Last reviewed 2026-04-20 · How we verify

Viramune (NEVIRAPINE)

Viramune works by binding to the reverse transcriptase enzyme, preventing HIV from replicating.

Viramune (NEVIRAPINE) is a small molecule, non-nucleoside analog reverse transcriptase inhibitor developed by Boehringer Ingelheim. It is used to treat human immunodeficiency virus (HIV) infection and was first approved by the FDA in 1996. As an off-patent medication, Viramune is available from multiple generic manufacturers. Key safety considerations include its potential for hepatotoxicity and skin reactions. Viramune's commercial status allows for generic competition, making it more accessible to patients.

At a glance

Mechanism of action

Nevirapine is an antiviral drug see Microbiology 12.4) ].

Approved indications

• Human immunodeficiency virus infection

Boxed warnings

• WARNING: LIFE-THREATENING (INCLUDING FATAL) HEPATOTOXICITY and SKIN REACTIONS Severe, life-threatening, and in some cases fatal hepatotoxicity, particularly in the first 18 weeks, has been reported in patients treated with nevirapine. In some cases, patients presented with non-specific prodromal signs or symptoms of hepatitis and progressed to hepatic failure. These events are often associated with rash. Female sex and higher CD4+ cell counts at initiation of therapy place patients at increased risk; women with CD4+ cell counts greater than 250 cells/mm3, including pregnant women receiving nevirapine in combination with other antiretrovirals for the treatment of HIV-1 infection, are at the greatest risk. However, hepatotoxicity associated with nevirapine use can occur in both sexes, all CD4+ cell counts and at any time during treatment. Hepatic failure has also been reported in patients without HIV taking nevirapine for post-exposure prophylaxis (PEP). Use of nevirapine for occupational and non-occupational PEP is contraindicated [see Contraindications (4)]. Patients with signs or symptoms of hepatitis, or with increased transaminases combined with rash or other systemic symptoms, must discontinue nevirapine and seek medical evaluation immediately [ see Warnings and Precautions ( 5.1 ) ]. SKIN REACTIONS: Severe, life-threatening skin reactions, including fatal cases, have occurred in patients treated with nevirapine. These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction. Patients developing signs or symptoms of severe skin reactions or hypersensitivity reactions must discontinue nevirapine and seek medical evaluation immediately. Transaminase levels should be checked immediately for all patients who develop a rash in the first 18 weeks of treatment. The 14-day lead-in period with immediate-release nevirapine tablets 200 mg daily dosing has been observed to decrease the incidence of rash and must be followed [ see Warnings and Precautions ( 5.2 )]. MONITORING FOR HEPATOXICITY AND SKIN REACTIONS: Patients must be monitored intensively during the first 18 weeks of therapy with nevirapine to detect potentially life-threatening hepatotoxicity or skin reactions. Extra vigilance is warranted during the first 6 weeks of therapy, which is the period of greatest risk of these events. Do not restart nevirapine following clinical hepatitis, or transaminase elevations combined with rash or other systemic symptoms, or following severe skin rash or hypersensitivity reactions. In some cases, hepatic injury has progressed despite discontinuation of treatment. WARNING: LIFE-THREATENING (INCLUDING FATAL) HEPATOTOXICITY and SKIN REACTIONS See full prescribing information for complete boxed warning. • Fatal and non-fatal hepatotoxicity have been reported in patients taking nevirapine extended-release tablets. Discontinue immediately if clinical hepatitis or transaminase elevations combined with rash or other systemic symptoms occur. Do not restart nevirapine extended-release tablets after recovery. ( 5.1 ) • Fatal and non-fatal skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions, have been reported. Discontinue immediately if severe skin reactions, hypersensitivity reactions, or any rash with systemic symptoms occur. Check transaminase levels immediately for all patients who develop a rash in the first 18 weeks of treatment. Do not restart nevirapine extended-release tablets after recovery. ( 5.2 ) • Monitoring during the first 18 weeks of therapy is essential. Extra vigilance is warranted during the first 6 weeks of therapy, which is the period of greatest risk of these events. ( 5.1 , 5.2 )

Common side effects

• Rash
• Any adverse event
• Nausea
• Diarrhea
• Myalgia
• Fatigue
• Abdominal pain
• Headache
• Hepatitis/hepatic failure
• Liver enzyme abnormalities
• Granulocytopenia
• Hypersensitivity reactions

Drug interactions

• CYP2B6 Substrates
• CYP3A4 Substrates
• ketoconazole
• levonorgestrel
• norelgestromin
• norethisterone
• norethynodrel
• norgestimate
• phenytoin
• rifampicin
• warfarin

Key clinical trials

• Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2,PHASE3)
• A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
• Early Infant HIV Treatment in Botswana (PHASE2,PHASE3)
• Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (PHASE3)
• Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
• Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (PHASE2,PHASE3)
• Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission (PHASE1,PHASE2)
• Population Pharmacokinetics of Antiretroviral in Children

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Viramune CI brief — competitive landscape report
• Viramune updates RSS · CI watch RSS
• Boehringer Ingelheim portfolio CI