Treximet Side Effects
Generic Name: naproxen / sumatriptan
Medically reviewed by Drugs.com. Last updated on Aug 30, 2020.
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)
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:
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
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:
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.
Frequently asked questions
More about Treximet (naproxen / sumatriptan)
- During Pregnancy
- Dosage Information
- Drug Images
- Drug Interactions
- Pricing & Coupons
- En Español
- 87 Reviews
- Generic Availability
- Drug class: antimigraine agents
- FDA Alerts (1)
- FDA Approval History
Consumer resources
Professional resources
Related treatment guides
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.