Viracept Side Effects

Generic name: nelfinavir

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

Some side effects of Viracept may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to nelfinavir: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking nelfinavir (the active ingredient contained in Viracept) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using nelfinavir and call your doctor at once if you have a serious side effect such as:

• signs of a new infection, such as fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• rapid heart rate, increased sweating, tremors in your hands, anxiety, feeling irritable, sleep problems (insomnia);

• diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;

• swelling in your neck or throat (enlarged thyroid);

• muscle weakness, tired feeling, trouble speaking or swallowing, joint or muscle pain, feeling short of breath;

• weakness or prickly feeling in your fingers or toes;

• problems with walking, breathing, speech, swallowing, or eye movement; or

• severe lower back pain, loss of bladder or bowel control.

Less serious side effects of nelfinavir may include:

• nausea, stomach pain, loss of appetite, gas;

• mild skin rash; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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.

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.

Nervous system

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

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.

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.

Other

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

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%).

Respiratory

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

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.

Cardiovascular

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

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.

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.

Ocular

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

Genitourinary

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

Psychiatric

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

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.

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