The following adverse events have been reported with NSAIDs and with naproxen: Gastrointestinal:
Inflammation bleeding (sometimes fatal, particularly in the elderly), ulceration, perforation and obstruction of the upper or lower gastrointestinal tract. (See Warnings and Precautions). Oesophagitis, gastritis, pancreatitis, stomatitis. Exacerbation of ulcerative colitis and Crohn's disease (See Warnings and Precautions). Heartburn, dyspepsia, abdominal pain, nausea, vomiting, diarrhoea, flatulence, constipation, haematemesis, melaena.
Blood and Lymphatic System Disorders:
agranulocytosis, aplastic anemia, eosinophilia, hemolytic anemia, leucopenia, thrombocytopenia.
Immune System Disorders:
Metabolic and Nutrition Disorders:
depression, dream abnormalities, insomnia.
Nervous System Disorders:
dizziness, drowsiness, headache, lightheadedness, retrobulbar optic neuritis, convulsions, cognitive dysfunction, inability to concentrate.
visual disturbances, corneal opacity, papillitis, papilloedema.
Ear and Labyrinth Disorders:
hearing impairment, hearing disturbances, tinnitus, vertigo.
palpitations, cardiac failure has been reported in association with NSAID treatment,- congestive heart failure.
Clinical trial and epidemiological data suggest that use of coxibs and some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Although data suggests that the use of naproxen (1000 mg/d) may be associated with a lower risk some risk cannot be excluded.
Respiratory, Thoracic and Mediastinal Disorders:
dyspnea, pulmonary edema, asthma, eosinophilic pneumonitis.
hepatitis (some cases of hepatitis have been fatal), jaundice.
Skin and Subcutaneous Tissue Disorders:
ecchymoses, itching (pruritus), purpura, skin eruptions, sweating, alopecia, epidermal necrolysis, very rarely toxic epidermal necrolysis, erythema multiforme, bullous reactions, including Stevens-Johnson syndrome, erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, skin rashes, SLE, urticaria, photosensitivity reactions, including rare cases resembling porphyria cutanea tarda ("pseudoporphyria") or epidermolysis bullosa and angioneurotic edema. If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored.
Musculoskeletal and Connective Tissue Disorders:
myalgia, muscle weakness.
Renal and Urinary Disorders:
hematuria, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, renal papillary necrosis.
Reproductive System and Breast Disorders:
General Disorders and Administration Site Conditions:
oedema, thirst, pyrexia (chills and fever), malaise.
abnormal liver function tests, raised serum creatinine.