Valdoxan Adverse Reactions

Summary of the Safety Profile: In clinical trials, over 8,000 depressed patients have received Valdoxan.
Adverse reactions were usually mild or moderate and occurred within the first 2 weeks of treatment.
The most common adverse reactions were nausea and dizziness.
These adverse reactions were usually transient and did not generally lead to cessation of therapy.
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 frequencies have not been corrected for placebo (see table).

Click on icon to see table/diagram/image

Other undesirable effects for Valdoxan 25 mg: Frequency unknown ≥1/1,000 to <1/100: Myalgia.
Reporting of Suspected Adverse Reactions: Reporting suspected adverse reactions after authorisation of Valdoxan is important. It allows continued monitoring of the benefit/risk balance of Valdoxan. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.