Viramune

Last updated on RxList: 7/13/2020
Viramune Side Effects Center

Last reviewed on RxList 10/4/2018

Viramune (nevirapine) is an antiviral medication used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Viramune is not a cure for HIV or AIDS. Viramune is available in generic form. Common side effects of Viramune include:

  • tiredness,
  • nausea,
  • vomiting,
  • diarrhea,
  • stomach pain,
  • muscle pain,
  • headache,
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist), or
  • rarely, drowsiness

The recommended dose for Viramune is one 200 mg tablet daily for the first 14 days, followed by one 200 mg tablet twice daily, in combination with other antiretroviral agents. Viramune may interact with itraconazole, St. John's wort, blood thinners, antibiotics, ergot medicines, heart or blood pressure medications, medication to prevent organ transplant rejection, other HIV medicines, or seizure medication. Many other medicines can interact with Viramune, or make it less effective. Tell your doctor all medications you use. During pregnancy, Viramune should be used only when prescribed. HIV medicines are usually given to pregnant women with HIV. Treatment has been shown to decrease the risk of HIV transmission to the baby. This drug may be part of that treatment. Consult your doctor. This medication passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.

Our Viramune (nevirapine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Viramune Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: joint or muscle pain, fever, mouth sores, facial swelling, blistering skin rash, flu symptoms, swollen glands, feeling weak or tired, severe tingling or numbness, pain or burning when you urinate, swelling in your legs or feet, cough, chest pain, trouble breathing, or swelling in your lips, tongue, or throat.

Nevirapine can cause life-threatening effects on the liver, especially in women. Call your doctor at once if you have any of these liver symptoms while taking nevirapine: nausea, loss of appetite, upper stomach pain, tiredness, fever, unexplained muscle pain or weakness, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Nevirapine may also cause severe or life-threatening skin reactions. Stop taking this medicine and get emergency medical help if you have: a fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, and a red or purple skin rash that spreads and causes blistering and peeling. This type of reaction is a medical emergency.

Nevirapine may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with nevirapine. Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;
  • chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;
  • cold sores, sores on your genital or anal area;
  • rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;
  • trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or
  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common side effects may include:

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

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Viramune (Nevirapine)

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Viramune Professional Information

SIDE EFFECTS

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical Trial Experience In Adult Patients

The most serious adverse reactions associated with VIRAMUNE 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 [see BOX WARNING and WARNINGS AND PRECAUTIONS].

Hepatic Reaction

In controlled clinical trials, symptomatic hepatic events regardless of severity occurred in 4% (range 0% to 11%) of subjects who received VIRAMUNE and 1% of subjects in control groups. Female gender and higher CD4 cell counts (greater than 250 cells/mm3 in women and greater than 400 cells/mm3 in men) place patients at increased risk of these events [see BOX WARNING and WARNINGS AND PRECAUTIONS].

Asymptomatic transaminase elevations (AST or ALT greater than 5X ULN) were observed in 6% (range 0% to 9%) of subjects who received VIRAMUNE and 6% of subjects in control groups. Co-infection with hepatitis B or C and/or increased transaminase elevations 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.

Liver enzyme abnormalities (AST, ALT, GGT) were observed more frequently in subjects receiving VIRAMUNE than in controls (see Table 3).

Skin Reaction

The most common clinical toxicity of VIRAMUNE is rash, which can be severe or life-threatening [see BOX WARNING and WARNINGS AND PRECAUTIONS]. 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 (Trials 1037, 1038, 1046, and 1090), Grade 1 and 2 rashes were reported in 13% of subjects receiving VIRAMUNE compared to 6% receiving placebo during the first 6 weeks of therapy. Grade 3 and 4 rashes were reported in 2% of VIRAMUNE recipients compared to less than 1% of subjects receiving placebo. Women tend to be at higher risk for development of VIRAMUNE-associated rash [see BOX WARNING and WARNINGS AND PRECAUTIONS].

Treatment-related, adverse experiences of moderate or severe intensity observed in greater than 2% of subjects receiving VIRAMUNE in placebo-controlled trials are shown in Table 2.

Table 2 Percentage of Subjects with Moderate or Severe Drug-Related Events in Adult Placebo-Controlled Trials

Trial 10901Trials 1037, 1038, 10462
VIRAMUNEPlaceboVIRAMUNEPlacebo
(n=1121)(n=1128)(n=253)(n=203)
Median exposure (weeks)58522828
Any adverse event15%11%32%13%
Rash5272
Nausea1194
Granulocytopenia23<10
Headache1<141
Fatigue<1<154
Diarrhea<1121
Abdominal pain<1<120
Myalgia<1012
1 Background therapy included 3TC for all subjects and combinations of NRTIs and PIs. Subjects had CD4+ cell counts less than 200 cells/mm3.
2 Background therapy included ZDV and ZDV+ddI; VIRAMUNE monotherapy was administered in some subjects. Subjects had CD4+ cell count greater than or equal to 200 cells/mm3.

Laboratory Abnormalities

Liver enzyme test abnormalities (AST, ALT) were observed more frequently in subjects receiving VIRAMUNE than in controls (Table 3). Asymptomatic elevations in GGT occur frequently but are not a contraindication to continue VIRAMUNE therapy in the absence of elevations in other liver enzyme tests. Other laboratory abnormalities (bilirubin, anemia, neutropenia, thrombocytopenia) were observed with similar frequencies in clinical trials comparing VIRAMUNE and control regimens (see Table 3).

Table 3 Percentage of Adult Subjects with Laboratory Abnormalities

Trial 10901Trials 1037, 1038, 10462
VIRAMUNEPlaceboVIRAMUNEPlacebo
Laboratory Abnormality(n=1121)(n=1128)(n=253)(n=203)
Blood Chemistry
  SGPT (ALT) >250 U/L54144
  SGOT (AST) >250 U/L4382
  Bilirubin >2.5 mg/dL2222
Hematology
  Hemoglobin <8.0 g/dL3400
  Platelets <50,000/mm311<12
  Neutrophils <750/mm3131441
1 Background therapy included 3TC for all subjects and combinations of NRTIs and PIs. Subjects had CD4+ cell counts less than 200 cells/mm3.
2 Background therapy included ZDV and ZDV+ddI; VIRAMUNE monotherapy was administered in some subjects. Subjects had CD4+ cell count greater than or equal to 200 cells/mm3.

Clinical Trial Experience In Pediatric Patients

Adverse events were assessed in BI Trial 1100.1032 (ACTG 245), a double-blind, placebo-controlled trial of VIRAMUNE (n=305) in which pediatric subjects received combination treatment with VIRAMUNE. In this trial two subjects were reported to experience Stevens- Johnson syndrome or Stevens-Johnson/toxic epidermal necrolysis transition syndrome. Safety was also assessed in trial BI 1100.882 (ACTG 180), an open-label trial of VIRAMUNE (n=37) in which subjects 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 subjects in trial BI 1100.892). The most frequently reported adverse events related to VIRAMUNE in pediatric subjects were similar to those observed in adults, with the exception of granulocytopenia, which was more commonly observed in children receiving both zidovudine and VIRAMUNE. Cases of allergic reaction, including one case of anaphylaxis, were also reported.

The safety of VIRAMUNE was also examined in BI Trial 1100.1368, an open-label, randomized clinical trial performed in South Africa in which 123 HIV-1 infected treatment-naïve subjects between 3 months and 16 years of age received combination treatment with VIRAMUNE oral suspension, lamivudine and zidovudine for 48 weeks [see Use In Specific Populations and CLINICAL PHARMACOLOGY]. Rash (all causality) was reported in 21% of the subjects, 4 (3%) of whom discontinued drug due to rash. All 4 subjects experienced the rash early in the course of therapy (less than 4 weeks) and resolved upon nevirapine discontinuation. Other clinically important adverse events (all causality) include neutropenia (9%), anemia (7%), and hepatotoxicity (2%) [see Use In Specific Populations and Clinical Studies].

Safety information on use of VIRAMUNE in combination therapy in pediatric subjects 2 weeks to less than 3 months of age was assessed in 36 subjects from the BI 1100.1222 (PACTG 356) trial. No unexpected safety findings were observed although granulocytopenia was reported more frequently in this age group compared to the older pediatric age groups and adults.

Post-Marketing Experience

In addition to the adverse events identified during clinical trials, the following adverse reactions have been identified during post-approval use of VIRAMUNE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole: fever, somnolence, drug withdrawal [see DRUG INTERACTIONS], redistribution/accumulation of body fat [see WARNINGS AND PRECAUTIONS]

Gastrointestinal: vomiting

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

Hematology: anemia, eosinophilia, neutropenia

Investigations: decreased serum phosphorus

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, drug reaction with eosinophilia and systemic symptoms (DRESS) [see WARNINGS AND PRECAUTIONS] plus one or more of the following: hepatitis, eosinophilia, granulocytopenia, lymphadenopathy, and/or renal dysfunction have been 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.

Read the entire FDA prescribing information for Viramune (Nevirapine)

© Viramune Patient Information is supplied by Cerner Multum, Inc. and Viramune Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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