MAXALT is indicated for the acute treatment of migraine attacks with or without aura in adults. MAXALT is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. Safety and effectiveness of MAXALT have not been established for cluster headache, which is present in an older, predominantly male population.

MAXALT should not be given to patients with ischemic heart disease (eg, angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetal's variant angina, or other significant underlying cardiovascular disease. Because MAXALT may increase blood pressure, it should not be given to patients with uncontrolled hypertension. MAXALT should not be used within 24 hours of treatment with another 5-HT₁ agonist, or an ergotamine-containing or ergot-type medication like dihydroergotamine or methysergide. MAXALT should not be administered to patients with hemiplegic or basilar migraine. Concurrent administration of MAO inhibitors or use of rizatriptan within 2 weeks of discontinuation of MAO inhibitor therapy is contraindicated. MAXALT is contraindicated in patients who are hypersensitive to rizatriptan or any of its inactive ingredients.

Because of the potential of this class of compounds (5-HT_1B/1D agonists) to cause coronary vasospasm, MAXALT should not be given to patients with documented ischemic or vasospastic coronary artery disease.

The most common adverse events include asthenia/fatigue, somnolence, pain/pressure sensations, and dizziness, and they appear to be dose related. Potentially important adverse events that have occurred in clinical practice and reported through postmarketing surveillance include cardiovascular: myocardial ischemia, myocardial infarction; peripheral vascular ischemia, cerebrovascular: stroke; special senses: dysgeusia; general: hypersensitivity: angioedema (eg, facial edema, tongue swelling, pharyngeal edema), wheezing, toxic epidermal necrolysis.

Serious adverse cardiac events, including acute myocardial infarction, have been reported within a few hours following the administration of rizatriptan. Life-threatening disturbances of cardiac rhythm and death have been reported within a few hours following the administration of other 5-HT₁ agonists. Considering the extent of use of 5-HT₁ agonists in patients with migraine, the incidence of these events is extremely low. MAXALT can cause coronary vasospasm.