This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: Not formally assigned to a pregnancy category.
US FDA pregnancy category: Not assigned.

Risk summary: Malformative risk with use of this drug in pregnant women is unlikely due to minimal systemic absorption.

Comments:
-Patients with exocrine pancreatic insufficiency should receive adequate nutritional support (including adequate caloric intake) during pregnancy to ensure normal maternal weight gain and fetal growth.
-Some experts recommend: This drug should be used in doses sufficient to provide adequate effects.

Animal studies have not been reported. Fetal harm and the effects on reproductive capacity are unknown. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Caution is recommended; benefit to mother should outweigh risk to the infant.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-The effects in the nursing infant are unknown.
-Some experts recommend: This drug should be used in doses sufficient to provide adequate effects to the mother.

See references