What Is Nevirapine Used For? FDA-Approved Uses

The FDA label says: “Nevirapine tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older. Limitations of Use: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablets is not recommended to be initiated, unless the benefit o...”

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Nevirapine, tablet

Indications and Usage, quoted from the label by Macleods Pharmaceuticals Limited (ANDA090688). Cross-references to other label sections are left out.

Nevirapine tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older. Limitations of Use: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablets is not recommended to be initiated, unless the benefit outweighs the risk, in: • adult females with CD4+ cell counts greater than 250 cells/mm3 or • adult males with CD4+ cell counts greater than 400 cells/mm3.

Source: DailyMed label, set id effb86cc-4b80-4fac-aaa3-9f373b3d0f7d, version 4, effective September 17, 2026. NDC 33342-004, one of 6 listings for this product.

Nevirapine, tablet, extended release

Indications and Usage, quoted from the label by Mylan Pharmaceuticals Inc. (ANDA205651). Cross-references to other label sections are left out.

Nevirapine extended-release tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 6 years of age or older with a body surface area (BSA) of 1.17 m2 or greater.
Limitations of Use:
Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine extended-release tablets are not recommended to be initiated, unless the benefit outweighs the risk, in:
adult females with CD4+ cell counts greater than 250 cells/mm3 or
adult males with CD4+ cell counts greater than 400 cells/mm3.

Source: DailyMed label, set id 690da74b-2481-47fc-93ae-8340e0caf0a4, version 10, effective October 15, 2024. NDC 0378-4890, one of 2 listings for this product.

Questions

What is nevirapine used for?

The FDA label says: “Nevirapine tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older. Limitations of Use: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablets is not recommended to be initiated, unless the benefit o...”

What drug class is nevirapine?

FDA lists nevirapine in the Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase 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.