THIS MEDICATION CAN CAUSE HARM TO YOUR BABY:
There is limited information available on the safety of budesonide/formoterol use during pregnancy. Women requiring treatment to control their asthma during pregnancy should speak with their doctor.
What is budesonide/formoterol?
Budesonide/formoterol is a combination medication used to treat inflammation and airway restriction associated with inflammatory lung diseases.
What is budesonide/formoterol used to treat?
Budesonide/formoterol is a prescription medication used for long-term control of chronic asthma (not for acute asthma exacerbations) in patients over 6 years old, and chronic obstructive pulmonary disease (COPD).
How does budesonide/formoterol work?
Budesonide/formoterol contains two medications: budesonide is a corticosteroid that prevents and controls respiratory inflammation; formoterol produces a long-lasting relaxation of the smooth muscle in the airway to allow for easier breathing.
If I am taking budesonide/formoterol, can it harm my baby?
There are limited human studies of budesonide/formoterol in pregnancy. Both drugs are expected to cross the human placenta to reach the baby. Animals studies have found that there may be an increased risk of some birth defects with use of this medication during pregnancy. A large analysis of multiple studies found that corticosteroids such as budesonide that are administered during pregnancy are not associated with birth defects, preterm delivery, or low birth weights. Budesonide may be associated with an increased risk of cardiac defects and cleft palate. It is generally recommended to give this medication during pregnancy only if the benefit to the mother outweighs the risk to the developing baby. Pregnant women with uncontrolled asthma also have an increased risk of preeclampsia and preterm birth.
If I am taking budesonide/formoterol and become pregnant, what should I do?
It is important that you speak with your doctor and decide if you should remain on budesonide/formoterol during pregnancy. There may be safer options to treat asthma during pregnancy. Budesonide/formoterol may interfere with uterine contractions during labor and delivery.
If I am taking budesonide/formoterol, can I safely breastfeed my baby?
The effect of budesonide/formoterol on breastfeeding infants is unknown. Budesonide can be detected in breast milk at 0.3% to 1% of the mother’s dose of the medication. It is important to weigh the risks and benefits of taking this medication while breastfeeding since limited information is available. Either breastfeeding or budesonide/formoterol administration can be discontinued.
If I am taking budesonide/formoterol, will it be more difficult to get pregnant?
There is not enough information available to determine if budesonide or formoterol can affect male or female fertility.
If I am taking budesonide/formoterol, what should I know?
Budesonide/formoterol has limited safety information available in humans. This medication should only be used during pregnancy if the benefit to the mother outweighs the risk to the developing baby.
If I am taking any medication, what should I know?
This report provides a summary of available information about the use of budesonide/formoterol during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.
You may find Pregistry’s expert report about asthma here, and reports about the individual medications used to treat respiratory disorders here. Additional information can also be found in the resources below.
For more information about budesonide/formoterol during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:
PI Central: Symbicort Prescribing Information