If you have these symptoms, do not drive a car, use machinery, or do anything that needs you to be alert.The most common side effects of rizatriptan benzoate tablets in adults include:Tell your doctor if you have any side effect that bothers you or that does not go away.If you take rizatriptan benzoate tablets too often, this may result in you getting chronic headaches. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of rizatriptan benzoate tablets. The treatment phase of the study had two stages. To report SUSPECTED ADVERSE REACTIONS, contact Breckenridge Pharmaceutical, Inc., at 1-800-367-3395 or go to Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.Dosing in pediatric patients is based on the patient's body weight. The diagnosis of MOH should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.Rizatriptan contains aspartame (E951) as a source of phenylalanine. The safety of rizatriptan for use in human pregnancy has not been established. NFollowing intravenous administration, AUC in men increases proportionally and in women near-proportionally with the dose over a dose range of 10-60 µg/kg. It may harm them.This Patient Information leaflet summarizes the most important information about rizatriptan benzoate tablets. If you are using sumatriptan regularly (twice a week or more) then please discuss the use of preventative migraine medication with your GP. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are those defined as those occurring in at least (>)1/100 patients; infrequent adverse experiences are those occurring in 1/100 to 1/1000 patients; and rare adverse experiences are those occurring in fewer than 1/1000 patients.Adverse reactions to rizatriptan benzoate were assessed in a controlled clinical trial in the acute treatment of migraines (Study 7) that included a total of 1382 pediatric patients 6-17 years of age, of which 977 (72%) administered at least one dose of study treatment (rizatriptan benzoate and/or placebo) In the following section, the frequencies of less commonly reported adverse events are presented. Headache relief occurred as early as 30 minutes following dosing, and response rates, (i.e. In a clinical pharmacology study in which 12 adult subjects received rizatriptan, at total cumulative doses of 80 mg (given within four hours), two subjects experienced syncope and/or bradycardia. Administration to lactating rats at approximately 10 times anticipated maximum clinical exposure resulted in significant reduction in pup body weight gain during lactation. Study 7 results are summarized in Table 4.The observed percentage of pediatric patients achieving no headache pain within 2 hours following initial treatment with rizatriptan benzoate orally disintegrating tablets is shown in Figure 5.The prevalence of the exploratory endpoints of absence of migraine-associated symptoms (nausea, photophobia, and phonophobia) at 2 hours after taking the dose was not statistically significantly different between patients who received rizatriptan benzoate orally disintegrating tablets and those who received placebo.NDC: 50090-3921-0 6 TABLET in a BLISTER PACK / 18 in a CARTON Inform patients that rizatriptan benzoate tablets may cause serious cardiovascular side effects such as myocardial infarction or stroke. Rizatriptan was patented in 1991 and came into medical use in 1998.