THIS MEDICATION MAY CAUSE HARM TO YOUR BABY:
Low potency topical hydrocortisone is considered safe when used at the lowest dose for the shortest amount of time. Low to mild potency topical corticosteroids are considered to have less risk of birth defects compared to high potency topical corticosteroids or systemic corticosteroids such as those that are injected or taken orally. Topical hydrocortisone is considered safe while breastfeeding. However, it is recommended that you use this medication only after weighing the potential risks versus benefits of use during pregnancy or while breastfeeding.
What is hydrocortisone cream/ointment?
Topical hydrocortisone (cortisol) is a medication known as a corticosteroid that is used to suppress inflammation. Cortisol is naturally produced by the body; however, it is also available as a medication (a synthetic form of natural cortisol or hydrocortisone). Hydrocortisone cream or ointment is currently available as a generic or brand name medication. Topical hydrocortisone is available in several over-the-counter formulations. Available hydrocortisone ointments and creams vary by potency, ingredients, frequency of application, and duration of therapy. Topical hydrocortisone is available as a cream, gel, lotion, spray, ointment, or solution. Some topical preparations come as a foam or rectal suppositories. Hydrocortisone ointment or cream is applied once or twice daily for 1-2 weeks depending on the indication and formulation. Hydrocortisone cream or ointment is available over-the-counter and by prescription.
What is hydrocortisone cream/ointment used to treat?
Topical hydrocortisone is used to treat external anal or genital itching, atopic dermatitis (eczema), contact dermatitis, psoriasis plaques, ulcerative colitis (rectal formulations only) or seborrheic dermatitis in children over 2 years of age, adolescents, and adults.Topical corticosteroids such as hydrocortisone are prescribed for pregnant women to treat skin conditions such as eczema. Eczema severity can worsen in some pregnant women due to hormone changes. Low or mild potency topical corticosteroids are typically seen as safe to use during pregnancy.
You can read more about eczema during pregnancy here.
How does hydrocortisone cream/ointment work?
Topical hydrocortisone works by blocking the production, release, and activity of inflammatory chemicals such as histamine in the body. Hydrocortisone (cortisol) is also produced naturally by the adrenal glands from the precursor, cortisone, and helps to decrease inflammation.
If I am using hydrocortisone cream/ointment, can it harm my baby?
Available studies suggest topical hydrocortisone poses minimal risk to the developing baby when used during pregnancy. However, absorption of topical hydrocortisone may vary by skin integrity (if you have a cut or scrape you may get more in your body) and use of occlusive dressings (like a bandage) that may increase absorption of hydrocortisone through the skin. The use of a low or mild potency topical hydrocortisone for the minimum recommended amount of time is advised in pregnant women.
Evidence from animal studies with topical hydrocortisone:
Animal studies have focused on the risk of injectable hydrocortisone, not topical hydrocortisone, but they suggest hydrocortisone may pose a risk of harm to the developing baby. When given to pregnant mice and hamsters, hydrocortisone resulted in an increased risk of cleft palate. In pregnant rats and rabbits, recommended human doses of hydrocortisone were associated with an increased risk of death of the offspring. In pregnant pigs exposed to recommended human doses of hydrocortisone, the offspring were at an increased risk of behavioral changes. Changes in growth and body weight, cataract development, polycystic kidney disease development, and preimplantation loss have been associated with hydrocortisone exposure in pregnant animals.
Evidence for the risks of topical hydrocortisone in human babies:
Systemic (injectable) corticosteroid use in women who are pregnant has been associated with an increased risk of low birth weight, cleft palate, and adrenal insufficiency. Larger studies such as the Collaborative Perinatal Project suggest hydrocortisone exposure during pregnancy does not increase the risk of birth defects. However, case reports suggest an increased risk of birth defects such as clubfoot, cleft palate, cataracts, brain/facial defects are possible. The MADRE (Malformation Drug Exposure Surveillance) project evaluated over 1400 infants and the Spanish Collaborative Study of Congenital Malformations evaluated over 1100 infants exposed to systemic corticosteroids during the first trimester, and found a possible association with cleft palate occurrence. The California Birth Defects Monitoring Program found corticosteroid use in pregnant women before up to 3 months after conception was associated with an increased risk of cleft palate or cleft lip. The Israeli Teratogen Information Service study reported no increased risk of cleft palate with first trimester systemic corticosteroid use; however, there was an increased risk of preterm delivery, low birth weight, and spontaneous abortion. The Hungarian Case–Control Surveillance of Congenital Abnormalities study found only 1.55% of infants with birth defects were exposed to systemic corticosteroids. The study found a lack of association between the use of topical corticosteroid ointment during the first trimester in pregnant women and a risk of birth defects in infants.
Studies suggest topical hydrocortisone poses a low risk of harm to the developing baby. However, topical use of high potency hydrocortisone maybe associated with low birth weight. A Danish study from 2002 found a lower rate of birth defects in women exposed to topical corticosteroids during the first trimester compared to women not exposed to topical corticosteroids (3.6% versus 1.8%). Several cohort studies have found no association between first trimester topical corticosteroid use and development of cleft palate in the baby. A study in 20,830 children primarily exposed to topical corticosteroids in utero after the first trimester found no increased risk of birth defects with exposure. Studies by Chi and colleagues have concluded there is no correlation between topical corticosteroid use during pregnancy and cleft palate, preterm delivery, or type of delivery. There was an increased risk of low birth weight infants whose mothers used more than 300 grams of potent topical corticosteroid during pregnancy. In pregnant women requiring topical hydrocortisone, a low or mild potency topical cream or ointment is recommended. Pregnant women should avoid prolonged or excessive use of topical hydrocortisone. Pregnant women who have clear indications for the use of a high potency topical corticosteroid should wait until after their first trimester to use the medication.
Bottom line: In pregnant women requiring topical hydrocortisone, a low or mild potency topical cream or ointment is recommended. Pregnant women should avoid prolonged or excessive use of topical hydrocortisone. Topical corticosteroids such as hydrocortisone are not associated with the same risk of birth defects as seen with high potency corticosteroids and systemic corticosteroids.
If I am using hydrocortisone cream/ointment and become pregnant, what should I do?
If you are using hydrocortisone cream/ointment and become pregnant, you should contact your doctor immediately. Your doctor will determine if your medication is medically necessary, or if it should be discontinued until after the birth of your baby.
If I am using hydrocortisone cream/ointment, can I safely breastfeed my baby?
It is unknown if topical hydrocortisone is present in breast milk. Topical hydrocortisone is generally considered safe during breastfeeding when used at the smallest doses possible and on the smallest area of skin required. Topical hydrocortisone should not be applied directly on the breast until breastfeeding is discontinued. Infants should avoid contact with areas on the mother’s skin that have been treated with topical hydrocortisone. One report of a breastfed infant exposed to a high potency topical corticosteroid on the nipple described the development of hig
h blood pressure in the baby. It is recommended that you weigh the potential risks versus benefits before using this medication while breastfeeding.
Bottom line: Topical hydrocortisone is generally considered safe during breastfeeding when used at the smallest doses possible and on the smallest area of skin required. However, it is recommended to weigh the risks versus benefits of this medication before using it while breastfeeding.
If I am using hydrocortisone cream/ointment, will it be more difficult to get pregnant?
There is currently no information on the effects of topical corticosteroids on human fertility.
If I am using hydrocortisone cream/ointment, what should I know?
Low or mild potency topical corticosteroids such as hydrocortisone are not associated with the same risk of adverse effects as seen in high potency or systemic corticosteroids. Topical hydrocortisone is considered safe in pregnant women and women who are breastfeeding when it is used in the smallest possible dose and on the smallest area possible. It is recommended to use this medication only after weighing the potential risks versus benefits.
If I am taking any medication, what should I know?
This report provides a summary of the available information about the use of hydrocortisone cream/ointment during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.
You may find Pregistry's expert report about eczema here, and reports about skin disorders and the medications used to treat them here. Additional information can also be found in the links below.
For more information about hydrocortisone cream/ointment during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following links:
National Eczema Association: Oh, baby! Eczema from pregnancy to menopause
National Institutes of Health: Hydrocortisone cream/ointment 2.5% Prescribing Information