Animal studies have failed to reveal evidence of adverse effects on embryofetal development at doses up to 1000 mg/kg/day. 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.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk summary: Malformative risk with use of this drug in pregnant women is unlikely as systemic absorption with oral formulations is low.

Comment: If this drug is used during pregnancy, fat-soluble vitamin levels should be monitored and deficiencies should be supplemented.

See references

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-The effects in the nursing infant and on milk production are unknown.
-If this drug is used during lactation, fat-soluble vitamin levels should be monitored and deficiencies should be supplemented.

This drug has low systemic absorption when administered orally.

See references