Gastrointestinal effects: The most frequently observed side effects are of a gastrointestinal nature. Peptic ulcers, perforations or gastrointestinal bleeding, sometimes fatal, may occur, particularly in the elderly.
Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, ulcerative stomatitis, abdominal pain, melaena, haematemesis, exacerbation of recto-colitis or Crohn's disease have been reported following administration of NSAIDs. Less frequently, gastritis has been observed.
Cardiovascular effects: Edema, hypertension and heart failure have been reported in association with NSAID treatment.
Rarely have been reported: Increased blood pressure, tachycardia, chest pain, arrhythmia, palpitations, hypotension, congestive heart failure.
Hypersensitivity reactions: Respiratory: possibility of occurrence of an asthma attack, in particular in subjects allergic to aspirin and other non-steroidal anti-inflammatory drugs.
Skin reactions: Very rarely bullous reactions (including Stevens-Johnson syndrome and Lyell's syndrome) have been observed.
Also reported: Rash, urticaria and aggravation of chronic urticaria, pruritus, purpura.
Cases of photosensitization have been exceptionally reported.
Biological changes: Liver: Transient and minimal elevation of serum transaminases.
Central Nervous System Effects: Headaches, slight feelings of dizziness and fatigue have been reported.
Kidney effects: Water and sodium retention, hyperkalaemia.
Functional acute renal failure (ARF) in patients with risk factors.
Organic kidney damage that may result in an ARF: Isolated cases of interstitial nephritis, acute tubular necrosis, nephrotic syndrome, papillary necrosis have been reported.
Cardiovascular thromboembolic risk (see also Precautions).
"Any adverse drug reactions should be immediately reported to the physician".
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