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efavirenz

Efavirenz Teva · ATC code J05AG03

Key facts
Active substance
efavirenz
Drug class
Direct acting antiviral
ATC code
J05AG03
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Efavirenz Teva 600 mg film-coated tablets
Information as of
2026-10-27

Key facts

Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It is used in antiretroviral combination treatment of HIV-1 infection in adults, adolescents and children 3 years and older.

What it is used for

  • HIV-1 infection in combination with other antiretrovirals, from 3 years of age
  • Not adequately studied in advanced HIV disease (CD4 < 50 cells/mm³) or after failure of PI-containing regimens

Dosing

  • Adults and adolescents over 40 kg: 600 mg once daily, with NRTIs with or without a PI
  • Taken on an empty stomach; bedtime dosing recommended
  • With voriconazole: efavirenz reduced to 300 mg once daily, voriconazole maintenance 400 mg every 12 hours
  • With rifampicin in patients 50 kg or more: an increase to 800 mg/day may be considered
  • Film-coated tablets not suitable for children under 40 kg
  • Mild liver disease: usual dose with careful monitoring

Contraindications

  • Hypersensitivity to the active substance or any of the excipients
  • Severe hepatic impairment (Child Pugh Class C)
  • Co-administration with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil or ergot alkaloids
  • Co-administration with elbasvir/grazoprevir or St. John's wort

Important warnings

  • Not used as monotherapy or as sole add-on to a failing regimen (rapid resistance)
  • Psychiatric reactions including severe depression, death by suicide and psychosis-like behaviour
  • Severe skin reactions (Stevens-Johnson syndrome, erythema multiforme)
  • Seizures
  • Co-administration with sofosbuvir/velpatasvir, glecaprevir/pibrentasvir or Ginkgo biloba not recommended

Side effects

  • Rash (11.6%), dizziness (8.5%), nausea (8.0%), headache (5.7%), fatigue (5.5%)
  • Nervous system symptoms usually begin early and resolve after the first 2 to 4 weeks
  • Severe skin reactions, severe depression, suicide, seizures

Interactions

  • Inducer of CYP3A4, CYP2B6 and UGT1A1: substrate concentrations may decrease
  • Caution with CYP3A4 substrates with a narrow therapeutic index
  • Net effect on CYP2C19 and CYP2C9 substrates is unclear

Pregnancy and breastfeeding

  • Not used during pregnancy unless clinically required; pregnancy test before initiation
  • Barrier plus other contraception; contraception for 12 weeks after discontinuation

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

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)

Source: European Medicines Agency (EMA), product information

Austria

  • Efavirenz SandozSandoz Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • Efavirenz AurobindoPuren Pharma Gmbh & Co. Kg · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • StocrinMERCK SHARP DOHME İLAÇLARI LTD. ŞTİ. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 13 more European countries
Belgium
Efavirenz Viatris
Cyprus
Efavirenz Aurobindo
Denmark
Efavirenz "sandoz", Efavirenz Aurobindo, Efavirenz Medical Valley
Estonia
Efavirenz Sandoz
Finland
Efavirenz Aurobindo, Efavirenz Sandoz
France
Efavirenz Arrow, Efavirenz Sandoz, Efavirenz Viatris
Iceland
Efavirenz Teva
Liechtenstein
Efavirenz Teva
Netherlands
Efavirenz Accord, Efavirenz Aurobindo, Efavirenz Mylan, Efavirenz Sandoz
Norway
Efavirenz Sandoz, Efavirenz Teva
Portugal
Efavirenz Aurobindo, Efavirenz Farmoz, Efavirenz Mylan
Spain
Efavirenz Aurovitas
Sweden
Efavirenz Aurobindo, Efavirenz Medical Valley, Efavirenz Sandoz

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

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Sources

  1. European Medicines Agency. Efavirenz Teva – EPAR, Product Information (OF THE TEXT {MM/YYYY} Detailed information on this medicinal). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/efavirenz-teva-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. 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), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC J05AG.

Editorial: Medelix editorial team · last updated 2026-10-27 · 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.