Like all medicines, Nevirapine Teva can cause side effects, although not everybody gets them.
As mentioned in ?Take special care with Nevirapine Teva', above, the most important side effects of Nevirapine Teva are severe and life threatening skin reactions and serious liver damage. These reactions occur mainly in the first 18 weeks of treatment with Nevirapine Teva. This is therefore an important period which requires close monitoring by your doctor.
If you ever observe any rash symptoms please inform your doctor immediately.
When rash occurs it is normally mild to moderate. However, in some patients a rash, which appears as a blistering skin reaction, can be severe or life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) and deaths have been recorded. Most of the cases of both severe rash and mild/moderate rash occur in the first six weeks of treatment.
If rash occurs with feeling sick, you must stop treatment and visit your doctor immediately.
Hypersensitivity (allergic) reactions can occur. Such reactions may appear in the form of anaphylaxis (characterised by rash, facial swelling, bronchial spasm or shock), or rash accompanied by other side effects such as fever, blistering, mouth sores, eye inflammation, facial swelling, general swelling, shortness of breath, muscle or joint aches, a reduction in white blood cells (granulocytopaenia), general feelings of illness or severe problems with liver or kidneys.
If you experience rash and any of the other side effects of a hypersensitivity (allergic) reaction, please be sure to tell your doctor immediately as such reactions can be potentially life-threatening.
Abnormal liver functioning has been reported with the use of Nevirapine Teva, including some cases of inflammation of the liver (hepatitis), which can be sudden and intense (fulminant hepatitis) and liver failure, which have resulted in deaths.
If you experience clinical symptoms suggesting an injury of the liver, such as loss of appetite, feeling sick (nausea), vomiting, yellow skin (jaundice), abdominal pain you should inform your doctor.
The side effects described below have been experienced by patients given nevirapine.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data).
Very common:
Common:
- reduction in white blood cells (granulocytopenia)
- allergic reactions (hypersensitivity)
- headache
- feeling sick (nausea)
- vomiting
- abdominal pain
- loose stools (diarrhoea)
- inflammation of the liver (hepatitis)
- muscle aches (myalgia)
- fatigue
- fever
- liver function tests abnormal
Uncommon:
- reduction in red blood cells (anaemia)
- yellow skin (jaundice)
- Stevens Johnson Syndrome/toxic epidermal necrolysis
- hives (urticaria)
- fluid under the skin (angioneurotic oedema)
- joint pain (arthralgia)
Rare:
- sudden and intense inflammation of the liver (hepatitis fulminant)
Not Known:
- drug rash with systemic symptoms (drug rash with eosinophilia and systemic symptoms)
- allergic reaction characterised by rash, facial swelling, bronchial spasm or shock (anaphylaxis)
Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution. These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (?buffalo hump?). The cause and long-term health effects of these conditions are not known at this time. Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.
The following events have also been reported when nevirapine has been used in combination with other antiretroviral agents:
- a reduction in red blood cells or in platelets
- inflammation of pancreas
- decrease in or abnormal skin sensations.
These events are commonly associated with other antiretroviral agents and may be expected to occur when Nevirapine Teva is used in combination with other agents; however, it is unlikely that these events are due to a treatment with Nevirapine Teva.
Use in children:
A reduction in white blood cells (granulocytopenia) can occur, which is more common in children. A reduction in red blood cells (anaemia), which may be related to nevirapine therapy, is also more commonly observed in children. As with rash symptoms, please inform your doctor of any side effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
