IbuprofenHypersensitivity reactions have been reported following treatment with ibuprofen and these may consist of:(a) Non-specific allergic reaction and anaphylaxis.(b) Respiratory tract reactivity, e.g. asthma, aggravated asthma, bronchospasm or dyspnoea.(c) Various skin reactions, e.g. pruritis, urticaria, angioedema and, more rarely, exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).The following list of adverse effects relates to those experienced with ibuprofen at OTC doses, for short-term use. In the treatment of chronic conditions, under long-term treatment, additional effects may occur.
Hypersensitivity reactionsUncommon: 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.
GastrointestinalThe most commonly-observed adverse events are gastrointestinal in nature.Uncommon: Abdominal pain, nausea and dyspepsia.Rare: Diarrhoea, flatulence, constipation and vomiting.Very rare: Peptic ulcer, perforation and gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis, gastritis and mouth ulceration.Exacerbation of colitis and Crohn's disease (see Section 4.4).
Nervous SystemUncommon: Headache, dizziness and tinnitus.Very rare: Aseptic meningitis - single cases have been reported very rarely.
RenalVery rare: Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema.
HepaticVery rare: Liver disorders.
HaematologicalVery 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.
DermatologicalUncommon: 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 SystemIn patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation, have been observed (see Section 4.4).
Cardiovascular and CerebrovascularOedema, hypertension and cardiac failure have been reported in association with NSAID treatment.Clinical trial and epidemiological data suggest that use of ibuprofen, 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 Section 4.4).
PhenylephrineHigh blood pressure with headache and vomiting, probably only in overdose. Rarely, palpitations.Also, rare reports of allergic reactions and occasionally urinary retention in males.