As Innovair contains beclometasone dipropionate and formoterol fumarate dihydrate, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following concurrent administration of the 2 compounds.
Undesirable effects which have been associated with beclometasone dipropionate and formoterol administered as a fixed combination (Innovair) and as single agents are given as follows, listed by system organ class. Frequencies are defined as: Very common (1/10), common (1/100 and <1/10), uncommon (1/1000 and <1/100), rare (1/10,000 and <1/1000) and very rare (1/10,000).
Common and uncommon adverse drug reactions were derived from clinical trial data. The incidence on placebo was not taken into account.
Infections and Infestations:
Common: Pharyngitis. Uncommon: Influenza, oral fungal infection, pharyngeal and oesophageal candidiasis, vaginal candidiasis, gastroenteritis, sinusitis.
Blood and Lymphatic System Disorders:
Uncommon: Granulocytopenia. Very Rare: Thrombocytopenia.
Immune System Disorders:
Uncommon: Allergic dermatitis. Very Rare: Hypersensitivity reactions, including erythema, lips, face, eye and pharyngeal oedema.
Very Rare: Adrenal suppression.
Metabolism and Nutrition Disorders:
Uncommon: Hypokalaemia, hyperglycaemia.
Uncommon: Restlessness. Very Rare: Abnormal behaviour, sleep disorder, hallucination.
Nervous System Disorders:
Common: Headache. Uncommon: Tremor, dizziness.
Very Rare: Glaucoma, cataract.
Ear and Labyrinth Disorders:
Uncommon: Palpitations, prolonged ECG QT corrected interval, ECG change, tachycardia, tachyarrhythmia. Rare: Ventricular extrasystoles, angina pectoris. Very Rare: Atrial fibrillation.
Uncommon: Hyperaemia, flushing.
Respiratory, Thoracic and Mediastinal Disorders:
Common: Dysphonia. Uncommon: Rhinitis, cough, productive cough, throat irritation, asthmatic crisis. Rare: Paradoxical bronchospasm. Very Rare: Dyspnoea, exacerbation of asthma.
Uncommon: Diarrhoea, dry mouth, dyspepsia, dysphagia, burning sensation of the lips, nausea, dysgeusia.
Skin and Subcutaneous Tissue Disorders:
Uncommon: Pruritus, rash, hyperhidrosis. Rare: Urticaria, angioneurotic oedema.
Musculoskeletal, Connective Tissue and Bone Disorders:
Uncommon: Muscle spasms, myalgia. Very Rare: Growth retardation in children and adolescents.
Renal and Urinary Disorders:
General Disorders and Administration Site Conditions:
Very Rare: Peripheral oedema.
Uncommon: Increased C-reactive protein, platelet count, free fatty acids, blood insulin, blood ketone body. Rare: Increased or decreased blood pressure. Very Rare: Decreased bone density.
As with other inhalation therapy, paradoxical bronchospasm may occur (see Precautions).
Among the observed adverse reactions those typically associated with formoterol are: Hypokalaemia, headache, tremor, palpitations, cough, muscle spasms and prolongation of QTc interval.
Adverse reactions typically associated with the administration of beclometasone dipropionate are: Oral fungal infections and candidiasis, dysphonia, throat irritation. Dysphonia and candidiasis may be relieved by gargling or rinsing the mouth with water or brushing the teeth after using Innovair. Symptomatic candidiasis can be treated with topical antifungal therapy while continuing the treatment with Innovair.
Systemic effects of inhaled corticosteroids (eg, beclometasone dipropionate) may occur particularly when administered at high doses prescribed for prolonged periods, these may include adrenal suppression, decrease in bone mineral density, growth retardation in children and adolescents, cataract and glaucoma.
Hypersensitivity reactions including rash, urticaria pruritus, erhythema and oedema of the eyes, face, lips and throat may also occur.