Molecule
Zidovudine is a human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor indicated for treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents, among other approved uses. MedsAcross supplies Zidovudine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
RETROVIR is a nucleoside analogue reverse transcriptase inhibitor indicated for: • Treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents. • Prevention of maternal-fetal HIV-1 transmission.
Source: US FDA prescribing information
Zidovudine is an antiretroviral agent.
Source: US FDA prescribing information
• Treatment of HIV-1 infection: Adults: Recommended oral dosage is 300 mg twice a day with other antiretroviral agents. For patients who are unable to take the oral formulations, the recommended intravenous dose is 1 mg per kg infused over 1 hour every 4 hours. Pediatric patients (aged 4 weeks to less than 18 years): Dosage should be calculated based on body weight not to exceed adult dose. • Prevention of maternal-fetal HIV-1 transmission: Specific dosage instructions for mother and infant. • Patients with severe anemia and/or neutropenia: Dosage interruption may be necessary. • Renal impairment: Recommended oral dosage in hemodialysis or peritoneal dialysis or in patients with creatinine clearance (CrCl) less than 15 mL per minute is 100 mg every 6 to 8 hours. Equivalent intravenous dosing is approximately 1 mg per kg every 6 to 8 hours.
Source: US FDA prescribing information
RETROVIR is contraindicated in patients who have had a potentially life-threatening hypersensitivity reaction (e.g., anaphylaxis, Stevens-Johnson syndrome) to any of the components of the formulations. Hypersensitivity to zidovudine or any of the components (e.g., anaphylaxis, Stevens-Johnson syndrome).
Source: US FDA prescribing information
Boxed warning: (zidovudine) capsules, oral solution, and injection have been associated with hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced HIV-1 disease. Prolonged use of RETROVIR has been associated with symptomatic myopathy. • See boxed warning for information about the following: hematologic toxicity, myopathy, and lactic acidosis and severe hepatomegaly. • Exacerbation of anemia has been reported in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine. Coadministration of ribavirin and zidovudine is not advised. • Hepatic decompensation (some fatal) has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy and interferon alfa with/without ribavirin. Discontinue RETROVIR as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both.
Source: US FDA prescribing information
The following adverse reactions are discussed in greater detail in other sections of the labeling: • Hematologic toxicity, including neutropenia and anemia. • Symptomatic myopathy. • Lactic acidosis and severe hepatomegaly with steatosis. • Hepatic decompensation in patients co-infected with HIV-1 and hepatitis C. • Most commonly reported adverse reactions (incidence greater than or equal to 15%) in adult HIV-1 clinical trials were headache, malaise, nausea, anorexia, and vomiting. • Most commonly reported adverse reactions (incidence greater than or equal to 15%) in pediatric HIV-1 clinical trials were fever and cough. • Most commonly reported adverse reactions in neonates (incidence greater than or equal to 15%) in the prevention of maternal-fetal transmission of HIV-1 clinical trial were anemia and neutropenia.
Source: US FDA prescribing information
• Avoid use with stavudine. • Avoid use with doxorubicin. • Bone marrow suppressive/cytotoxic agents: May increase the hematologic toxicity of zidovudine.
Source: US FDA prescribing information
Store at 15° to 25°C (59° to 77°F) and protect from moisture. Store at 15° to 25°C (59° to 77°F). Store vials at 15° to 25°C (59° to 77°F) and protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
6 presentations of Zidovudine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Zidovudine 300 mg tabletOralGeneric name | — | US FDA | Available on request |
| Zidovudine 100 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Retrovir 10 mg/mL oral solutionOral | ViiV Healthcare | US FDA | Available on request |
| Retrovir 100 mg capsuleOral | ViiV Healthcare | US FDA | Available on request |
| Retrovir 200 mg/20 mL injectionIntravenous | ViiV Healthcare | US FDA | Available on request |
| Zidovudine 10 mg/mL syrupOralGeneric name | — | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 19 March 1987 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Zidovudine in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 6 presentations of Zidovudine and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Zidovudine, including Retrovir.
Yes. The US FDA first approved Zidovudine on 19 March 1987, according to Drugs@FDA.
No listed presentation of Zidovudine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Zidovudine is classified under ATC code J05AF01 (Zidovudine).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.