Imitrex Oral - Side Effects & Drug Interactions

Sumatriptan

• Imitrex Oral - Drug Description
• Imitrex Oral - Warnings & Precautions
• Imitrex Oral - Additional Info
• Imitrex Oral - Clinical Pharmacology
• Imitrex Oral - Overdosage & Contraindications
• Imitrex Oral - Indications & Dosage
• Imitrex Oral - Patient Info

ADVERSE REACTIONS

Serious cardiac events, including some that have been fatal, have occurred following the use of IMITREX Injection or Tablets. These events are extremely rare and most have been reported in patients with risk factors predictive of CAD. Events reported have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS). Significant hypertensive episodes, including hypertensive crises, have been reported on rare occasions in patients with or without a history of hypertension (see WARNINGS).

Incidence in Controlled Clinical Trials:

Table 2 lists adverse events that occurred in placebo-controlled clinical trials in patients who took at least 1 dose of study drug. Only events that occurred at a frequency of 2% or more in any group treated with IMITREX Tablets and were more frequent in that group than in the placebo group are included in Table 2. The events cited reflect experience gained under closely monitored conditions of clinical trials in a highly selected patient population. In actual clinical practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ.

Other events that occurred in more than 1% of patients receiving IMITREX Tablets and at least as often on placebo included nausea and/ or vomiting, migraine, headache, hyposalivation, dizziness, and drowsiness/ sleepiness. IMITREX Tablets are generally well tolerated. Across all doses, most adverse reactions were mild and transient and did not lead to long-lasting effects. The incidence of adverse events in controlled clinical trials was not affected by gender or age of the patients. There were insufficient data to assess the impact of race on the incidence of adverse events.

Other Events Observed in Association With the Administration of IMITREX Tablets:

In the paragraphs that follow, the frequencies of less commonly reported adverse clinical events are presented. Because the reports include events observed in open and uncontrolled studies, the role of IMITREX Tablets in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, etc., limit the value of quantitative frequency estimates provided.