Prescription medicine
Efavirenz First approved as Sustiva
Efavirenz (Sustiva) is a prescription medicine with an FDA approval on record since 1998. FDA's NDC Directory lists it from 5 generic labelers, and pharmacies paid $1.28 per efavirenz 600 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the efavirenz FDA label on DailyMed (effective March 31, 2024, Cipla USA Inc.); the NDA 20972 record on Drugs@FDA; every efavirenz label on DailyMed.
Highlights of the record
FDA label of March 31, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageEfavirenz tablets are a non-nucleoside reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5kg.
Forms and strengths
- 50 mg
- 100 mg
- 200 mg
- 600 mg
Film-coated tablet; capsule; tablet.
On the market
- Earliest approval on file
- September 17, 1998 Sustiva, Bristol Myers Squibb; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first February 17, 2016; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 5 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.28 per tablet Efavirenz 600 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 2 more by firms not listed as its makers
- FAERS reports
- 11,083 through July 30, 2026
What is efavirenz used for?
From the label: indications and usageEfavirenz tablets are a non-nucleoside reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5kg. ( 1 ) Efavirenz in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg.
Conditions named in the indications of efavirenz's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor.
Source: FDA drug label (Efavirenz), Cipla USA Inc., effective March 31, 2024 (SPL set 92603fa5-7a2c-4bfb-9a70-aadb4fba952c), via openFDA; the full label on DailyMed
Is there a generic for efavirenz (Sustiva)?
The FDA approved the first generic efavirenz on February 17, 2016. 9 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 12 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists efavirenz from 5 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1998 earliest approval on file
- 2016 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for efavirenz (Sustiva)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.28 per Efavirenz 600 mg tablet, down 27% from $1.74 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Efavirenz 600 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Efavirenz 600 mg tablet | Generic | $1.28 per tablet | $38.28 | -27% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has efavirenz been recalled?
The FDA's Enforcement Report lists 2 recalls naming efavirenz since 2013: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of efavirenz and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: EFAVIRENZ, Capsule, 200 mg may have potentially been mislabeled as the following drug: metFORMIN HCl, Tablet 500 mg, NDC 23155010201 … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: EFAVIRENZ, Tablet, 600 mg may have potentially been mislabeled as the following drug: NIACIN ER, Tablet, 500 mg, NDC 00074307490 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the efavirenz label say about other medicines?
The efavirenz label names 53 other medicines in its interaction, contraindication or warning sections. The labels of 47 other medicines name efavirenz. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Abacavir | drug interactions | Interactions with Efavirenz No dosage adjustment is recommended when efavirenz is given with the following: aluminum/magnesium hydroxide antacids, azithromycin, cetirizine, famotidine, fluconazole, lorazepam, nelfinavir, nucleoside reverse transcriptase inhibitors (abacavir, emtricitabine, lamivudine, stavudine … |
| Artemether and lumefantrine | drug interactions | Antimalarials: Artemether/lumefantrine Atovaquone/ proguanil ↓ artemether * ↓ dihydroartemisinin * ↓ lumefantrine * ↓ atovaquone ↓ proguanil Consider alternatives to artemether/ lumefantrine because of the risk of QT interval prolongation. |
| Atazanavir | drug interactions | Concomitant Drug Class/Drug Name: Protease inhibitor: Atazanavir; Effect: ↓ atazanavir *; Clinical Comment: Treatment-naive patients: When coadministered with efavirenz, the recommended dose of atazanavir is 400 mg with ritonavir 100 mg (together once daily with food) and efavirenz 600 mg (once daily on an empty … |
| Atorvastatin | drug interactions | Concomitant Drug Class/Drug Name: HMG-CoA reductase inhibitors: Atorvastatin Pravastatin Simvastatin; Effect: ↓ atorvastatin * ↓ pravastatin * ↓ simvastatin *; Clinical Comment: Plasma concentrations of atorvastatin, pravastatin and simvastatin decreased. … |
| Atovaquone | drug interactions | Concomitant Drug Class/Drug Name: Antimalarials: Artemether/lumefantrine Atovaquone/ proguanil; Effect: ↓ artemether * ↓ dihydroartemisinin * ↓ lumefantrine * ↓ atovaquone ↓ proguanil; Clinical Comment: Consider alternatives to artemether/ lumefantrine because of the risk of QT interval prolongation. … |
| Atovaquone and proguanil | drug interactions | Antimalarials: Artemether/lumefantrine Atovaquone/ proguanil ↓ artemether * ↓ dihydroartemisinin * ↓ lumefantrine * ↓ atovaquone ↓ proguanil Consider alternatives to artemether/ lumefantrine because of the risk of QT interval prolongation. |
| Azithromycin | drug interactions | Interactions with Efavirenz No dosage adjustment is recommended when efavirenz is given with the following: aluminum/magnesium hydroxide antacids, azithromycin, cetirizine, famotidine, fluconazole, lorazepam, nelfinavir, nucleoside reverse transcriptase inhibitors (abacavir, emtricitabine, lamivudine, stavudine … |
| Bupropion | drug interactions | Concomitant Drug Class/Drug Name: Antidepressant: Bupropion Sertraline; Effect: ↓ bupropion * ↓ sertraline *; Clinical Comment: Increases in bupropion dosage should be guided by clinical response. Bupropion dose should not exceed the maximum recommended dose. … |
| Carbamazepine | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants:Carbamazepine Phenytoin Phenobarbital; Effect: ↓ carbamazepine * ↓ efavirenz * ↓ anticonvulsant ↓ efavirenz; Clinical Comment: There are insufficient data to make a dose recommendation for efavirenz. Alternative anticonvulsant treatment should be used. … |
| Cetirizine | drug interactions | Interactions with Efavirenz No dosage adjustment is recommended when efavirenz is given with the following: aluminum/magnesium hydroxide antacids, azithromycin, cetirizine, famotidine, fluconazole, lorazepam, nelfinavir, nucleoside reverse transcriptase inhibitors (abacavir, emtricitabine, lamivudine, stavudine … |
| Clarithromycin | drug interactions | Concomitant Drug Class/Drug Name: Anti-infective: Clarithromycin; Effect: ↓ clarithromycin * ↑ 14-OH metabolite *; Clinical Comment: Consider alternatives to macrolide antibiotics because of the risk of QT interval prolongation. |
| Cyclosporine | drug interactions | Concomitant Drug Class/Drug Name: Immunosuppressants: Cyclosporine, tacrolimus, sirolimus and others metabolized by CYP3A; Effect: ↓ immunosuppressant; Clinical Comment: Dose adjustments of the immunosuppressant may be required. … |
| Diltiazem | drug interactions | Concomitant Drug Class/Drug Name: Calcium channel blockers: Diltiazem Others (e.g., felodipine, nicardipine, nifedipine, verapamil); Effect: ↓ diltiazem * ↓ desacetyl diltiazem * ↓ N-monodesmethyl diltiazem * ↓ calcium channel blocker; … |
| Elbasvir and grazoprevir | drug interactions | Elbasvir/Grazoprevir ↓ elbasvir ↓ grazoprevir Coadministration of efavirenz with elbasvir/grazoprevir is contraindicated [see Contraindications ( 4 )] because it may lead to loss of virologic response to elbasvir/grazoprevir. |
Every other medicine the efavirenz label names
| Medicine named | Section | What the label says |
|---|---|---|
| Emtricitabine | drug interactions | … nelfinavir, nucleoside reverse transcriptase inhibitors (abacavir, emtricitabine, lamivudine, stavudine, tenofovir disoproxil fumarate, zidovudine), paroxetine, and raltegravir. |
| Etonogestrel | drug interactions | Concomitant Drug Class/Drug Name: Hormonal contraceptives: Oral Ethinyl estradiol/ Norgsetimate Implant Etonogestrel; Effect: ↑ active metabolites of norgestimate * ↓ etonogestrel; … |
| Famotidine | drug interactions | … following: aluminum/magnesium hydroxide antacids, azithromycin, cetirizine, famotidine, fluconazole, lorazepam, nelfinavir, nucleoside reverse transcriptase inhibitors (abacavir, emtricitabine … |
| Felodipine | drug interactions | Concomitant Drug Class/Drug Name: Calcium channel blockers: Diltiazem Others (e.g., felodipine, nicardipine, nifedipine, verapamil); … |
| Fluconazole | drug interactions | … aluminum/magnesium hydroxide antacids, azithromycin, cetirizine, famotidine, fluconazole, lorazepam, nelfinavir, nucleoside reverse transcriptase inhibitors (abacavir, emtricitabine, lamivudine … |
| Fosamprenavir | drug interactions | Concomitant Drug Class/Drug Name: Protease inhibitor: Fosamprenavir Calcium; Effect: ↓ amprenavir; Clinical Comment: Fosamprenavir (unboosted): Appropriate doses of the combinations with respect to … |
| Glecaprevir and pibrentasvir | drug interactions | Pibrentasvir/Glecaprevir ↓ pibrentasvir ↓ glecaprevir Coadministration of efavirenz is not recommended because it may lead to reduced therapeutic effect of pibrentasvir/glecaprevir. |
| Itraconazole | drug interactions | Concomitant Drug Class/Drug Name: Antifungals: Voriconazole Itraconazole Ketoconazole Posaconazole; Effect: ↓ voriconazole * ↑ efavirenz * ↓ itraconazole * ↓ hydroxy itraconazole * ↓ ketoconazole ↓ … |
| Ketoconazole | drug interactions | Concomitant Drug Class/Drug Name: Antifungals: Voriconazole Itraconazole Ketoconazole Posaconazole; Effect: ↓ voriconazole * ↑ efavirenz * ↓ itraconazole * ↓ hydroxy itraconazole * ↓ ketoconazole ↓ … |
| Lamivudine | drug interactions | … nucleoside reverse transcriptase inhibitors (abacavir, emtricitabine, lamivudine, stavudine, tenofovir disoproxil fumarate, zidovudine), paroxetine, and raltegravir. |
| Lopinavir and ritonavir | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Lorazepam | drug interactions | … hydroxide antacids, azithromycin, cetirizine, famotidine, fluconazole, lorazepam, nelfinavir, nucleoside reverse transcriptase inhibitors (abacavir, emtricitabine, lamivudine, stavudine, tenofovir … |
| Magnesium hydroxide | drug interactions | Interactions with Efavirenz No dosage adjustment is recommended when efavirenz is given with the following: aluminum/magnesium hydroxide antacids, azithromycin, cetirizine, famotidine, fluconazole … |
| Maraviroc | drug interactions | Concomitant Drug Class/Drug Name: CCR5 co-receptor antagonist: Maraviroc; Effect: ↓ maraviroc *; Clinical Comment: Refer to the full prescribing information for maraviroc for guidance on … |
| Methadone | drug interactions | Concomitant Drug Class/Drug Name: Narcotic analgesic: Methadone; Effect: ↓ methadone *; Clinical Comment: Monitor for signs of methadone withdrawal and increase methadone dose if required to … |
| Nelfinavir | drug interactions | … antacids, azithromycin, cetirizine, famotidine, fluconazole, lorazepam, nelfinavir, nucleoside reverse transcriptase inhibitors (abacavir, emtricitabine, lamivudine, stavudine, tenofovir disoproxil … |
| Nicardipine | drug interactions | Concomitant Drug Class/Drug Name: Calcium channel blockers: Diltiazem Others (e.g., felodipine, nicardipine, nifedipine, verapamil); … |
| Nifedipine | drug interactions | Concomitant Drug Class/Drug Name: Calcium channel blockers: Diltiazem Others (e.g., felodipine, nicardipine, nifedipine, verapamil); … |
| Paroxetine | drug interactions | … lamivudine, stavudine, tenofovir disoproxil fumarate, zidovudine), paroxetine, and raltegravir. |
| Phenobarbital | drug interactions | Drugs to Affect Efavirenz Drugs that induce CYP3A activity (e.g., phenobarbital, rifampin, rifabutin) would be expected to increase the clearance of efavirenz resulting in lowered plasma … |
| Phenytoin | warnings and precautions | Patients who are receiving concomitant anticonvulsant medications primarily metabolized by the liver, such as phenytoin and phenobarbital, may require periodic monitoring of plasma levels [see Drug … |
| Posaconazole | drug interactions | Concomitant Drug Class/Drug Name: Antifungals: Voriconazole Itraconazole Ketoconazole Posaconazole; Effect: ↓ voriconazole * ↑ efavirenz * ↓ itraconazole * ↓ hydroxy itraconazole * ↓ ketoconazole ↓ … |
| Pravastatin | drug interactions | Concomitant Drug Class/Drug Name: HMG-CoA reductase inhibitors: Atorvastatin Pravastatin Simvastatin; Effect: ↓ atorvastatin * ↓ pravastatin * ↓ simvastatin *; … |
| Praziquantel | drug interactions | Concomitant Drug Class/Drug Name: Anthelmintic: Praziquantel; Effect: ↓ praziquantel; Clinical Comment: Coadministration with efavirenz is not recommended due to significant decrease in plasma … |
| Raltegravir | drug interactions | … stavudine, tenofovir disoproxil fumarate, zidovudine), paroxetine, and raltegravir. |
| Rifabutin | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterial: Rifabutin Rifampin; Effect: ↓ rifabutin * ↓ efavirenz *; Clinical Comment: Increase daily dose of rifabutin by 50%. … |
| Rifampin | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterial: Rifabutin Rifampin; Effect: ↓ rifabutin * ↓ efavirenz *; Clinical Comment: Increase daily dose of rifabutin by 50%. … |
| Ritonavir | drug interactions | … respect to safety and efficacy have not been established. Fosamprenavir/ritonavir: An additional 100 mg/day (300 mg total) of ritonavir is recommended when efavirenz is administered with … |
| Sertraline | drug interactions | Concomitant Drug Class/Drug Name: Antidepressant: Bupropion Sertraline; Effect: ↓ bupropion * ↓ sertraline *; Clinical Comment: Increases in bupropion dosage should be guided by clinical response. … |
| Simvastatin | drug interactions | Concomitant Drug Class/Drug Name: HMG-CoA reductase inhibitors: Atorvastatin Pravastatin Simvastatin; Effect: ↓ atorvastatin * ↓ pravastatin * ↓ simvastatin *; … |
| Sirolimus | drug interactions | Concomitant Drug Class/Drug Name: Immunosuppressants: Cyclosporine, tacrolimus, sirolimus and others metabolized by CYP3A; Effect: ↓ immunosuppressant; … |
| Sofosbuvir and velpatasvir | drug interactions | Velpatasvir/ Sofosbuvir ↓ velpatasvir Coadministration of efavirenz and sofosbuvir/velpatasvir is not recommended because it may result in loss of therapeutic effect of sofosbuvir/velpatasvir. |
| Sofosbuvir and velpatasvir and voxilaprevir | drug interactions | Velpatasvir /Sofosbuvir/ Voxilaprevir ↓ velpatasvir ↓ voxilaprevir Coadministration of efavirenz and sofosbuvir/velpatasvir/voxilaprevir is not recommended because it may result in loss of … |
| Tacrolimus | drug interactions | Concomitant Drug Class/Drug Name: Immunosuppressants: Cyclosporine, tacrolimus, sirolimus and others metabolized by CYP3A; Effect: ↓ immunosuppressant; … |
| Tenofovir disoproxil | drug interactions | … transcriptase inhibitors (abacavir, emtricitabine, lamivudine, stavudine, tenofovir disoproxil fumarate, zidovudine), paroxetine, and raltegravir. |
| Verapamil | drug interactions | Concomitant Drug Class/Drug Name: Calcium channel blockers: Diltiazem Others (e.g., felodipine, nicardipine, nifedipine, verapamil); … |
| Voriconazole | drug interactions | Concomitant Drug Class/Drug Name: Antifungals: Voriconazole Itraconazole Ketoconazole Posaconazole; Effect: ↓ voriconazole * ↑ efavirenz * ↓ itraconazole * ↓ hydroxy itraconazole * ↓ ketoconazole ↓ … |
| Warfarin | drug interactions | Concomitant Drug Class/Drug Name: Anticoagulant:Warfarin; Effect: ↑ or ↓ warfarin; Clinical Comment: Monitor international normalised ratio (INR) and adjust warfarin dosage if necessary. |
| Zidovudine | drug interactions | … emtricitabine, lamivudine, stavudine, tenofovir disoproxil fumarate, zidovudine), paroxetine, and raltegravir. |
Other labels that name efavirenz
Source: FDA drug label (Efavirenz), Cipla USA Inc., effective March 31, 2024 (SPL set 92603fa5-7a2c-4bfb-9a70-aadb4fba952c), via openFDA; the full label on DailyMed
What do FAERS reports show for efavirenz?
The FDA Adverse Event Reporting System holds 11,083 reports that list efavirenz among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,540 are coded as a death and 2,892 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as efavirenz?
42 other medicines are given the same way (oral) and in the same FDA class as efavirenz or labeled mainly for the same use (HIV), the same class first. HIV lists all 47 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Etravirine | HIV | 5 labelers | $9.94 per tablet 200 mg tablet | A presentation being discontinued |
| Nevirapine | HIV | 6 labelers | $0.147 per tablet 200 mg tablet | No current entry |
| Rilpivirine | HIV | 2 labelers | $48.04 per tablet 25 mg tablet | No current entry |
| Emtricitabine and rilpivirine and tenofovir disoproxil | HIV | 2 labelers | $114.50 per tablet 200-25-300 mg tablet | No current entry |
| Doravirine | HIV | none listed | $60.79 per tablet 100 mg tablet | No current entry |
| Dolutegravir and rilpivirine | HIV | none listed | $121.87 per tablet 50-25 mg tablet | No current entry |
| Doravirine and islatravir | HIV | none listed | n/a | No current entry |
| Doravirine and lamivudine and tenofovir disoproxil | HIV | none listed | $93.06 per tablet 100-300-300 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to efavirenz
- 42 medicines for the same use
- Other human immunodeficiency virus 1 non-nucleoside analog reverse transcriptase inhibitors
- the pharmacologic class, with prices and generics
- Efavirenz side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other