Symbicort Adverse Reactions

Since Symbicort 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 β₂ agonist therapy, such as tremor and palpitations. These tend to be mild and usually disappear within a few days of treatment.
Turbuhaler: 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).
Adverse reactions, which have been associated with budesonide or formoterol, are given in Table 10, listed by system organ class and frequency. Frequency is defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10000 and <1/1000) and very rare (<1/10000). (See Table 10.)

Click on icon to see table/diagram/image

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 (see Precautions).
Treatment with β₂ agonists may result in an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies.
The excipient lactose contains small amounts of milk proteins. These may cause allergic reactions.
Rapihaler: Adverse reactions, which have been associated with budesonide or formoterol, are given in Table 11. (See Table 11.)

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 β₂ agonists may result in an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies.