Hydrocortisone
MedicationProctozone-HC
Topical corticosteroid
Research strength: 3 / 5
MotherToBaby identifies hydrocortisone as a topical corticosteroid and says studies of this group have not found an increased chance of birth defects. A UK cohort found no association between topical corticosteroid prescriptions and orofacial clefts or fetal death, including miscarriage, while a Danish cohort found no increased small-for-gestational-age or low-birth-weight risk in its hydrocortisone subgroup overall; neither cohort reports a separate hydrocortisone first-trimester estimate. NHS guidance says most skin hydrocortisone types can be used during pregnancy, usually in small amounts for the shortest possible time. The Proctozone-HC label says topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential fetal risk, and not extensively, in large amounts, or for long periods. These sources differ in how cautious to be; the cohort findings are observational and do not establish a trimester-specific effect. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- MotherToBaby: Topical CorticosteroidsTeratology service
- DailyMed: PROCTOZONE-HC hydrocortisone cream labelDrug company label
- NHS: Pregnancy, breastfeeding and fertility while using hydrocortisone for skinUK government
- Chi et al., J Invest Dermatol 2011: Topical corticosteroids in pregnancy cohortUS government
- Cochrane: Safety of topical corticosteroids in pregnancyUS government
Research strength: 3 / 5
MotherToBaby says topical corticosteroids used as directed are not expected to increase pregnancy complications, although very strong products over large areas for a long time might be associated with lower birth weight. The Danish cohort found no increased small-for-gestational-age or low-birth-weight risk in its hydrocortisone subgroup overall, but did not report a second-trimester-specific result. Cochrane described a probable low-birth-weight association with potent or very potent products in very large cumulative amounts, while the Danish cohort found no increase. NHS guidance says most skin hydrocortisone types can be used in pregnancy in small amounts for the shortest possible time. The Proctozone-HC label says topical corticosteroids should be used only if the potential benefit justifies the potential fetal risk and not extensively, in large amounts, or for long periods. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- MotherToBaby: Topical CorticosteroidsTeratology service
- DailyMed: PROCTOZONE-HC hydrocortisone cream labelDrug company label
- NHS: Pregnancy, breastfeeding and fertility while using hydrocortisone for skinUK government
- Andersson et al., JAMA Dermatol 2021: Danish topical corticosteroid cohort (full text)US government
- Cochrane: Safety of topical corticosteroids in pregnancyUS government
Research strength: 3 / 5
MotherToBaby's fact sheet gives class-wide results, not a separate hydrocortisone-specific third-trimester finding. It says use as directed is not expected to raise pregnancy complication chances, but very strong products used over large areas for a long time might be linked to lower birth weight. A Cochrane review described a probable low-birth-weight association with potent or very potent products in very large cumulative amounts, while the Danish cohort found no increase; it did not report a third-trimester hydrocortisone estimate. The Danish cohort reported a hydrocortisone subgroup overall with no increased small-for-gestational-age or low-birth-weight risk. The Proctozone-HC label says use only if the potential benefit justifies the potential fetal risk and advises against extensive, large-amount, or prolonged use. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- MotherToBaby: Topical CorticosteroidsTeratology service
- DailyMed: PROCTOZONE-HC hydrocortisone cream labelDrug company label
- NHS: Pregnancy, breastfeeding and fertility while using hydrocortisone for skinUK government
- Andersson et al., JAMA Dermatol 2021: Danish topical corticosteroid cohort (full text)US government
- Cochrane: Safety of topical corticosteroids in pregnancyUS government
Hydrocortisone — Breastfeeding
Research strength: 1 / 5
LactMed says topical hydrocortisone has not been studied during breastfeeding and says short-term use is unlikely to pose a risk through milk; it advises the least potent product, the smallest area, and no direct infant contact with treated skin. MotherToBaby says typical topical corticosteroid use is not expected to pose a risk, though strong products on large areas or for long periods may increase milk exposure. NHS Specialist Pharmacy Service lists hydrocortisone as low potency and says topical corticosteroids can be used while breastfeeding, but its guidance applies to full-term, healthy infants. The Proctozone-HC label says it is not known whether topical use can lead to detectable amounts in milk and advises caution. LactMed cites an infant case after a different corticosteroid was applied to the mother's nipples, not hydrocortisone; NHS says hydrocortisone on the chest should be washed off before feeding. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- LactMed: Hydrocortisone, TopicalUS government
- MotherToBaby: Topical CorticosteroidsTeratology service
- NHS Specialist Pharmacy Service: Using inhaled or topical corticosteroids during breastfeedingUK government
- NHS: Pregnancy, breastfeeding and fertility while using hydrocortisone for skinUK government
- DailyMed: PROCTOZONE-HC hydrocortisone cream labelDrug company label
- De Stefano et al., Helv Paediatr Acta 1983: Nipple-applied corticosteroid case reportUS government
Pregnancy
The pregnancy findings are mainly from observational studies. Chi et al. (2011) studied a UK cohort with 35,503 exposed and 48,630 unexposed pregnancies; prescriptions were counted from 85 days before the last menstrual period through delivery or fetal death. The study found no association with orofacial clefts, preterm delivery, or fetal death, including miscarriage and stillbirth. It did report fetal growth restriction with potent or very potent products (adjusted relative risk 2.08, 95% CI 1.40 to 3.10; number needed to harm 168), with a dose-response signal. A 2015 Cochrane review of 14 observational studies and 1,601,515 subjects found no causal association with congenital abnormalities, preterm delivery, or fetal death, but described a probable low-birth-weight association with potent or very potent products, especially at very large cumulative amounts; evidence quality was low or very low for several outcomes. Andersson et al. (2021) matched 60,497 exposed pregnancies with 241,986 unexposed pregnancies in Denmark. In its hydrocortisone subgroup of 5,344 pregnancies, SGA occurred in 498 infants (9.3%; RR 1.00, 95% CI 0.92 to 1.08) and low birth weight occurred in 183 infants (3.4%; RR 0.96, 95% CI 0.83 to 1.10). These results were overall pregnancy estimates, not trimester-specific. The broader cohort found no increased SGA or low-birth-weight risk with potent to very potent products, including in post hoc analyses above 200 g.
Breastfeeding
LactMed's January 2024 entry says topical hydrocortisone has not been studied during breastfeeding and that relevant maternal or infant milk-level information was not found. It considers short-term topical hydrocortisone unlikely to pose a risk through milk, while advising the least potent product on the smallest area and avoiding direct infant contact with treated skin. MotherToBaby and NHS SPS give class-level guidance that typical topical use leads to low exposure; NHS SPS says its recommendations apply to full-term, healthy infants. LactMed cites De Stefano et al. (1983), a report of a 2-month-old infant with severe hypertension, low potassium, alkalosis, prolonged QT, and poor growth after the mother used a nipple cream containing 1% 9-alpha-fluoroprednisolone-21-acetate. LactMed identifies the product as isofluprednone acetate. This is a different corticosteroid, and the report does not measure hydrocortisone in milk or establish a milk-transfer effect; direct exposure from treated nipples is a concern. The Proctozone-HC label states that detectable milk quantities after topical use are unknown and advises caution.
The live brand, Proctozone-HC, is a 2.5% hydrocortisone cream for external use. DailyMed states that each gram contains 25 mg of hydrocortisone. The listed inactive ingredients are purified water, propylene glycol, glyceryl monostearate SE, cholesterol, isopropyl myristate, polysorbate 60, cetyl alcohol, sorbitan monostearate, polyoxyl 40 stearate, sorbic acid, methylparaben, and propylparaben. Other hydrocortisone products may have different strengths, routes, and ingredients.
What was tested
Pregnancy evidence consists mainly of observational studies of topical corticosteroids. Chi et al. (2011) used UK prescription records and assessed clefts, preterm delivery, fetal death, and fetal growth restriction. Andersson et al. (2021) used Danish registry data and assessed small-for-gestational-age and low-birth-weight outcomes; the full paper reports a hydrocortisone subgroup but no hydrocortisone-specific trimester results. The Cochrane review assessed 14 observational studies. No controlled trial was found for the Proctozone-HC product in pregnancy. For breastfeeding, LactMed found no published milk-level or infant-level data for topical hydrocortisone as of its revision date. The only cited infant case involved a different topical corticosteroid applied to the nipple.
Pregnancy: product-label caution versus class-level clinical guidance
- Source A says
- The Proctozone-HC label says topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and not extensively, in large amounts, or for prolonged periods. It cites animal findings and a lack of adequate controlled studies in pregnant women. (DailyMed: PROCTOZONE-HC hydrocortisone cream label)
- Source B says
- MotherToBaby says topical corticosteroids are often first-line during pregnancy for skin conditions. The NHS says most skin hydrocortisone types can be used during pregnancy, usually in small amounts for the shortest possible time. The Cochrane review and cohort studies report no class-wide association with several major outcomes. Andersson et al. also report no increased SGA or low-birth-weight risk in a hydrocortisone subgroup overall, while higher-potency birth-weight findings remain mixed. (MotherToBaby: Topical Corticosteroids, NHS: Pregnancy, breastfeeding and fertility while using hydrocortisone for skin, Cochrane: Safety of topical corticosteroids in pregnancy, Chi et al., J Invest Dermatol 2011: Topical corticosteroids in pregnancy cohort, Andersson et al., JAMA Dermatol 2021: Danish topical corticosteroid cohort (full text))
- Why they differ
- The product label emphasizes animal findings and the absence of controlled human trials for topical corticosteroids. Clinical summaries weigh observational class data and low absorption with typical topical use. The evidence does not isolate the Proctozone-HC product or each trimester.
- What the evidence shows overall
- The product label's use limits should remain visible. Human observational studies include one hydrocortisone subgroup with no increased newborn-size outcomes overall, but do not establish trimester-specific effects. The higher-potency birth-weight concern is not a result about this low-potency ingredient. The label's caution is not evidence of established human harm.
Pregnancy: high-potency products and low birth weight
- Source A says
- The 2011 UK cohort found fetal growth restriction associated with potent or very potent topical corticosteroids, and the Cochrane review described a probable low-birth-weight association, especially with very large cumulative amounts. (Chi et al., J Invest Dermatol 2011: Topical corticosteroids in pregnancy cohort, Cochrane: Safety of topical corticosteroids in pregnancy)
- Source B says
- The 2021 Danish matched cohort found no increase in small-for-gestational-age or low-birth-weight outcomes with potent or very potent topical corticosteroids, including in post hoc analyses of large amounts. (Andersson et al., JAMA Dermatol 2021: Danish topical corticosteroid cohort (full text))
- Why they differ
- The studies used different populations, exposure measurements, outcome definitions, and analyses. The Danish cohort was larger and reported a hydrocortisone subgroup, but neither study gives a trimester-specific hydrocortisone estimate.
- What the evidence shows overall
- The class-level signal for high-potency, high-volume exposure remains uncertain. The Danish hydrocortisone subgroup did not show an increased SGA or low-birth-weight estimate overall, but there is no trimester-specific estimate. The class signal should not be presented as an established hydrocortisone effect, and it should not be omitted when discussing the broader class.
Breastfeeding: no direct topical hydrocortisone data versus general compatibility guidance
- Source A says
- LactMed says topical hydrocortisone has not been studied during breastfeeding. The Proctozone-HC label says it is not known whether topical corticosteroids can produce detectable amounts in milk and advises caution. (LactMed: Hydrocortisone, Topical, DailyMed: PROCTOZONE-HC hydrocortisone cream label)
- Source B says
- MotherToBaby says typical topical corticosteroid use is not expected to pose a risk to a breastfed baby. NHS SPS says topical hydrocortisone can be used while breastfeeding, with extra attention to large-area or prolonged use and direct contact. (MotherToBaby: Topical Corticosteroids, NHS Specialist Pharmacy Service: Using inhaled or topical corticosteroids during breastfeeding)
- Why they differ
- The product label and LactMed emphasize that direct topical hydrocortisone milk data are missing. The clinical sources base their guidance on expected low absorption with typical topical use and the broader experience with topical corticosteroids.
- What the evidence shows overall
- Direct milk-level evidence for topical hydrocortisone remains absent. Typical low-area, short-term use is described as compatible by clinical sources, while the product label's caution and the need to prevent direct infant contact remain visible. The nipple-cream case involved a different steroid and does not show hydrocortisone milk transfer.
- MotherToBaby says strength, skin condition, treated area, and coverings can affect absorption; it describes using the lowest effective strength for the shortest needed time. (MotherToBaby)
- The Proctozone-HC label states that topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential fetal risk, and not extensively, in large amounts, or for prolonged periods. (DailyMed: PROCTOZONE-HC label)
- NHS SPS says the lowest effective dose for the shortest effective duration can minimize infant exposure; it also says to avoid direct contact with treated areas and to remove treatment from the breast before feeding. (NHS Specialist Pharmacy Service)
- NHS guidance says to check with a pharmacist or doctor before using skin hydrocortisone during pregnancy or breastfeeding. (NHS)
General research, not specific to pregnancy.
The MHRA's 2024 Drug Safety Update says topical steroid withdrawal reactions are estimated to be rare and have been reported after long-term use, generally six months or more, of moderate or stronger products. The MHRA lists hydrocortisone as mild potency. DailyMed warns that systemic absorption can suppress the HPA axis and cause Cushing's syndrome, high blood sugar, or glucose in urine, with greater absorption from stronger products, large areas, prolonged use, or dressings.
- The MHRA says topical steroid withdrawal reactions have been reported after long-term use, generally six months or more, of moderate or stronger topical steroids; the exact frequency cannot be determined, and reactions are estimated to be rare. It lists hydrocortisone as a mild-potency example. (UK MHRA Drug Safety Update: Topical steroids and withdrawal reactions)
- DailyMed says systemic absorption of topical corticosteroids has produced reversible HPA-axis suppression, Cushing's syndrome, high blood sugar, and glucose in urine. Stronger products, large surface areas, prolonged use, and occlusive dressings can increase absorption. (DailyMed: PROCTOZONE-HC hydrocortisone cream label)
- MotherToBaby: Topical CorticosteroidsTeratology serviceSecondary
- LactMed: Hydrocortisone, TopicalUS governmentSecondaryPage dated 2024-01-15
- DailyMed: PROCTOZONE-HC hydrocortisone cream labelDrug company labelTertiary
- NHS: Pregnancy, breastfeeding and fertility while using hydrocortisone for skinUK governmentSecondaryPage dated 2024-01-04Independent check
- NHS Specialist Pharmacy Service: Using inhaled or topical corticosteroids during breastfeedingUK governmentSecondaryPage dated 2023-07-17Independent check
- Chi et al., J Invest Dermatol 2011: Topical corticosteroids in pregnancy cohortUS governmentPrimaryIndependent check
- Andersson et al., JAMA Dermatol 2021: Danish topical corticosteroid cohort (full text)US governmentPrimaryIndependent check
- Cochrane: Safety of topical corticosteroids in pregnancyUS governmentPrimaryPage dated 2015-10-26Independent check
- De Stefano et al., Helv Paediatr Acta 1983: Nipple-applied corticosteroid case reportUS governmentPrimaryIndependent check
- UK MHRA Drug Safety Update: Topical steroids and withdrawal reactionsUK governmentSecondaryPage dated 2024-05-29Independent check
Last reviewed 2026-10-16
Independent check 2026-10-16
Not yet clinician-reviewed
Ask your provider about your situation.
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