What the label lists and what reports show
Zidovudine side effects
Zidovudine's FDA label: “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.” FAERS holds 13,295 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is anaemia (934 reports).
- Generic listed
- Boxed warning
Check it at the source: the zidovudine FDA label on DailyMed (effective February 10, 2025, Aurobindo Pharma Limited); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost commonly reported adverse reactions (incidence greater than or equal to 15%) in adult HIV-1 clinical trials were headache, malaise, nausea, anorexia, and vomiting.
Table 5. Selected Clinical Adverse Reactions and Physical Findings (Greater than or Equal to 5% Frequency) in Pediatric Subjects in Trial ACTG 300
| Adverse Reaction | EPIVIR plus Zidovudine (n = 236) | Didanosine (n = 235) |
|---|---|---|
| Fever | 25% | 32% |
| Hepatomegaly | 11% | 11% |
| Nausea & vomiting | 8% | 7% |
| Diarrhea | 8% | 6% |
| Stomatitis | 6% | 12% |
| Splenomegaly | 5% | 8% |
| Cough | 15% | 18% |
| Abnormal breath sounds/wheezing | 7% | 9% |
| Signs or symptoms of ears a | 7% | 6% |
| Nasal discharge or congestion | 8% | 11% |
| Skin rashes | 12% | 14% |
| Lymphadenopathy | 9% | 11% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in greater detail in other sections of the labeling: Hematologic toxicity, including neutropenia and anemia [see Boxed Warning, Warnings and Precautions (5.1) ]. Symptomatic myopathy [see Boxed Warning, Warnings and Precautions (5.2) ]. Lactic acidosis and severe hepatomegaly with steatosis [see Boxed Warning, Warnings and Precautions (5.3) ]. Hepatic decompensation in patients co-infected with HIV-1 and hepatitis C [see Warnings and Precautions (5.4) ]. 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. (6.1) Most commonly reported adverse reactions (incidence greater than or equal to 15%) in pediatric HIV-1 clinical trials were fever and cough. (6.1) 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. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, 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?
13,295 reports list zidovudine among the medicines taken, 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. Of the 17 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Zidovudine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions