Nelfinavir Side Effects

Brand Names: Viracept

Please note - some side effects for Nelfinavir may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Nelfinavir - for the Consumer

Nelfinavir

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nelfinavir:

Diarrhea; gas; loss of appetite; nausea; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever, chills, or sore throat; mental or mood changes; suicidal thoughts or actions; symptoms of high blood sugar (eg, confusion; flushed face; fruit-like breath odor; increased thirst, hunger, or urination; unusual drowsiness); unusual bleeding or bruising.

Nelfinavir Powder

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nelfinavir Powder:

Diarrhea; gas; loss of appetite; nausea; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever, chills, or sore throat; mental or mood changes; suicidal thoughts or actions; symptoms of high blood sugar (eg, confusion; flushed face; fruit-like breath odor; increased thirst, hunger, or urination; unusual drowsiness); unusual bleeding or bruising.

Side Effects by Body System

General

Nelfinavir is generally well-tolerated with most adverse effects regarded as mild to moderate in severity.

Gastrointestinal

Gastrointestinal side effects have included diarrhea as the most frequent side effect. The incidence ranges from 14% to 32% depending on dose and concomitant antiretroviral therapy. Diarrhea was reported in 39% to 47% of pediatric patients in clinical trials. Nausea (3% to 7%), flatulence (3% to 8%), abdominal pain (up to 4%), anorexia, dyspepsia, epigastric pain, gastrointestinal bleeding, mouth ulceration, pancreatitis, and vomiting have also been reported.

Nervous system

Nervous system adverse 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 neutropenia, anemia, leukopenia, and thrombocytopenia 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 elevations in AST (SGOT), ALT (SGPT), and GGT, hepatitis, and jaundice.

Endocrine

Endocrine side effects have included new onset and exacerbation of preexisting diabetes mellitus during postmarketing surveillance in patients receiving protease inhibitor therapy. Careful monitoring of blood glucose levels should be done and either initiation or dose adjustments of insulin or oral hypoglycemic agents may be needed.

Other

Other side effects have included redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement, peripheral wasting, breast enlargement, and "cushingoid appearance" in patients receiving protease inhibitors. The mechanism and long-term consequences of these events are currently unknown and a causal relationship has not been established.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, arthritis, cramps, myalgia, myasthenia, and myopathy in less than 2% of patients.

Respiratory

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

Dermatologic

Dermatologic side effects have included rash in up to 4% of patients. 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 postmarketing reports of QTc prolongation and torsades de pointes.

Metabolic

Metabolic side effects occurring in less than 2% of patients have included increases in alkaline phosphatase, amylase, creatine phosphokinase, lactic dehydrogenase; hyperlipidemia, hyperuricemia, hyperglycemia, hypoglycemia, dehydration, bilirubinemia, and metabolic acidosis.

Hypersensitivity

Hypersensitivity reactions including bronchospasm, moderate to severe rash, fever, and edema have been reported.

Other

Side effects affecting the body as a whole have included abdominal pain, accidental injury, asthenia, back pain, fever, headache, malaise, and pain in less than 2% of patients.

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.

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