Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Zyprexa

ZYPREXA 2.5 mg coated tablets ZYPREXA 5 mg coated tablets ZYPREXA 7.5 mg coated tablets ZYPREXA 10 mg coated tablets ZYPREXA 15 mg coated tablets ZYPREXA 20 mg coated tablets · Abschnitt 4.8 · PDF-Seite 9–10

HOS-085964 · Präparat HOS-083234

9  Skin and subcutaneous tissue disorders Rash Photosensitivity reaction Alopecia Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Musculoskeletal and connective tissue disorders Arthralgia9 Rhabdomyolysis11 Renal and urinary disorders Urinary incontinence, urinary retention Urinary hesitation11 Pregnancy, puerperium and perinatal conditions Drug withdrawal syndrome neonatal (see section 4.6) Reproductive system and breast disorders Erectile dysfunction Amenorrhea Priapism12 in males Breast enlargement Decreased libido in Galactorrhea in males and females females Gynaecomastia/breast enlargement in males General disorders and administration site conditions Asthenia Fatigue Oedema Pyrexia10 Investigations Elevated Increased alkaline Increased total plasma phosphatase10 bilirubin prolactin High creatine levels8 phosphokinase11 High Gamma Glutamyltransferase10 High uric acid 10 1 Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories. Following short term treatment (median duration 47 days), weight gain ≥ 7 % of baseline body weight was very common (22.2 %), ≥ 15 % was common (4.2 %) and ≥ 25 % was uncommon (0.8 %). Patients gaining ≥ 7 %, ≥ 15 % and ≥ 25 % of their baseline body weight with long-term exposure (at least 48 weeks) were very common (64.4 %, 31.7 % and 12.3 % respectively). 2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline. 3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high (≥ 6.2 mmol/l). Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17 - < 6.2 mmol/l) to high (≥ 6.2 mmol/l) were very common.

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