Foster Adverse Reactions

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 two 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 (≥ 1/1,000 and <1/100), rare (≥ 1/10,000 <1/1,000) and very rare (≤1/10,000).
Common and uncommon ADRs were derived clinical trials in asthmatic and COPD patients. (See table.)

Click on icon to see table/diagram/image

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 the product. Symptomatic candidiasis can be treated with topical anti-fungal therapy whilst continuing the treatment with Foster.
Systemic effects of inhaled corticosteroids (e.g. 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.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.