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.

For the professional

Viramune

The most serious adverse reactions associated with Viramune (nevirapine) are hepatitis/hepatic failure, Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions. Hepatitis/hepatic failure may be isolated or associated with signs of hypersensitivity which may include severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, eosinophilia, granulocytopenia, lymphadenopathy, or renal dysfunction.

Adults

The most common clinical toxicity of Viramune is rash, which can be severe or life-threatening. Rash occurs most frequently within the first 6 weeks of therapy. Rashes are usually mild to moderate, maculopapular erythematous cutaneous eruptions, with or without pruritus, located on the trunk, face and extremities. In controlled clinical trials, Grade 1 and 2 rashes were reported in 13.3% of patients receiving Viramune compared to 5.8% receiving placebo during the first 6 weeks of therapy. Grade 3 and 4 rashes were reported in 1.5% of Viramune recipients compared to 0.1% of subjects receiving placebo. Women tend to be at higher risk for development of Viramune associated rash.

In controlled clinical trials, symptomatic hepatic events regardless of severity occurred in 4.0% (range 0% to 11.0%) of patients who received Viramune and 1.2% of patients in control groups. Female gender and higher CD4 counts (>250 cells/mm3 in women and >400 cells/mm3 in men) place patients at increased risk of these events.

Asymptomatic transaminase elevations (AST or ALT > 5X ULN) were observed in 5.8% (range 0% to 9.2%) of patients who received Viramune and 5.5% of patients in control groups. Co-infection with hepatitis B or C and/or increased liver function tests at the start of therapy with Viramune are associated with a greater risk of later symptomatic events (6 weeks or more after starting Viramune) and asymptomatic increases in AST or ALT.

Treatment related, adverse experiences of moderate or severe intensity observed in >2% of patients receiving Viramune in placebo-controlled trials are shown in Table 5.

Laboratory Abnormalities: Liver function test abnormalities (AST, ALT) were observed more frequently in patients receiving Viramune than in controls (Table 6). Asymptomatic elevations in GGT occur frequently but are not a contraindication to continue Viramune therapy in the absence of elevations in other liver function tests. Other laboratory abnormalities (bilirubin, anemia, neutropenia, thrombocytopenia) were observed with similar frequencies in clinical trials comparing Viramune and control regimens.

Post Marketing Surveillance: In addition to the adverse events identified during clinical trials, the following events have been reported with the use of Viramune in clinical practice:

 

Body as a Whole: fever, somnolence, drug withdrawal, redistribution/accumulation of body fat

 

Gastrointestinal: vomiting

 

Liver and Biliary: jaundice, fulminant and cholestatic hepatitis, hepatic necrosis, hepatic failure

 

Hematology: anemia, eosinophilia, neutropenia

 

Musculoskeletal: arthralgia, rhabdomyolysis associated with skin and/or liver reactions

 

Neurologic: paraesthesia

 

Skin and Appendages: allergic reactions including anaphylaxis, angioedema, bullous eruptions, ulcerative stomatitis and urticaria have all been reported. In addition, hypersensitivity syndrome and hypersensitivity reactions with rash associated with constitutional findings such as fever, blistering, oral lesions, conjunctivitis, facial edema, muscle or joint aches, general malaise, fatigue or significant hepatic abnormalities plus one or more of the following: hepatitis, eosinophilia, granulocytopenia, lymphadenopathy and/or renal dysfunction have been reported with the use of Viramune.

Pediatric Patients

Safety was assessed in trial BI 882 in which patients were followed for a mean duration of 33.9 months (range: 6.8 months to 5.3 years, including long-term follow-up in 29 of these patients in trial BI 892). The most frequently reported adverse events related to Viramune in pediatric patients were similar to those observed in adults, with the exception of granulocytopenia, which was more commonly observed in children receiving both zidovudine and Viramune. Serious adverse events were assessed in ACTG 245, a double-blind, placebo-controlled trial of Viramune (n = 305) in which pediatric patients received combination treatment with Viramune. In this trial two patients were reported to experience Stevens-Johnson syndrome or Stevens-Johnson/toxic epidermal necrolysis transition syndrome. Cases of allergic reaction, including one case of anaphylaxis, were also reported. In post-marketing surveillance anemia has been more commonly observed in children although development of anemia due to concomitant medication use cannot be ruled out.

More resources:

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Viramune - Includes detailed dosage instructions.

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