Budesonide (Pulmicort Turbuhaler ®)
SUMMARY: Budesonide is considered to be safe for use in pregnancy. Budesonide
is the drug of choice for the maintenance treatment of asthma.
Corticosteroid. Molecular weight: 430.5.
"Budesonide produced fetal loss, decreased pup
weight, and skeletal abnormalities at subcutaneous doses of 25 mcg/kg/day in
rabbits (approximately 1/3 the maximum recommended daily inhalation dose in
adults on a mcg/m 2
basis) and 500 mcg/kg/day in rats (approximately
3 times the maximum recommended daily inhalation dose in adults on a mcg/m
No teratogenic or embryocidal effects were observed in rats when budesonide
was administered by inhalation at doses up to 250 mcg/kg/day (approximately 2
times the maximum recommended daily inhalation dose in adults on a mcg/m 2
Analysis of data in the Swedish Medical Birth Registry showed no increase in the incidence of congenital defects in a population of 2014 infants whose mothers used budesonide during early pregnancy .
Data from the same registry compared 2,968 mothers who reported use of inhaled
budesonide during early pregnancy with those reporting no asthma medication
usage. The mothers who reported use of inhaled budesonide during early pregnancy
gave birth to infants of normal gestational age, birth weight, and length, with
no increased rate of stillbirths or multiple births compared to the unexposed
The American College of Obstetricians and Gynecologists (ACOG) and The American College of Allergy, Asthma and Immunology (ACAAI) consider beclomethasone and budesonide
to be the inhaled steroids of choice for use during pregnancy .
BREAST FEEDING: "Corticosteroids are secreted in human milk. Because
of the potential for adverse reactions in nursing infants from any
corticosteroid, a decision should be made whether to discontinue nursing or
discontinue the drug, taking into account the importance of the drug to the
mother. Actual data for budesonide are lacking" .
1. Physicians Desk Reference 57th ed. Montvale, NJ: Thomson PDR;
2. Kallen B, Rydhstroem H, Aberg A. Congenital malformations after the use of inhaled budesonide in early pregnancy.
Obstet Gynecol. 1999 Mar;93(3):392-5.
3. Norjavaara E and de Verdier MG. Normal pregnancy outcomes in a population-based study including 2,968 pregnant
women exposed to budesonide.J Allergy Clin Immunol. 2003;111:736-42. MEDLINE
4. The use of newer asthma and allergy medications during pregnancy.
Position Statement. The American College of Obstetricians and Gynecologists (ACOG) and The American
College of Allergy, Asthma and Immunology (ACAAI). Ann Allergy Asthma Immunol. 2000;84:475-480.
Update: 6/26/2007 Mark Curran, M.D. FACOG