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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.

Some side effects of naproxen / sumatriptan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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