Symbicort Adverse Reactions

Turbuhaler: Since SYMBICORT contains both budesonide and formoterol, the same pattern of adverse reactions as reported for these substances may occur. No increased incidence of adverse reactions has been seen following concurrent administration of the two compounds. The most common drug-related adverse reactions are pharmacologically predictable side effects of beta₂-agonist therapy, such as tremor and palpitations. These tend to be mild and usually disappear within a few days of treatment. In a 3-year clinical trial with budesonide in COPD, skin bruises and pneumonia occurred at a frequency of 10% and 6%, respectively, compared with 4% and 3% in the placebo group (p<0.001 and p<0.01, respectively) (Turbuhaler 160/4.5 mcg/dose).
Adverse reactions which have been associated with budesonide or formoterol, are given as follows, listed by frequency and system organ class. (See Table 4.)


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As with other inhalation therapy, paradoxical bronchospasm may occur in very rare cases (see Precautions).
Systemic effects of inhaled corticosteroids may occur particularly at high doses prescribed for prolonged periods. These may include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.
Treatment with beta₂-agonists may result in an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies.
Rapihaler: Since Symbicort Rapihaler contains both budesonide and formoterol, the same type and intensity of undesirable effects as reported for these substances may occur. No increased incidence of adverse reactions has been seen following concurrent administration of the two compounds. The most common drug related adverse reactions are pharmacologically predictable side effects of beta₂-agonist therapy, such as tremor and palpitations. These tend to be mild and disappear within a few days of treatment.
In the clinical program comparing Symbicort Rapihaler with Symbicort Turbuhaler, 679 adults and adolescents (Study 681 and Study 715) were exposed to Symbicort Rapihaler 800/24 μg daily with a median duration of 359 days and a range of 1 to 427 days.
There were no apparent differences in the overall pattern of AE's between the Symbicort Rapihaler and Symbicort Turbuhaler groups in the clinical program. The AEs were generally mild to moderate in intensity and the pattern was that usually seen in a population with persistent asthma and dominated by symptoms of upper respiratory events.
Overall, the AE profile was similar for patients receiving Symbicort Rapihaler and Symbicort Turbuhaler with regard to total daily dose, age, sex and ethnic group and no new safety concerns were identified with Symbicort Rapihaler.
If oropharyngeal candidiasis develops, it may be treated with appropriate anti-fungal therapy whilst still continuing with Symbicort therapy. The incidence of candidiasis can generally be held to a minimum by having patients rinse their mouth out with water after inhaling their maintenance dose.
Adverse reactions, which have been associated with budesonide or formoterol, are given as follows: see Table 5.


Click on icon to see table/diagram/image


As with other inhalation therapy, paradoxical bronchospasm may occur in very rare cases.
Systemic effects of inhaled corticosteroids may occur particularly at high doses prescribed for prolonged periods.
Treatment with beta₂-agonists may result in an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies.