c] (complementary list): Other specified congenital anomaly of great arteries including arterial duct.

Are there safety signals or safety updates for Alprostadil?

US FDA: 3 entries (latest 2025-12-22).

Active substance

Alprostadil

SFDA 3
US FDA 10
Health Canada 3
US price lines 4
NHS prices 10
WHO EML 1
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CAVERJECT 20MCG VIAL	20 µg	Powder and solvent for solution for injection · Intravenous use	1 Vial	SAR 44.55	NCE · Prescription	PFIZER	Valid
PROSTIN VR AMP	0.5 mg/ml	Concentrate for solution for infusion · Intravenous use	5 Ampoule	SAR 1325.65	NCE · Prescription	PFIZER	Valid
VITAROS 3MG/GM CREAM	3 mg/g	Cream · Topical	4 Single Dose Container	SAR 300.00	NCE · Prescription	ELIS PHARMACEUTICAL LTD	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
PROSTIN VR PEDIATRIC	0.5MG/ML	injectable · injection	PFIZER	Prescription	16 Oct 1981
CAVERJECT	0.01MG/VIAL; 0.02MG/VIAL; 0.04MG/VIAL	injectable · injection	PFIZER	Prescription	6 Jul 1995
EDEX	0.01MG/VIAL; 0.02MG/VIAL; 0.04MG/VIAL	injectable · injection	ENDO OPERATIONS	Prescription	12 Jun 1997
ALPROSTADIL	0.5MG/ML	injectable · injection	HIKMA PHARMS	Prescription	20 Jan 1998
ALPROSTADIL	0.5MG/ML	injectable · injection	MEITHEAL	Prescription	30 Apr 1999
CAVERJECT IMPULSE	0.01MG/VIAL; 0.02MG/VIAL	injectable · injection	PFIZER	Prescription	11 Jun 2002
CAVERJECT	0.005MG/VIAL	injectable · injection	PFIZER	Discontinued	6 Jul 1995
MUSE	0.125MG; 0.25MG; 0.5MG; 1MG	suppository · urethral	VIATRIS	Discontinued	19 Nov 1996
EDEX	0.005MG/VIAL	injectable · injection	ENDO OPERATIONS	Discontinued	12 Jun 1997
CAVERJECT	0.005MG/ML; 0.01MG/ML; 0.02MG/ML	injectable · injection	PFIZER	Discontinued	31 Oct 1997

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CAVERJECT STERILE POWDER	02215756	20 MCG / VIAL	LIQUID; KIT; POWDER FOR SOLUTION · INTRACAVERNOSAL	PFIZER CANADA ULC
CAVERJECT STERILE POWDER - PWS 23.2MCG/VIAL	02215187	20 MCG / VIAL	POWDER FOR SOLUTION · INTRACAVERNOSAL	PFIZER CANADA ULC
PROSTIN VR STERILE SOLUTION	00559253	500 MCG / ML	SOLUTION · INTRA-ARTERIAL; INTRAVENOUS	PFIZER CANADA ULC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CAVERJECT IMPULSE 10 MCG KIT	$82.49054	per EA	1 Jan 2026
US NADAC	CAVERJECT IMPULSE 20 MCG KIT	$106.23769	per EA	23 Sep 2026
US NADAC	EDEX 10 MCG CARTRIDGE 2-PK KIT	$182.91666	per EA	18 Feb 2026
US NADAC	EDEX 20 MCG CARTRIDGE 2-PK KIT	$237.372	per EA	23 Sep 2026
NHS Drug Tariff	Alprostadil 10microgram powder and solvent for solution for injection cartridges with device	£35.55	2 cartridge	1 Oct 2026
NHS Drug Tariff	Alprostadil 10microgram powder and solvent for solution for injection pre-filled disposable devices	£14.70	2 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Alprostadil 10microgram powder and solvent for solution for injection vials	£9.24	1 vial	1 Oct 2026
NHS Drug Tariff	Alprostadil 1mg urethral sticks	£11.56	1 applicator	1 Oct 2026
NHS Drug Tariff	Alprostadil 20microgram powder and solvent for solution for injection cartridges with device	£35.55	2 cartridge	1 Oct 2026
NHS Drug Tariff	Alprostadil 20microgram powder and solvent for solution for injection pre-filled disposable devices	£19.00	2 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Alprostadil 20microgram powder and solvent for solution for injection vials	£11.94	1 vial	1 Oct 2026
NHS Drug Tariff	Alprostadil 3mg/g cream	£40.00	4 applicator	1 Oct 2026
NHS Drug Tariff	Alprostadil 40microgram powder and solvent for solution for injection cartridges with device	£35.55	2 cartridge	1 Oct 2026
NHS Drug Tariff	Alprostadil 500microgram urethral sticks	£11.30	1 applicator	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)

22.7. Medicines administered to the neonate [c] · complementary
Other specified congenital anomaly of great arteries including arterial duct
Parenteral > General injections > IV: 0.5 mg per mL in alcohol (EMLc)

Safety signals and safety-related labeling changes

US FDA 22 Dec 2025 PROSTIN VR PEDIATRIC — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 23 Dec 2022 CAVERJECT — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 23 Dec 2022 CAVERJECT IMPULSE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for alprostadil →

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.