ONZETRA® Xsail® is a prescription medication approved for the acute treatment of migraine, with or without aura in adults. ONZETRA Xsail is used for people who have been told by a healthcare provider that they have migraine headaches. ONZETRA Xsail is not for the prevention of migraines or for other types of headaches, including cluster headache.
Important Safety Information
What important information should I know about ONZETRA Xsail?
ONZETRA Xsail may cause serious side effects, including:
- Heart attack and other heart problems, which may lead to death. Stop using ONZETRA Xsail and get emergency medical help right away if you have any symptoms of a heart attack like shortness of breath or tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw that is severe or does not go away
- Changes in color or sensation in your fingers and toes (Raynaud’s syndrome)
- Stomach and intestinal problems (gastrointestinal and colonic ischemic events)
- Problems with blood circulation to your legs and feet (peripheral vascular ischemia)
- Serious allergic reactions (symptoms include hives; tongue, mouth, lip, or throat swelling; problems breathing)
- Medication overuse headaches. Some people who use ONZETRA Xsail too many times may have worse headaches. If your headaches get worse your doctor may decide to stop your treatment with ONZETRA Xsail
- Serotonin syndrome, a rare but serious problem that can happen in people using ONZETRA Xsail, especially if ONZETRA Xsail is used with antidepressant medicines called SSRIs, SNRIs, or TCAs. Call your doctor right away if you have any of the following symptoms of serotonin syndrome: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; trouble walking; or nausea, vomiting, or diarrhea
- Seizures. Seizures have happened in people taking sumatriptan who have never had seizures before