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Label Changes for:

Retrovir (zidovudine) Tablets, Capsules, and Syrup

September 2008

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2008


The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.

Summary View


Sections Modified


  • Clinical Trials Experience
  • Adults
  • In addition to the adverse reactions listed in Table 2, adverse reactions observed at an incidence of >5% in any treatment arm in clinical studies (NUCA3001, NUCA3002, NUCB3001, and NUCB3002)...
  • ...hyperbilirubinemia was reported at an incidence of <0.8%.
  • Pediatrics
    • Macrocytosis was reported in the majority of pediatric patients receiving Retrovir 180 mg/m2 every 6 hours in open-label studies. Additionally, adverse reactions reported at an incidence of <6%...


  • Pregnancy
  • Pediatric Use


  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Reproductive and Developmental Toxicology Studies