Hypersensitivity reactions to NSAIDs 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, dyspnoea; (c) Various skin reactions, e.g. pruritus, urticaria, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. There is insufficient data to exclude such a risk for flurbiprofen oromucosal spray, solution.
The following list of adverse effects relates to those experienced with flurbiprofen at OTC doses for short-term use. (Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to <1/100), Rare (≥1/10000 to <1/1000), Very rare (<1/10000), not known (cannot be estimated from the available data)).
Blood and lymphatic system disorders: Not known: anaemia, thrombocytopenia.
Cardiovascular and cerebrovascular disorders: Not known: Oedema, hypertension, cardiac failure.
Nervous System disorders: Common: dizziness, headache, paresthesia. Uncommon: somnolence.
Respiratory, thoracic and mediastinal disorders: Common: throat irritation. Uncommon: exacerbation of asthma and bronchospasm, dyspnoea, wheezing, oropharyngeal blistering, pharyngeal hypoaesthesia.
Gastrointestinal disorders: Common: diarrhoea, mouth ulceration, nausea, oral pain, paraesthesia oral, oropharyngeal pain, oral discomfort (warm or burning feeling or tingling of the mouth). Uncommon: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossodynia, dysgeusia, oral dysaesthesia, vomiting.
Skin and subcutaneous tissue disorders: Uncommon: various skin rashes, pruritus. Not known: severe forms of skin reaction such as bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
General disorders and administration site conditions: Uncommon: pyrexia, pain.
Immune System disorders: Rare: anaphylactic reaction.
Psychiatric disorders: Uncommon: insomnia.
Hepatobiliary disorders: Not known: hepatitis.