TREXIMET, which contains sumatriptan and naproxen sodium [a nonsteroidal anti-inflammatory drug (NSAID)], may increase the chance of a heart attack or stroke that can lead to death. This chance increases:

• with longer use of NSAID medicines
• in people who have heart disease

NSAID-containing medicines, such as TREXIMET, should never be used right before or after a heart surgery called a coronary artery bypass graft (CABG).

TREXIMET is not recommended for people with risk factors for heart disease unless a heart exam is done and shows no problems.

The risk factors for heart disease include:

• high blood pressure
• high cholesterol levels
• smoking
• obesity
• diabetes
• family history of heart disease
• female who has gone through menopause
• male over age 40

Do not take TREXIMET if you have or have had:

• uncontrolled high blood pressure
• a heart attack or a history or symptoms of heart disease (such as chest pain or angina)
• a stroke, mini-stroke (transient ischemic attack or TIA), or other stroke-like syndrome
• problems with blood circulation to parts of your body, such as less blood flow to your intestines (ischemic bowel disease)

Before starting TREXIMET, tell your healthcare provider about:

• chest pain, shortness of breath, irregular heartbeats

Serious side effects include:

• heart attack
• heartbeat problems
• stroke
• high blood pressure
• heart failure from body swelling (fluid retention)
• loss of blood circulation to areas of your body

Call your healthcare provider if you have symptoms of serotonin syndrome, which include:

• mental changes (hallucinations, agitation, coma)
• fast heartbeat
• changes in blood pressure
• high body temperature or sweating
• tight muscles
• trouble walking
• nausea, vomiting, diarrhea.

Get emergency help right away if you have any of the following symptoms:

• shortness of breath or trouble breathing
• chest pain
• weakness in one part or on one side of your body
• slurred speech

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NSAID-containing medicines, such as TREXIMET, can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

• can happen without warning symptoms
• may cause death

The chance of a person getting an ulcer or bleeding increases with:

• the use of medicines called steroid hormones (corticosteroids) and blood thinners (anticoagulants)
• longer use
• more frequent use
• smoking
• drinking alcohol
• older age
• having poor health

Serious side effects:

• bleeding and ulcers in the stomach and intestine

Other side effects:

• stomach pain
• constipation
• diarrhea
• gas
• heartburn
• nausea
• vomiting

Stop TREXIMET and call your healthcare provider right away if you have any of the following symptoms:

• nausea that seems out of proportion to your migraine
• stomach pain
• sudden/severe pain in your belly
• vomit blood
• blood in your bowel movement or it is black and sticky like tar

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"Serotonin syndrome" is a serious and life-threatening problem that may occur with TREXIMET, especially if used with antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (SNRIs).

Commonly used SSRIs are:

• CELEXA^® (citalopram HBr)
• LEXAPRO^® (escitalopram oxalate)
• PAXIL^® (paroxetine)
• PROZAC^®/SARAFEM^® (fluoxetine)
• SYMBYAX^® (olanzapine/fluoxetine)
• ZOLOFT^® (sertraline)
• LUVOX^® (fluvoxamine)

Commonly used SNRIs are:

• CYMBALTA^® (duloxetine)
• EFFEXOR^® (venlafaxine)

Call your healthcare provider if you have symptoms of serotonin syndrome, which include:

• mental changes (hallucinations, agitation, coma)
• fast heartbeat
• changes in blood pressure
• high body temperature or sweating
• tight muscles
• trouble walking
• nausea, vomiting, diarrhea

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TREXIMET already contains an NSAID (naproxen). Do not use TREXIMET with other medicines to lessen pain or fever without talking to your healthcare provider first, because they may contain an NSAID also.

Do not take TREXIMET right before or after heart bypass surgery.

Do not take TREXIMET if you have or have had:

• uncontrolled high blood pressure
• hemiplegic or basilar migraine. (Ask your doctor if you are not sure what type of migraine you have.)
• liver problems
• an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
• a heart attack or a history or symptoms of heart disease (such as chest pain or angina)
• a stroke, mini-stroke (transient ischemic attack or TIA), or other stroke-like syndrome
• problems with blood circulation to parts of your body, such as less blood flow to your intestines (ischemic bowel disease)
• allergic reactions to sumatriptan, naproxen, or other ingredients in TREXIMET

Do not take TREXIMET if you take or have taken an antidepressant medicine called a monoamine oxidase (MAO) inhibitor within the last 2 weeks. Common MAO inhibitors are

• isocarboxazid (MARPLAN^®)
• phenelzine (NARDIL^®)
• tranylcypromine (PARNATE^®)
• selegiline (ELDEPRYL^®, EMSAM^®)

Ask your healthcare provider if you are not sure if your medicine is an MAO inhibitor.

Do not take TREXIMET if you have taken other migraine medicines in the last 24 hours such as:

• ergotamine-containing medicine or
• another triptan medicine

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Serious side effects include: heart attack heartbeat problems stroke high blood pressure heart failure from body swelling (fluid retention) kidney problems including kidney failure bleeding and ulcers in the stomach and intestine low red blood cells (anemia) life-threatening skin reactions life-threatening allergic reactions liver problems including liver failure asthma attacks in people who have asthma loss of blood circulation to areas of your body serotonin syndrome

Other side effects include: pain, tightness, or pressure in the chest, neck, and throat stomach pain constipation diarrhea gas heartburn nausea vomiting dizziness drowsiness tiredness weakness tingling and numbness unusual body sensation redness of face (flushed)

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Before starting TREXIMET, tell your healthcare provider about:

• all of your medical conditions including kidney or liver problems
• all allergies to any medicines
• chest pain, shortness of breath, irregular heartbeats
• medicines you may take for migraines, depression, or other health problems such as MAO inhibitors, SSRIs, or SNRIs
• all the prescription and non-prescription medicines you take, including vitamins and herbal supplements. Some medicines can interact with TREXIMET and cause serious side effects

Keep a list of your medicines to show to your healthcare provider.

Before starting TREXIMET, tell your healthcare provider if you:

• are pregnant, think you might be pregnant, or are trying to become pregnant. TREXIMET should not be used by pregnant women late in their pregnancy.
• are breastfeeding
• have a headache that is different from your usual migraine
• have or have had epilepsy or seizures

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Get emergency help right away if you have any of the following symptoms:

• shortness of breath or trouble breathing
• chest pain
• swelling of the face or throat
• weakness in one part or on one side of your body
• slurred speech

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Stop TREXIMET and call your healthcare provider right away if you have any of the following symptoms:

• nausea that seems out of proportion to your migraine
• stomach pain
• sudden/severe pain in your belly
• vomit blood
• blood in your bowel movement or it is black and sticky like tar
• itching
• skin rash or blisters with fever
• yellow skin or eyes
• swelling of the arms and legs, hands, feet, face, lips, or tongue
• unusual weight gain
• more tired or weaker than usual
• flu-like symptoms
• serotonin syndrome (see TREXIMET and Antidepressants)

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