AZ & Me

For patients requiring inhaled corticosteroid (ICS) monotherapy for asthma control

PULMICORT Flexhaler provided significant and sustained improvement in lung function in adults and children1

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has proven clinical efficacy in both adults and children with asthma1,2

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PULMICORT FLEXHALER contains budesonide, the ONLY ICS with a Pregnancy Category B rating1PULMICORT FLEXHALER® the only Pregnancy Category B ICS for the treatment of asthma

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PULMICORT FLEXHALER Clinical Presentation

PULMICORT FLEXHALER® (budesonide inhalation powder, 90 mcg & 180 mcg) Clinical PresentationExplore clinical data with this interactive module.

  • Because studies in humans cannot rule out the possibility of fetal harm, PULMICORT FLEXHALER should be used in pregnancy only if clearly needed

*Animal reproduction studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus. Nevertheless, because the studies in humans cannot rule out the possibility of harm, PULMICORT FLEXHALER should be used in pregnancy only if clearly needed.3
Inhaled corticosteroid.

PULMICORT FLEXHALER [package insert], 2010. AstraZeneca LP, Wilmington, DE.
Data on File, 266665, AZPLP.
US Food and Drug Administration. CFR-Code of Federal Regulations Title 21. cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=201.57. Accessed November 27, 2012.
Childhood Asthma Management Program Research Group. Long-term effects of budesonide or nedocromil in children with asthma. N Engl J Med. 2000;343(15):1054-1063.
Data on File, 268208, AZPLP.
Tinkelman DG, Bronsky EA, Gross G, Schoenwetter WF, Spector SL. Efficacy and safety of budesonide inhalation powder (PULMICORT TURBUHALER) during 52 weeks of treatment in adults and children with persistent asthma. J Asthma. 2003;40(3):225-236.
Labiris NR, Dolovich MB. Pulmonary drug delivery, Part II: the role of inhalant delivery devices and drug formulations in therapeutic effectiveness of aerosolized medications. Br J Clin Pharmacol. 2003;56(6):600-612.
940006-3014809 Last Updated 8/14


  • PULMICORT FLEXHALER is not a bronchodilator and is NOT indicated for the relief of acute bronchospasm.
  • Particular care is needed for patients who are transferred from systemically active corticosteroids to  PULMICORT FLEXHALER because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.
  • Due to possible immunosuppression, potential worsening of infections could occur. A more serious or even fatal course of chickenpox or measles can occur in susceptible patients.
  • It is possible that systemic corticosteroid effects such as hypercorticism, reduced bone mineral density, and adrenal suppression may appear in a small number of patients, particularly at higher doses.
  • Inhaled corticosteroids may cause a reduction in growth velocity. The long-term effect on final adult height is unknown.
  • Rare instances of glaucoma, increased intraocular pressure, and cataracts have been reported following the inhaled administration of corticosteroids.
  • Hypersensitivity reactions, including anaphylaxis, have been reported with budesonide.
  • PULMICORT FLEXHALER contains small amounts of lactose, which contains trace levels of milk proteins. In patients who have severe milk protein allergy (not those who are lactose intolerant) cough, wheezing, or bronchospasm may occur.
  • Adverse reactions that occurred at a rate of ≥ 1% are: nasopharyngitis, nasal congestion, pharyngitis, allergic rhinitis, viral upper respiratory tract infection, nausea, viral gastroenteritis, otitis media, and oral candidiasis.


  • PULMICORT FLEXHALER is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age or older.

Please click here for full Prescribing Information for PULMICORT FLEXHALER.PDF

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