Rizatriptan (Maxalt) Adverse Reactions
- angioedema
- asthenia
- chest pain (unspecified)
- chest pressure syndrome
- coronary vasospasm
- diarrhea
- dizziness
- drowsiness
- dysgeusia
- dyspnea
- euphoria
- fatigue
- flushing
- hot flashes
- myocardial infarction
- nausea/vomiting
- palpitations
- paresthesias
- toxic epidermal necrolysis
- tremor
- wheezing
- xerostomia
Rizatriptan (Maxalt) Adverse Reactions
The adverse reaction profile is similar between Maxalt® tablets and Maxalt-MLT™ disintegrating tablets.
Rizatriptan is generally well tolerated with the majority of the side effects being mild to moderate in severity. The most common adverse events associated with rizatriptan 10 mg versus placebo, respectively, are asthenia/fatigue (7% vs. 2%), somnolence (8% vs. 4%), pain/pressure sensation (9% vs. 3%) and dizziness (9% vs. 5%).
During rizatriptan therapy, chest pressure syndrome has been reported; this syndrome includes sensations of chest pain (unspecified), tightness and or/heaviness and jaw pain and tightness and regional pain and pressure. These events have not been associated with arrhythmias or definite ischemic ECG changes in clinical trials. However, in postmarketing reports, serious adverse cardiac events, including myocardial ischemia, myocardial infarction, and stroke, were reported within a few hours following the administration of rizatriptan. A causal relationship has not been determined. Serious cardiac events (some fatal events) have been reported following therapy with other 5-HT1 agonists; these events have included coronary vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation. These serious cardiac events are extremely rare and have been primarily reported in patients with risk factors predictive of coronary artery disease.
Hypersensitivity reactions such as angioedema (e.g., facial edema, tongue swelling, pharyngeal edema), wheezing, and toxic epidermal necrolysis (TEN) have been reported during postmarketing surveillance with rizatriptan.
The following adverse events were reported in > 1/100 patients involved in the clinical trial with rizatriptan: paresthesias including warm/cold sensations, palpitations, diarrhea, nausea/vomiting, tremor, headache, hypesthesia, decreased mental acuity, drowsiness, euphoria, dyspnea, flushing and hot flashes. Xerostomia and dysgeusia have also been noted.
During a placebo-controlled, crossover, post-marketing study of rizatriptan use in pediatric patients 6 - 17 years of age, adverse effects were reported by 14% and 2% of patients during the rizatriptan and placebo phases of the study, respectively. Patients were assigned to receive 2 rizatriptan treatments (5 mg or 10 mg depending upon weight) and 1 placebo treatment for 3 separate migraine attacks in a blinded, random design. A total of 116 children used at least one of the three required treatments during the study. Side effects reported during rizatriptan use included tiredness, xerostomia, flushing, burning sensation, ankle pain, nausea/vomiting, faintness, and throat/head pressure. Although not statistically significant, a higher percentage of children in the 10 mg rizatriptan group reported side effects than those receiving 5 mg. Two children reported side effects following placebo administration (tiredness, vomiting).
[ Last revised: 9/21/2006 4:54:00 PM ]
References
. Ahonen K, Hamalainen ML, Eerola M, et al. A randomized trial of rizatriptan in migraine attacks in children. Neurology 2006;67:1 - 6.
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