Treximet Side Effects
Generic name: naproxen / sumatriptan
Medically reviewed by Drugs.com. Last updated on Apr 13, 2022.
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
Oral route (Tablet)
Risk of Serious Cardiovascular and Gastrointestinal EventsNonsteroidal anti-inflammatory drugs (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 coronary artery bypass graft (CABG) surgery.NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
Side effects requiring immediate medical attention
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:
- 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
Side effects not requiring immediate medical attention
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:
- Acid or sour stomach
- dry mouth
- feeling hot
- feeling of warmth
- lack or loss of strength
- muscle tightness
- 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
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]
Common (1% to 10%): Chest discomfort/chest pain, hot flush
Very rare (less than 0.01%): Acute coronary syndrome
Rare (less than 0.1%): Serious cardiac events including acute myocardial infarction
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]
Common (1% to 10%): Dizziness, somnolence, paresthesia
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
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]
Frequency not reported: Transient and permanent blindness and significant partial vision loss[Ref]
US FDA Drug Safety Communication (10-2020): The FDA is requiring a new warning be added to NSAID labeling describing the risk of fetal kidney problems that may result in low amniotic fluid. The FDA is recommending pregnant women avoid NSAID use at 20 weeks gestation or later. Through 2017, the FDA has received 35 reports of low amniotic fluid levels or kidney problems in mothers who took NSAIDs while pregnant. Five newborns died; 2 had kidney failure and confirmed low amniotic fluid, 3 had kidney failure without confirmed low amniotic fluid. The low amniotic fluid started as early as 20 weeks of pregnancy. There were 11 reports of low amniotic fluid levels during pregnancy and the fluid volume returned to normal after the NSAID was stopped. The medical literature has reported low amniotic fluid levels with use of NSAIDs for varying amounts of time, ranging from 48 hours to multiple weeks. Complications of prolonged oligohydramnios may include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required. In other cases, the condition was reversible within 3 to 6 days of stopping the NSAID and in these cases reappeared when the same NSAID was restarted.[Ref]
-Frequency not reported: renal papillary necrosis, renal toxicity
-Postmarketing reports: Fetal kidney problems resulting in low amniotic fluid[Ref]
Frequency not reported: Premature closure of ductus arteriosus[Ref]
Common (1% to 10%): Elevated liver tests
Frequency not reported: Anemia[Ref]
Frequently asked questions
More about Treximet (naproxen / sumatriptan)
- Drug interactions
- Dosage information
- During pregnancy
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- Generic availability
- En español
- Drug class: antimigraine agents
- FDA approval history
Related treatment guides
1. "Product Information. Treximet (naproxen-sumatriptan)." Pernix Therapeutics, Magnolia, TX.
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.