Viramune Side Effects

Generic Name: nevirapine

Please note - some side effects for Viramune 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 Viramune - for the Consumer

Viramune

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 Viramune:

Diarrhea; headache; mild nausea or stomach pain; tiredness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; dark urine; eye irritation, pain, redness, or swelling; fever, chills, or sore throat; general feeling of being unwell; loss of appetite; mouth sores; muscle or joint aches or pain; pale stools; red, swollen, peeling, or blistered skin; severe, persistent, or unusual nausea, stomach pain, tiredness, or weakness; swollen lymph glands; yellowing of the skin or eyes.

Viramune Suspension

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 Viramune Suspension:

Diarrhea; headache; mild nausea or stomach pain; tiredness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; dark urine; eye irritation, pain, redness, or swelling; fever, chills, or sore throat; general feeling of being unwell; loss of appetite; mouth sores; muscle or joint aches or pain; pale stools; red, swollen, peeling, or blistered skin; severe, persistent, or unusual nausea, stomach pain, tiredness, or weakness; swollen lymph glands; yellowing of the skin or eyes.

Viramune Side Effects - for the Professional

Viramune

• The most common adverse reaction is rash. In adults the incidence of rash is 14.8% vs. 5.9% with placebo, with Grade 3/4 rash occurring in 1.5% of patients (6.1)
• In pediatric patients the incidence of rash (all causality) was 21% (6.2).

Side Effects by Body System

General

Nevirapine is generally well tolerated however, serious adverse effects can occur. The most serious side effects have included hepatitis, hepatic failure, Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions. The first 18 weeks of therapy with nevirapine are a critical period during which it is essential that patients be monitored intensively to detect potentially life-threatening hepatotoxicity or skin reactions. Nevirapine should not be restarted following severe hepatic, skin or hypersensitivity reactions.

Dermatologic

Dermatologic side effects have included rash as the major side effect. Rash has developed in approximately 20% of patients. In clinical trials, 37% of patients treated with nevirapine and zidovudine experienced rash, compared with 20% of patients receiving either zidovudine alone or zidovudine and didanosine. Rash was severe or life-threatening in approximately 8% of patients receiving nevirapine. Among the patients experiencing severe rash, 25% required hospitalization and one patient required surgical intervention. Overall, 7% of patients discontinued nevirapine therapy because of rash.

Rashes associated with nevirapine are usually mild to moderate, maculopapular erythematous cutaneous eruptions, with or without pruritus, located on the face, trunk, and extremities. However, severe, life-threatening skin reactions, including fatal cases, have occurred. These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction. Rashes that are severe usually occur within the first 28 days of therapy. Rash generally resolves following discontinuation of treatment with the drug. Utilization of the 14-day lead-in period with nevirapine reduces the frequency of rash.

Hepatic

Hepatic side effects have included elevated serum concentrations of ALT, AST, and total bilirubin in up to 3.5% of patients, and severe, in some cases fatal, hepatotoxicity. These cases have included fulminant and cholestatic hepatitis, hepatic necrosis, jaundice, and hepatic failure. In clinical trials, the risk of hepatitis was 1%. Serious hepatic events occur most frequently during the first 12 weeks of therapy and have been reported as early as within the first weeks of therapy. However, approximately one third of cases have been reported after the first 12 weeks. In controlled studies, asymptomatic elevations of gamma-glutamyltransferase (GGT) occurred more frequently in patients receiving nevirapine. Elevated alkaline phosphatase has also been reported.

Patients with increased AST or ALT levels and/or history of hepatitis B and C prior to the start of antiretroviral therapy are associated with a greater risk of adverse hepatic effects. Some events occurred after short-term exposure to nevirapine and in patients who presented with nonspecific prodromal signs and symptoms of hepatitis which then progressed to hepatic failure. Patients with signs or symptoms of hepatitis must immediately seek medical evaluation, have liver function test performed, and be advised to discontinue nevirapine as soon as possible.

Hypersensitivity

Hypersensitivity reactions have included anaphylaxis, angioedema, bullous eruptions, ulcerative stomatitis, urticaria, and rash associated with fever, blistering, oral lesions, conjunctivitis, facial edema, muscle or joint aches, general malaise, fatigue, hepatic abnormalities and/or hepatitis, eosinophilia, granulocytopenia, lymphadenopathy, and renal dysfunction.

Gastrointestinal

Gastrointestinal side effects have included nausea (15%), vomiting (5%), diarrhea (4%), abdominal pain, and anorexia.

Hematologic

Hematologic side effects have included anemia, granulocytopenia, neutropenia, thrombocytopenia, and eosinophilia.

Musculoskeletal

Musculoskeletal side effects have included myalgia (4%), arthralgia (3%), arthromyalgia, and arthritis. Rhabdomyolysis associated with skin and/or liver reactions has been reported during postmarketing experience.

Nervous system

Nervous system adverse effects have included headache (8%), fatigue (7%), somnolence (3%), paresthesia, and neuropathy.

Other

Redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement, peripheral wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown and a causal relationship has not been established.

Other

Other side effects have included fever, asthenia, drug withdrawal (as a result of drug interactions), and flu-like symptoms.

Metabolic

Metabolic side effects have included hyperlactatemia and unspecified metabolic alterations. Elevated total cholesterol has also been reported.

Respiratory

Respiratory side effects have rarely included dry cough, dyspnea, and interstitial pulmonary infiltration.

Psychiatric

Psychiatric side effects have included depression.

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