OverviewDosageSide EffectsInteractionsHalf-Life

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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