Prescription medicine
Nelfinavir Brand names: Viracept
Nelfinavir (Viracept) is a prescription medicine with an FDA approval on record since 1997. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the nelfinavir FDA label on DailyMed (effective December 11, 2025, AGOURON); the NDA 20778 record on Drugs@FDA; every nelfinavir label on DailyMed.
Highlights of the record
FDA label of December 11, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVIRACEPT in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection.
Forms and strengths
- 250 mg
- 625 mg
Film-coated tablet.
On the market
- Earliest approval on file
- March 14, 1997 Viracept, Agouron Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2014 0 Class I among all firms' recalls; latest July 8, 2014
- FAERS reports
- 2,090 through July 30, 2026
What is nelfinavir used for?
From the label: indications and usageVIRACEPT in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection. VIRACEPT is a protease inhibitor indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents.
Conditions named in the indications of nelfinavir's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Protease Inhibitor.
Source: FDA drug label (VIRACEPT), AGOURON, effective December 11, 2025 (SPL set e72c2bc6-9462-4a2e-8e1d-b97592376cbd), via openFDA; the full label on DailyMed
Is there a generic for nelfinavir (Viracept)?
No generic nelfinavir is approved (Drugs@FDA, October 8, 2026).
- 1997 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has nelfinavir been recalled?
The FDA's Enforcement Report lists 1 recall naming nelfinavir since 2014: 0 Class I (the most serious), 0 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 8, 2014 | Class III | Pfizer Inc. | Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the nelfinavir label say about other medicines?
The nelfinavir label names 38 other medicines in its interaction, contraindication or warning sections. The labels of 43 other medicines name nelfinavir. 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 |
|---|---|---|
| Alfuzosin | contraindications | Drug Class: Alpha 1-adrenoreceptor antagonist; Drugs Within Class That Are Contraindicated With VIRACEPT: Alfuzosin; Clinical Comment: Potentially increased alfuzosin concentrations can result in hypotension. |
| Amiodarone | contraindications | Drug Class: Antiarrhythmics; Drugs Within Class That Are Contraindicated With VIRACEPT: Amiodarone, quinidine; Clinical Comment: Potential for serious and/or life-threatening cardiac arrhythmia. |
| Atorvastatin | drug interactions | Concomitant Drug Class/Drug Name: Atorvastatin Rosuvastatin; Effect on Concentration: ↑ atorvastatin ↑ rosuvastatin; Clinical Comment: Titrate atorvastatin dose carefully and use the lowest necessary dose; do not exceed atorvastatin 40 mg/day. |
| Azithromycin | drug interactions | Concomitant Drug Class/Drug Name: Azithromycin; Effect on Concentration: ↑ azithromycin; Clinical Comment: Dose adjustment of azithromycin is not recommended, but close monitoring for known side effects such as liver enzyme abnormalities and hearing impairment is warranted. |
| Bosentan | drug interactions | Concomitant Drug Class/Drug Name: Bosentan; Effect on Concentration: ↑ bosentan; Clinical Comment: Concentrations of bosentan may be increased when coadministered with VIRACEPT. Coadministration of bosentan in patients on VIRACEPT or coadministration of VIRACEPT in patients on bosentan: Start at or adjust bosentan to … |
| Carbamazepine | drug interactions | Concomitant Drug Class/Drug Name: Carbamazepine Phenobarbital Phenytoin; Effect on Concentration: ↓ nelfinavir ↓ phenytoin; Clinical Comment: Concentrations of nelfinavir may be decreased. VIRACEPT may not be effective due to decreased nelfinavir plasma concentrations in patients taking these agents concomitantly. … |
| Colchicine | drug interactions | Concomitant Drug Class/Drug Name: Colchicine; Effect on Concentration: ↑ colchicines; Clinical Comment: Patients with renal or hepatic impairment should not be given colchicine with VIRACEPT due to the risk of colchicine toxicity. … |
| Cyclosporine | drug interactions | Concomitant Drug Class/Drug Name: Cyclosporine Tacrolimus Sirolimus; Effect on Concentration: ↑ immuno-suppressants ↑ nelfinavir; Clinical Comment: Concentrations of these immunosuppressants and nelfinavir may be increased by coadministration of these agents with nelfinavir. |
| Dihydroergotamine | contraindications | Drug Class: Ergot Derivatives; Drugs Within Class That Are Contraindicated With VIRACEPT: Dihydroergotamine, ergotamine, methylergonovine; Clinical Comment: Potential for serious and/or life threatening reactions such as ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other … |
| Ergotamine | contraindications | Drug Class: Ergot Derivatives; Drugs Within Class That Are Contraindicated With VIRACEPT: Dihydroergotamine, ergotamine, methylergonovine; Clinical Comment: Potential for serious and/or life threatening reactions such as ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other … |
| Fluticasone | drug interactions | Concomitant Drug Class/Drug Name: Fluticasone; Effect on Concentration: ↑ fluticasone; Clinical Comment: Concomitant use of fluticasone propionate and VIRACEPT may increase plasma concentrations of fluticasone propionate. Use with caution. Consider alternatives to fluticasone propionate, particularly for long-term use. |
| Lovastatin | contraindications | HMG-CoA Reductase Inhibitors Lovastatin, Simvastatin Potential for serious reactions such as myopathy including rhabdomyolysis. |
| Lurasidone | contraindications | Drug Class: Antipsychotics; Drugs Within Class That Are Contraindicated With VIRACEPT: Lurasidone Pimozide; Clinical Comment: Potential for serious and/or life-threatening reactions. Potential for serious and/or life threatening reactions such as cardiac arrhythmias. |
| Methadone | drug interactions | Concomitant Drug Class/Drug Name: Methadone; Effect on Concentration: ↓ methadone; Clinical Comment: Concentrations of methadone were decreased when coadministered with VIRACEPT. Dosage of methadone may need to be increased when coadministered with VIRACEPT. |
Every other medicine the nelfinavir label names
| Medicine named | Section | What the label says |
|---|---|---|
| Methylergonovine | contraindications | Drug Class: Ergot Derivatives; Drugs Within Class That Are Contraindicated With VIRACEPT: Dihydroergotamine, ergotamine, methylergonovine; … |
| Midazolam | contraindications | Sedative/Hypnotics Triazolam, oral midazolam Potential for serious and/or life threatening reactions such as prolonged or increased sedation or respiratory depression. |
| Nevirapine | drug interactions | Concomitant Drug Class/Drug Name: Nevirapine; Effect on Concentration: ↓ nelfinavir (C min); Clinical Comment: Concentrations of nelfinavir were decreased when coadministered with nevirapine. … |
| Norethindrone | drug interactions | Concomitant Drug Class/Drug Name: Ethinyl estradiol Norethindrone; Effect on Concentration: ↓ ethinyl estradiol ↓ norethindrone; … |
| Omeprazole | drug interactions | Concomitant Drug Class/Drug Name: Omeprazole; Effect on Concentration: ↓ nelfinavir; Clinical Comment: Omeprazole decreases the plasma concentrations of nelfinavir. … |
| Phenobarbital | drug interactions | Concomitant Drug Class/Drug Name: Carbamazepine Phenobarbital Phenytoin; Effect on Concentration: ↓ nelfinavir ↓ phenytoin; Clinical Comment: Concentrations of nelfinavir may be decreased. … |
| Phenytoin | drug interactions | Concomitant Drug Class/Drug Name: Carbamazepine Phenobarbital Phenytoin; Effect on Concentration: ↓ nelfinavir ↓ phenytoin; Clinical Comment: Concentrations of nelfinavir may be decreased. … |
| Pimozide | contraindications | Drug Class: Antipsychotics; Drugs Within Class That Are Contraindicated With VIRACEPT: Lurasidone Pimozide; Clinical Comment: Potential for serious and/or life-threatening reactions. … |
| Quetiapine | drug interactions | Consider alternative antiretroviral therapy to avoid increases in quetiapine drug exposures. |
| Quinidine | contraindications | Drug Class: Antiarrhythmics; Drugs Within Class That Are Contraindicated With VIRACEPT: Amiodarone, quinidine; Clinical Comment: Potential for serious and/or life-threatening cardiac arrhythmia. |
| Rifabutin | drug interactions | Concomitant Drug Class/Drug Name: Rifabutin; Effect on Concentration: ↑ rifabutin ↓ nelfinavir (750 mg TID) ↔ nelfinavir (1250 mg BID); … |
| Rifampin | contraindications | Drug Class: Antimycobacterial Agents; Drugs Within Class That Are Contraindicated With VIRACEPT: Rifampin; Clinical Comment: Plasma concentrations of nelfinavir can be reduced by concomitant use of … |
| Ritonavir | drug interactions | Concomitant Drug Class/Drug Name: Ritonavir; Effect on Concentration: ↑ nelfinavir ↔ ritonavir; Clinical Comment: Concentrations of nelfinavir were increased when coadministered with ritonavir. … |
| Rosuvastatin | drug interactions | Concomitant Drug Class/Drug Name: Atorvastatin Rosuvastatin; Effect on Concentration: ↑ atorvastatin ↑ rosuvastatin; Clinical Comment: Titrate atorvastatin dose carefully and use the lowest necessary … |
| Salmeterol | drug interactions | Concomitant Drug Class/Drug Name: Salmeterol; Effect on Concentration: ↑ salmeterol; Clinical Comment: Concurrent administration of salmeterol with VIRACEPT is not recommended. … |
| Sildenafil | contraindications | Drug Class: PDE5 Inhibitors; Drugs Within Class That Are Contraindicated With VIRACEPT: Sildenafil (Revatio ®) [for treatment of pulmonary arterial hypertension] See, for coadministration of … |
| Simvastatin | contraindications | HMG-CoA Reductase Inhibitors Lovastatin, Simvastatin Potential for serious reactions such as myopathy including rhabdomyolysis. |
| Sirolimus | drug interactions | Concomitant Drug Class/Drug Name: Cyclosporine Tacrolimus Sirolimus; Effect on Concentration: ↑ immuno-suppressants ↑ nelfinavir; … |
| Tacrolimus | drug interactions | Concomitant Drug Class/Drug Name: Cyclosporine Tacrolimus Sirolimus; Effect on Concentration: ↑ immuno-suppressants ↑ nelfinavir; … |
| Tadalafil | contraindications | … arterial hypertension] See, for coadministration of sildenafil and tadalafil when dosed for erectile dysfunction.; Clinical Comment: A safe and effective dose has not been established when used with … |
| Trazodone | drug interactions | Concomitant Drug Class/Drug Name: Trazodone; Effect on Concentration: ↑ trazodone; Clinical Comment: Concomitant use of trazodone and VIRACEPT may increase plasma concentrations of trazodone. … |
| Triazolam | contraindications | Sedative/Hypnotics Triazolam, oral midazolam Potential for serious and/or life threatening reactions such as prolonged or increased sedation or respiratory depression. |
| Vardenafil | drug interactions | Concomitant Drug Class/Drug Name: Sildenafil Vardenafil Tadalafil; Effect on Concentration: ↑ PDE5 Inhibitors; Clinical Comment: Concomitant use of PDE5 inhibitors and VIRACEPT should be undertaken … |
| Warfarin | drug interactions | Concomitant Drug Class/Drug Name: Warfarin; Effect on Concentration: Warfarin; Clinical Comment: Coadministration of warfarin and VIRACEPT may affect concentrations of warfarin. … |
Other labels that name nelfinavir
- Afatinib
- Avanafil
- Budesonide
- Buprenorphine
- Cabazitaxel
- Cabozantinib
- Calcifediol
- Darifenacin
- Dexlansoprazole
- Doxazosin
- Erlotinib
- Esomeprazole
- 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
- Etravirine
- Fosamprenavir
- Irinotecan
- Lansoprazole
- Mifepristone
- Mometasone
- Nifedipine
- Nimodipine
- Paclitaxel
- Palbociclib
- Pantoprazole
- Paricalcitol
- Rabeprazole
- Ranolazine
- Saxagliptin
- Suvorexant
- Temsirolimus
- Ticagrelor
- Toremifene
- Trabectedin
- Trastuzumab emtansine
- Umeclidinium and vilanterol
Source: FDA drug label (VIRACEPT), AGOURON, effective December 11, 2025 (SPL set e72c2bc6-9462-4a2e-8e1d-b97592376cbd), via openFDA; the full label on DailyMed
What do FAERS reports show for nelfinavir?
The FDA Adverse Event Reporting System holds 2,090 reports that list nelfinavir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 110 are coded as a death and 674 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 nelfinavir?
44 other medicines are given the same way (oral) and in the same FDA class as nelfinavir 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 |
|---|---|---|---|---|
| Darunavir | HIV | 13 labelers | $1.16 per tablet 600 mg tablet | No current entry |
| Atazanavir | HIV | 4 labelers | $2.23 per capsule 300 mg capsule | No current entry |
| Ritonavir | HIV | 7 labelers | $0.607 per tablet 100 mg tablet | A presentation being discontinued |
| Lopinavir and ritonavir | HIV | 3 labelers | $4.46 per tablet 200-50 mg tablet | A presentation being discontinued |
| Cobicistat and darunavir | HIV | none listed | $79.99 per tablet 800 mg-150 mg tablet | No current entry |
| Fosamprenavir | HIV | 2 labelers | n/a | No current entry |
| Atazanavir and cobicistat | HIV | none listed | $52.05 per tablet 300 mg-150 mg tablet | A presentation being discontinued |
| Cobicistat, darunavir, emtricitabine and tenofovir alafenamide | HIV | none listed | $152.87 per tablet 800-150-200-10 mg tablet | No current entry |
Every medicine labeled for the same conditions as nelfinavir
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to nelfinavir
- 44 medicines for the same use
- Other protease inhibitors
- the pharmacologic class, with prices and generics
- Nelfinavir side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other