Symbicort Turbuhaler Adverse Reactions

Since Symbicort Turbuhaler/Symbicort Forte Turbuhaler contains both budesonide and formoterol, the same pattern 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 adrenoceptor 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) (for 160/4.5 mcg and 320/9 mcg only).
Adverse reactions, which have been associated with budesonide or formoterol, are given as follows. (See Table 10.)

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 adrenoceptor 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.
160/4.5 mcg: Symbicort anti-inflammatory reliever therapy (SYGMA 1* and 2**): Overall, Symbicort anti-inflammatory reliever therapy is generally well tolerated, based on the frequency and nature of adverse effects. No new safety concerns were identified for the use of Symbicort Turbuhaler 160/4.5 mcg as needed in a mild asthma population.
_{*SYGMA 1 = Inhaled Combined Budesonide-Formoterol as Needed in Mild Asthma
**SYGMA 2 = As-Needed Budesonide-Formoterol versus Maintenance Budesonide in Mild Asthma
SYGMA = SYmbicort Given as needed in Mild Asthma}