Summary of the safety profile: The most common adverse reaction was nausea.
Tabulated list of adverse reactions: Adverse reactions are listed as follows using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). The list is based on information from clinical trials and post-marketing experience. (See table.)
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Description of selected adverse reactions: Nausea: Nausea was usually mild or moderate and occurred within the first two weeks of treatment. The reactions were usually transient and did not generally lead to cessation of therapy. Gastrointestinal adverse reactions, such as nausea, occurred more frequently in women than men.
Elderly patients: For doses ≥10 mg vortioxetine once daily, the withdrawal rate from the studies was higher in patients aged ≥65 years.
For doses of 20 mg vortioxetine once daily, the incidences of nausea and constipation were higher in patients aged ≥65 years (42% and 15%, respectively) than in patients aged <65 years (27% and 4%, respectively) (see Precautions).
Sexual dysfunction: In clinical studies, sexual dysfunction was assessed using the Arizona Sexual Experience Scale (ASEX). Doses of 5 to 15 mg showed no difference to placebo. However, the 20 mg dose of vortioxetine was associated with an increase in treatment-emergent sexual dysfunction (TESD) (see Pharmacology: Pharmacodynamics under Actions).
Class effect: Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving a drug from related pharmacological classes of antidepressants (SSRIs or TCAs). The mechanism behind this risk is unknown, and it is not known if this risk is also relevant for vortioxetine.
Paediatric population: A total of 308 adolescent patients aged 12 to 17 years with major depressive disorder (MDD) were treated with vortioxetine in a double-blind, placebo-controlled study. In general, the adverse reaction profile of vortioxetine in adolescents was similar to that seen for adults except for higher incidences reported in adolescents than in adults for abdominal pain-related events and suicidal ideation.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Patient may report any side effects or adverse drug reactions directly to the National Centre for Adverse Drug Reaction Monitoring by calling Tel: 03-78835550, or visiting the website portal.bpfk.gov.my (Healthcare Professional→Reporting).