Prescription medicine
Nevirapine First approved as Viramune
Nevirapine (Viramune) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 6 generic labelers, and pharmacies paid $0.147 per nevirapine 200 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the nevirapine FDA label on DailyMed (effective July 15, 2026, Mylan Pharmaceuticals Inc.); the NDA 20636 record on Drugs@FDA; every nevirapine label on DailyMed.
Highlights of the record
FDA label of July 15, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
LIFE-THREATENING (INCLUDING FATAL).
HEPATOTOXICITY and SKIN REACTIONS HEPATOTOXICITY: Severe, life-threatening, and in some cases fatal hepatotoxicity, particularly in the first 18 weeks, has been reported in patients treated with nevirapine. In some cases, patients presented with non-specific prodromal signs or symptoms of hepatitis and progressed to hepatic failure. These events are often associated with rash. Female gender and higher CD4 + cell counts at initiation of therapy place patients at increased risk; women with CD4 + cell counts greater than 250 cells/mm 3 , including pregnant women receiving nevirapine in combination with other antiretrovirals for the treatment of HIV-1 infection, are at the greatest risk. However, hepatotoxicity associated with nevirapine use can occur in both genders, all CD4 + cell counts and at any time during treatment. Hepatic failure has also been reported in patients without HIV taking nevirapine for post-exposure prophylaxis (PEP). Use of nevirapine for occupational and non-occupational PEP is contraindicated [see Contraindications (4) ]. Patients with signs or symptoms of hepatitis, or with increased transaminases combined with rash or other systemic symptoms, must discontinue nevirapine and seek medical evaluation immediately [see Warnings and Precautions (5.1) ]. […]
Used for
From the label: indications and usageNevirapine is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older [see Clinical Studies (14.1 , 14.2) ].
Forms and strengths
- 200 mg
- 400 mg
- 50 mg/5ml
Tablet; extended-release tablet; suspension.
On the market
- Earliest approval on file
- June 21, 1996 Viramune, Boehringer Ingelheim; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 23 first May 22, 2012; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 6 under generic applications, 0 under brand applications, repackagers included
- Last listed patent
- March 12, 2029 Viramune XR tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.147 per tablet Nevirapine 200 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2018 0 Class I among all firms' recalls; latest December 14, 2018
- FAERS reports
- 8,970 through July 30, 2026
What is nevirapine used for?
From the label: indications and usageNevirapine is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older [see Clinical Studies (14.1 , 14.2) ]. Limitations of Use: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine is not recommended to be initiated, unless the benefit outweighs the risk, in:
adult females with CD4 + cell counts greater than 250 cells/mm 3 or
adult males with CD4 + cell counts greater than 400 cells/mm 3 [see Warnings and Precautions (5.1) ]. […]
Conditions named in the indications of nevirapine'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 (Nevirapine), Mylan Pharmaceuticals Inc., effective July 15, 2026 (SPL set c6e93829-7024-48f6-8023-da6ff27dfc0a), via openFDA; the full label on DailyMed
What does the patient leaflet for nevirapine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about nevirapine tablets?Nevirapine tablets can cause severe liver and skin problems that may lead to death. These problems can happen at any time during treatment, but your risk is higher during the first 18 weeks of treatment. Nevirapine tablets can cause serious side effects, including: • Severe liver problems. Some people taking nevirapine tablets may develop severe liver problems that can lead to liver failure and the need for a liver transplant, or death. If you have liver problems, you may get a rash. o Women have a higher risk of developing liver problems during treatment with nevirapine tablets than men. o People who have abnormal liver test results before starting nevirapine tablets and people with hepatitis B or C also have a greater risk of getting liver problems. People who have higher CD4 + cell counts when they begin nevirapine tablets have a higher risk of liver problems, especially: o Women with CD4 + counts higher than 250 cells/mm 3 . This group has the highest risk. o Men with CD4 + counts higher than 400 cells/mm 3 . Stop taking nevirapine tablets and call your doctor right away if you have any of the following symptoms of liver problems with or without a skin rash: • dark (tea colored) urine • light-colored bowel movements (stools) • feeling sick to your stomach (nausea) • pain or tenderness on your right side below your ribs • loss of appetite • yellowing of your skin or whites of your eyes • fever • feel unwell or like you have the flu • tiredness • Severe skin reactions and rash. Some skin reactions and rashes may be severe, life-threatening, and in some people, may lead to death. […]
From the patient leaflet: How should I store nevirapine tablets?Store nevirapine tablets at room temperature between 20° to 25°C (68° to 77°F). Keep nevirapine tablets and all medicines out of the reach of children.
Source: FDA drug label (Nevirapine), Mylan Pharmaceuticals Inc., effective July 15, 2026 (SPL set c6e93829-7024-48f6-8023-da6ff27dfc0a), via openFDA; the full label on DailyMed
Is there a generic for nevirapine (Viramune)?
The FDA approved the first generic nevirapine on May 22, 2012. 23 generic applications are approved; 11 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 6 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists nevirapine from 6 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.
The Orange Book lists 1 patent for Viramune XR tablets, the last expiring on March 12, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1996 earliest approval on file
- 2012 first generic approved
- 2029 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for nevirapine (Viramune)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.147 per Nevirapine 200 mg tablet, up 10% from $0.133 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.
- Nevirapine 200 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Nevirapine 200 mg tablet | Generic | $0.147 per tablet | $4.42 | +10% |
| Nevirapine ER 400 mg tablet | Generic | $1.57 per tablet | $47.16 | -8% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has nevirapine been recalled?
The FDA's Enforcement Report lists 1 recall naming nevirapine since 2018: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 14, 2018 | Class II | Cipla Limited | Failed Dissolution Specifications. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the nevirapine label say about other medicines?
The nevirapine label names 38 other medicines in its interaction, contraindication or warning sections. The labels of 40 other medicines name nevirapine. 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 |
|---|---|---|
| Amiodarone | drug interactions | Antiarrhythmics: Amiodarone, disopyramide, lidocaine Plasma concentrations may be decreased. |
| Atazanavir | drug interactions | Drug Name: Atazanavir/Ritonavir The interaction between nevirapine and the drug was evaluated in a clinical study. All other drug interactions shown are predicted.; Effect on Concentration of Nevirapine or Concomitant Drug: ↓ Atazanavir ↑ Nevirapine; … |
| Azithromycin | drug interactions | … avium-intracellulare complex, overall activity against this pathogen may be altered. Alternatives to clarithromycin, such as azithromycin, should be considered. |
| Carbamazepine | drug interactions | Anticonvulsants: Carbamazepine, clonazepam, ethosuximide Plasma concentrations of nevirapine and the anticonvulsant may be decreased. |
| Clarithromycin | drug interactions | Drug Name: Antibiotics: Clarithromycin; Effect on Concentration of Nevirapine or Concomitant Drug: ↓ Clarithromycin ↑ 14-OH clarithromycin; Clinical Comment: Clarithromycin exposure was significantly decreased by nevirapine; however, 14-OH metabolite concentrations were increased. … |
| Clonazepam | drug interactions | Anticonvulsants: Carbamazepine, clonazepam, ethosuximide Plasma concentrations of nevirapine and the anticonvulsant may be decreased. |
| Cyclophosphamide | drug interactions | Cancer Chemotherapy: Cyclophosphamide Plasma concentrations may be decreased. |
| Cyclosporine | drug interactions | Immunosuppressants: Cyclosporine, tacrolimus, sirolimus Plasma concentrations may be decreased. |
| Darunavir | drug interactions | Co-administered Drug: Darunavir/Ritonavir Based on between-trial comparison.; Dose of Co-administered Drug: 400/100 mg BID; Dose Regimen of Nevirapine: 200 mg BID; n: 8; % Change of Co-administered Drug Pharmacokinetic Parameters (90% CI): ↑24 (↓3 to ↑57); ↑40 (↑14 to ↑73); ↑2 (↓21 to ↑32) |
| Diltiazem | drug interactions | Calcium Channel blockers: Diltiazem, nifedipine, verapamil Plasma concentrations may be decreased. |
| Disopyramide | drug interactions | Antiarrhythmics: Amiodarone, disopyramide, lidocaine Plasma concentrations may be decreased. |
| Efavirenz | drug interactions | Drug Name: Efavirenz; Effect on Concentration of Nevirapine or Concomitant Drug: ↓ Efavirenz; Clinical Comment: The appropriate doses of these combinations with respect to safety and efficacy have not been established. |
| Ergotamine | drug interactions | Ergot Alkaloids: Ergotamine Plasma concentrations may be decreased. |
| Ethosuximide | drug interactions | Anticonvulsants: Carbamazepine, clonazepam, ethosuximide Plasma concentrations of nevirapine and the anticonvulsant may be decreased. |
Every other medicine the nevirapine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Etravirine | drug interactions | Etravirine Rilpivirine Plasma concentrations may be altered. |
| Fentanyl | drug interactions | Opiate Agonists: Fentanyl Plasma concentrations may be decreased. |
| Fluconazole | drug interactions | Drug Name: Antifungals: Fluconazole; Effect on Concentration of Nevirapine or Concomitant Drug: ↑ Nevirapine; Clinical Comment: Because of the risk of increased exposure to nevirapine, caution should … |
| Fosamprenavir | drug interactions | Drug Name: Fosamprenavir; Effect on Concentration of Nevirapine or Concomitant Drug: ↓ Amprenavir ↑ Nevirapine; Clinical Comment: Co-administration of nevirapine and fosamprenavir without ritonavir … |
| Itraconazole | drug interactions | Drug Name: Itraconazole; Effect on Concentration of Nevirapine or Concomitant Drug: ↓ Itraconazole; Clinical Comment: Nevirapine and itraconazole should not be administered concomitantly due to … |
| Ketoconazole | drug interactions | Drug Name: Ketoconazole; Effect on Concentration of Nevirapine or Concomitant Drug: ↓ Ketoconazole; Clinical Comment: Nevirapine and ketoconazole should not be administered concomitantly because … |
| Lidocaine | drug interactions | Antiarrhythmics: Amiodarone, disopyramide, lidocaine Plasma concentrations may be decreased. |
| 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. |
| Maraviroc | drug interactions | Co-administered Drug: Maraviroc Based on historical controls.; Dose of Co-administered Drug: 300 mg SD; Dose Regimen of Nevirapine: 200 mg BID; n: 8; … |
| Methadone | drug interactions | Drug Name: Analgesics: Methadone; Effect on Concentration of Nevirapine or Concomitant Drug: ↓ Methadone; Clinical Comment: Methadone levels were decreased; … |
| Nelfinavir | drug interactions | Drug Name: Nelfinavir; Effect on Concentration of Nevirapine or Concomitant Drug: ↓ Nelfinavir M8 Metabolite ↓ Nelfinavir C min; … |
| Nifedipine | drug interactions | Calcium Channel blockers: Diltiazem, nifedipine, verapamil Plasma concentrations may be decreased. |
| Norethindrone | drug interactions | Drug Name: Oral Contraceptives: Ethinyl estradiol and Norethindrone; Effect on Concentration of Nevirapine or Concomitant Drug: ↓ Ethinyl Estradiol ↓ Norethindrone; … |
| Prednisone | warnings and precautions | In a clinical trial, concomitant prednisone use (40 mg per day for the first 14 days of nevirapine administration) was associated with an increase in incidence and severity of rash during the first 6 … |
| Progesterone | drug interactions | Co-administered Drug: Depomedroxy- Progesterone Acetate; Dose of Co-administered Drug: 150 mg every 3 months; Dose Regimen of Nevirapine: 200 mg QD x 14 days; 200 mg BID x 14 days; n: 32; … |
| Rifabutin | drug interactions | Drug Name: Rifabutin; Effect on Concentration of Nevirapine or Concomitant Drug: ↑ Rifabutin; Clinical Comment: Rifabutin and its metabolite concentrations were moderately increased. … |
| Rifampin | drug interactions | Drug Name: Rifampin; Effect on Concentration of Nevirapine or Concomitant Drug: ↓ Nevirapine; Clinical Comment: Nevirapine and rifampin should not be administered concomitantly because decreases in … |
| Rilpivirine | drug interactions | Etravirine Rilpivirine Plasma concentrations may be altered. |
| Ritonavir | drug interactions | Drug Name: Atazanavir/Ritonavir The interaction between nevirapine and the drug was evaluated in a clinical study. All other drug interactions shown are predicted.; … |
| Sirolimus | drug interactions | Immunosuppressants: Cyclosporine, tacrolimus, sirolimus Plasma concentrations may be decreased. |
| Tacrolimus | drug interactions | Immunosuppressants: Cyclosporine, tacrolimus, sirolimus Plasma concentrations may be decreased. |
| Verapamil | drug interactions | Calcium Channel blockers: Diltiazem, nifedipine, verapamil Plasma concentrations may be decreased. |
| Warfarin | drug interactions | Drug Name: Antithrombotics: Warfarin; Effect on Concentration of Nevirapine or Concomitant Drug: Plasma concentrations may be increased.; Clinical Comment: Potential effect on anticoagulation. … |
| Zidovudine | drug interactions | 200 mg BID x 14 days 6 ↔ ↔ § Zidovudine 100-200 mg TID 200 mg QD x 14 days; |
Other labels that name nevirapine
- Cabozantinib
- Cobicistat
- Dolutegravir
- Doravirine
- Ethinyl estradiol and ferrous bisglycinate and levonorgestrel
- Ethinyl estradiol and ferrous fumarate and levonorgestrel
- Ethinyl estradiol and levonorgestrel
- Ethinyl estradiol and norelgestromin
- Ethinyl estradiol and norgestimate
- Ethinyl estradiol and segesterone
- Etonogestrel
- Hydrocortisone
- Lenacapavir
- Letermovir
- Methylergonovine
Source: FDA drug label (Nevirapine), Mylan Pharmaceuticals Inc., effective July 15, 2026 (SPL set c6e93829-7024-48f6-8023-da6ff27dfc0a), via openFDA; the full label on DailyMed
What do FAERS reports show for nevirapine?
The FDA Adverse Event Reporting System holds 8,970 reports that list nevirapine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,523 are coded as a death and 1,649 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 rose sharply in 2017 (1,157, against a median of 318 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
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 nevirapine?
44 other medicines are given the same way (oral) and in the same FDA class as nevirapine 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 |
| Efavirenz | HIV | 5 labelers | $1.28 per tablet 600 mg tablet | No current entry |
| Efavirenz and emtricitabine and tenofovir disoproxil | HIV | 7 labelers | $1.12 per tablet 600-200-300 mg tablet | No current entry |
| Rilpivirine | HIV | 2 labelers | $48.04 per tablet 25 mg tablet | No current entry |
| Efavirenz and lamivudine and tenofovir disoproxil | HIV | 1 labeler | n/a | 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 |
Every medicine labeled for the same conditions as nevirapine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to nevirapine
- 44 medicines for the same use
- Other human immunodeficiency virus 1 non-nucleoside analog reverse transcriptase inhibitors
- the pharmacologic class, with prices and generics
- Nevirapine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other