As Foster 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 (Foster) 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 <1/1000) and very rare (≤1/10,000).
Common and uncommon adverse reactions were derived from clinical trials in asthmatic and COPD patients.
Infections and Infestations:
Common: Pharyngitis, oral candidiasis. Uncommon: Influenza, oral fungal infection, oropharyngeal and oesophageal candidiasis, vulvovaginal candidiasis, gastroenteritis, sinusitis rhinitis, pneumonia*.
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. Unknown*: Psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioural changes (predominantly in children).
Nervous System Disorders:
Common: Headache. Uncommon: Tremor, dizziness.
Very Rare: Glaucoma, cataract.
Ear and Labyrinth Disorders:
Uncommon: Palpitations, prolonged electrocardiogram QT corrected interval, electrocardiogram change, tachycardia, tachyarrhythmia, atrial fibrillation*. Rare: Ventricular extrasystoles, angina pectoris.
Uncommon: Hyperaemia, flushing.
Respiratory, Thoracic and Mediastinal Disorders:
Common: Dysphonia. Uncommon: Cough, productive cough, throat irritation, asthmatic crisis. Rare: Bronchospasm paradoxical. 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, urticaria. Rare: Angioedema.
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 and blood ketone body, decreased blood cortisol*. Rare: Increased or decreased blood pressure. Very Rare: Decreased bone density.
*One related non serious case of pneumonia was reported by one patient treated with Foster in a pivotal clinical trial in COPD patients. Other adverse reactions observed with Foster in COPD clinical trials were: Reduction of blood cortisol and atrial fibrillation.
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, oral candidiasis, dysphonia, throat irritation. Dysphonia and candidiasis may be relieved by gargling or rinsing the mouth with water or brushing the teeth after using Foster. Symptomatic candidiasis can be treated with topical antifungal therapy whilst continuing the treatment with Foster.
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 (see Precautions).
Hypersensitivity reactions including rash, urticaria pruritus, erhythema and oedema of the eyes, face, lips and throat may also occur.