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The following adverse events have been reported with NSAIDs: Gastrointestinal: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohns disease have been reported following administration. Less frequently, gastritis, has been observed.
Hypersensitivity: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of: non specific allergic reactions and anaphylaxis;
respiratory tract reactivity comprising asthma, bronchospasms or dyspnoea, or;
assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Cardiovascular: Oedema has been reported in association with NSAID treatment.
Other adverse events reported less commonly include: Renal: Nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome and renal failure.
Hepatic: Abnormal liver function, hepatitis and jaundice.
Neurological & special senses: Visual disturbances, optic neuritis, headaches, paraesthesia, reports of aseptic meningitis (especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation, depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise, fatigue and drowsiness.
Haematological: Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.
Dermatological: Occasional: rashes or skin eruptions cases of hair loss, bullous eruptions, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), and photosensitivity reactions have been reported.
Cardiac Disorders: Uncommon*: Myocardial infarction, cardiac failure, palpitations, chest pain.
*The frequency reflects data from long-term treatment with a high dose (150mg/day).
Description of selected adverse drug reactions: Arteriothrombotic events: Meta-analysis and pharmacoepidemiological data point towards an increased risk of arteriothrombotic events (for example myocardial infarction) associated with use of diclofenac, particularly at a high dose (150mg daily) and during long-term treatment (see PRECAUTIONS).
