Treximet Side Effects

Generic name: naproxen / sumatriptan

Medically reviewed by Drugs.com. Last updated on Nov 18, 2023.

Note: This document provides detailed information about Treximet Side Effects associated with naproxen / sumatriptan. Some dosage forms listed on this page may not apply specifically to the brand name Treximet.

Applies to naproxen / sumatriptan: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests will be needed to check for unwanted effects.

Check with your doctor if you have used this medicine and have not had good relief. Also, check with your doctor if your migraine headaches are worse, or if they are occurring more often, than before you started using this medicine.

Using this medicine during the later part of a pregnancy can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.

Do not take this medicine if you have used an MAO inhibitor (MAOI) such as isocarboxazid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®), or tranylcypromine (Parnate®) within the past 2 weeks. Do not use this medicine if you have taken other migraine medicines (eg, almotriptan, frovatriptan, naratriptan, rizatriptan, zolmitriptan, Axert™, Frova®, Amerge®, Maxalt®, or Zomig®) or an ergotamine medicine (eg, dihydroergotamine, methysergide, Cafergot®, D.H.E. 45®, Ergomar®, or Migranal®) within the past 24 hours.

This medicine may cause problems if you have heart disease. If your doctor thinks you might have a problem with this medicine, he or she may want you to take your first dose in the doctor’s office or clinic.

This medicine may increase your risk of having a blood clot, heart attack, or stroke. This is more likely to occur if you or a family member already has a heart disease, if you have diabetes, high blood pressure, high cholesterol, if you smoke, if you are male and over 40 years of age, or if you are female and have gone through menopause. People who use this medicine for a long time might also have a higher risk. Check with your doctor if you have chest pain, faintness, nausea, unusual sweating, trouble breathing, trouble seeing, or trouble speaking while using this medicine.

Check with your doctor right away if you have chest discomfort, jaw or neck tightness after using this medicine. Also, tell your doctor if you have sudden or severe stomach pain after taking this medicine.

This medicine might cause bleeding or ulcers in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (eg, steroid medicine, blood thinner).

Do not use this medicine if you are also using other medicines containing naproxen. Using these medicines together may cause serious unwanted effects.

Make sure your doctor knows about all the medicines you are using. Sumatriptan and naproxen combination may cause a serious condition called serotonin syndrome when taken with some medicines. This especially includes medicines used to treat depression, including citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, olanzapine, paroxetine, sertraline, venlafaxine, Celexa®, Lexapro®, Cymbalta®, Effexor®, Paxil®, Prozac®, or Zoloft®. Check with your doctor first before taking any other medicines.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, or weakness or heaviness of the legs.

This medicine may cause serious allergic reaction called anaphylaxis, which can be life-threatening and requires medical attention. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal antiinflammatory drugs (NSAIDs). Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) may also occur during treatment with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

Check with your doctor right away if you have any symptoms of liver problems, including dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellowing of your skin or eyes.

If you are rapidly gaining weight, having trouble breathing, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of heart problems or your body keeping too much water.

Using too much of this medicine or any other migraine medicines (eg, ergotamine, triptans, opioids, or a combination treatment for 10 or more days per month) may worsen your headache. Talk to your doctor about this risk. It may also be helpful to note of how often your migraine attacks occur and how much medicines you use.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your eyes may need to be checked by an ophthalmologist (eye doctor).

Drinking alcoholic beverages can make headaches worse or cause new headaches to occur. People who suffer from severe headaches should probably avoid alcoholic beverages, especially during a headache.

This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

This medicine may cause some people to become dizzy, drowsy, or less alert than normal. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous while you are dizzy or less alert.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Treximet

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:

Other side effects of Treximet

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:

See also:

For healthcare professionals

Applies to naproxen / sumatriptan: oral tablet.

General adverse events

The most commonly reported adverse reactions for the combination product (naproxen-sumatriptan) included dizziness, somnolence, nausea, chest discomfort/chest pain, neck/throat/jaw pain/tightness/pressure, paresthesia, dyspepsia, dry mouth in adults. In pediatric patients, the most common adverse reaction were hot flush/flashes and muscle tightness.

Refer to the manufacturer product information (i.e., naproxen and sumatriptan alone and in combination) for descriptions of adverse reactions and/or for definitions of included terms.^[Ref]

Cardiovascular

NAPROXEN-SUMATRIPTAN:

• Common (1% to 10%): Hot flush/flashes
• Frequency not reported: Elevated blood pressure/hypertensive crisis

NAPROXEN (monotherapy):

• Common (1% to 10%): Worsening of heart failure
• Uncommon (0.1% to 1%): Palpitations
• Very rare (less than 0.01%): Vasculitis

NSAIDs:

• Frequency not reported: Hospitalization for heart failure, myocardial infarction and stroke especially post coronary artery bypass graft surgery

SUMATRIPTAN (monotherapy):

• Common (1% to 10%): Transient increases in blood pressure arising soon after treatment, flushing
• Rare (0.01% to 0.1%): Serious cardiac adverse events
• Very rare: Coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, ventricular fibrillation
• Frequency not reported: Non-coronary vasospastic reactions (peripheral vascular ischemia, gastrointestinal vascular ischemia/infarction, splenic infarction, Raynauds syndrome), bradycardia, tachycardia, palpitations, angina

Dermatologic

NAPROXEN (monotherapy):

• Common (1% to 10%): Pruritus, skin rashes, urticaria, increased sweating, purpura, ecchymosis
• Rare (0.01% to 0.1%): Hair loss, photosensitivity, pseudoporphyria
• Very rare: Exacerbation of lichen planus, exacerbation of erythema nodosum, exacerbation of lupus erythematosus disseminatus (SLE), toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome
• Frequency not reported: Drug reaction with eosinophilia and systemic symptoms, fixed drug eruption

NSAIDs:

• Frequency not reported: Anemia, drug reaction with eosinophilia and systemic symptoms (DRESS)
• Postmarketing reports: Exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, fixed drug eruption

SUMATRIPTAN (monotherapy):

• Frequency not reported: Hyperhidrosis

Gastrointestinal

NAPROXEN-SUMATRIPTAN:

• Common (1% to 10%): Nausea, dyspepsia, dry mouth
• Rare (0.01% to 0.1%): Reoccurrence of gastric ulcer

NAPROXEN (monotherapy):

• Very common (10% or more): Upper abdominal pain, heartburn, nausea, constipation
• Common (1% to 10%): Stomatitis, diarrhea, vomiting, dyspepsia
• Uncommon (0.1% to 1%): Gastrointestinal ulcers, hemorrhages and/or perforations, hematemesis, melena, exacerbation of ulcerative colitis and Crohn's disease
• Very rare (less than 0.01%): Sialadenitis, pancreatitis, gastritis
• Frequency not reported: Flatulence, constipation

NSAIDs:

• Common (1% to 10%): Gastrointestinal inflammation/bleeding/ulceration, perforation of stomach/small intestine/large intestine

SUMATRIPTAN (monotherapy):

• Common (1% to 10%): Nausea, vomiting
• Frequency not reported: Ischemic colitis, diarrhea, dysphagia

Only 1 in 5 patients who develop a serious upper gastrointestinal adverse event on NSAID therapy is symptomatic. Upper gastrointestinal ulcers, gross bleeding, or perforation caused by NSAIDs appear to occur in approximately 1% of patients treated daily for 3 to 6 months and in about 2% to 4% of patients treated for 1 year. However, even short-term therapy is not without risk.

Hematologic

NAPROXEN (monotherapy):

• Very rare (less than 0.01%): Eosinophilia, thrombocytopenia, leucopenia, pancytopenia, hemolytic anemia, aplastic anemia, agranulocytosis

Hepatic

NAPROXEN (monotherapy):

• Uncommon (0.1% to 1%): Elevated liver enzyme levels, jaundice
• Rare (0.01% to 0.1%): Toxic hepatitis

NSAIDs:

• Very common (10% or more): Elevated transaminases

SUMATRIPTAN (monotherapy):

• Very rare (less than 0.01%): Minor disturbances in liver function tests

Hypersensitivity

NAPROXEN (monotherapy):

• Rare (0.01% to 0.1%): Hypersensitivity reactions, anaphylactic reaction, angioneurotic edema
• Frequency not reported: Anaphylactic reactions (in patients with known hypersensitivity or aspirin sensitive asthma)

SUMATRIPTAN (monotherapy):

• Frequency not reported: Hypersensitivity reactions ranging from cutaneous (e.g., urticaria) to anaphylaxis

Metabolic

NAPROXEN (monotherapy):

• Uncommon (0.1% to 1%): Hyperkalemia, fluid retention

NSAIDs:

• Frequency not reported: Increased serum potassium/hyperkalemia, fluid retention, edema

Musculoskeletal

NAPROXEN-SUMATRIPTAN:

• Common (1% to 10%): Chest discomfort/chest pain, neck/throat/jaw pain/tightness/pressure, muscle tightness

NAPROXEN (monotherapy):

• Rare (0.01% to 0.1%): Myalgia, muscle weakness

SUMATRIPTAN (monotherapy):

• Common (1% to 10%): Myalgia
• Frequency not reported: Neck stiffness, arthralgia

Nervous system

NAPROXEN-SUMATRIPTAN:

• Common (1% to 10%): Dizziness, somnolence, paresthesia

NAPROXEN (monotherapy):

• Common (1% to 10%): Headache, dizziness, lightheadedness
• Uncommon (0.1% to 1%): Convulsions
• Very rare (less than 0.01%): Aseptic meningitis, worsening of Parkinson disease

NSAIDs:

• Frequency not reported: Anemia

SUMATRIPTAN (monotherapy):

• Common (1% to 10%): Dizziness, tingling, drowsiness, sensory disturbance (paresthesia and hypoesthesia
• Frequency not reported: Seizures, cerebral/subarachnoid hemorrhage, stroke, tremor, dystonia, nystagmus, scotoma

Ocular

NAPROXEN (monotherapy):

• Common (1% to 10%): Visual disturbance

SUMATRIPTAN (monotherapy):

• Frequency not reported: Flickering, diplopia, reduced vision, loss of vision including permanent defects

Other

NAPROXEN (monotherapy):

• Common (1% to 10%): Tinnitus, hearing disorders, tiredness, thirst, pyrexia
• Rare (0.01% to 0.1%): Hearing loss

SUMATRIPTAN (monotherapy):

• Common (1% to 10%): Pain, sensations of heat or cold, pressure or tightness (often transient, but may be intense), feelings of weakness, fatigue

Psychiatric

NAPROXEN (monotherapy):

• Uncommon (0.1% to 1%): Mood changes, depression, impaired ability to concentrate, cognitive disorder, insomnia, sleep disorder

SUMATRIPTAN (monotherapy):

• Frequency not reported: Anxiety

Renal

NAPROXEN (monotherapy):

• Very rare (less than 0.01%): Hematuria, renal failure, glomerulonephritis, interstitial nephritis, nephrotic syndrome, papillary necrosis

NSAIDS:

• Frequency not reported: Renal papillary necrosis and other renal injury^[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]

Respiratory

NAPROXEN (monotherapy):

• Rare (0.01% to 0.1%): Pulmonary edema, worsening of asthma
• Very rare (less than 0.01%): Eosinophilic pneumonitis

Frequently asked questions

• What are the brands of sumatriptan?

Further information

Treximet side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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