Naproxenside effects

The following serious adverse reactions are described below and elsewhere in labeling: Cardiovascular Thrombotic Events GI Bleeding, Ulceration and Perforation Arrhythmias Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure Cerebrovascular Events Other Vasospasm Reactions Hepatotoxicity Hypertension Heart Failure and Edema Medication Overuse Headache Serotonin Syndrome Renal Toxicity and Hyperkalemia Anaphylactic Reactions Serious Skin Reactions Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Hematological Toxicity Exacerbation Asthma Related to Aspirin Sensitivity Seizures The most common adverse reactions (incidence ≥ 2%) were: Adults: Dizziness, somnolence, nausea, chest discomfort/chest pain, neck/throat/jaw pain/tightness/pressure, paresthesia, dyspepsia, dry mouth.

Pediatrics: Hot flush (i.e., hot flash[es]) and muscle tightness. To report SUSPECTED ADVERSE REACTIONS, contact NorthStar RxLLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 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 sumatriptan and naproxen sodium tablets 85 mg/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 sumatriptan and naproxen sodium tablets 85 mg/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 Sumatriptan and Naproxen Sodium Tablets 85 mg/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 sumatriptan and naproxen sodium tablets 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 sumatriptan and naproxen sodium tablets 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 sumatriptan and naproxen sodium tablets 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 Sumatriptan and Naproxen Sodium Tablets 10/60 mg % (n = 96) Sumatriptan and Naproxen Sodium Tablets 30/180 mg % (n = 97) Sumatriptan and Naproxen Sodium Tablets 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

6.2 Postmarketing

Experience The following adverse reactions have been identified during post-approval use of NSAIDs, such as naproxen, which is a component of sumatriptan and naproxen sodium tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin and Appendages: exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and fixed drug eruption (FDE).