Is Zidovudine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Zidovudine, including RETROVIR 50MG\5ML ORAL SUSPENTION (10 mg/ml, Oral suspension, SAR 53.20); RETROVIR CAPS 100MG (100 mg, Capsule, SAR 549.20).

Is Zidovudine approved by the US FDA?

Drugs@FDA lists 19 application product lines for Zidovudine, including RETROVIR (Prescription); RETROVIR (Prescription); RETROVIR (Prescription); ZIDOVUDINE (Prescription); ZIDOVUDINE (Prescription).

Is Zidovudine on the WHO Model List of Essential Medicines?

Yes — 6.4.2.1. Antiretrovirals > Nucleoside/Nucleotide reverse transcriptase inhibitors (core list): Human immunodeficiency virus disease without mention of tuberculosis or malaria, clinical stage unspecified.

Are there safety signals or safety updates for Zidovudine?

EMA PRAC: 2 entries; US FDA: 6 entries (latest 2021-02-17).

Active substance

Zidovudine

SFDA 2
US FDA 19
Health Canada 3
US price lines 1
WHO EML 1
Safety 8

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
RETROVIR 50MG\5ML ORAL SUSPENTION	10 mg/ml	Oral suspension · Oral use	1 Bottle	SAR 53.20	NCE · Prescription	Glaxo Saudi Arabia Ltd.	Valid
RETROVIR CAPS 100MG	100 mg	Capsule · Oral use	100 Tablet Container	SAR 549.20	NCE · Prescription	Glaxo Saudi Arabia Ltd	Valid

Indications — CHI Daman Drug Formulary

CASTLEMAN DISEASE; HUMAN IMMUNODEFICIENCY VIRUS; T-CELL LYMPHOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
RETROVIR	100MG	capsule · oral	VIIV HLTHCARE	Prescription	19 Mar 1987
RETROVIR	50MG/5ML	solution · oral	VIIV HLTHCARE	Prescription	28 Sep 1989
RETROVIR	10MG/ML	injectable · injection	VIIV HLTHCARE	Prescription	2 Feb 1990
ZIDOVUDINE	300MG	tablet · oral	AUROBINDO	Prescription	19 Sep 2005
ZIDOVUDINE	50MG/5ML	solution · oral	AUROBINDO	Prescription	19 Sep 2005
ZIDOVUDINE	100MG	capsule · oral	AUROBINDO PHARMA LTD	Prescription	27 Mar 2006
ZIDOVUDINE	100MG	capsule · oral	CIPLA LTD	Prescription	23 May 2007
ZIDOVUDINE	300MG	tablet · oral	HETERO LABS LTD III	Prescription	25 Apr 2008
ZIDOVUDINE	50MG/5ML	solution · oral	CIPLA LTD	Prescription	26 Jun 2008
ZIDOVUDINE	300MG	tablet · oral	CIPLA	Prescription	27 Oct 2010
RETROVIR	200MG; 300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	VIIV HLTHCARE	Discontinued	19 Dec 1995
ZIDOVUDINE	300MG	tablet · oral	HIKMA PHARMS	Discontinued	19 Sep 2005
ZIDOVUDINE	300MG	tablet · oral	PHARMOBEDIENT	Discontinued	14 Feb 2008
ZIDOVUDINE	60MG	tablet · oral	AUROBINDO PHARMA	Discontinued	23 Jul 2009
ZIDOVUDINE	10MG/ML	injectable · injection	AM REGENT	Discontinued	6 May 2010
ZIDOVUDINE	100MG	tablet · oral	PHARMOBEDIENT	Discontinued	23 Feb 2011
ZIDOVUDINE	300MG	tablet · oral	HEC PHARM	Discontinued	7 Oct 2011
ZIDOVUDINE	10MG/ML	injectable · injection	LIAONING CHENGDA	Discontinued	26 Nov 2013
ZIDOVUDINE	300MG	tablet · oral	RANBAXY LABS LTD	Discontinued

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-ZIDOVUDINE	01946323	100 MG	CAPSULE · ORAL	APOTEX INC
RETROVIR (AZT)	01902644	10 MG / ML	SOLUTION · INTRAVENOUS	VIIV HEALTHCARE ULC
RETROVIR (AZT)	01902652	50 MG / 5 ML	SYRUP · ORAL	VIIV HEALTHCARE ULC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ZIDOVUDINE 300 MG TABLET	$0.46377	per EA	23 Sep 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)

6.4.2.1. Antiretrovirals > Nucleoside/Nucleotide reverse transcriptase inhibitors · core
Human immunodeficiency virus disease without mention of tuberculosis or malaria, clinical stage unspecified
Parenteral > General injections > IV: 10 mg per mL in 20 mL vial solution for IV infusion (EML) | Oral > Liquid: 50 mg per 5 mL | Oral > Solid > tablet: 300 mg (EML) | Oral > Solid > capsule: 250 mg (EML)

Safety signals and safety-related labeling changes

US FDA 17 Feb 2021 TRIZIVIR — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 27 Dec 2019 ZIDOVUDINE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 10 May 2019 COMBIVIR — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 10 Sep 2018 RETROVIR — 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 10 Sep 2018 RETROVIR — 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 10 Sep 2018 RETROVIR — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 12 Jul 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: Yes
EMA PRAC 8 Mar 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: No

All safety entries for zidovudine →

Combinations containing Zidovudine

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.