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Naprelan Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Naprelan (naproxen sodium) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis and acute gout. Naprelan is also used in the relief of mild to moderate pain and the treatment of primary dysmenorrhea. Common side effects of Naprelan include headache, flu-like symptoms, upset stomach, indigestion/heartburn, nausea, diarrhea, constipation, gas, skin itching or rash, dizziness, drowsiness, insomnia, ringing in your ears, or vision problems.
The recommended starting dose of Naprelan in adults depends on the condition being treated, but ranges from two 375 mg tablets (750 mg) once daily, or two 500 mg tablets (1000 mg) once a daily. Naprelan may interact with aspirin, diuretics, lithium, methotrexate, or warfarin. Tell your doctor all medications and supplements you use. During pregnancy, Naprelan should be used only if prescribed. It should be avoided in late pregnancy because it may harm the fetus. Naprelan passes into breast milk. It is not recommended for use while breastfeeding.
Our Naprelan (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 Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Naprelan FDA Prescribing Information: Side Effects
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
- GI Bleeding, Ulceration and Perforation [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
- Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
- Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
- Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
- Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]
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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
As with all drugs in this class, the frequency and severity of adverse events depends on several factors: the dose of the drug and duration of treatment; the age, the sex, physical condition of the patient; any concurrent medical diagnoses or individual risk factors. The following adverse reactions are divided into three parts based on frequency and whether or not the possibility exists of a causal relationship between drug usage and these adverse events. In those reactions listed as “Probable Causal Relationship” there is at least one case for each adverse reaction where there is evidence to suggest that there is a causal relationship between drug usage and the reported event. The adverse reactions reported were based on the results from two double-blind controlled clinical trials of three months duration with an additional nine month open-label extension. A total of 542 patients received NAPRELAN Tablets either in the double-blind period or in the nine month open-label extension. Of these 542 patients, 232 received NAPRELAN Tablets, 167 were initially treated with Naprosyn®*** and 143 were initially treated with placebo. Adverse reactions reported by patients who received NAPRELAN Tablets are shown by body system. Those adverse reactions observed with naproxen but not reported in controlled trials with NAPRELAN Tablets are italicized.
The most frequent adverse events from the double-blind and open-label clinical trials were headache (15%), followed by dyspepsia (14%), and flu syndrome (10%). The incidence of other adverse events occurring in 3% - 9% of the patients are marked with an asterisk.
Those reactions occurring in less than 3% of the patients are unmarked.
Incidence greater than 1% (probable causal relationship)
Body as a Whole-Pain (back)*, pain*, infection*, fever, injury (accident), asthenia, pain chest, headache (15%), flu syndrome (10%).
Dermatologic-Skin rash*, skin eruptions*, ecchymoses*, purpura.
Metabolic and Nutrition-Peripheral edema, hyperglycemia.
Central Nervous System-Dizziness, paresthesia, insomnia, drowsiness*, lightheadedness.
Cardiovascular-Hypertension, edema*, dyspnea*, palpitations.
Special Senses-Tinnitus*, hearing disturbances, visual disturbances.
Incidence less than 1% (probable causal relationship)
Gastrointestinal-Anorexia, cholecystitis, cholelithiasis, eructation, GI hemorrhage, rectal hemorrhage, stomatitis aphthous, stomatitis ulcer, ulcer mouth, ulcer stomach, periodontal abscess, cardiospasm, colitis, esophagitis, gastroenteritis, GI disorder, rectal disorder, tooth disorder, hepatosplenomegaly, liver function abnormality, melena, ulcer esophagus, hematemesis, jaundice, pancreatitis, necrosis.
Renal-Dysmenorrhea, dysuria, kidney function abnormality, nocturia, prostate disorder, pyelonephritis, carcinoma breast, urinary incontinence, kidney calculus, kidney failure, menorrhagia, metrorrhagia, neoplasm breast, nephrosclerosis, hematuria, pain kidney, pyuria, urine abnormal, urinary frequency, urinary retention, uterine spasm, vaginitis, glomerular nephritis, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, renal papillary necrosis.
Central Nervous System-Depression, anxiety, hypertonia, nervousness, neuralgia, neuritis, vertigo, amnesia, confusion, co-ordination, abnormal diplopia, emotional lability, hematoma subdural, paralysis, dream abnormalities, inability to concentrate, muscle weakness.
Dermatologic: Angiodermatitis, herpes simplex, dry skin, sweating, ulcer skin, acne, alopecia, dermatitis contact, eczema, herpes zoster, nail disorder, skin necrosis, subcutaneous nodule, pruritus, urticaria, neoplasm skin, photosensitive dermatitis, photosensitivity reactions resembling porphyria cutaneous tarda, epidermolysis bullosa.
Cardiovascular-Angina pectoris, coronary artery disease, myocardial infarction, deep thrombophlebitis, vasodilation, vascular anomaly, arrhythmia, bundle branch block, abnormal ECG, heart failure right, hemorrhage, migraine, aortic stenosis, syncope, tachycardia, congestive heart failure.
Metabolic and Nutrition-Creatinine increase, glucosuria, hypercholesteremia, albuminuria, alkalosis, BUN increased, dehydration, edema, glucose tolerance decrease, hyperuricemia, hypokalemia, SGOT increase, SGPT increase, weight decrease.
General-Anaphylactoid reactions, angioneurotic edema, menstrual disorders, hypoglycemia, pyrexia (chills and fevers).
Incidence less than 1% (causal relationship unknown)
Other adverse reactions listed in the naproxen package label, but not reported by those who received NAPRELAN Tablets are shown in italics. These observations are being listed as alerting information to the physician.
Hematologic-Aplastic anemia, hemolytic anemia.
Central Nervous System-Aseptic meningitis, cognitive dysfunction.
Dermatologic-Epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome.
Gastrointestinal-Non-peptic GI ulceration, ulcerative stomatitis.
Read the entire FDA prescribing information for Naprelan (Naproxen Sodium)
Additional Naprelan Information
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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