Can I take isotretinoin while pregnant or breastfeeding?
A plain-words look at what the NHS, the US drug label and LactMed say about isotretinoin.
In short
Pregnancy: You must not take isotretinoin if you're pregnant or trying for a baby.
Breastfeeding: You must not take isotretinoin while breastfeeding, as it can cause side effects in your baby.
Your doctor, midwife or pharmacist can help you decide.
What this means for you
Pregnancy
- It can cause miscarriage or serious problems with your baby's development.
- You need to have stopped it for at least one month before you start trying for a baby.
- Let your doctor know if you're pregnant or trying for a baby.
Breastfeeding
- Let your doctor know if you're breastfeeding and they will offer you another treatment.
Talk to your doctor or pharmacist
This page is educational, not advice for your own situation. Talk to your doctor, midwife or pharmacist before you start, stop or change any medicine in pregnancy or while breastfeeding.
The details: what each source says
Isotretinoin in pregnancy
The NHS says
You must not take isotretinoin if you're pregnant or trying for a baby. It can cause miscarriage or serious problems with your baby's development. You need to have stopped it for at least one month before you start trying for a baby.
Let your doctor know if you're pregnant or trying for a baby.
In our words, from the NHS page Isotretinoin (Roaccutane) (nhs.uk). Contains public sector information licensed under the Open Government Licence v3.0 (OGL v3.0). The NHS does not endorse this site.
What these words mean
- contraindicated
- there is a reason not to use this medicine, because it may be harmful
Definitions adapted from the NCI Dictionary of Cancer Terms (National Cancer Institute).
The US drug label says
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that documents pregnancies in patients exposed to isotretinoin during pregnancy. Report any suspected fetal exposure during or 1 month after isotretinoin treatment immediately to the FDA via the MedWatch telephone number 1-800-FDA-1088 and also to the iPLEDGE pregnancy registry at 1-866-495-0654 or via the internet ( www.ipledgeprogram.com) . Risk Summary Isotretinoin is contraindicated during pregnancy because isotretinoin can cause fetal harm when administered to a pregnant patient. There is an increased risk of major congenital malformations, spontaneous abortions, and premature births following isotretinoin exposure during pregnancy in humans. If isotretinoin is used during pregnancy, or if the patient becomes pregnant while taking isotretinoin, apprise the patient of the potential hazard to a fetus. If pregnancy occurs during treatment of a patient who is taking isotretinoin, immediately discontinue isotretinoin and refer the patient to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.
Prescribing label, section “8.1 Pregnancy” (opening excerpt): ISOTRETINOIN (oral), Aurobindo Pharma Limited. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.
More on isotretinoin in pregnancy: Bumps (Best Use of Medicines in Pregnancy) leaflet (external site).
Isotretinoin while breastfeeding
The NHS says
You must not take isotretinoin while breastfeeding, as it can cause side effects in your baby. Let your doctor know if you're breastfeeding and they will offer you another treatment.
In our words, from the NHS page Isotretinoin (Roaccutane) (nhs.uk). Contains public sector information licensed under the Open Government Licence v3.0 (OGL v3.0). The NHS does not endorse this site.
LactMed says
No information is available on the use of isotretinoin during breastfeeding. Various topical agents that are less likely to be absorbed by the mother may be preferred during breastfeeding, especially while nursing a newborn or preterm infant.
“Summary of Use during Lactation”, LactMed record “Isotretinoin” (LM735), quoted verbatim. Everything LactMed reports about Isotretinoin while breastfeeding.
The US prescribing label says
8.2 Lactation Risk Summary There are no data on the presence of isotretinoin in either animal or human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions in nursing infants from isotretinoin, advise patients that breastfeeding is not recommended during treatment with isotretinoin, and for at least 8 days after the last dose of isotretinoin.
Prescribing label, section “8.2 Lactation”: ISOTRETINOIN (oral), Aurobindo Pharma Limited. Label on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.
Other names
UK brand names (per the NHS): Roaccutane.
Sources
- NHS, Isotretinoin (Roaccutane) (nhs.uk), page last reviewed 26 June 2026. Paraphrased. Contains public sector information licensed under the Open Government Licence v3.0.
- US drug label: ISOTRETINOIN (oral), Aurobindo Pharma Limited, human prescription drug, label effective 7 September 2026, set ID 4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e6. DailyMed (National Library of Medicine). Public domain; quoted verbatim.
- Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Isotretinoin” (LM735), bulk release of 22 September 2026. LactMed on NCBI Bookshelf. Public domain; quoted verbatim. LactMed is a registered trademark of the U.S. Department of Health and Human Services.
- Bumps (Best Use of Medicines in Pregnancy), UK Teratology Information Service: Bumps (Best Use of Medicines in Pregnancy) leaflet. Linked, not reproduced.
Sources checked 26 September 2026. How we source and check every page.
Educational summary of named sources, not medical advice.