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Naproxen / sumatriptan Side Effects

For the Consumer

Applies to naproxen / sumatriptan: oral tablet

Along with its needed effects, naproxen/sumatriptan may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking naproxen / sumatriptan:

Less Common

  • 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

Some side effects of naproxen / sumatriptan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less Common

  • 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]

References

1. "Product Information. Treximet (naproxen-sumatriptan)." Pernix Therapeutics, Magnolia, TX.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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