Is budesonide safe during pregnancy?

Is Budesonide Safe for Pregnancy?

Yes, budesonide is considered safe during pregnancy and is the preferred corticosteroid due to the most extensive safety data available. 1

Key Safety Evidence

Budesonide carries a Category B pregnancy classification (FDA) and Category A (Australian TGA), indicating no evidence of risk in humans. 1, 2, 3 This makes it the only inhaled corticosteroid with this favorable classification, based on robust data from the Swedish Medical Birth Registry and multiple subsequent studies. 3, 4

Major Malformations and Birth Defects

• A large Swedish cohort study of 2,534 pregnancies exposed to inhaled budesonide showed no increased risk of congenital malformations (3.6% vs 3.5% in general population). 2
• Specifically, orofacial clefts occurred at expected population rates (4 cases vs 3.3 expected). 2
• A more recent nationwide cohort of nearly 52,000 pregnancies with first-trimester corticosteroid exposure showed no increased risk of malformations, contradicting older literature that suggested a 3.4-fold increased risk. 1
• A randomized controlled trial of 313 pregnancies found 81% healthy deliveries with budesonide vs 77% with placebo, with no significant difference in adverse outcomes. 4

Pregnancy Outcomes

At usual doses, inhaled corticosteroids including budesonide have not been associated with increased risk of intrauterine growth restriction (IUGR), preterm delivery, or low birth weight. 1

Multiple studies across different populations (Swedish, Australian, Canadian, Hungarian, Japanese, and US registries) confirmed no increased risk for decreased gestational age, birth weight, or birth length. 5

Formulation-Specific Recommendations

Inhaled Budesonide (for Asthma/COPD)

• Budesonide and beclomethasone are preferred during pregnancy due to more extensive safety data. 1
• Use the lowest effective dose necessary to maintain disease control. 1
• If a woman is well-controlled on another inhaled corticosteroid pre-pregnancy, she may continue it during pregnancy. 1

Nasal Budesonide (for Rhinosinusitis)

• Modern nasal corticosteroids including budesonide, fluticasone, and mometasone are safe at recommended doses for chronic rhinosinusitis maintenance during pregnancy. 1
• Off-label use of budesonide irrigations or nasal drops is NOT recommended. 1

Oral Budesonide (for Inflammatory Bowel Disease)

• Prednisone and budesonide are considered low risk in pregnancy and lactation for autoimmune hepatitis and inflammatory bowel disease. 1
• Budesonide may lower fetal exposure compared to prednisone due to high first-pass metabolism. 1
• Case series of 8 pregnant women with Crohn's disease treated with oral budesonide (6-9 mg/day) showed no maternal adrenal suppression, glucose intolerance, or fetal abnormalities. 6
• Four pregnancies exposed to budesonide MMX resulted in normal births with no congenital abnormalities. 7

Critical Clinical Considerations

Disease Control Priority

The risk of poorly controlled asthma or inflammatory bowel disease during pregnancy exceeds any theoretical risk from budesonide therapy. 1, 2 Uncontrolled asthma increases risk of preeclampsia, prematurity, low birth weight, and small-for-gestational-age infants. 2

Breastfeeding

Budesonide is compatible with breastfeeding. 1 Excretion into breast milk is minimal due to extensive first-pass metabolism.

Dosing Caveats

• One study showed doses >1000 µg/day of beclomethasone were associated with small increased risk of congenital malformation, suggesting dose-dependent effects may exist at very high doses. 1
• Always use the minimum effective dose to maintain control. 1, 2

Monitoring

No special adrenal or glucose monitoring is required for inhaled budesonide at standard doses. 6 However, for oral budesonide or systemic corticosteroids, consider diabetes screening if prolonged courses are needed. 1

Common Pitfalls to Avoid

• Do not discontinue effective budesonide therapy due to pregnancy concerns—the disease control benefit outweighs theoretical risks. 1, 2, 3
• Do not switch from budesonide to less-studied alternatives during pregnancy if disease is well-controlled. 1
• Do not confuse the safety profile of inhaled/topical budesonide with systemic corticosteroids, which carry higher risks. 1
• Do not use off-label formulations (like budesonide irrigations) without clear indication, as safety data are limited. 1