Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In a long-term, open-label study where patients were allowed to treat multiple attacks for up to 1 year, 2% (10 out of 420 adolescent patients) withdrew due to adverse events.

The most common adverse reactions during treatment with almotriptan malate were dizziness, somnolence, headache, paresthesia, nausea, and vomiting. Adverse events were assessed in controlled clinical trials that included 362 adolescent patients who received almotriptan malate and 172 adolescent patients who received placebo. In long-term open-label studies where patients were allowed to treat multiple attacks for up to 1 year, 5% (63 out of 1347 patients) withdrew due to adverse experiences. The most common adverse reactions during treatment with almotriptan malate were nausea, somnolence, headache, paresthesia, and dry mouth.

The following adverse reactions are discussed in more detail in other sections of the labeling: Risk of Myocardial Ischemia and Infarction and Other Adverse Cardiac Events Sensations of Pain, Tightness, Pressure in the Chest and/or Throat, Neck, and Jaw Cerebrovascular Events and Fatalities Other Vasospasm-Related Events, including Peripheral Vascular Ischemia and Colonic Ischemia Serotonin Syndrome Increases in Blood Pressure Adverse events were assessed in controlled clinical trials that included 1840 adult patients who received one or two doses of almotriptan malate and 386 adult patients who received placebo. Reactions reported in association with triptans have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation. These reactions are extremely rare and most have been reported in patients with risk factors predictive of CAD. 6 ADVERSE REACTIONS Serious cardiac reactions, including myocardial infarction, have occurred following the use of almotriptan malate tablets.

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