Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Abilify

ABILIFY 10 mg orodispersible tablets ABILIFY 15 mg orodispersible tablets ABILIFY 30 mg orodispersible tablets · Abschnitt 4.8 · PDF-Seite 32

HOS-217840 · Präparat HOS-216111

Schizophrenia in adolescents aged 15 years and older In a short-term placebo-controlled clinical trial involving 302 adolescents (13 to 17 years) with schizophrenia, the frequency and type of adverse reactions were similar to those in adults except for the following reactions that were reported more frequently in adolescents receiving aripiprazole than in adults receiving aripiprazole (and more frequently than placebo): Somnolence/sedation and extrapyramidal disorder were reported very commonly (≥ 1/10), and dry mouth, increased appetite, and orthostatic hypotension were reported commonly (≥ 1/100, < 1/10). The safety profile in a 26-week open-label extension trial was similar to that observed in the short- term, placebo-controlled trial. The safety profile of a long-term, double-blind, placebo-controlled trial was also similar except for the following reactions that were reported more frequently than paediatric patients taking placebo: weight decreased, blood insulin increased, arrhythmia, and leukopenia were reported commonly (≥ 1/100, < 1/10).

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