FDA label
What is atazanavir used for?
The FDA-approved uses of atazanavir, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Atazanavir capsule is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg.”
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Atazanavir, capsule
Indications and Usage, quoted from the label by Aurobindo Pharma Limited (ANDA204806). Cross-references to other label sections are left out.
Atazanavir capsule is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg.
Limitations of Use:
- Atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus.
- Use of atazanavir capsules with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions.
Source: DailyMed label, set id 7fbea274-d6b5-4faa-bbf0-05fefab42114, version 8, effective August 6, 2025. NDC 65862-710, one of 13 listings for this product.
Questions
What is atazanavir used for?
The FDA label says: “Atazanavir capsule is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg.”
What drug class is atazanavir?
FDA lists atazanavir in the Protease Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.