The most common adverse reaction is tremor. In a 12-week clinical trial with Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster Nexthaler), tremor was seen only with the highest dose regimen (2 inhalations bid), appeared most frequently at the beginning of treatment and was mild in intensity. No patient was withdrawn from the trial as a result of tremor.
Clinical Trials Experience in asthma patients: The safety of Foster Nexthaler was assessed in active- and placebo-controlled clinical trials in which 719 patients aged 12 and older with asthma of varying severity were exposed to the drug. The incidence of adverse reactions in the table as follows relates to asthmatic patients aged 12 years and older and is based upon the safety findings of two pivotal clinical trials where Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster Nexthaler) was administered at the doses recommended in this monograph for a period of 8-12 weeks. No psychiatric disorders were observed in the clinical trials with Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster Nexthaler) but they are included in the table as a potential class-effect of inhaled corticosteroids.
Undesirable effects which have been associated with beclometasone dipropionate and formoterol administered as a fixed combination are given as follows, listed by system organ class. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000), not known (cannot be estimated from the available data). (See table.)
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Among the observed adverse reactions those typically associated with formoterol are: tremor, headache, tachycardia, sinus bradycardia, angina pectoris, myocardial ischaemia, QT prolongation.
Among the observed adverse reactions those typically associated with beclometasone dipropionate are: nasopharyngitis, oral candidiasis, dysphonia, throat irritation, irritability, cortisol free urine decreased, blood cortisol decreased, blood glucose increased.
Additional adverse reactions not observed in the clinical experience with Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster Nexthaler) but typically associated with the inhaled administration of beclometasone dipropionate are other oral fungal infections. Taste disturbances have occasionally been reported during inhaled corticosteroid therapy.
See Precautions for measures to minimize the occurrence of oral fungal infections, oral candidiasis and dysphonia.
Systemic effects of inhaled corticosteroids (e.g. beclometasone dipropionate) may occur particularly when administered at high doses prescribed for prolonged periods, these may include Cushing's Syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, growth retardation in children and adolescents, cataract and glaucoma (see also Precautions).
Additional adverse reactions not observed in the clinical experience with therapeutic doses of Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster Nexthaler) but typically associated with the administration of beta2-agonist such as formoterol are palpitations, atrial fibrillation, ventricular extrasystoles, tachyarrhythmia, potentially serious hypokalaemia and increase/decrease of blood pressure. Insomnia, dizziness, restlessness, and anxiety have occasionally been reported during inhaled formoterol therapy. Formoterol may also induce muscle cramps, myalgia.
Hypersensitivity reactions including rashes, urticaria, pruritus and erythema and oedema of the eye, face, lips and throat (angioedema) have been reported.
As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing, cough and shortness of breath after dosing (see also Precautions).
Paediatric population: There is no information on the safety of Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster Nexthaler) in children up to 11 years of age, and only limited information in adolescents 12-17 years of age. In a 12 weeks randomised clinical trial in adults and adolescents, 162 adolescents aged 12-17 years with moderate to severe asthma received Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster Nexthaler) or the corresponding pressurised inhalation solution formulation, 1 or 2 inhalations bid; the frequency, type and severity of adverse drug reactions were not different in adolescents compared to adults.
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.