Hypersensitivity reactions have been reported and these may consist of: (a) Non-specific allergic reactions and anaphylaxis; (b) respiratory tract reactivity e.g. asthma, aggravated asthma, bronchospasm, dyspnea; or (c) various skin reactions e.g. pruritus, urticaria, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Hypersensitivity Reactions: Uncommon: Hypersensitivity reactions with urticaria and pruritus. Very rare: Severe hypersensitivity reactions. Symptoms could be facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Exacerbation of asthma and bronchospasm.
Gastrointestinal: The most commonly observed adverse events are gastrointestinal in nature. Uncommon: Abdominal pain, nausea, dyspepsia. Rare: Diarrhoea, flatulence, constipation and vomiting. Very rare: Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis, gastritis. Exacerbation of colitis and Crohn's disease (see Precautions).
Nervous System: Uncommon: Headache. Very rare: Aseptic meningitis - single cases have been reported very rarely.
Renal: Very rare:Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema.
Hepatic: Very rare: Liver disorders.
Haematological: Very rare: Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.
Dermatological: Uncommon: Various skin rashes. very rare: Severe forms of skin reactions such as bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis can occur.
Immune System: In patients with existing autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of asepti meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed (see Precautions).
Cardiovascular and Cerebrovascular: Oedema, hypertension and cardiac failure, have been reported in association with NSAID treatment. Clinical trial and epidemiological data suggest that the use of NSAIDs (particularly at high doses 2400 mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see Precautions).