Prescription medicine
Zidovudine Brand names: Retrovir
Zidovudine (Retrovir) is a prescription medicine with an FDA approval on record since 1987. FDA's NDC Directory lists it from 3 generic labelers, and pharmacies paid $0.464 per zidovudine 300 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the zidovudine FDA label on DailyMed (effective February 10, 2025, Aurobindo Pharma Limited); the NDA 19655 record on Drugs@FDA; every zidovudine label on DailyMed.
Highlights of the record
FDA label of February 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
RISK OF HEMATOLOGICAL TOXICITY, MYOPATHY, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS.
Zidovudine oral solution has 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) ]. WARNING: RISK OF HEMATOLOGICAL TOXICITY, MYOPATHY, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS See full prescribing information for complete boxed warning. Hematologic toxicity including neutropenia and severe anemia have been associated with the use of zidovudine. (5.1) Symptomatic myopathy associated with prolonged use of zidovudine. ( 5.2 ) Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues including zidovudine. […]
Used for
From the label: indications and usageZidovudine oral solution is a nucleoside analogue reverse transcriptase inhibitor indicated for: Treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents.
Forms and strengths
- 100 mg
- 300 mg
- 10 mg/ml
Tablet; capsule; injection (solution); film-coated tablet; syrup.
On the market
- Earliest approval on file
- March 19, 1987 Retrovir, Viiv Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first September 19, 2005; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 3 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.464 per tablet Zidovudine 300 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 13,295 through July 30, 2026
What is zidovudine used for?
From the label: indications and usageZidovudine oral solution is a nucleoside analogue reverse transcriptase inhibitor indicated for: Treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents. (1.1) Prevention of maternal-fetal HIV-1 transmission. (1.2) 1.1 Treatment of HIV-1 Zidovudine oral solution, a nucleoside reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. 1.2 Prevention of Maternal-Fetal HIV-1 Transmission Zidovudine oral solution is indicated for the prevention of maternal-fetal HIV-1 transmission [see Dosage and Administration (2.3) ]. […]
Conditions named in the indications of zidovudine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor.
Source: FDA drug label (Zidovudine), Aurobindo Pharma Limited, effective February 10, 2025 (SPL set 51abd2ce-6be1-412d-b806-5f24935ac5e3), via openFDA; the full label on DailyMed
Is there a generic for zidovudine (Retrovir)?
The FDA approved the first generic zidovudine on September 19, 2005. 12 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists zidovudine from 3 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1987 earliest approval on file
- 2005 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for zidovudine (Retrovir)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.464 per Zidovudine 300 mg tablet, up 13% from $0.412 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Zidovudine 300 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Zidovudine 300 mg tablet | Generic | $0.464 per tablet | $13.91 | +13% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the zidovudine label say about other medicines?
The zidovudine label names 7 other medicines in its interaction, contraindication or warning sections. The labels of 32 other medicines name zidovudine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Divalproex | drug interactions | For patients experiencing pronounced anemia or other severe zidovudine-associated events while receiving chronic administration of zidovudine and some of the drugs (e.g., fluconazole, valproic acid) listed in Table 4, zidovudine dose reduction may be considered. |
| Doxorubicin | drug interactions | DRUG INTERACTIONS Avoid use with stavudine. ( 7.1 ) Avoid use with doxorubicin. ( 7.2 ) Bone marrow suppressive/cytotoxic agents: |
| Fluconazole | drug interactions | For patients experiencing pronounced anemia or other severe zidovudine-associated events while receiving chronic administration of zidovudine and some of the drugs (e.g., fluconazole, valproic acid) listed in Table 4, zidovudine dose reduction may be considered. |
| Ganciclovir | drug interactions | Coadministration of ganciclovir, interferon alfa, ribavirin, and other bone marrow suppressive or cytotoxic agents may increase the hematologic toxicity of zidovudine. |
| Phenytoin | drug interactions | Phenytoin plasma levels have been reported to be low in some patients receiving RETROVIR, while in 1 case a high level was documented. |
| Ribavirin | drug interactions | Nucleoside Analogues Affecting DNA Replication Some nucleoside analogues affecting DNA replication, such as ribavirin, antagonize the in vitro antiviral activity of zidovudine against HIV-1; concomitant use of such drugs should be avoided. |
| Valproic acid | drug interactions | For patients experiencing pronounced anemia or other severe zidovudine-associated events while receiving chronic administration of zidovudine and some of the drugs (e.g., fluconazole, valproic acid) listed in Table 4, zidovudine dose reduction may be considered. |
Other labels that name zidovudine
Source: FDA drug label (Zidovudine), Aurobindo Pharma Limited, effective February 10, 2025 (SPL set 51abd2ce-6be1-412d-b806-5f24935ac5e3), via openFDA; the full label on DailyMed
What do FAERS reports show for zidovudine?
The FDA Adverse Event Reporting System holds 13,295 reports that list zidovudine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,654 are coded as a death and 3,342 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as zidovudine?
42 other medicines are given the same way (oral) and in the same FDA class as zidovudine or labeled mainly for the same use (HIV), the same class first. HIV lists all 47 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Emtricitabine and tenofovir disoproxil | HIV | 25 labelers | $0.529 per tablet 200-300 mg tablet | No current entry |
| Lamivudine | HIV | 14 labelers | $0.489 per tablet 150 mg tablet | No current entry |
| Tenofovir disoproxil | HIV | 15 labelers | $0.294 per tablet 300 mg tablet | No current entry |
| Abacavir | HIV | 12 labelers | $0.546 per tablet 300 mg tablet | No current entry |
| Efavirenz and emtricitabine and tenofovir disoproxil | HIV | 7 labelers | $1.12 per tablet 600-200-300 mg tablet | No current entry |
| Abacavir and lamivudine | HIV | 6 labelers | $1.48 per unit 600-300 mg | No current entry |
| Bictegravir and emtricitabine and tenofovir alafenamide | HIV | none listed | $136.73 per tablet 50-200-25 mg tablet | No current entry |
| Emtricitabine | HIV | 2 labelers | $12.69 per capsule 200 mg capsule | A presentation being discontinued |
Every medicine labeled for the same conditions as zidovudine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to zidovudine
- 42 medicines for the same use
- Other human immunodeficiency virus nucleoside analog reverse transcriptase inhibitors
- the pharmacologic class, with prices and generics
- Zidovudine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other