Isotretinoin
MedicationAbsorica, Amnesteem, Claravis, Accutane
Oral retinoid (acne)
Research strength: 5 / 5
DailyMed's boxed warning says, "ABSORICA/ABSORICA LD can cause life-threatening birth defects and is contraindicated in pregnancy." The label says any amount, even brief exposure, can cause life-threatening birth defects; if pregnancy occurs, it directs immediate discontinuation and referral to an obstetrician-gynecologist experienced in reproductive toxicity. Lammer et al. (1985) described defects involving the face, heart, thymus, and central nervous system, but its study does not establish a universal individual risk estimate. For patients who can get pregnant, the label says they "must use 2 forms of contraception simultaneously" and comply with iPLEDGE pregnancy tests, subject to listed exceptions. FDA says iPLEDGE modifications are delayed until November 15, 2026; pre-treatment tests remain in a medical setting, while a prescriber may permit home tests during or after treatment. Ask your provider about your situation.
Last reviewed: 2026-10-14
Sources
- DailyMed: Absorica and Absorica LD (isotretinoin) labelDrug company label
- MotherToBaby: Isotretinoin (Accutane) fact sheetTeratology service
- Lammer et al., Retinoic acid embryopathy, NEJM 1985US government
- EMA PRAC: Retinoid Article 31 referral, Annex IIEU agencyEuropean guidance
- FDA: iPLEDGE Risk Evaluation and Mitigation StrategyUS government
Research strength: 4 / 5
DailyMed's boxed warning says, "ABSORICA/ABSORICA LD can cause life-threatening birth defects and is contraindicated in pregnancy." The contraindication applies throughout pregnancy, including the second trimester; the label reports miscarriage and IQ scores below 85 in some children exposed in utero. MotherToBaby describes possible hearing, vision, behavior, and learning concerns that may appear as a child grows. Lammer et al. (1985) reported pregnancy outcomes after fetal exposure, but the abstract does not give a separate risk estimate for second-trimester exposure. FDA says iPLEDGE modifications are delayed until November 15, 2026; pre-treatment pregnancy tests remain in a medical setting, and prescriber-permitted home tests during or after treatment are covered by enforcement discretion. Ask your provider about your situation.
Last reviewed: 2026-10-14
Sources
- DailyMed: Absorica and Absorica LD (isotretinoin) labelDrug company label
- MotherToBaby: Isotretinoin (Accutane) fact sheetTeratology service
- Lammer et al., Retinoic acid embryopathy, NEJM 1985US government
- EMA PRAC: Retinoid Article 31 referral, Annex IIEU agencyEuropean guidance
- FDA: iPLEDGE Risk Evaluation and Mitigation StrategyUS government
Research strength: 4 / 5
DailyMed's boxed warning says, "ABSORICA/ABSORICA LD can cause life-threatening birth defects and is contraindicated in pregnancy." The contraindication applies throughout pregnancy, including the third trimester; the label reports miscarriage and IQ scores below 85 in some children exposed in utero. MotherToBaby describes possible hearing, vision, behavior, and learning concerns that may appear as a child grows. Lammer et al. (1985) described exposed pregnancies but did not report a separate late-pregnancy risk estimate. FDA says iPLEDGE modifications are delayed until November 15, 2026; pre-treatment pregnancy tests remain in a medical setting, and prescriber-permitted home tests during or after treatment are covered by enforcement discretion. Ask your provider about your situation.
Last reviewed: 2026-10-14
Sources
- DailyMed: Absorica and Absorica LD (isotretinoin) labelDrug company label
- MotherToBaby: Isotretinoin (Accutane) fact sheetTeratology service
- Lammer et al., Retinoic acid embryopathy, NEJM 1985US government
- EMA PRAC: Retinoid Article 31 referral, Annex IIEU agencyEuropean guidance
- FDA: iPLEDGE Risk Evaluation and Mitigation StrategyUS government
Isotretinoin — Breastfeeding
Research strength: 1 / 5
LactMed says it has no information on oral isotretinoin during breastfeeding. It says less-absorbed topical acne treatments may be preferred for a newborn or preterm infant. The Absorica label states, "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." It also says, "breastfeeding is not recommended during treatment with ABSORICA/ABSORICA LD, and for at least 8 days after the last dose of ABSORICA/ABSORICA LD." This entry covers oral isotretinoin only; LactMed's alternatives are not evidence about topical isotretinoin. Ask your provider about your situation.
Last reviewed: 2026-10-14
Pregnancy
The Absorica label states that oral isotretinoin can cause life-threatening birth defects and is contraindicated during pregnancy. The label also documents increased risk of major congenital malformations and spontaneous abortions. The label separately cites premature births; MotherToBaby also cites preterm delivery and low birth weight, but no primary study or Approved-Independent check for those outcomes was identified, so they remain not verified and are omitted from entry prose. Lammer et al. (1985) studied 154 exposed human pregnancies; the abstract reports 95 elective terminations, 26 infants without major malformations, 12 spontaneous abortions, and 21 malformed infants. It describes craniofacial, cardiac, thymic, and central nervous system malformations. MotherToBaby also reports possible hearing or vision problems, behavior problems, or intellectual disability that may appear as a child grows; the label reports IQ scores below 85 in some children exposed in utero. Because Lammer's series is selected and includes many elective terminations, its counts do not provide a universal individual probability. MotherToBaby and the EMA PRAC review publish different absolute risk estimates. The accessible Lammer abstract does not verify a directly comparable individual risk, so the estimates remain not verified in this audit and are not repeated in the period summaries. The MHRA's January 2026 update removed the second-prescriber requirement for initiating treatment in patients under 18, while retaining the Pregnancy Prevention Programme and other risk-minimisation measures. FDA says changes to iPLEDGE are delayed until November 15, 2026; pre-treatment tests remain in a medical setting, with enforcement discretion for certain other pregnancy testing requirements until full implementation.
Breastfeeding
LactMed's entry, last revised October 15, 2024, says no information is available on isotretinoin use during breastfeeding and reports no published maternal milk levels, infant levels, or infant effects as of its revision. The Absorica label also states that there are no data on the drug in human milk, effects on a breastfed infant, or milk production. The label says breastfeeding is not recommended during treatment and for at least 8 days after the last dose. LactMed's note that some topical acne treatments are less likely to be absorbed concerns alternative topical agents and does not establish the effects of topical isotretinoin. This entry covers oral isotretinoin only.
The Absorica label identifies isotretinoin as 13-cis-retinoic acid and describes Absorica capsules for oral use. This entry covers oral isotretinoin. Evidence about topical retinoid medicines or cosmetic retinol is separate and was not substituted for evidence about oral isotretinoin.
What was tested
The pregnancy evidence reviewed here includes human case series, pregnancy registries, regulator reviews, and product labeling. Lammer et al. (1985) studied 154 pregnancies with fetal exposure and reported outcomes for a prospective subset of 36. No randomized pregnancy study was identified in the cited source set. LactMed and the product label report no human milk-level or infant-outcome data for oral isotretinoin. The pregnancy and breastfeeding summaries distinguish oral treatment from topical agents.
Absolute estimates for birth defects and miscarriage after oral isotretinoin exposure
- Source A says
- MotherToBaby states that birth defects occur in 35% or more of exposed infants and that miscarriage can be as high as 40% with early-pregnancy use. (MotherToBaby: Isotretinoin (Accutane) fact sheet)
- Source B says
- The EMA PRAC review gives class-level estimates of up to 30% for malformations and about one-third for spontaneous abortion. Lammer et al. (1985) reports outcomes among 154 isotretinoin-exposed pregnancies, but its abstract does not establish a directly comparable universal percentage. (EMA PRAC: Retinoid Article 31 referral, Annex II, Lammer et al., Retinoic acid embryopathy, NEJM 1985)
- Why they differ
- The EMA figure is for oral retinoids as a class, while MotherToBaby's figures are presented for isotretinoin. The primary study reports outcome counts in a selected series that included many elective terminations, not one shared denominator for a simple individual risk estimate. The accessible sources do not show that the percentages use the same population, exposure window, or outcome denominator.
- What the evidence shows overall
- The evidence establishes major human fetal risk and pregnancy is contraindicated. Exact percentages differ by source and the accessible primary abstract does not verify a single comparable estimate, so the period summaries leave the percentages out.
- The Absorica label states that if pregnancy occurs during treatment, the medication is discontinued immediately and the patient is referred to an obstetrician-gynecologist experienced in reproductive toxicity. (DailyMed: Absorica and Absorica LD label)
- FDA states that pre-treatment pregnancy tests must remain in a medical setting. During the current enforcement-discretion period, a prescriber may permit home pregnancy tests during and after treatment. (FDA: iPLEDGE REMS)
- The Absorica label states that breastfeeding is not recommended during treatment and for at least 8 days after the last dose. (DailyMed: Absorica and Absorica LD label)
General research, not specific to pregnancy.
The Absorica label lists dry lips, dry skin, back pain, dry eyes, joint pain, and other effects among common reactions. The MHRA's 2023 and 2026 updates maintain counselling and monitoring for possible mental health and sexual-function effects.
- The label lists dry lips, dry skin, back pain, dry eyes, joint pain, nose bleeds, headache, upper respiratory infection, skin reactions, muscle problems, and eye problems among common effects. (DailyMed: Absorica and Absorica LD (isotretinoin) label)
- The MHRA's 2023 measures introduced counselling about possible mental health and sexual-function effects; its January 2026 update kept counselling and monitoring in place. (MHRA: Isotretinoin introduction of new safety measures, October 2023, MHRA Drug Safety Update: Isotretinoin prescribing changes, January 2026)
- MotherToBaby: Isotretinoin (Accutane) fact sheetTeratology serviceSecondaryPage dated 2026-01-01Independent check
- LactMed: IsotretinoinUS governmentSecondaryPage dated 2024-10-15Independent check
- DailyMed: Absorica and Absorica LD (isotretinoin) labelDrug company labelTertiaryIndependent check
- EMA: Updated measures for pregnancy prevention during retinoid useEU agencySecondaryPage dated 2018-03-23Independent checkEuropean guidance
- EMA PRAC: Retinoid Article 31 referral, Annex IIEU agencySecondaryIndependent checkEuropean guidance
- Lammer et al., Retinoic acid embryopathy, NEJM 1985US governmentPrimaryIndependent check
- FDA: iPLEDGE Risk Evaluation and Mitigation StrategyUS governmentSecondaryPage dated 2026-06-16Independent check
- MHRA: Isotretinoin introduction of new safety measures, October 2023UK governmentSecondaryPage dated 2023-10-31Independent check
- MHRA Drug Safety Update: Isotretinoin prescribing changes, January 2026UK governmentSecondaryIndependent check
Last reviewed 2026-10-14
Independent check 2026-10-14
Not yet clinician-reviewed
Ask your provider about your situation.