Gastrointestinal:
Gastrointestinal disorders are the most commonly observed adverse events. 4 ‘Special warnings and precautions for use’). 4 ‘Special warnings and precautions for use’) have been reported. Less frequently, gastritis has been observed. Isolated cases of pancreatitis, oesophagitis, oesophageal ulcer, benign stricture of the oesophagus and small bowel obstruction have also been reported.
Hypersensitivity:
Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) associated skin disorders including rashes of various types, pruritus, urticaria, purpura, angioedema and more rarely exfoliative and bullous dermatoses (including Stevens Johnson syndrome, epidermal necrolysis and erythema multiforme).
Isolated cases of serum sickness, lymphadenopathy, vasculitis, systemic lupus erythematosus-like syndrome, eosinophilic pulmonary infiltrates and fever have also been reported.
Cardiovascular and cerebrovascular:
Oedema, hypertension and cardiac failure, have been reported in association with NSAID treatment. 4 ‘Special warnings and precautions for use’). Rare: congestive heart failure, pulmonary oedema. Isolated cases: hypertension, myocarditis, pericarditis.
Body as a whole:
Frequent: oedema, water / sodium retention.
Endocrine system:
Occasional: goitre, lowering of plasma thyroid hormone concentration. Isolated cases: hypothyroidism. 4 ‘Special warnings and precautions for use’), depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise and drowsiness.
Isolated cases: peripheral neuropathy, excitation, blurred vision, retinal haemorrhage, hearing loss.
Haematological:
Rare: anaemia due to occult gastrointestinal blood loss, haemolytic anaemia, thrombocytopenia, neutropenia, agranulocytosis, leucopenia, pancytopenia, bone marrow depression, aplastic anaemia.
Hepatic:
Rare: increase in serum transaminases, hepatitis and jaundice. Isolated cases: fulminant hepatitis. Frequency unknown: abnormal liver function. Renal Rare: impaired renal function, acute renal failure, haematuria, proteinuria. Isolated cases: acute tubular necrosis, acute interstitial nephritis, nephrotic syndrome, glomerulonephritis, papillary necrosis, ureteral obstruction with uric acid crystal formation.
Frequency unknown: nephrotoxicity in various forms.
Respiratory tract:
Isolated cases: exacerbation of bronchial asthma and of an “acute pulmonary syndrome” – marked by dyspnoea, fever, shadows in radiographs of the lungs and sometimes also by eosinophilia have been reported. Although a casual relationship with the latter has not been proven, the drug should be withdrawn at first signs of this potentially serious syndrome for the treatment of which corticosteroids and supportive cardiotherapy may be necessary.
Dermatological :
Very rare: bullous reactions including Stevens Johnson syndrome and toxic epidermal necrolysis. Frequency unknown: photosensitivity.
Others:
Occasional stomatitis. Rare: salivary gland enlargement, dry mouth. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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