Drug Information for Naproxen Tablets USPNaproxen Sodium Tablets USP (Altura Pharmaceuticals, Inc.): ADVERSE REACTIONS

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  • Adverse reactions reported in controlled clinical trials in 960 patients treated for rheumatoid arthritis or osteoarthritis are listed below. In general, reactions in patients treated chronically were reported 2 to 10 times more frequently than they were in short-term studies in the 962 patients treated for mild to moderate pain or for dysmenorrhea. The most frequent complaints reported related to the gastrointestinal tract.

    A clinical study found gastrointestinal reactions to be more frequent and more severe in rheumatoid arthritis patients taking daily doses of 1500 mg naproxen compared to those taking 750 mg naproxen (see CLINICAL PHARMACOLOGY).

    In controlled clinical trials with about 80 pediatric patients and in well-monitored, open-label studies with about 400 pediatric patients with juvenile arthritis treated with naproxen, the incidence of rash and prolonged bleeding times were increased, the incidence of gastrointestinal and central nervous system reactions were about the same, and the incidence of other reactions were lower in pediatric patients than in adults.

    In patients taking naproxen in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are:

    Gastrointestinal (GI) Experiences, including: heartburn*, abdominal pain*, nausea*, constipation*, diarrhea, dyspepsia, stomatitis

    Central Nervous System: headache*, dizziness*, drowsiness*, lightheadedness, vertigo

    Dermatologic: pruritus (itching)*, skin eruptions*, ecchymoses*, sweating, purpura

    Special Senses: tinnitus*, visual disturbances, hearing disturbances

    Cardiovascular: edema*, palpitations

    General: dyspnea*, thirst

    *Incidence of reported reaction between 3% and 9%. Those reactions occurring in less than 3% of the patients are unmarked.

    In patients taking NSAIDs, the following adverse experiences have also been reported in

    approximately 1% to 10% of patients.

    Gastrointestinal (GI) Experiences, including: flatulence, gross bleeding/perforation, GI ulcers (gastric/duodenal), vomiting

    General: abnormal renal function, anemia, elevated liver enzymes, increased bleeding time, rashes

    The following are additional adverse experiences reported in <1% of patients taking naproxen during clinical trials and through postmarketing reports. Those adverse reactions observed through postmarketing reports are italicized.

    Body as a Whole: anaphylactoid reactions, angioneurotic edema, menstrual disorders, pyrexia (chills and fever)

    Cardiovascular: congestive heart failure, vasculitis, hypertension, pulmonary edema

    Gastrointestinal: gastrointestinal bleeding and/or perforation, hematemesis, pancreatitis, vomiting, colitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn’s disease), nonpeptic gastrointestinal ulceration, ulcerative stomatitis, esophagitis, peptic ulceration

    Hepatobiliary: jaundice, abnormal liver function tests, hepatitis (some cases have been fatal)

    Hemic and Lymphatic: eosinophilia, leucopenia, melena, thrombocytopenia, agranulocytosis, granulocytopenia, hemolytic anemia, aplastic anemia

    Metabolic and Nutritional: hyperglycemia, hypoglycemia

    Nervous System: inability to concentrate, depression, dream abnormalities, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis, cognitive dysfunction, convulsions

    Respiratory: eosinophilic pneumonitis, asthma

    Dermatologic: alopecia, urticaria, skin rashes, toxic epidermal necrolysis, erythema multiforme, erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, systemic lupus erythematoses, bullous reactions, including Stevens-Johnson syndrome, photosensitive dermatitis, photosensitivity reactions, including rare cases resembling porphyria cutanea tarda (pseudoporphyria) or epidermolysis bullosa. If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored.

    Special Senses: hearing impairment, corneal opacity, papillitis, retrobulbar optic neuritis, papilledema

    Urogenital: glomerular nephritis, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, renal papillary necrosis, raised serum creatinine

    Reproduction (female): infertility

    In patients taking NSAIDs, the following adverse experiences have also been reported in <1% of patients.

    Body as a Whole: fever, infection, sepsis, anaphylactic reactions, appetite changes, death

    Cardiovascular: hypertension, tachycardia, syncope, arrhythmia, hypotension, myocardial infarction

    Gastrointestinal: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, glossitis, eructation

    Hepatobiliary: hepatitis, liver failure

    Hemic and Lymphatic: rectal bleeding, lymphadenopathy, pancytopenia

    Metabolic and Nutritional: weight changes

    Nervous System: anxiety, asthenia, confusion, nervousness, paresthesia, somnolence, tremors, convulsions, coma, hallucinations

    Respiratory: asthma, respiratory depression, pneumonia

    Dermatologic: exfoliative dermatitis

    Special Senses: blurred vision, conjunctivitis

    Urogenital: cystitis, dysuria, oliguria/polyuria, proteinuria

  • Drug Information Provided by National Library of Medicine (NLM).
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