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Prescription TREXIMET is for the acute treatment of migraine attacks in adults.

Important Safety Information About TREXIMET

TREXIMET may increase the risk of heart attack, stroke, serious stomach and intestinal problems such as bleeding and ulcers, and serious rash that may be fatal and occur without warning. Risk of stomach and intestinal problems increases in the elderly.

Do not take TREXIMET if you have a history of heart or liver disease, stroke, TIAs, problems with blood circulation, uncontrolled blood pressure, or allergic reaction to aspirin, NSAIDs, or sumatriptan (Imitrex®); or right before or after heart surgery called coronary artery bypass graft (CABG).

Talk to your doctor before taking TREXIMET if you have risk factors for heart disease like high blood pressure, high cholesterol, smoking, obesity, diabetes, family history of heart disease, are a post-menopausal female, or male over age 40.

Talk to your doctor before taking TREXIMET if you have stomach ulcers or bleeding; chest pain, shortness of breath, irregular heartbeats; kidney problems; asthma; Crohn's disease or ulcerative colitis; are pregnant, nursing, or thinking about becoming pregnant; or taking medications, especially pain relievers or antidepressants. TREXIMET should not be used in late pregnancy (third trimester) because TREXIMET can harm your unborn baby. TREXIMET should not be used if you are breastfeeding or plan to breastfeed because TREXIMET passes into your breast milk and may harm your baby. Serotonin syndrome, a life-threatening problem, may occur with TREXIMET, especially if used with antidepressants called SSRIs or SNRIs. Do not take TREXIMET if you have taken an MAOI antidepressant within the last 2 weeks. Do not take TREXIMET if you have taken ergotamine-containing medicines or other triptans within the last 24 hours. TREXIMET should only be used exactly as prescribed, at the lowest dose and for the shortest time possible.

Some people who take TREXIMET too often may have worse headaches. If your headaches get worse, your doctor may stop treatment with TREXIMET. Your doctor may encourage you to track your headache frequency and medication use.