Maxalt-MLT Side Effects

Generic name: rizatriptan

Note: This document contains side effect information about rizatriptan. Some of the dosage forms listed on this page may not apply to the brand name Maxalt-MLT.

Some side effects of Maxalt-MLT may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to rizatriptan: oral tablet, oral tablet disintegrating

Get emergency medical help if you have any of these signs of an allergic reaction while taking rizatriptan (the active ingredient contained in Maxalt-MLT) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using rizatriptan and call your doctor at once if you have a serious side effect such as:

• feeling of pain or tightness in your jaw, neck, or throat;

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• sudden numbness or weakness, especially on one side of the body;

• sudden severe headache, confusion, problems with vision, speech, or balance;

• sudden and severe stomach pain and bloody diarrhea;

• numbness or tingling and a pale or blue-colored appearance in your fingers or toes; or

• (if you are also taking an antidepressant) -- agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Less serious side effects of rizatriptan may include:

• mild headache (not a migraine);

• dry mouth, mild nausea;

• pressure or heavy feeling in any part of your body;

• dizziness, drowsiness, tired feeling; or

• warmth, redness, or mild tingling under your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to rizatriptan: oral tablet, oral tablet disintegrating

Cardiovascular

Cardiovascular side effects including chest pain (tightness/pressure and/or heaviness) have been reported (up to 3%).

Gastrointestinal

Gastrointestinal side effects (9% to 13%) have been reported including nausea (4% to 6%) and dry mouth (3%).

Nervous system

Nervous system effects (14% to 20%) have been reported including dizziness (4% to 9%), somnolence (4% to 8%), and headache (up to 2%). Atypical sensations (4% to 5%), including paresthesia (3% to 4%) have also been reported. A case of transient ischemic attack has also been reported.

General

General side effects including pain and other pressure sensations (6% to 9%) have been reported including, pain (unspecified location) (3%), neck/throat/jaw (pain, tightness, pressure) (up to 2%), and regional pain (tightness, pressure, heaviness) (up to 2%).

Other

Other side effects including asthenia/fatigue have been reported (4% to 7%).

Hypersensitivity

Hypersensitivity side effects including angioedema (e.g., facial edema, tongue swelling, pharyngeal edema), wheezing, and toxic epidermal necrolysis have been reported.

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