Treximet Side Effects

Generic Name: naproxen / sumatriptan

Note: This page contains side effects data for the generic drug naproxen / sumatriptan. It is possible that some of the dosage forms included below may not apply to the brand name Treximet.

In Summary

Common side effects of Treximet include: increased liver enzymes. Other side effects include: dizziness. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to naproxen / sumatriptan: oral tablet

As well as its needed effects, naproxen / sumatriptan may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking naproxen / sumatriptan, check with your doctor immediately:

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest discomfort or pain
• fast, irregular, pounding, or racing heartbeat or pulse
• jaw, neck, or throat pain

Minor Side Effects

Some naproxen / sumatriptan side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

• Acid or sour stomach
• belching
• dizziness
• dry mouth
• feeling hot
• feeling of warmth
• heartburn
• indigestion
• lack or loss of strength
• muscle tightness
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• sleepiness or unusual drowsiness
• stomach discomfort, upset, or pain
• sudden sweating

For Healthcare Professionals

Applies to naproxen / sumatriptan: oral tablet

General

The most common adverse reactions occurring in adult patients included dizziness, somnolence, nausea, chest discomfort/chest pain, neck/throat/jaw pain/tightness/pressure, paresthesia, dyspepsia, dry mouth. In pediatric patients, hot flush and muscle tightness were the most commonly reported adverse reactions.^[Ref]

Cardiovascular

Sumatriptan-naproxen:
Common (1% to 10%): Chest discomfort/chest pain, hot flush
Very rare (less than 0.01%): Acute coronary syndrome

5-HT1 agonists:
Rare (less than 0.1%): Serious cardiac events including acute myocardial infarction
Frequency not reported: Coronary artery vasospasm (Prinzmetal's angina), peripheral vascular ischemia, Raynaud's syndrome, arrhythmias including ventricular tachycardia and ventricular fibrillation

NSAIDs:
Frequency not reported: Hypertension, new onset or worsening; increased risk of serious cardiovascular thrombotic events, myocardial infarction, heart failure, edema^[Ref]

During clinical trials in 3302 adult patients, 1 patient, a 47-year old female patient with cardiac risk factors experienced acute coronary syndrome approximately 2 hours after taking sumatriptan-naproxen.^[Ref]

Nervous system

Sumatriptan-naproxen:
Common (1% to 10%): Dizziness, somnolence, paresthesia

5-HT1 agonists:
Frequency not reported: Seizures, cerebrovascular events including cerebral hemorrhage, subarachnoid hemorrhage, stroke, serotonin syndrome^[Ref]

Gastrointestinal

Sumatriptan-naproxen:
Common (1% to 10%): Nausea, dyspepsia, dry mouth, neck/throat/jaw pain/tightness/pressure
Very rare (less than 0.01%): Recurrence of gastric ulcer, gastric ulcer

5-HT-1 agonists:
Frequency not reported: Gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction

NSAIDs:
Frequency not reported: Gastrointestinal bleeding, ulceration, perforation^[Ref]

During clinical trials in 3302 adult patients, 1 patient experienced recurrence of a gastric ulcer after taking 8 doses of sumatriptan-naproxen over 3 weeks and 1 patient developed a gastric ulcer after treating an average of 8 attacks over a 7 month period.^[Ref]

Ocular

5-HT1 agonists:
Frequency not reported: Transient and permanent blindness and significant partial vision loss^[Ref]

Renal

NSAIDs:
-Frequency not reported: renal papillary necrosis, renal toxicity^[Ref]

Dermatologic

NSAIDs:
Frequency not reported: Exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis

Endocrine

NSAIDs
Frequency not reported: Premature closure of ductus arteriosus^[Ref]

Hepatic

NSAIDs:
Common (1% to 10%): Elevated liver tests
Frequency not reported: Severe hepatic reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure^[Ref]

Hematologic

NSAIDs
Frequency not reported: Anemia^[Ref]

It is possible that some side effects of Treximet may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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