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nevirapine

Viramune · ATC code J05AG01

Also known as: Nevirapin · Brand names: Viramune, Nevirapin Viatris, Nevirapin Abdi, Nevirapin Aurobindo, Nevirapin Axiromed, Nevirapin Heumann, Nevirapin Hexal, Nevirapin Hormosan, Nevirapin Mylan, Nevirapin Ratiopharm

Key facts
Active substance
nevirapine
Drug class
Direct acting antiviral
ATC code
J05AG01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Viramune 200 mg tablets · Viramune 50 mg/5 mL oral suspension · Viramune 400 mg prolonged-release tablets
Marketing authorisation holder
Boehringer Ingelheim International GmbH
Information as of
2026-10-28

Key facts

Nevirapine (Viramune) is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It is used with other antiretroviral medicines to treat HIV-1 infection.

What it is used for

  • Viramune 200 mg tablets and oral suspension: HIV-1 infection in adults, adolescents and children of any age, in combination with other antiretrovirals.
  • Viramune 400 mg prolonged-release tablets: adults, adolescents and children three years and above able to swallow tablets; not suitable for the 14-day lead-in phase.

Dosing

  • 200 mg tablets (16 years and older): 200 mg once daily for the first 14 days (the lead-in lessens the frequency of rash), then 200 mg twice daily, with at least two other antiretroviral agents.
  • Oral suspension (16 years and older): 20 mL (200 mg) once daily for 14 days, then twice daily; children by body surface area 150 mg/m2 once daily for two weeks, then 150 mg/m2 twice daily (total daily dose not more than 400 mg).
  • 400 mg prolonged-release tablets: after a 14-day lead-in with 200 mg immediate-release tablets, 400 mg once daily.
  • If rash occurs during the lead-in, do not increase the dose until it resolves; do not continue the lead-in dose beyond 28 days. Restart with the lead-in after interruptions of more than 7 days.
  • Dialysis: an additional 200 mg after each dialysis; not for severe hepatic impairment (Child-Pugh C).

Contraindications

  • Hypersensitivity to the active substance or any of the excipients.
  • Readministration after permanent discontinuation for severe rash, hypersensitivity or clinical hepatitis due to nevirapine.
  • Severe hepatic impairment (Child-Pugh C) or pre-treatment ASAT/ALAT > 5 ULN until stabilised.
  • Co-administration with St John's wort preparations.

Important warnings

  • Severe, sometimes life-threatening skin and liver reactions (Stevens-Johnson syndrome, TEN, hepatitis/hepatic failure); greatest risk in the first 6 weeks, close monitoring in the first 18 weeks.
  • Higher hepatotoxicity risk in women with CD4+ > 250/mm3 and men with CD4+ > 400/mm3 with detectable viral load.
  • Discontinue immediately and do not restart if signs of hepatitis, severe skin reaction or hypersensitivity occur.
  • Not to be used as the sole active antiretroviral (resistance).

Side effects

  • Most frequent: rash, allergic reactions, hepatitis, abnormal liver tests, nausea, vomiting, diarrhoea, abdominal pain, fatigue, fever, headache, myalgia.
  • Most serious: Stevens-Johnson syndrome/toxic epidermal necrolysis, serious hepatitis/hepatic failure and DRESS.
  • Common: granulocytopenia; uncommon: anaemia.

Interactions

  • Nevirapine induces CYP3A (and potentially CYP2B6) and may lower levels of many medicines.
  • Not recommended with rifampicin, efavirenz, ketoconazole, etravirine, rilpivirine, atazanavir/ritonavir, fosamprenavir and elvitegravir/cobicistat.
  • St John's wort is contraindicated; oral contraceptives should not be the sole method of birth control.

Pregnancy and breastfeeding

  • Available data show no malformative toxicity; use with caution in pregnancy, particularly with CD4+ counts above 250 cells/mm3 and detectable viral load.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • ViramuneBoehringer Ingelheim International GmbH · EMEA/H/C/000183

Source: European Medicines Agency (EMA), product information

Austria

  • Nevirapin ViatrisViatris Limited · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • Nevirapin AbdiAbdi Farma Gmbh · 1 register entry
  • Nevirapin AurobindoPuren Pharma Gmbh & Co. Kg · 1 register entry
  • Nevirapin AxiromedMedical Valley Invest Ab · 1 register entry
  • Nevirapin HeumannHeumann Pharma Gmbh & Co. Generica Kg · 1 register entry
  • Nevirapin HexalHexal Ag · 1 register entry
  • Nevirapin HormosanHormosan Pharma Gmbh · 1 register entry
  • Nevirapin MylanViatris Germany Gmbh · 1 register entry
  • Nevirapin RatiopharmRatiopharm Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Brand names in 15 more European countries
Belgium
Nevirapine Viatris
Denmark
Nevirapine Medical Valley, Nevirapine Viatris
Finland
Nevirapine Viatris
France
Nevirapine Arrow Lab, Nevirapine Cristers, Nevirapine Lp Accord, Nevirapine Lp Arrow, Nevirapine Lp Sandoz, Nevirapine Sandoz, Nevirapine Teva Lp
Greece
Nevirapine Vocate
Iceland
Viramune
Italy
Nevirapina Aurobindo, Nevirapina Mylan
Liechtenstein
Viramune
Luxembourg
Nevirapine Viatris
Netherlands
Nevirapine Accord, Nevirapine Amarox, Nevirapine Aurobindo, Nevirapine Sandoz, Nevirapine Viatris, Nevirapine Vocate
Norway
Viramune
Portugal
Nevirapina Accord, Nevirapina Aurovitas, Nevirapina Farmoz, Nevirapina Generis, Nevirapina Mylan
Romania
Nevirapina Accord, Nevirapină Accord
Spain
Nevirapina Aurovitas, Nevirapina Kern Pharma, Nevirapina Normon, Nevirapina Tarbis Farma, Nevirapina Teva
Sweden
Nevirapine Medical Valley

EMA – Article 57 product data (EU/EEA), 2026-10-29

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Sources

  1. European Medicines Agency. Viramune – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/viramune-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. Wikidata (CC0): ATC J05AG.

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.