Viracept Side Effects

Generic Name: nelfinavir

Note: This page contains side effects data for the generic drug nelfinavir. It is possible that some of the dosage forms included below may not apply to the brand name Viracept.

It is possible that some side effects of Viracept may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to nelfinavir: oral powder for suspension, oral tablet

As well as its needed effects, nelfinavir (the active ingredient contained in Viracept) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking nelfinavir, check with your doctor immediately:

Less common
  • Confusion
  • dehydration
  • dry or itchy skin
  • fatigue
  • fruity mouth odor
  • increased hunger
  • increased thirst
  • increased urination
  • nausea
  • vomiting
  • weight loss
Incidence not known
  • Abdominal or stomach pain
  • chills
  • clay-colored stools
  • cough
  • dark urine
  • difficulty with breathing
  • dizziness
  • drowsiness
  • fever
  • headache
  • irregular heartbeat
  • loss of appetite
  • muscle tremors
  • noisy breathing
  • rapid, deep breathing
  • recurrent fainting
  • restlessness
  • shortness of breath
  • skin rash
  • stomach cramps
  • tightness in the chest
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vomiting of blood
  • wheezing
  • yellow eyes or skin

Some nelfinavir side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Diarrhea
Less common
  • Intestinal gas
  • redistribution or accumulation of body fat

For Healthcare Professionals

Applies to nelfinavir: oral powder for reconstitution, oral tablet

General

Nelfinavir (the active ingredient contained in Viracept) is generally well tolerated with most adverse effects regarded as mild to moderate in severity.[Ref]

Gastrointestinal

Gastrointestinal side effects of moderate or severe intensity have included diarrhea (up to 20%), nausea (up to 7%), and flatulence (up to 5%). Anorexia, dyspepsia, epigastric pain, gastrointestinal bleeding, mouth ulceration, pancreatitis, and vomiting have been reported in less than 2% of patients.[Ref]

Nervous system

Nervous system side effects have included dizziness, hyperkinesia, insomnia, migraine, paresthesia, seizures, sleep disorder, and somnolence in less than 2% of patients.[Ref]

Hematologic

Hematologic side effects have included decreased lymphocytes (up to 6%), neutrophils (up to 5%), and hemoglobin (up to 3%). Anemia, leukopenia, and thrombocytopenia have been reported in less than 2% of patients.

Hematologic side effects associated with protease inhibitors have included spontaneous bleeding in patients with hemophilia A and B. 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]

Hepatic

Hepatic side effects have included elevated AST (SGOT) and elevated ALT (SGPT) in up to 2% of patients. Elevated gamma glutamyl transpeptidase, abnormal liver function tests, and hepatitis have been reported in less than 2% of patients. Jaundice has been reported during postmarketing experience.[Ref]

Other

Other side effects have included abdominal pain, accidental injury, asthenia, back pain, fever, headache, malaise, and pain in less than 2% of patients.[Ref]

Musculoskeletal

Musculoskeletal side effects have included arthralgia, arthritis, cramps, myalgia, myasthenia, and myopathy in less than 2% of patients. Elevated creatine kinase has been reported (up to 2%).[Ref]

Respiratory

Respiratory side effects have included dyspnea, pharyngitis, rhinitis, and sinusitis in less than 2% of patients.[Ref]

Dermatologic

Dermatologic side effects of moderate or severe intensity have included rash (up to 3%). Dermatitis, folliculitis, fungal dermatitis, maculopapular rash, pruritus, sweating, and urticaria have been reported in less than 2% of patients.[Ref]

Cardiovascular

Cardiovascular side effects have included QTc prolongation and torsades de pointes during postmarketing experience.[Ref]

Metabolic

Metabolic side effects have included increased alkaline phosphatase, increased amylase, increased creatine phosphokinase, increased lactic dehydrogenase, hyperlipidemia, hyperuricemia, hyperglycemia, hypoglycemia, and dehydration in less than 2% of patients. Bilirubinemia and metabolic acidosis have been reported during postmarketing experience. Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving protease inhibitors; however, a causal relationship has not been established. New onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, hyperglycemia, and ketoacidosis have been reported during postmarketing experience in patients receiving protease inhibitors.[Ref]

Hypersensitivity

Hypersensitivity side effects have included allergic reaction. Hypersensitivity reactions (including bronchospasm, moderate to severe rash, fever, and edema) have been reported during postmarketing experience.[Ref]

Ocular

Ocular side effects have included acute iritis and eye disorder in less than 2% of patients.[Ref]

Genitourinary

Genitourinary side effects have included kidney calculus, sexual dysfunction, and urine abnormality in less than 2% of patients.[Ref]

Psychiatric

Psychiatric side effects have included anxiety, depression, emotional lability, and suicidal ideation in less than 2% of patients.[Ref]

Immunologic

Immunologic side effects have included immune reconstitution syndrome. Autoimmune disorders (e.g., Graves' disease, polymyositis, and Guillain-Barre syndrome) have been reported in the setting of immune reconstitution.

References

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2. 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 11 (1996): 25(ab.no.mo.b.413)

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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 100 (1996): 370-2

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6. "Drugs for HIV infection." Med Lett Drugs Ther 43 (2001): 103-8

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

8. 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 49 (2005): 643-9

9. 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 18 (2004): 1529-1537

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11. HHS Panel on Antiretroviral Guidelines for Adults and Adolescents – A Working Group of the 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. Available from: URL: http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf." ([2011 Oct 14]):

12. 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 55 (2003): 115-125

13. 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 17 (2003): 209-14

14. 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 45 (2001): 3445-50

15. "Drugs for HIV infection." Treat Guidel Med Lett 7 (2009): 11-22

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

17. Carr A "HIV protease inhibitor-related lipodystrophy syndrome." Clin Infect Dis 30 (2000): s135-42

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

19. 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 11 (1996): 18(ab.no.mo.b.173)

20. Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children. NIH. National Institutes of Health "Guidelines for the use of antiretroviral agents in pediatric HIV infection. Available from: URL: http://aidsinfo.nih.gov/guidelines/html/2/pediatric-treatment-guidelines/0" ([2012 Nov 5]):

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 23 (2001): 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 17 (2003): 1988-90

23. Manfredi R, Calza L, Chiodo F "Gynecomastia associated with highly antiretroviral therapy." Ann Pharmacother 35 (2001): 438-9

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 357 (2001): 592-8

25. 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 19 (2005): 1807-1818

26. Abraham PE, Sorensen SJ, Baker WH, Cushing HE "Nelfinavir desensitization." Ann Pharmacother 35 (2001): 553-6

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28. 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 17 Suppl 1 (2003): S162-9

29. 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 88 (2003): 5186-92

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