Treximet Side Effects

Please note - some side effects for Treximet may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Treximet - for the Consumer

Treximet

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Treximet:

Constipation; diarrhea; dizziness; drowsiness; gas; heartburn; mild feeling of heaviness or pressure; mild numbness or tingling of the skin; nausea; stomach upset; tiredness; warm/hot sensation.

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; bloody or black, tarry stools; change in the amount of urine produced; chest, neck, or jaw pain, tightness, or pressure; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; loss of vision or other vision changes; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe or prolonged flushing; severe vomiting; shortness of breath; slurred speech or other speech changes; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; very cold or blue fingers or toes; vomit that looks like coffee grounds; wheezing; yellowing of the skin or eyes.

Treximet Side Effects - for the Professional

Treximet

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.

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.

Infrequent was lymphadenopathy. Rare were anemia, ecchymosis, leukopenia.

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

Infrequent were ear pain, tinnitus. Rare were motion sickness, vertigo.

Rare were diabetes mellitus, goiter, hypoglycemia, hypothyroidism.

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

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.

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

Rare was biliary colic.

Rare were kidney infection, pneumonia, sepsis, staphylococcal infection, viral myocarditis.

Infrequent were arthralgia, back pain, muscular weakness, myalgia, sensation of heaviness.

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

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

Infrequent was nephrolithiasis. Rare was renal insufficiency.

Infrequent were asthma, cough, dyspnea, oropharyngeal swelling. Rare was pleurisy.

Infrequent were facial swelling, hyperhydrosis, pruritus, rash, urticaria. Rare was systemic lupus erythematosus.

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

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