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Treximet

Last reviewed on RxList: 7/2/2018
Treximet Side Effects Center

Last reviewed on RxList 7/2/2018

Treximet (sumatriptan and naproxen sodium) is a combination of a headache medicine and a nonsteroidal anti-inflammatory drug (NSAID) used to treat migraine headaches. Treximet will only treat a headache that has already begun. Treximet will not prevent headaches or reduce the number of attacks. Common side effects of Treximet include:

  • dizziness
  • drowsiness
  • flushing (warmth, heat, or tingly feeling)
  • redness in your face
  • feelings of prickling/heat
  • tiredness
  • nausea
  • heartburn
  • constipation
  • upset stomach
  • dry mouth
  • tight muscles
  • weakness

mild pressure or heavy feeling in any part of your body

Treximet is a tablet with a fixed dose combination of 85 mg sumatriptan and 500 mg naproxen sodium. The usual dose is one tablet. Treximet may interact with blood thinners, lithium, methotrexate, probenecid, diuretics (water pills), steroids, aspirin, other NSAIDs (nonsteroidal anti-inflammatory drugs), ACE inhibitors, beta-blockers, or antidepressants. Tell your doctor all medications you use. During the first 6 months of pregnancy, Treximet should be used only when prescribed. Naproxen is not recommended for use during the last 3 months of pregnancy due to possible harm to the fetus and interference with normal labor/delivery. These drugs pass into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding. Avoid breastfeeding for at least 12 hours after any treatment with sumatriptan.

Our Treximet (sumatriptan and naproxen sodium) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Who suffers more frequently from migraine headaches? See Answer
Treximet Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop taking this medicine and seek emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop using this medicine and call your doctor at once if you have:

  • numbness, tingling, pale or blue-colored appearance in your fingers or toes;
  • leg cramps, burning, coldness, or heavy feeling in your feet or legs;
  • severe headache, blurred vision, pounding in your neck or ears;
  • a seizure;
  • heart problems--swelling, rapid weight gain, feeling short of breath;
  • high levels of serotonin in the body--agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea;
  • kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
  • liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath;
  • signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
  • stomach problems--sudden severe stomach pain (especially after eating), vomiting, constipation, bloody diarrhea, weight loss.

Common side effects may include:

  • dizziness, drowsiness, feeling weak or tired;
  • irregular heartbeats;
  • numbness or tingling in your fingers or toes;
  • dry mouth, heartburn, nausea;
  • feeling hot; or
  • tight muscles, pain or pressure in your chest or throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Treximet (Sumatriptan and Naproxen Sodium Tablets)

SLIDESHOW

Slideshow: 12 Surprising Headache Triggers Tips See Slideshow
Treximet Professional Information

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults

The adverse reactions reported below are specific to the clinical trials with TREXIMET 85/500 mg. See also the full prescribing information for naproxen and sumatriptan products.

Table 1 lists adverse reactions that occurred in 2 placebo-controlled clinical trials (Study 1 and 2) in adult patients who received 1 dose of study drug. Only adverse reactions that occurred at a frequency of 2% or more in any group treated with TREXIMET 85/500 mg and that occurred at a frequency greater than the placebo group are included in Table 1.

Table 1: Adverse Reactions in Pooled Placebo-Controlled Trials in Adult Patients with Migraine

Adverse Reactions TREXIMET 85/500 mg %
(n = 737)
Placebo %
(n = 752)
Sumatriptan 85 mg %
(n = 735)
Naproxen Sodium 500 mg %
(n = 732)
Nervous system disorders
  Dizziness 4 2 2 2
  Somnolence 3 2 2 2
  Paresthesia 2 < 1 2 < 1
Gastrointestinal disorders
  Nausea 3 1 3 < 1
  Dyspepsia 2 1 2 1
  Dry mouth 2 1 2 < 1
Pain and other pressure sensations
  Chest discomfort/chest pain 3 < 1 2 1
  Neck/throat/jaw pain/tightness/pressure 3 1 3 1

The incidence of adverse reactions in controlled clinical trials was not affected by gender or age of the patients. There were insufficient data to assess the impact of race on the incidence of adverse reactions.

Pediatric Patients 12 To 17 Years Of Age

In a placebo-controlled clinical trial that evaluated pediatric patients 12 to 17 years of age who received 1 dose of TREXIMET 10/60 mg, 30/180 mg, or 85/500 mg, adverse reactions occurred in 13% of patients who received 10/60 mg, 9% of patients who received 30/180 mg, 13% who received 85/500 mg, and 8% who received placebo. No patients who received TREXIMET experienced adverse reactions leading to withdrawal from the trial. The incidence of adverse reactions in pediatric patients 12 to 17 years of age was comparable across all 3 doses compared with placebo. Table 2 lists adverse reactions that occurred in a placebo-controlled trial in pediatric patients 12 to 17 years of age at a frequency of 2% or more with TREXIMET and were more frequent than the placebo group.

Table 2: Adverse Reactions in a Placebo-Controlled Trial in Pediatric Patients 12 to 17 Years of Age with Migraine

Adverse Reactions TREXIMET 10/60 mg %
(n = 96)
TREXIMET 30/180 mg %
(n = 97)
TREXIMET 85/500 mg %
(n = 152)
Placebo %
(n = 145)
Vascular
  Hot flush (i.e., hot flash[es]) 0 2 < 1 0
Musculoskeletal
  Muscle tightness 0 0 2 0

Read the entire FDA prescribing information for Treximet (Sumatriptan and Naproxen Sodium Tablets)

Related Resources for Treximet

Read the Treximet User Reviews »

© Treximet Patient Information is supplied by Cerner Multum, Inc. and Treximet Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

QUESTION

Who suffers more frequently from migraine headaches? See Answer

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