Diphenhydramine / hydrocortisone topical Pregnancy and Breastfeeding Warnings

Diphenhydramine / hydrocortisone topical Pregnancy Warnings

Diphenhydramine-hydrocortisone topical has not been formally assigned to a pregnancy category by the FDA. Animal studies on diphenhydramine-hydrocortisone topical have not been reported. There are no controlled data in human pregnancy. Diphenhydramine-hydrocortisone topical should only be given during pregnancy when benefits outweigh risks.

Systemic diphenhydramine has been assigned to pregnancy category B by the FDA. Systemic hydrocortisone has not been assigned to an FDA pregnancy category.

Animal studies on systemic diphenhydramine have failed to reveal teratogenicity. One study reported a statistical relationship between diphenhydramine use in the first trimester and cleft palate. One case of withdrawal in an infant whose mother ingested 150 mg per day of diphenhydramine has been reported. This infant developed tremor on the fifth day of life which was treated with phenobarbital. Animal studies involving corticosteroids have revealed evidence of an increased incidence of cleft palate in offspring. There are no controlled data in human pregnancy, however, corticosteroids have been used during human pregnancy without evidence of teratogenicity.

See references

Diphenhydramine / hydrocortisone topical Breastfeeding Warnings

There are no data on the excretion of diphenhydramine-hydrocortisone topical into human milk. Systemic diphenhydramine is excreted into human milk. Systemic diphenhydramine may also inhibit lactation. The manufacturer of systemic diphenhydramine recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. There are no data on the excretion of hydrocortisone into human milk. Some corticosteroids are excreted into human milk in small amounts. The manufacturer of systemic hydrocortisone recommends against the use of pharmacologic doses of hydrocortisone by nursing women.

See references