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Treximet

Generic Name: naproxen and sumatriptan (na PROX en and SOO ma TRIP tan)
Brand Names: Treximet
Treximet is used to treat migraine headaches. Learn about side effects, interactions and indications.
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Drug Information:
Treximet is a tablet containing a combination of Sumatriptan and Naproxen. Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). Sumatriptan is a migraine headache medicine. Treximet is used to treat migraine headaches. This medicine will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks. Treximet should not be used to treat cluster headaches or any headache that causes loss of movement on one side of your body. You should not use Treximet if you have heart problems, uncontrolled high blood pressure, blood circulation problems, Wolff-Parkinson-White Syndrome, a history of heart attack or stroke, severe liver disease, a history of severe allergic Reaction to Aspirin or an NSAID, or if you are in late pregnancy. Learn more

Treximet Side Effects

Treximet Side Effects

Note: This document contains side effect information about naproxen / sumatriptan. Some of the dosage forms listed on this page may not apply to the brand name Treximet.

For the Consumer

Applies to naproxen / sumatriptan: oral tablet

Warning

Oral route (Tablet)

NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Naproxen sodium/sumatriptan succinate is contraindicated in the setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal (GI) adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur without warning symptoms and at any time during therapy.

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.

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

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.

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

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

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.

Ocular

5-HT1 agonists:

Frequency not reported: Transient and permanent blindness and significant partial vision loss

Renal

NSAIDs:

-Frequency not reported: renal papillary necrosis, renal toxicity

Dermatologic

NSAIDs:

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

Endocrine

NSAIDs

Frequency not reported: Premature closure of ductus arteriosus

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

Hematologic

NSAIDs

Frequency not reported: Anemia

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Treximet (www.drugs.com/treximet.html).