Valdoxan Adverse Reactions

Summary of the safety profile: Adverse reactions were usually mild or moderate and occurred within the first two weeks of treatment. The most common adverse reactions were headache, nausea and dizziness.
These adverse reactions were usually transient and did not generally lead to cessation of therapy.
Tabulated list of adverse reactions: The table as follows gives the adverse reactions observed from placebo-controlled and active-controlled clinical trials.
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.)


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Reported of suspected adverse reactions: Reporting suspected adverse reactions after authorization 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 PUSAT FARMAKOVIGILANS-BPOM: Tlp. 021- 4245459, 021-4244755 Ext. 111, Fax. 021-4243605, 021-42885404; Email: pvcenter@pom.go.id and/or Indonesia-MESO-BadanPOM@hotmail.com.