In clinical trials in mild to severe dementia, involving 1,784 patients treated with Memantine and 1,595 patients treated with placebo, the overall incidence rate of adverse events with Memantine did not differ from those with placebo; the adverse events were usually mild to moderate in severity. The most frequently occurring adverse events with a higher incidence in the Memantine group than in the placebo group were dizziness (6.3% vs 5.6%, respectively), headache (5.2% vs 3.9%), constipation (4.6% vs 2.6%), somnolence (3.4% vs 2.2%) and hypertension (4.1% vs 2.8%).
The following Adverse Drug Reactions listed in the Table as follows have been accumulated in clinical studies with Memantine and since its introduction in the market. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See table.)
Adverse reactions are ranked according to system organ class, 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).
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Alzheimer's disease has been associated with depression, suicidal ideation and suicide. In post-marketing experience these events have been reported in patients treated with Memantine.