Is ursodiol safe during pregnancy?
No harmonised reproductive classification on ECHA Annex VI and no evidence of teratogenicity in human clinical literature: ursodeoxycholic acid (ursodiol) is used therapeutically in pregnancy (intrahepatic cholestasis of pregnancy) without demonstrated fetal malformations (PubMed). No SCCS/CIR safety restriction identified for reproductive effects. Systemic exposure is expected only if taken systemically; for cosmetic topical use dermal absorption is likely low but measurable. Sources: ECHA Annex VI (no harmonised CLP), PubMed clinical literature on ursodeoxycholic acid in pregnancy, PubChem.
Related ingredients
Frequently asked questions
- Is ursodiol safe during pregnancy?
- No harmonised reproductive classification on ECHA Annex VI and no evidence of teratogenicity in human clinical literature: ursodeoxycholic acid (ursodiol) is used therapeutically in pregnancy (intrahepatic cholestasis of pregnancy) without demonstrated fetal malformations (PubMed). No SCCS/CIR safety restriction identified for reproductive effects. Systemic exposure is expected only if taken systemically; for cosmetic topical use dermal absorption is likely low but measurable. Sources: ECHA Annex VI (no harmonised CLP), PubMed clinical literature on ursodeoxycholic acid in pregnancy, PubChem.
- Is ursodiol safe while breastfeeding?
- No evidence of reproductive or developmental hazard from therapeutic literature; ursodeoxycholic acid is reported in clinical literature to be compatible with breastfeeding with low levels reported in milk. For topical cosmetic use, dermal absorption is expected to be low but measurable. Sources: PubMed clinical literature, PubChem.
- Is ursodiol safe for baby skin?
- No infant-specific hazard data indicating reproductive/developmental toxicity. Because measurable dermal absorption is plausible for ursodiol (not an inert insoluble polymer) and infant skin has higher absorption, exposure score increased by +1 for 0–3 year olds. No evidence of infant-specific toxicity in available literature. Sources: PubMed, PubChem, ECHA Annex VI (no harmonised CLP).
- How does VeriMom score ursodiol?
- VeriMom scores ursodiol at 93/100 (no known risks) based on EU CosIng status, ECHA hazard classifications, and peer-reviewed PubMed studies. Our scoring pipeline is fully transparent.
- What are pregnancy-safe alternatives to ursodiol?
- See our curated list of pregnancy-safe alternatives to ursodiol based on similar function and a no-known-risks safety band.
Check every label in 2 seconds
Get VeriMom free — scan any product and see the pregnancy safety score instantly.
Medical Disclaimer
This information is for educational purposes only and does not constitute medical advice. Safety scores are based on publicly available data and may not reflect all risks. Always consult your healthcare provider before using any product during pregnancy or breastfeeding.