1 INDICATIONS AND USAGE Fluvoxamine maleate extended-release capsules is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) ( 1 ). Efficacy was demonstrated in: One 12-week study fluvoxamine maleate extended-release capsules in adults ( 14.1 ). Two 10-week studies with immediate-release (IR) fluvoxamine tablets in adults and one 10-week study with IR fluvoxamine tablets in children and adolescents ( 14.1 , 14.3 ). One maintenance st...
6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Most common reactions in controlled trials with OCD patients and patients from another studied population (incidence ≥5% and at least twice that for placebo) were abnormal ejaculation, anorexia, anorgasmia, ...
Source: OpenFDA. This is not medical advice.