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.

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Treximet:

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, throat, 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; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; loss of appetite; loss of vision or other vision changes; mental or mood changes (eg, depression); numbness of an arm or leg; one-sided weakness; pale stools; 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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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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.

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

aEvents 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.
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

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.

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Side Effects by Body System - for Healthcare Professionals

Nervous system

Nervous system side effects including dizziness (4%), somnolence (3%), and paresthesia have been reported. Burning sensation, disturbance of attention, insomnia, mental impairment, and tremor have been reported infrequently. Aphasia, facial palsy, impairment of psychomotor skills, and sedation have been reported rarely.

Gastrointestinal

Gastrointestinal side effects including nausea (3%), dyspepsia (2%), and dry mouth (2%) have been reported. Abdominal pain has been reported frequently. Abdominal distention, constipation, diarrhea, dysgeusia, dysphagia, flatulence, gastritis, gastroesophageal reflux disease, and vomiting have been reported infrequently. Colitis, diverticulitis, gastric ulcer, irritable bowel syndrome, oral mucosal blistering, and swollen tongue have been reported rarely.

Other

Other side effects including chest discomfort/chest pain (3%) and neck/throat/jaw pain/tightness/pressure (3%) have been reported. Flushing, hot flushes, ear pain, and tinnitus have been reported infrequently. Pneumonia, sepsis, staphylococcal infection, epistaxis, peripheral coldness, motion sickness, and vertigo have been reported rarely.

General

General side effects including fatigue have been reported frequently. Feeling jittery, lethargy, malaise, peripheral edema, pyrexia, temperature intolerance, and thirst has been reported infrequently. Difficulty in walking has been reported rarely.

Hematologic

Hematologic side effects including lymphadenopathy, anemia, ecchymosis, and leukopenia have been reported infrequently.

Ocular

Ocular side effects including conjunctivitis have been reported infrequently. Cataract, conjunctival hemorrhage, and visual disturbance have been reported rarely.

Psychiatric

Psychiatric side effects including anxiety, depression, irritability, and nervousness have been reported infrequently. Disorientation and panic attack have been reported rarely.

Renal

Renal side effects including nephrolithiasis have been reported infrequently. Renal insufficiency has been reported rarely.

Dermatologic

Dermatologic side effects including facial swelling, hyperhidrosis, pruritus, rash, and urticaria have been reported infrequently. Systemic lupus erythematosus has been reported rarely.

Cardiovascular

Cardiovascular side effects including tachycardia and hypertension have been reported infrequently. Acute coronary syndrome, cardiac flutter, congestive cardiac failure, right ventricular failure, viral myocarditis, and ventricular extrasystoles have been reported rarely.

Musculoskeletal

Musculoskeletal side effects including arthralgia, back pain, muscular weakness, myalgia, and a sensation of heaviness have been reported infrequently.

Respiratory

Respiratory side effects including asthma, cough, dyspnea, and oropharyngeal swelling have been reported infrequently. Pleurisy has been reported rarely.

Metabolic

Metabolic side effects including hypoglycemia and diabetes mellitus have been reported rarely.

Endocrine

Endocrine side effects including goiter and hypothyroidism have been reported rarely.

Hepatic

Hepatic side effects including biliary colic have been reported rarely.

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