Efavirenz
Non-Nucleoside Reverse Transcriptase Inhibitors
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- Drug class
- Non-Nucleoside Reverse Transcriptase Inhibitors
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 23
- FDA reports (12 mo)
- 107
Overview
Plain-language summary, compiled from the cited regulatory records
Efavirenz is a non-nucleoside reverse transcriptase inhibitor [1]. It is approved for use in combination with other antiretroviral agents to treat human immunodeficiency virus type 1 (HIV-1) infection [1]. This indication applies to adults and pediatric patients who are at least 3 months old and weigh at least 3.5 kg [1].
Efavirenz is available under various brand names [1]. In the past 12 months, there have been 107 adverse event reports associated with this active ingredient [2]. Among the frequently reported adverse events are drug interactions, acute kidney injury, anemia, vomiting, and increased alanine aminotransferase levels [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 9 | May 15, 2026 |
| CA Canada | Health Canada | 8 | April 29, 2026 |
| EU European Union | EMA | 5 | November 18, 2025 |
| US United States | FDA | 1 | June 28, 2024 |
GBUnited Kingdom· MHRA
9 products
Uses
5 kg.. Efavirenz has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease inhibitor (PI) containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI based combination therapy after failure of regimens containing efavirenz.
1.
How to take
CACanada· Health Canada
8 products
Uses
66 TEVA-EFAVIRENZ/EMTRICITABINE/TENOFOVIR Product Monograph 3 PrTEVA-EFAVIRENZ/EMTRICITABINE/TENOFOVIR Efavirenz, Emtricitabine and Tenofovir Tablets PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form/Strength Clinically Relevant Nonmedicinal Ingredients Oral Tablet / Efavirenz 600 mg / Emtricitabine 200 mg / Tenofovir Disoproxil Fumarate 300 mg Lactose monohydrate For a complete listing, see Dosage Form, Composition and Packaging section INDICATIONS AND CLINICAL USE TEVA-EFAVIRENZ/EMTRICITABINE/TENOFOVIR (efavirenz [EFV]/emtricitabine [FTC]/tenofovir disoproxil fumarate [TDF]) is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.
(see CLINICAL TRIALS, Description of Clinical Studies and ADVERSE REACTIONS).
Geriatrics (>65 years of age):
Clinical studies of the components of TEVA-EFAVIRENZ/EMTRICITABINE/TENOFOVIR did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
EUEuropean Union· EMA
5 products
Uses
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. It is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months.
1). 1). No data are currently available from clinical studies with efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients. No data are available to support the combination of efavirenz/emtricitabine/tenofovir disoproxil and other antiretroviral agents
How to take
USUnited States· FDA
1 product
Uses
5 kg. ( 1 )
How to take
Drug interactions
Known interactions involving Efavirenz. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 600. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL200750517 · revised May 1, 2026
- [2]Health Canada (DPD) · 02393549 · revised April 29, 2026
- [3]European Medicines Agency · EMEA/H/C/004240 · revised November 18, 2025
- [4]FDA DailyMed · 13ca3456-e5bf-4b… · revised June 28, 2024 [PDF]
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.