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Viracept Side Effects

Generic name: nelfinavir

Medically reviewed by Drugs.com. Last updated on May 12, 2023.

Note: This document contains side effect information about nelfinavir. Some dosage forms listed on this page may not apply to the brand name Viracept.

Applies to nelfinavir: oral tablet.

Serious side effects of Viracept

Along with its needed effects, nelfinavir (the active ingredient contained in Viracept) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking nelfinavir:

Less common

Incidence not known

Other side effects of Viracept

Some side effects of nelfinavir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

For Healthcare Professionals

Applies to nelfinavir: oral powder for reconstitution, oral tablet.

General

Most side effects were of mild severity. The most common side effect was diarrhea, which was usually of mild to moderate severity.[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 20%)

Common (1% to 10%): Nausea, flatulence

Frequency not reported: Abdominal pain, dyspepsia, epigastric pain, gastrointestinal bleeding, increased amylase, mouth ulceration, pancreatitis, vomiting[Ref]

Hematologic

Increased bleeding (including spontaneous skin hematomas and hemarthrosis) in patients with hemophilia type A and B has been associated with protease inhibitors. In many of the reported cases, treatment with protease inhibitors was continued or restarted and some patients required additional factor VIII. A causal relationship between protease inhibitor therapy and these episodes has not been established.[Ref]

Common (1% to 10%): Decreased lymphocytes, decreased neutrophils, decreased hemoglobin

Frequency not reported: Anemia, leukopenia, thrombocytopenia

HIV protease inhibitor therapy:

-Frequency not reported: Increased bleeding (including spontaneous skin hematomas, hemarthrosis) in hemophiliacs[Ref]

Hepatic

Common (1% to 10%): Elevated AST, elevated ALT

Frequency not reported: Elevated GGT, abnormal liver function tests, hepatitis

Postmarketing reports: Jaundice, bilirubinemia[Ref]

Musculoskeletal

Common (1% to 10%): Elevated creatine kinase

Frequency not reported: Arthralgia, arthritis, back pain, cramps, increased creatine phosphokinase, myalgia, myasthenia, myopathy[Ref]

Dermatologic

Common (1% to 10%): Rash

Frequency not reported: Dermatitis, folliculitis, fungal dermatitis, maculopapular rash, pruritus, sweating, urticaria[Ref]

Nervous system

Frequency not reported: Dizziness, headache, hyperkinesia, migraine, paresthesia, seizures, somnolence[Ref]

Other

Frequency not reported: Accidental injury, asthenia, fever, malaise, pain[Ref]

Respiratory

Frequency not reported: Dyspnea, pharyngitis, rhinitis, sinusitis[Ref]

Cardiovascular

Postmarketing reports: QTc prolongation, torsades de pointes[Ref]

Metabolic

Frequency not reported: Anorexia, increased alkaline phosphatase, increased LDH, hyperlipidemia, hyperuricemia, hyperglycemia, hypoglycemia, dehydration, redistribution/accumulation of body fat

Postmarketing reports: Metabolic acidosis

Combination antiretroviral therapy:

-Frequency not reported: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance")

HIV protease inhibitor therapy:

-Postmarketing reports: New onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, hyperglycemia, ketoacidosis[Ref]

Psychiatric

Frequency not reported: Anxiety, depression, emotional lability, insomnia, sleep disorder, suicidal ideation[Ref]

Hypersensitivity

Frequency not reported: Allergic reaction

Postmarketing reports: Hypersensitivity reactions (including bronchospasm, moderate to severe rash, fever, edema)[Ref]

Renal

Frequency not reported: Kidney calculus[Ref]

Genitourinary

Frequency not reported: Sexual dysfunction, urine abnormality[Ref]

Immunologic

Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)

Ocular

Frequency not reported: Acute iritis, eye disorder[Ref]

References

1. Product Information. Viracept (nelfinavir). Agouron Pharma Inc. 2001;PROD.

2. AIDSinfo. NIH. National Institutes of Health. Guidelines for the use of antiretroviral agents in pediatric HIV infection. http://aidsinfo.nih.gov/contentfiles/lvguidelines/pediatricguidelines.pdf 2015.

3. HHS Panel on Antiretroviral Guidelines for Adults and Adolescents. Office of AIDS Research Advisory Council (OARAC). NIH. National Institutes of Health. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. http://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf 2015.

4. Flanigan TP, Ramratnam B, Graeber C, Hellinger J, Smith D, Wheeler D, Hawley P, Heathchiozzi M, Ward DJ, Brummitt C, Turner J. Prospective trial of paromomycin for cryptosporidiosis in AIDS. Am J Med. 1996;100:370-2.

5. Gathe J, Burkhardt B, Hawley P, Conant M, Peterkin J, Chapman S. A randomized phase II study of VIRACEPT, a novel HIV proteas inhibitor, used in combination with stavudine (d4T) vs. stavudin (d4T) alone. Int Conf AIDS. 1996;11:25(ab.no.mo.b.413).

6. Moyle GJ, Youle M, Higgs C, Monaghan J, Peterkin J, Chapman S, Nelson M. Extended follow-up of safety and activity of agouron's HIV proteinas inhibitor ag1343 (Viracept) in virological responders from the UK phase I/II dose finding study. Int Conf AIDS. 1996;11:18(ab.no.mo.b.173).

7. Carr A. HIV protease inhibitor-related lipodystrophy syndrome. Clin Infect Dis. 2000;30:s135-42.

8. Hsyu PH, Schultz-Smith MD, Lillibridge JH, Lewis RH, Kerr BM. Pharmacokinetic Interactions between Nelfinavir and 3-Hydroxy-3-Methylglutaryl Coenzyme A Reductase Inhibitors Atorvastatin and Simvastatin. Antimicrob Agents Chemother. 2001;45:3445-50.

9. Drugs for HIV infection. Med Lett Drugs Ther. 2001;43:103-8.

10. Ghosn J, Lamotte C, Ait-Mohand H, et al. Efficacy of a twice-daily antiretroviral regimen containing 100 mg ritonavir/400 mg indinavir in HIV-infected patients. AIDS. 2003;17:209-14.

11. Aarnoutse RE, Droste JA, Van Oosterhout JJ, et al. Pharmacokinetics, food intake requirements and tolerability of once-daily combinations of nelfinavir and low-dose ritonavir in healthy volunteers. Br J Clin Pharmacol. 2003;55:115-125.

12. Guest JL, Ruffin C, Tschampa JM, DeSilva KE, Rimland D. Differences in rates of diarrhea in patients with human immunodeficiency virus receiving lopinavir-ritonavir or nelfinavir. Pharmacotherapy. 2004;24:727-35.

13. Gathe JC Jr, Ive P, Wood R, et al. SOLO: 48-week efficacy and safety comparison of once-daily fosamprenavir /ritonavir versus twice-daily nelfinavir in naive HIV-1-infected patients. AIDS. 2004;18:1529-1537.

14. Heeswijk RP, Khaliq Y, Gallicano KD, et al. The pharmacokinetics of nelfinavir and M8 during pregnancy and post partum. Clin Pharmacol Ther. 2004;76:588-97.

15. Regazzi M, Maserati R, Villani P, et al. Clinical Pharmacokinetics of Nelfinavir and Its Metabolite M8 in Human Immunodeficiency Virus (HIV)-Positive and HIV-Hepatitis C Virus-Coinfected Subjects. Antimicrob Agents Chemother. 2005;49:643-9.

16. Timmermans S, Tempelman C, Godfried MH, et al. Nelfinavir and nevirapine side effects during pregnancy. AIDS. 2005;19:795-799.

17. Perry CM, Frampton JE, McCormack PL, Siddiqui MA, Cvetkovic RS. Nelfinavir: A Review of its Use in the Management of HIV Infection. Drugs. 2005;65:2209-44.

18. Damle B, Hewlett D Jr, Hsyu PH, Becker M, Petersen A. Pharmacokinetics of nelfinavir in subjects with hepatic impairment. J Clin Pharmacol. 2006;46:1241-9.

19. Warnke D, Barreto J, Temesgen Z. Antiretroviral drugs. J Clin Pharmacol. 2007;47:1570-9.

20. Drugs for HIV infection. Treat Guidel Med Lett. 2009;7:11-22.

21. Marzolini C, Buclin T, Decosterd LA, Biollaz J, Telenti A. Nelfinavir plasma levels under twice-daily and three-times-daily regimens: High interpatient and low intrapatient variability. Ther Drug Monit. 2001;23:394-8.

22. Puro V, Soldani F, De Carli G, Lazarevic Z, Mattioli F, Ippolito G. Drug-induced aminotransferase alterations during antiretroviral HIV post-exposure prophylaxis. AIDS. 2003;17:1988-90.

23. Abraham PE, Sorensen SJ, Baker WH, Cushing HE. Nelfinavir desensitization. Ann Pharmacother. 2001;35:553-6.

24. Martinez E, Mocroft A, GarciaViejo MA, PerezCuevas JB, Blanco JL, Mallolas J, Bianchi L, Conget I, Blanch J, Phillips A, Gatell. Risk of lipodystrophy in HIV-1-infected patients treated with protease inhibitors: a prospective cohort study. Lancet. 2001;357:592-8.

25. Manfredi R, Calza L, Chiodo F. Gynecomastia associated with highly antiretroviral therapy. Ann Pharmacother. 2001;35:438-9.

26. Dube MP, Parker RA, Tebas P, et al. Glucose metabolism, lipid, and body fat changes in antiretroviral-naive subjects randomized to nelfinavir or efavirenz plus dual nucleosides. AIDS. 2005;19:1807-1818.

27. Fantoni M, Del Borgo C, Autore C. Evaluation and management of metabolic and coagulative disorders in HIV-infected patients receiving highly active antiretroviral therapy. AIDS. 2003;17 Suppl 1:S162-9.

28. Fisac C, Virgili N, Ferrer E, et al. A comparison of the effects of nevirapine and nelfinavir on metabolism and body habitus in antiretroviral-naive human immunodeficiency virus-infected patients: a randomized controlled study. J Clin Endocrinol Metab. 2003;88:5186-92.

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30. Engeler DS, John H, Rentsch KM, Ruef C, Oertle D, Suter S. Nelfinavir urinary stones. J Urol. 2002;167:1384-5.

31. Roling J, Schmid H, Fischereder M, Draenert R, Goebel FD. HIV-Associated Renal Diseases and Highly Active Antiretroviral Therapy-Induced Nephropathy. Clin Infect Dis. 2006;42:1488-95.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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