May 4, 2016
Recommended Topic Related To:

Treximet

"Most of us get headaches from time to time. Some are mild. Others cause throbbing pain. They can last for minutes or days. There are many different types of headaches. How you treat yours depends on which kind you have.

Headaches migh"...

A A A

Treximet




Treximet Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Treximet (sumatriptan and naproxen sodium) is used to treat migraine headaches. It will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks. Sumatriptan is a headache medicine, and naproxen is a nonsteroidal anti-inflammatory drug (NSAID). Common side effects include dizziness, drowsiness, flushing, tiredness, nausea, and heartburn.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Treximet in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: runny or stuffy nose; hives; wheezing or trouble breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you a serious side effect such as:

  • chest pain or pressure, tight feeling in your neck or jaw, pain spreading to your arm or shoulder;
  • sudden numbness or weakness, confusion, problems with vision, speech, or balance;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • swelling or rapid weight gain, urinating less than usual or not at all;
  • pale skin, weakness, easy bruising, flu symptoms;
  • numbness, tingling, pale or blue-colored appearance in your fingers or toes;
  • severe blistering, peeling, and red skin rash;
  • seizure (convulsions); or
  • (if you are also taking an antidepressant) -- agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Less serious side effects may include:

  • dizziness, drowsiness;
  • constipation, upset stomach, dry mouth;
  • warmth or tingly feeling, redness in your face;
  • tight muscles; or
  • mild pressure or heavy feeling in any part of your body.

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)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Treximet Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Flushing, feelings of tingling/numbness/prickling/heat, nausea, upset stomach, tiredness, weakness, drowsiness, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: blue fingers/toes/nails, cold hands/feet, difficult/painful swallowing, easy bleeding/bruising, hearing changes (such as ringing in the ears), mental/mood changes, swelling of the ankles/feet/hands, sudden/unexplained weight gain, change in the amount of urine, unexplained stiff neck, unusual tiredness.

Chest/jaw/neck tightness can commonly occur soon after using sumatriptan. Only rarely are these signs of a serious condition. However, you may not be able to tell it apart from a serious reaction due to a lack of blood flow to the heart, brain, or other parts of the body. Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, fainting, fast/irregular/pounding heartbeat, vision changes, weakness on one side of the body, confusion, slurred speech, sudden or severe stomach/abdominal pain.

This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting/loss of appetite, yellowing eyes/skin.

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Treximet (Sumatriptan and Naproxen Sodium Tablets)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Treximet FDA Prescribing Information: Side Effects
(Adverse Reactions)

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)

Treximet - User Reviews

Treximet User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Treximet sorted by most helpful. Patient Discussions FAQs

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.


Living Better

Find the secrets to longer life.