Is Symbicort (budesonide and formoterol) safe during pregnancy?

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Last updated: October 1, 2025View editorial policy

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Safety of Symbicort During Pregnancy

Symbicort (budesonide/formoterol) is safe to use during pregnancy, with budesonide having the most reassuring safety profile among inhaled corticosteroids. The combination medication can be continued throughout pregnancy when needed for asthma control.

Evidence for Safety

Budesonide, one of the active components in Symbicort, has the most extensive safety data during pregnancy:

  • Budesonide is classified as FDA Pregnancy Category B, while most other inhaled corticosteroids are Category C 1
  • At usual doses, inhaled corticosteroids have not been associated with increased risk of major malformations, intrauterine growth restriction, preterm delivery, or low birth weight 1
  • Extensive human safety data from Swedish registries covering approximately 99% of pregnancies showed no increased risk for congenital malformations from inhaled budesonide use during early pregnancy 2
  • A review of more than 6,600 infants whose mothers used inhaled budesonide during pregnancy found no clinically significant effects on fetal outcomes 3

Formoterol (the long-acting beta-2 agonist in Symbicort) has limited human pregnancy data but is considered "probably safe" during pregnancy 1.

Clinical Recommendations

  1. For women already using Symbicort before pregnancy:

    • Continue Symbicort during pregnancy if it effectively controls asthma 1, 4
    • Use the lowest effective dose to maintain asthma control 1
  2. For women starting treatment during pregnancy:

    • If inhaled corticosteroid monotherapy is sufficient, budesonide alone may be preferred due to its more extensive safety data 1, 4
    • If combination therapy is needed, Symbicort is appropriate 4

Importance of Asthma Control During Pregnancy

Maintaining optimal asthma control is crucial during pregnancy:

  • Poorly controlled asthma poses greater risks to mother and fetus than medication side effects 4
  • Uncontrolled asthma increases risks of preeclampsia, prematurity, low birth weight, and small-for-gestational-age infants 2

Monitoring During Pregnancy

  • Monthly evaluations of asthma status and pulmonary function are recommended 4
  • Spirometry is preferred for initial assessment and follow-up monitoring 4
  • For moderate to severe asthma, consider serial ultrasound examinations starting at 32 weeks 4

Common Pitfalls to Avoid

  1. Don't discontinue asthma medications during pregnancy - uncontrolled asthma poses greater risks than medication side effects
  2. Don't substitute less effective medications due to unfounded safety concerns
  3. Don't delay treatment of asthma exacerbations during pregnancy
  4. Don't overlook the need for regular monitoring throughout pregnancy

In summary, Symbicort can be safely used during pregnancy, with budesonide having the most reassuring safety profile among inhaled corticosteroids. The benefits of maintaining good asthma control with Symbicort outweigh potential risks of the medication.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Guideline

Asthma Management During Pregnancy

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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