Symbicort Turbuhaler信必可

Symbicort Turbuhaler Adverse Reactions

budesonide + formoterol




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Full Prescribing Info
Adverse Reactions
Since Symbicort Turbuhaler contains both budesonide and formoterol, the same adverse effects as reported for these substances may be expected. 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 commencing treatment.
If oropharyngeal candidiasis develops, it may be treated with appropriate anti-fungal therapy whilst still continuing with Symbicort Turbuhaler 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, formoterol and Symbicort, are given in Table 12. (See Table 12.)

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As with other inhalation therapy, paradoxical bronchospasm may occur in very rare cases.
Treatment with β-sympathomimetics may result in an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies.
Pneumonia: The following table provides the incidence of pneumonia observed in the four pivotal phase III COPD studies (see Pharmacology: Pharmacodynamics: Clinical trials under Actions) for the Symbicort (as Turbuhaler or Rapihaler 200/6) and comparative placebo arms. (See Table 13.)

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In these placebo-controlled studies, the incidence of pneumonia was low.
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 μg/dose as needed in a mild asthma population.
Reporting suspected adverse effects: 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 recommended to report any suspected adverse reactions to AstraZeneca.
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