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Rxulti · 4.8 · Neuroleptic malignant syndrome No TEAEs related to NMS have been reported in the adolescent schizophrenia tria
Eintrag öffnenRxulti · 4.8 · Paediatric population
Eintrag öffnenRxulti · 4.8 · Pregnancy, Drug withdrawal puerperium and syndrome perinatal conditions neonatal (see section 4.6)
Eintrag öffnenRxulti · 4.8 · Prolactin In the short-term trial, no treatment emergent adverse events associated with elevated prolactin wer
Eintrag öffnenRxulti · 4.8 · Prolactin The incidence of blood prolactin increased was 0.9 % in the 2 mg to 4 mg brexpiprazole group compare
Eintrag öffnenRxulti · 4.8 · Psychiatric disorders Suicide attempt Gambling Suicidal ideation disorder Impulsive behaviour Binge eating Com
Eintrag öffnenRxulti · 4.8 · QT prolongation In the short-term controlled trials with brexpiprazole, 3 TEAEs related to QT prolongation wer
Eintrag öffnenRxulti · 4.8 · QT prolongation No TEAEs related to QT prolongation have been reported in the adolescent schizophrenia trials.
Eintrag öffnenRxulti · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenRxulti · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenRxulti · 4.8 · Respiratory, thoracic Cough and mediastinal disorders
Eintrag öffnenRxulti · 4.8 · Somnolence including sedation and hypersomnia In short-term trial, the incidence of somnolence-related TEAEs (
Eintrag öffnenRxulti · 4.8 · Suicidal behaviour In a short-term, controlled trial, a TEAE of suicidal behaviour was reported in 1 subject (
Eintrag öffnenRxulti · 4.8 · Suicidal behaviour In short-term, controlled trials, Treatment Emergent Adverse Events (TEAEs) related to suic
Eintrag öffnenRxulti · 4.8 · Summary of the safety profile
Eintrag öffnenRxulti · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenRxulti · 4.8 · The effects of brexpiprazole at therapeutic (4 mg) and supra-therapeutic (12 mg) doses on QT interval were eva
Eintrag öffnenRxulti · 4.8 · The incidence of akathisia in the short -term, controlled trials (5.4 %) was similar to the incidence in the l
Eintrag öffnenRxulti · 4.8 · The incidences of the ADRs associated with brexpiprazole therapy are tabulated below. The table is based on ad
Eintrag öffnenRxulti · 4.8 · The most frequently observed adverse drug reactions (ADRs) in adults were akathisia (5.6 %) and weight gain (3
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