According to the FDA, the following serious adverse reactions of naproxen are discussed in greater detail in other sections:
- indigestion, heartburn, stomach pain, nausea
- headache, dizziness, drowsiness
- bruising, itching, rash
- swelling or ringing in your ears.
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.
In controlled clinical trials with about 80 pediatric patients and in wellmonitored, 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 reporte
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: eosinophila, 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 erythematosus, 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, hypotension, myocardial infarction
Gastrointestinal: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, glossitis, eructation syncope, arrhythmia
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
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