Is Propoxyphene approved by the US FDA?

Drugs@FDA lists 30 application product lines for Propoxyphene, including DARVON (Discontinued); PROPOXYPHENE HYDROCHLORIDE (Discontinued); PROPOXYPHENE HYDROCHLORIDE (Discontinued); DOLENE (Discontinued); PROPOXYPHENE HYDROCHLORIDE (Discontinued).

Are there safety signals or safety updates for Propoxyphene?

MHRA: 1 entry (latest 2014-12-11).

Active substance

Propoxyphene

US FDA 30
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
DARVON	32MG; 65MG	capsule · oral	XANODYNE PHARM	Discontinued	16 Aug 1957
PROPOXYPHENE HYDROCHLORIDE	65MG	capsule · oral	PAR PHARM	Discontinued	30 Nov 1971
PROPOXYPHENE HYDROCHLORIDE	65MG	capsule · oral	WATSON LABS	Discontinued	7 Aug 1972
DOLENE	65MG	capsule · oral	HERITAGE PHARMS INC	Discontinued	15 Sep 1972
PROPOXYPHENE HYDROCHLORIDE	65MG	capsule · oral	SANDOZ	Discontinued	18 Oct 1972
PROPOXYPHENE HYDROCHLORIDE	65MG	capsule · oral	NEXGEN PHARMA INC	Discontinued	2 Nov 1972
PROPOXYPHENE HYDROCHLORIDE	65MG	capsule · oral	MUTUAL PHARM	Discontinued	18 Dec 1972
PROPOXYPHENE HYDROCHLORIDE	65MG	capsule · oral	PUREPAC PHARM	Discontinued	15 Jan 1973
KESSO-GESIC	65MG	capsule · oral	MK LABS	Discontinued	6 Jun 1973
PROPOXYPHENE HYDROCHLORIDE	65MG	capsule · oral	WEST WARD	Discontinued	20 Jun 1973
PROPOXYPHENE HYDROCHLORIDE	32MG; 65MG	capsule · oral	ROXANE	Discontinued	13 Aug 1973
PROPOXYPHENE HYDROCHLORIDE	65MG	capsule · oral	IMPAX LABS	Discontinued	23 Oct 1973
PROPOXYPHENE HYDROCHLORIDE	32MG	capsule · oral	IVAX SUB TEVA PHARMS	Discontinued	11 Dec 1973
PROPOXYPHENE HYDROCHLORIDE	65MG	capsule · oral	SANDOZ	Discontinued	27 Aug 1974
PROPOXYPHENE HYDROCHLORIDE	32MG	capsule · oral	SANDOZ	Discontinued	9 Sep 1974
PROPOXYPHENE HYDROCHLORIDE	65MG	capsule · oral	SANDOZ	Discontinued	13 Feb 1975
PROPOXYPHENE HYDROCHLORIDE	65MG	capsule · oral	PVT FORM	Discontinued	20 Aug 1976
PROPOXYPHENE HYDROCHLORIDE	32MG	capsule · oral	PVT FORM	Discontinued	20 Aug 1976
PROPOXYPHENE HYDROCHLORIDE	65MG	capsule · oral	WATSON LABS	Discontinued	8 Nov 1976
PROPOXYPHENE HYDROCHLORIDE	65MG	capsule · oral	SANDOZ	Discontinued	7 Jul 1980
PROPOXYPHENE HYDROCHLORIDE	65MG	capsule · oral	TEVA	Discontinued	22 Oct 1984
PROPOXYPHENE HYDROCHLORIDE	65MG	capsule · oral	MYLAN	Discontinued	16 Dec 2004
PROPOXYPHENE HYDROCHLORIDE	65MG	capsule · oral	VINTAGE PHARMS	Discontinued	17 Jul 2009
PROPOXYPHENE HYDROCHLORIDE	65MG	capsule · oral	VALEANT PHARM INTL	Discontinued
PROPOXYPHENE HYDROCHLORIDE	65MG	capsule · oral	ALRA	Discontinued

5 more — full table

Safety signals and safety-related labeling changes

MHRA 11 Dec 2014 (Dextro)propoxyphene: new studies confirm cardiac risks
(Dextro)propoxyphene can have serious effects on the electrical activity of the heart (resulting in prolongation of the P-R and Q-T intervals, and widened QRS complexes), even at normal therapeutic doses.

All safety entries for propoxyphene →

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.