Efavirenz, Emtricitabine, and Tenofovir
Efavirenz, emtricitabine, and tenofovir is a three-drug combination antiviral tablet used to treat HIV-1 infection in adults and children weighing at least 40 kg.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 7 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
If you have both HIV and hepatitis B, do not stop this medication without your doctor's guidance. When people who are infected with both HIV-1 and hepatitis B virus (HBV) stop taking medicines that contain emtricitabine or tenofovir disoproxil fumarate — both components of this tablet — hepatitis B can suddenly and severely worsen. This flare-up can lead to liver failure and can be life-threatening. If you need to stop this medication, your doctor will monitor your liver function with blood tests and clinical check-ups for at least several months after stopping. In some cases, starting a specific hepatitis B treatment may be necessary to protect your liver.
📖 Efavirenz, Emtricitabine, and Tenofovir: Patient Information Guide
A plain-language walkthrough of Efavirenz, Emtricitabine, and Tenofovir — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
This three-drug combination tablet is used to treat HIV-1 infection.
- Indicated for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg (approximately 88 lbs)
- Can be used as a complete, self-contained antiretroviral regimen on its own
- Can also be used in combination with additional antiretroviral agents when needed
⚙️How it works▾
This tablet works by attacking HIV-1 at two different points in the virus's replication cycle. Efavirenz — a non-nucleoside reverse transcriptase inhibitor (NNRTI) — binds directly to and disables an enzyme called reverse transcriptase, which HIV needs to convert its genetic material into a form it can use to reproduce. Emtricitabine and tenofovir disoproxil fumarate (TDF) are nucleoside/nucleotide analogs — they mimic the building blocks of viral DNA, and when the virus mistakenly incorporates them, replication stalls and stops. This multi-pronged approach makes it much harder for HIV-1 to replicate and spread in the body.
Because efavirenz works through a different mechanism than the other two drugs, the combination creates a more robust barrier against the virus and reduces the chance of HIV developing resistance to treatment.
💊How it's taken▾
This tablet is taken once daily by mouth, on an empty stomach. Taking it at bedtime is specifically recommended because the dizziness and unusual dreams it can cause are less disruptive during sleep. There is no standard food interaction data for the full combination tablet, but the efavirenz component is known to reach significantly higher blood levels with a high-fat meal, which may increase side effects.
- Take exactly as prescribed — do not skip doses or stop without talking to your doctor
- If you are also taking rifampin and weigh 50 kg or more, your doctor may prescribe an additional daily efavirenz dose alongside this tablet
- Not recommended if kidney function is significantly reduced (creatinine clearance below 50 mL/min) or if you have moderate to severe liver disease
🤒Side effects — in detail▾
The most common side effects reported in clinical trials include:
- Dizziness
- Abnormal or vivid dreams
- Insomnia (trouble sleeping)
- Difficulty concentrating
- Headache
- Nausea, diarrhea, or upset stomach
- Fatigue
- Depression or anxiety
- Skin rash (usually mild, appearing in the first 1–2 weeks)
Most nervous system side effects — like dizziness and strange dreams — tend to improve after the first 2 to 4 weeks. However, contact your doctor right away if you experience serious psychiatric symptoms like suicidal thoughts, paranoia, or hallucinations, or if a rash is severe, blistering, or accompanied by fever.
⚠️Warnings & precautions▾
- Hepatitis B flare on stopping: If you have both HIV and hepatitis B, abruptly stopping this medication can trigger a severe, potentially fatal hepatitis B flare. Your liver must be monitored for several months after stopping.
- Psychiatric symptoms: Serious mental health effects — including severe depression, suicidal ideation, paranoia, and psychosis — have been reported. Seek immediate medical evaluation if these occur.
- Liver toxicity (hepatotoxicity): Fatal liver failure has been reported, including in people without pre-existing liver disease. Liver enzymes should be monitored regularly.
- Nervous system symptoms: Dizziness, poor concentration, and vivid dreams are common early on. Rare late-onset neurotoxicity (confusion, loss of coordination, psychosis) can appear months to years later, particularly in people with a CYP2B6 genetic variation causing higher efavirenz blood levels.
- Kidney problems: Tenofovir can cause kidney damage, including Fanconi syndrome. Kidney function should be checked before and during treatment.
- Bone density loss: Decreases in bone mineral density have been observed with antiretroviral therapy; patients with risk factors for osteoporosis or prior fractures should be assessed.
- Embryo-fetal toxicity: Efavirenz may cause neural tube defects if taken during the first trimester. Avoid pregnancy during treatment and for 12 weeks after stopping.
- QTc prolongation: Efavirenz can lengthen the QTc interval (an electrical delay in the heart that can cause dangerous arrhythmias). Use caution if you take other medications that also affect heart rhythm.
🔀What it interacts with▾
This tablet interacts with a wide range of medicines. Always tell your doctor and pharmacist about everything you take.
- Voriconazole (antifungal): Contraindicated — efavirenz dramatically lowers voriconazole levels, making it ineffective
- Elbasvir/grazoprevir (hepatitis C treatment): Contraindicated — this tablet reduces its levels to the point of treatment failure
- Rifampin (tuberculosis antibiotic): Requires an additional efavirenz dose for patients weighing 50 kg or more
- HIV protease inhibitors (atazanavir, lopinavir/ritonavir, darunavir/ritonavir): Some combinations are not recommended; others require dose adjustments or close monitoring for tenofovir toxicity
- Other NNRTIs: Should not be combined with this tablet, which already contains efavirenz
- Kidney-clearing drugs (aminoglycosides, cidofovir, acyclovir, high-dose NSAIDs): Compete with tenofovir and emtricitabine for kidney elimination, raising the risk of drug buildup and kidney damage
- Warfarin (blood thinner): Efavirenz can unpredictably raise or lower warfarin levels; close monitoring is required
- Antiseizure medications (carbamazepine, phenytoin, phenobarbital): Can lower efavirenz levels and vice versa; alternative antiseizure medicines are preferred
- Boceprevir, simeprevir, glecaprevir/pibrentasvir, sofosbuvir/velpatasvir (hepatitis C agents): Combinations are not recommended due to reduced effectiveness
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Hepatitis B coinfection: You must be tested for hepatitis B before starting; stopping this medication without a plan can cause a life-threatening flare
- Liver disease: This tablet is not recommended for moderate to severe hepatic impairment; those with mild liver disease need careful monitoring
- Kidney disease: Not recommended if creatinine clearance is below 50 mL/min; kidney function must be checked before and during treatment
- Pregnancy: Efavirenz is associated with a risk of neural tube defects in the first trimester; pregnancy must be ruled out before starting, and effective contraception must be used during treatment and for 12 weeks after stopping
- Breastfeeding: Not recommended — HIV can be transmitted through breast milk, and drug components pass into breast milk
- Psychiatric history: People with a history of depression, psychiatric illness, or prior psychiatric medication use are at higher risk of serious psychiatric side effects
- Seizure history: Efavirenz should be used with caution in people with a history of seizures
- Children under 40 kg: This tablet formulation is not approved for pediatric patients weighing less than 40 kg
- Heart rhythm problems: Use with caution if you take other drugs that prolong the QTc interval, as efavirenz also has this effect
🚑If you take too much▾
If too much of this medication is taken, the patient should be monitored for signs of toxicity and given supportive care. For efavirenz, taking more than prescribed has been linked to increased nervous system symptoms — one reported case involved involuntary muscle contractions. Activated charcoal may help reduce absorption of efavirenz if given soon after ingestion. Hemodialysis (a kidney-filtering procedure) can remove meaningful amounts of emtricitabine and tenofovir, but is unlikely to significantly clear efavirenz from the body.
📡Pharmacodynamics — effects in the body▾
Efavirenz can affect the heart's electrical activity by prolonging the QTc interval — the time it takes the heart's lower chambers to reset between beats. This effect is related to efavirenz blood levels, and people with a genetic variation called CYP2B6 *6/*6 tend to have higher drug levels and a more pronounced QTc effect. This is why caution is needed when combining this tablet with other drugs that also affect heart rhythm. The three-drug combination does not appear to have other significant measurable cardiovascular or blood pressure effects based on available label data.
🔬Pharmacokinetics — how your body processes it▾
The three drugs in this tablet are absorbed and cleared by the body at different rates. Efavirenz reaches peak blood levels in 3 to 5 hours and has a long half-life of 40 to 76 hours, meaning it stays in the body for days after a dose — which supports once-daily dosing but also means it takes 6 to 10 days to reach steady, stable blood levels. It is heavily bound to blood proteins and is broken down mainly by liver enzymes (CYP3A and CYP2B6), with waste excreted in urine and stool. Emtricitabine absorbs quickly (peak in 1 to 2 hours), has a shorter half-life of about 10 hours, and is mainly cleared by the kidneys. Tenofovir (from tenofovir disoproxil fumarate) peaks within about 1 hour in fasted patients and has a half-life of approximately 17 hours; it is also cleared primarily by the kidneys. Because both emtricitabine and tenofovir depend heavily on kidney elimination, reduced kidney function significantly affects how they are cleared from the body.
📦How to store it▾
Store at 25°C (77°F); excursions permitted to 15°C –30°C (59°F –86°F) .
📄 Written from Efavirenz, Emtricitabine, and Tenofovir’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Efavirenz, Emtricitabine, and Tenofovir — the kind of thing our pharmacy team would talk through with you at the counter.
Why do I need to take this on an empty stomach, and does it really matter? ▾
I keep having really strange dreams and feel dizzy in the morning — is this normal? ▾
I also have hepatitis B — is there anything special I need to know? ▾
Can I take this if I'm pregnant or trying to get pregnant? ▾
Are there medications I absolutely cannot take with this? ▾
What side effects should make me call the doctor or go to the hospital? ▾
Is Efavirenz, Emtricitabine, and Tenofovir available over the counter? ▾
When was Efavirenz, Emtricitabine, and Tenofovir first available? ▾
Who makes Efavirenz, Emtricitabine, and Tenofovir? ▾
💬 Answers drafted from Efavirenz, Emtricitabine, and Tenofovir’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Efavirenz, Emtricitabine, and Tenofovir comes
Efavirenz, Emtricitabine, and Tenofovir is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Atripla and the generic tablet are used to treat HIV-1 infection in adults and pediatric patients weighing at least 40 kg, either as a complete regimen or combined with other antiretroviral medicines
- Take one tablet by mouth once daily on an empty stomach
- Taking the tablet at bedtime may help reduce dizziness and other nervous system side effects
- If your doctor also prescribes rifampin and you weigh 50 kg or more, your prescriber may add an additional efavirenz dose — follow their guidance exactly
- This tablet is not recommended if your kidney function (creatinine clearance) is below 50 mL/min or if you have moderate to severe liver disease
📊 Efavirenz, Emtricitabine, and Tenofovir across the U.S. market
How Efavirenz, Emtricitabine, and Tenofovir appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Efavirenz, Emtricitabine, and Tenofovir is used
A general measure of how commonly Efavirenz, Emtricitabine, and Tenofovir is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Efavirenz, Emtricitabine, and Tenofovir is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Efavirenz, Emtricitabine, and Tenofovir prescribed? Of the 1,594 medications we measure, Efavirenz, Emtricitabine, and Tenofovir ranks #1,074 by Medicaid prescriptions — more than 33% of them.
Utilization by Efavirenz, Emtricitabine, and Tenofovir product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet
Summed across the 5 of 13 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 643066
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Efavirenz, Emtricitabine, and Tenofovir, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 5 of 13 listed Efavirenz, Emtricitabine, and Tenofovir NDCs with Medicaid activity.
🔍 Compare Efavirenz, Emtricitabine, and Tenofovir products
A representative set of FDA-listed product records for Efavirenz, Emtricitabine, and Tenofovir — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| EFAVIRENZ 600 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg | — | Aurobindo Pharma Limited | DRUG FOR FURTHER PROCESSING | View NDC → |
| EFAVIRENZ 600 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 600; 200; 300 mg/1; mg/1; mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| EFAVIRENZ 600 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| EFAVIRENZ 600 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| EFAVIRENZ 600 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg | Oral | Cipla USA Inc. | ANDA | View NDC → |
| 600; 200; 300 mg/1; mg/1; mg | Oral | Exelan Pharmaceuticals, Inc. | ANDA | Find on DailyMed ↗ |
| 600; 200; 300 mg/1; mg/1; mg | Oral | Gilead Sciences, LLC | NDA | View NDC → |
| EFAVIRENZ 600 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg | Oral | Laurus Labs Limited | ANDA | View NDC → |
| 600; 200; 300 mg/1; mg/1; mg | Oral | Laurus Labs Limited | ANDA | View NDC → |
| EFAVIRENZ 600 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg | Oral | Macleods Pharmaceuticals Limited | ANDA | View NDC → |
| 600; 200; 300 mg/1; mg/1; mg | Oral | Remedyrepack Inc. × 2 listings | ANDA | View NDC → |
| EFAVIRENZ 600 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg | — | Takeda GmbH | DRUG FOR FURTHER PROCESSING | View NDC → |
| EFAVIRENZ 600 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 600; 200; 300 mg/1; mg/1; mg | Oral | Teva Pharmaceuticals USA, Inc. × 2 listings | ANDA | View NDC → |
Showing 17 of 17 products — FDA National Drug Code Directory. See every product, package size and price: browse all 17 Efavirenz, Emtricitabine, and Tenofovir NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Efavirenz, Emtricitabine, and Tenofovir — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Efavirenz, Emtricitabine, and Tenofovir in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Efavirenz, Emtricitabine, and Tenofovir went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & shortage status
Whether Efavirenz, Emtricitabine, and Tenofovir is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Efavirenz, Emtricitabine, and Tenofovir belongs to the Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 7 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Teva Pharmaceuticals USA, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.