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Zidovudine

Retrovir · ATC code J05AF01

Also known as: Zidovudin

Key facts
Active substance
Zidovudine
Drug class
Direct acting antiviral
ATC code
J05AF01
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Boxed warning

Zidovudine capsules have been associated with hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced HIV-1 disease [see Warnings and Precautions (5.1)].
Prolonged use of zidovudine has been associated with symptomatic myopathy [see Warnings and Precautions (5.2)].
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including zidovudine and other antiretrovirals. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur [see Warnings and Precautions (5.3)].

Key facts

Zidovudine is a nucleoside reverse transcriptase inhibitor. According to the US prescribing information, it is used with other antiretrovirals to treat HIV-1 infection and to prevent maternal-fetal HIV-1 transmission.

What it is used for

  • Treatment of HIV-1 infection in combination with other antiretroviral agents
  • Prevention of maternal-fetal HIV-1 transmission (antepartum, intrapartum and neonatal therapy), in most cases combined with other antiretroviral drugs

Dosing

  • Adults (HIV-1 treatment): 300 mg twice daily with other antiretroviral agents
  • Children aged 4 weeks to less than 18 years: dose by body weight or body surface area per the label table, not exceeding the adult dose
  • Pregnant women (after 14 weeks): 100 mg orally 5 times per day until labor, then intravenous dosing until umbilical cord clamping
  • Neonates: start within 12 hours after birth and continue through 6 weeks of age, orally 2 mg/kg every 6 hours or intravenously
  • Dialysis or CrCl less than 15 mL per min: 100 mg every 6 to 8 hours
  • Significant anemia or neutropenia may require dose interruption

Contraindications

  • Potentially life-threatening hypersensitivity reaction (e.g. anaphylaxis, Stevens-Johnson syndrome) to any component

Important warnings

  • Boxed warning: hematologic toxicity including neutropenia and severe anemia, particularly in advanced HIV-1 disease; monitor blood counts
  • Boxed warning: symptomatic myopathy with prolonged use
  • Boxed warning: lactic acidosis and severe hepatomegaly with steatosis, including fatal cases; suspend treatment if suspected
  • With interferon and ribavirin in HIV-1/HCV co-infection: worsening anemia and hepatic decompensation; coadministration with ribavirin not advised
  • Immune reconstitution syndrome
  • Lipoatrophy (loss of subcutaneous fat), related to cumulative exposure

Side effects

  • Common in trials: headache, malaise, nausea, vomiting, anorexia, asthenia
  • Also: abdominal pain, myalgia, arthralgia, insomnia, neuropathy, fatigue
  • Serious: anemia, neutropenia, myopathy, lactic acidosis, hepatomegaly with steatosis

Interactions

  • Stavudine and doxorubicin: avoid (antagonistic in vitro)
  • Ribavirin and other nucleoside analogues affecting DNA replication: avoid
  • Ganciclovir, interferon alfa, ribavirin and other bone marrow suppressive or cytotoxic agents: may increase hematologic toxicity

Pregnancy and breastfeeding

  • Pregnancy: registry data show no difference in the overall risk of birth defects compared with the background rate
  • Lactation: zidovudine is present in human milk; mothers receiving zidovudine are instructed not to breastfeed

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • RetrovirViiv Healthcare B.V. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • RetrovirViiv Healthcare B.V. · 3 register entries
  • Zidovudin AurobindoPuren Pharma Gmbh & Co. Kg · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • RetrovirGLAXOSMİTHKLİNE İLAÇLARI SAN. VE TİC. A.Ş. · 3 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 17 more European countries
Belgium
Retrovir
Bulgaria
Ретровир
Czechia
Retrovir
Denmark
Retrovir
Estonia
Retrovir
Finland
Retrovir
France
Retrovir
Greece
Retrovir
Ireland
Retrovir
Italy
Retrovir
Luxembourg
Retrovir
Netherlands
Retrovir
Poland
Retrovir
Portugal
Retrovir, Zidovudina Aurobindo
Romania
Retrovir
Spain
Retrovir, Zidovudina Accord, Zidovudina Altan
Sweden
Retrovir

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. Zidovudine (Aurobindo Pharma Limited) – Prescribing Information, 2025-02-10. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9907acb2-e4a0-46f9-93c0-a8d7b7ce98cf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC J05AF.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.