Valdoxan Adverse Reactions

In clinical trials, over 9,200 patients have received agomelatine 25-50 mg for MDD (N=8,084) or for GAD (N=1,170).
In clinical trials dose escalation was associated with an increase in liver function abnormalities. The incidence of ALT and/or AST elevations > 3x ULN according to agomelatine dose in clinical trials was: 0.6% on agomelatine 1-10 mg (4/679 patients), 1.3% on agomelatine 25 mg (72/5,581 patients), 2.6% on agomelatine 50 mg (66/2,577 patients) and 3.5% on agomelatine 100 mg (2/57 patients), compared to 0.4% in the placebo group (6/1,629 patients) - see Precautions. Whilst 1-10 mg and 100 mg doses were included in dose ranging trials, these are not within the approved therapeutic dose range of 25 mg to 50 mg (see Dosage & Administration).
Patients with MDD and/or GAD display a number of symptoms that are associated with the illness itself. It is therefore sometimes difficult to ascertain which symptoms are a result of the illness itself and which are a result of treatment with agomelatine.
Adverse events were usually mild or moderate and occurred within the first two weeks of treatment. The most common adverse events were headache, nausea, nasopharyngitis and dizziness which were also commonly reported in the placebo treatment group. These adverse events were usually transient and did not generally lead to cessation of therapy (see Table 10).

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Table 11 describes adverse reactions reported with VALDOXAN in the clinical program (MDD and GAD indications). The frequency of side effects is defined by 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), and not known (cannot be estimated from the available data) and have not been corrected for placebo. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 11.)

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Table 12 describes adverse reactions reported with VALDOXAN during post-marketing experience (MDD and GAD indications). (See Table 12.)

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Reporting suspected adverse effects: Reporting suspected adverse reactions after registration 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.