Abnormal laboratory tests indicate Viramune can seriously damage the liver, cause moderate to severe rashes, and can induce life-threatening conditions like Stevens-Johnson syndrome, the sloughing off of the skin, nails, and mucus membranes.

Among the adverse events observed include increased liver enzymes (hepatitis) such as alanine aminotransferase {ALT or SGPT}, aspartate aminotransferase {AST or SGOT}, gamma glutamyl transpeptidase {GGT} and increased bilirubin (bile pigments, {BILI}.

Increases in liver enzymes may occur more frequently among those with hepatitis B or C virus infection. While both anemia (low red cell count or hemoglobin {HCT, HGB}) and thrombocytopenia (low platelet cells, responsible for normal clotting) has occurred among patients taking Viramune, it also occurred at the same rate among patients taking placebo (inactive pill that looked like active Viramune).

Increased white cell eosinophils {EOS} can occur from Viramune due to allergic-related reactions. Low white cell counts (neutropenia {PMN’s}) has occurred more commonly among children with HIV who took Viramune than adults. Increases in the prothrombin time {PT} can occur due to decreased output of clotting proteins from the liver due to Viramune-induced hepatitis.

The most common side effect with Viramune is skin rash that occurs among 17% of patients. While most rashes are mild-to-moderate, they can be severe or life-threatening in 7% of patients. Rare cases of death have occurred. (See The Inside Word and Dosage to minimize rash occurrence and severity.)

The rash usually starts as round, red spots that are either flat or raised (bumpy). However, the spots can come together forming large, generalized patches of rash that can spread throughout the entire skin. The rash is not necessarily itchy, but it can be. The rate of Viramune skin rash may be significantly higher in patients of Chinese ancestry.

The majority of severe rashes from Viramune occur within the first four weeks of therapy. Symptoms of a more severe rash include the associated symptoms of skin blistering (fluid bubbles within the skin layers), sores in the mouth, redness or swelling of the whites of the eyes (conjunctivitis), swelling in any location, fever, achy muscles or joints, swollen lymph glands (neck, armpits or groin) or generalized weakness.

If you have any of these symptoms with a skin rash while taking Viramune, contact your physician immediately, or report to the closest emergency room or call "911". Severe complications from a life-threatening Viramune rash include sloughing of the entire skin, nails and mucous (moist-lining) membranes in the mouth and intestines. Hospitalization and sometimes surgery is required.

Besides rash, other common side effects include headache (11%), fever (8%), fatigue (8%), nausea (6%), sleepiness (6%), mouth ulcers (4%), hepatitis (liver inflammation, 4%), diarrhea (4%), vomiting (3%), muscle aches (3%), stomach-intestine pain (2%), dizziness (2%) and numbness-tingling sensation (2%). Hepatitis can have symptoms of abdomen pain, nausea, vomiting, loss of appetite, itching, fever and sometimes, jaundice (yellowing of the whites of the eyes and sometimes the skin). Rarely, Viramune has caused liver failure leading to death.

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