Is Symbicort (budesonide and formoterol) safe to use during pregnancy in patients with asthma or Chronic Obstructive Pulmonary Disease (COPD)?

Is Symbicort Safe to Use in Pregnancy?

Yes, Symbicort (budesonide/formoterol) is safe to continue during pregnancy, particularly if you were well-controlled on it before conception, as the risks of poorly controlled asthma far exceed any theoretical medication risks. 1, 2

Safety Profile of Individual Components

Budesonide (The Corticosteroid Component)

• Budesonide is the preferred inhaled corticosteroid during pregnancy with the most extensive safety data and carries FDA Pregnancy Category B classification. 2, 3, 4
• Large epidemiological studies of over 6,600 pregnancies show no increased risk of congenital malformations, intrauterine growth restriction, preterm delivery, or low birth weight at usual doses. 1, 5
• Swedish registry data covering approximately 99% of pregnancies (1995-1997) found the rate of congenital malformations was 3.8% versus 3.5% in the general population—essentially identical. 4
• The rate of orofacial clefts was also similar to expected population rates (4 observed versus 3.3 expected). 4

Formoterol (The Long-Acting Beta-Agonist Component)

• Formoterol has limited human pregnancy data, but animal studies suggest low risk. 1, 2
• While salmeterol has historically been preferred due to longer clinical experience, if you were well-controlled on formoterol before pregnancy, it is acceptable—and even preferable—to continue the same medication rather than switching. 1, 2
• The pharmacologic profile of formoterol is similar to short-acting beta-agonists like albuterol, which have extensive reassuring pregnancy data. 2

Critical Clinical Principle: Disease Risk vs. Medication Risk

The single most important concept: Poorly controlled asthma poses substantially greater risks to both mother and fetus than any theoretical medication risks. 1, 2, 6

Risks of Uncontrolled Asthma Include:

• Preeclampsia 6
• Preterm birth 6, 4
• Low birth weight and small-for-gestational-age infants 6, 4
• Gestational diabetes 6
• Perinatal mortality 6
• Maternal hypoxia with direct adverse fetal effects 1, 6

Evidence Supporting Continued Treatment:

• Inhaled asthma medications have been used for many years without documentation of adverse fetal effects, while the effects of undertreated asthma resulting in severe exacerbation with maternal hypoxia are well-documented to harm the fetus. 1
• Active asthma management during pregnancy reduces adverse outcomes including preterm birth, neonatal hospitalization, and gestational diabetes. 6

Clinical Algorithm for Symbicort Use in Pregnancy

If Already on Symbicort Before Pregnancy:

• Continue the medication without interruption if asthma is well-controlled. 2, 3
• Do not switch to salmeterol unnecessarily—this is a common pitfall that provides no benefit and risks destabilizing control. 2
• Use the lowest effective dose necessary to maintain control. 1, 3

If Starting Combination Therapy During Pregnancy:

• Budesonide is the preferred inhaled corticosteroid component due to most extensive safety data. 2, 3
• For the LABA component, salmeterol has more pregnancy data, but formoterol is acceptable. 1, 2
• For moderate persistent asthma, combination low-dose ICS plus LABA is a preferred treatment option. 2

Monitoring Throughout Pregnancy:

• Regular monitoring of asthma symptoms is recommended throughout pregnancy. 2
• Monthly assessment of asthma symptoms and lung function. 6
• Manage exacerbations aggressively due to potential fetal risks from maternal hypoxia. 2, 6

Dosing Considerations

• Use the lowest effective dose to maintain asthma control—this principle applies to all asthma medications during pregnancy. 1, 3
• Very high doses of inhaled corticosteroids (>1000 µg/day beclomethasone equivalent) may carry small increased risks, reinforcing the importance of using minimum effective doses. 3
• Symbicort allows for adjustable maintenance dosing, which can reduce overall medication exposure while maintaining control. 7

Common Pitfalls to Avoid

Never Discontinue Asthma Medications Due to Unfounded Safety Concerns

• This is the most dangerous mistake—discontinuing controller therapy leads to poor asthma control and increases risks to both mother and fetus that far exceed any medication risks. 2, 6

Do Not Switch from Formoterol to Salmeterol Unnecessarily

• If previously well-controlled on formoterol, switching provides no safety benefit and risks destabilizing asthma control. 2

Do Not Undertreat Asthma Exacerbations

• Failing to aggressively manage exacerbations can lead to maternal hypoxia and adverse fetal outcomes. 2
• Maternal hypoxia from poorly controlled asthma has well-documented adverse fetal effects. 6

Breastfeeding Compatibility

• Both budesonide and formoterol are compatible with breastfeeding. 3, 6
• Inhaled medications have minimal systemic absorption and negligible transfer to breast milk. 1

Labor and Delivery

• Continue all asthma medications during labor and delivery. 6
• Maintain oxygen saturation at normal levels. 6
• Consider early epidural analgesia to reduce anxiety and maternal stress without causing respiratory depression. 6