Nebenwirkungen · Efavirenz Teva
Efavirenz Teva 600 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 21
HOS-215327 · Präparat HOS-155418
Efavirenz has been studied in over 9,000 patients. In a subset of 1,008 adult patients who received 600 mg efavirenz daily in combination with PIs and/or NRTIs in controlled clinical studies, the most frequently reported adverse reactions of at least moderate severity reported in at least 5% of patients were rash (11.6%), dizziness (8.5%), nausea (8.0%), headache (5.7%) and fatigue (5.5%). The most notable adverse reactions associated with efavirenz are rash and nervous system symptoms. Nervous system symptoms usually begin soon after therapy onset and generally resolve after the first 2- 4 weeks. Severe skin reactions such as Stevens-Johnson syndrome and erythema multiforme, psychiatric adverse reactions including severe depression, death by suicide, and psychosis-like behaviour, and seizures have been reported in patients treated with efavirenz. The administration of efavirenz with food may increase efavirenz exposure and may lead to an increase in the frequency of adverse reactions (see section 4.4).
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