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

• Anxiety
• bleeding gums
• bloating
• blood in the urine or stools
• bloody, black, tarry stools
• blurred vision
• chest pain
• chills
• coma
• confusion
• constipation
• cool, pale skin
• cough
• darkened urine
• dehydration
• dizziness
• dry mouth
• fast heartbeat
• fever
• flushed, dry skin
• fruity mouth odor
• increased hunger
• increased thirst
• increased urination
• indigestion
• joint pain, stiffness, or swelling
• loss of appetite
• nausea
• nervousness
• nightmares
• painful or difficult urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pinpoint red spots on the skin
• seizures
• shakiness
• slurred speech
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sweating
• swelling of the feet or lower legs
• swollen glands
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• vomiting of blood or material that looks like coffee grounds
• yellow eyes or skin
• weight loss

Incidence not known

• Clay-colored stools
• difficulty with breathing
• drowsiness
• fainting
• headache
• irregular heartbeat
• muscle tremors
• noisy breathing
• rapid, deep breathing
• recurrent fainting
• restlessness
• skin rash
• unpleasant breath odor
• vomiting of blood

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

• Diarrhea

Less common

• Acid or sour stomach
• belching
• burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings
• difficulty in moving
• discouragement
• feeling sad or empty
• heartburn
• increase in body movements
• irritability
• loss of interest or pleasure
• muscle aches, cramps, pain, or stiffness
• muscular tenderness, wasting or weakness
• passing gas
• redistribution or accumulation of body fat
• sleepiness or unusual drowsiness
• trouble concentrating
• trouble sleeping

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]