Intraperitoneal animal studies at doses of 2 times the maximum recommended human dose (MRHD) have revealed evidence of fetotoxicity. Oral and subcutaneous animal studies at doses up to 32 times the MRHD failed to reveal evidence of fetal harm or impaired fertility. An increased risk of abnormalities was not shown In 2 human studies during the first, second, and third trimesters of pregnancy.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Use is recommended only if clearly needed and the benefit outweighs the risk.

US FDA pregnancy category: B

See references

Use is contraindicated.

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

Comments:
-Some manufacturers state that a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
-The effects in the nursing infant are unknown.
-Use of antihistamines in neonates and premature infants was associated with adverse events (e.g., apnea, cyanosis, respiratory depression).

See references