Medically Reviewed on 11/3/2022

Generic Name: Naproxen-Sumatriptan

Brand Name: Treximet

Drug Class: NSAIDs; Serotonin 5-HT-Receptor Agonists

What is naproxen/sumatriptan, and what is it used for?

Naproxen/sumatriptan is a combination medicine used for the treatment of migraine headaches

Naproxen/sumatriptan is available under the following different brand names: Treximet

What are the side effects of naproxen/sumatriptan?

Common side effects of naproxen/sumatriptan include:

Serious side effects of naproxen/sumatriptan include:

Rare side effects of naproxen/sumatriptan include:

  • none 

Seek medical care or call 911 at once if you have the following serious side effects:

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug.

Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

What is the dosage for naproxen/sumatriptan?

Adult dosage


  • 60 mg/10 mg
  • 500 mg/85 mg

Migraine Headache

Adult dosage

  • 500 mg/85 mg orally, may repeat once after 2 hours, not to exceed 2 tablets/24 hours

Pediatric dosage

  • Children below 12 years: Safety and efficacy not established
  • Children above 12 years: The recommended dose is 1 tablet (60 mg/10 mg) orally per 24 hours or as needed; the maximum dose is 1 tablet (500 mg/85 mg) per 24 hours

What drugs interact with naproxen/sumatriptan?

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. 

Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.


Who suffers more frequently from migraine headaches? See Answer

Pregnancy and breastfeeding


  • Use of NSAIDs can cause premature closure of fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment
  • Because of these risks, limit dose, and duration of use between about 20 and 30 weeks of gestation, and avoid use at about 30 weeks of gestation and later in pregnancy
  • Use of NSAIDs at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of fetal ductus arteriosus
  • Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment
  • If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit use to the lowest effective dose and shortest duration possible; if treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios; if oligohydramnios occurs, discontinue the drug and follow up according to clinical practice
  • Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive
  • Data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population
  • In animal studies, administration of sumatriptan and naproxen, alone or in combination, during pregnancy resulted in developmental toxicity (increased incidences of fetal malformations, embryofetal, and pup mortality, decreased embryofetal growth) at clinically relevant doses
  • Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization
  • In animal studies, administration of prostaglandin synthesis inhibitors such as naproxen sodium resulted in increased pre-and post-implantation loss
  • Prostaglandins also have been shown to have an important role in fetal kidney development; in published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses
  • Several studies have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy
  • Labor or Delivery
  • There are no studies on the effects of naproxen tablets during labor or delivery; in animal studies, NSAIDs, including naproxen, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth
  • Infertility
  • Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs may delay or private rupture of ovarian follicles, which has been associated with reversible infertility in some women
  • Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation
  • Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation; consider withdrawal of NSAIDs, including naproxen tablets, in women who have difficulties conceiving or who are undergoing investigation of infertility


  • The naproxen anion has been found in the milk of lactating women at a concentration equivalent to approximately 1% of the maximum naproxen concentration in plasma
  • Sumatriptan is excreted in human milk following subcutaneous administration; there is no information regarding sumatriptan concentrations in milk from lactating women following administration of sumatriptan tablets
  • There are no data on the effects of naproxen or sumatriptan on breastfed infants or effects of naproxen or sumatriptan on milk production; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition
  • Infant exposure to sumatriptan can be minimized by avoiding breastfeeding for 12 hours after treatment with sumatriptan tablets
  • Following subcutaneous administration of a 6-mg dose of sumatriptan injection in 5 lactating volunteers, sumatriptan was present in milk


Naproxen/sumatriptan is a combination medicine used for the treatment of migraine headaches. Common side effects of naproxen/sumatriptan include dizziness, drowsiness, flushing (warmth, heat, or tingly feeling), redness in the face, feelings of prickling/heat, tiredness, nausea, heartburn, constipation, upset stomach, dry mouth, tight muscles, weakness, and mild pressure or heavy feeling in any part of your body. There is the potential for fetal harm; consult your doctor if pregnant. Consult your doctor if breastfeeding.

Treatment & Diagnosis

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Medically Reviewed on 11/3/2022