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Treximet

"Jan. 15, 2013 -- Women who have migraine with aura may have a higher risk of heart attacks, and they may face a higher risk of dangerous blood clots if they use certain hormonal contraceptives.

Those are the findings from two newly pu"...

Treximet

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

Incidence In Controlled Clinical Trials

Table 2 lists adverse events that occurred in 2 placebo-controlled clinical trials evaluating patients who took at least 1 dose of study drug. Only events that occurred at a frequency of 2% or more with TREXIMET and were more frequent than in the placebo group are included in Table 2. The events cited reflect experience gained under closely monitored conditions of clinical trials in a highly selected patient population. In actual clinical practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ.

Table 2: Treatment-Emergent Adverse Events Reported by at Least 2% of Patients in 2 Controlled Migraine Trialsa

Adverse Event Percent of Patients Reporting
TREXIMET
(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
a Events that occurred at a frequency of 2% or more in the group treated with TREXIMET and that occurred more frequently in the group treated with TREXIMET than in the placebo group.

Other events that occurred in more than 1% of patients receiving TREXIMET and occurred at a frequency greater than the placebo group included asthenia, feeling hot, muscle tightness, and palpitations.

TREXIMET was generally well tolerated. Most adverse reactions were mild and transient. The incidence of adverse events 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 events.

Other Events Observed In Migraine Clinical Trials Associated With The Administration Of TREXIMET

The occurrence of less commonly reported adverse clinical events is presented in this section. Because the reports include events observed in an open-label, long-term safety study in which TREXIMET was used as needed for up to 12 months, the role of TREXIMET cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, etc., limit the value of quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used TREXIMET and reported an event divided by the total number of patients (N = 3,302) exposed to TREXIMET. Events listed in the previous table and text are not included below. Those events described too generally to be informative or those unlikely to be associated with the use of TREXIMET are excluded. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are those occurring in at least 1/100 patients, infrequent adverse events are those occurring in 1/100 to 1/1,000 patients, and rare adverse events are those occurring in fewer than 1/1,000 patients.

Blood and Lymphatic Disorders: Infrequent was lymphadenopathy. Rare were anemia, ecchymosis, leukopenia.

Cardiac Disorders: Infrequent was tachycardia. Rare were acute coronary syndrome, cardiac flutter, congestive cardiac failure, right ventricular failure, ventricular extrasystoles.

Ear and Labyrinth Disorders: Infrequent were ear pain, tinnitus. Rare were motion sickness, vertigo.

Endocrine, Metabolic, and Nutrition Disorders: Rare were diabetes mellitus, goiter, hypoglycemia, hypothyroidism.

Eye Disorders: Infrequent was conjunctivitis. Rare were cataract, conjunctival hemorrhage, visual disturbance.

Gastrointestinal Disorders: Frequent was abdominal pain. Infrequent were abdominal distention, constipation, diarrhea, dysgeusia, dysphagia, flatulence, gastritis, gastroesophageal reflux disease , vomiting. Rare were colitis, diverticulitis, gastric ulcer, irritable bowel syndrome, oral mucosal blistering, swollen tongue.

General Disorders: Frequent was fatigue. Infrequent were feeling jittery, lethargy, malaise, peripheral edema, pyrexia, temperature intolerance, thirst. Rare was difficulty in walking.

Hepatobiliary Disorders: Rare was biliary colic.

Infections and Infestations: Rare were kidney infection, pneumonia, sepsis, staphylococcal infection, viral myocarditis.

Musculoskeletal and Connective Tissue: Infrequent were arthralgia, back pain, muscular weakness, myalgia, sensation of heaviness.

Nervous System Disorders: Infrequent were burning sensation, disturbance of attention, insomnia, mental impairment, tremor. Rare were aphasia, facial palsy, impairment of psychomotor skills, sedation.

Psychiatric Disorders: Infrequent were anxiety, depression, irritability, nervousness. Rare were disorientation, panic attack.

Renal and Urinary Disorders: Infrequent was nephrolithiasis. Rare was renal insufficiency.

Respiratory, Thoracic, and Mediastinal: Infrequent were asthma, cough, dyspnea, oropharyngeal swelling. Rare was pleurisy.

Skin and Subcutaneous Disorders: Infrequent were facial swelling, hyperhydrosis, pruritus, rash, urticaria. Rare was systemic lupus erythematosus.

Vascular Disorders: Infrequent were flushing, hot flush, hypertension. Rare were epistaxis, peripheral coldness.

Drug Abuse And Dependence

The potential for abuse with TREXIMET has not been studied.

One clinical study with sumatriptan succinate injection enrolling 12 patients with a history of substance abuse failed to induce subjective behavior and/or physiologic response ordinarily associated with drugs that have an established potential for abuse.

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

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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.


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