Accutane and pregnancy: the risks and iPLEDGE rules

Isotretinoin, the drug many people still call Accutane, causes severe birth defects. The FDA label opens with a boxed warning, the warning printed in a box at the top of the label, and it says that isotretinoin can cause life-threatening birth defects and must not be taken during pregnancy. This guide sets out what the label, the FDA's iPLEDGE program, MedlinePlus, the NHS and the American Academy of Dermatology (AAD) say about pregnancy, in their own terms. For the drug itself, see the Accutane guide.

Skinli gives general education and is not a doctor. Isotretinoin is prescribed and monitored by a doctor, and every rule below is one your prescriber will go through with you in person. If you have severe acne and are pregnant or planning a pregnancy, read when to see a dermatologist for severe acne and tell the dermatologist about your plans at the first visit.

If you are taking isotretinoin and think you might be pregnant, stop taking it and call your prescriber now.

What the boxed warning says

The August 2026 label for one generic isotretinoin capsule states these points in its boxed warning:

• Isotretinoin "can cause life-threatening birth defects and is contraindicated in pregnancy," which means it must not be used in pregnancy.
• The risk applies if pregnancy occurs while taking "any amount" of the drug, "even for short periods of time."
• "Potentially any fetus exposed during pregnancy can be affected."
• "There are no accurate means of determining prenatally whether an exposed fetus has been affected." In plain words, no test during pregnancy can show whether the baby was harmed.
• If pregnancy occurs, the drug must be stopped immediately and the patient referred to an obstetrician experienced in how drugs harm unborn babies.

MedlinePlus, the National Library of Medicine's consumer site, puts it this way: there is "a high risk" that isotretinoin will cause loss of the pregnancy, a baby born too early, a baby who dies shortly after birth, or a baby born with birth defects.

The defects the label lists

The label's human data section lists malformations of the face, eyes, ears, skull, brain and nervous system, heart and blood vessels, and the thymus and parathyroid glands. Examples it names include missing or small ears, small eyes, cleft palate, fluid on the brain and a small head. It reports IQ scores below 85 in some children exposed in the womb, with or without other defects, and says that in some cases death has occurred because of the malformations. It also reports a higher risk of miscarriage and premature birth.

A 1985 study in the New England Journal of Medicine followed 154 pregnancies exposed to isotretinoin:

Outcome	Number of pregnancies
Ended by choice	95
Miscarriage	12
Baby with major birth defects	21
Baby without major birth defects	26

The researchers calculated that exposure raised the risk of a group of major malformations 25.6-fold, and they described the same pattern of face, heart, thymus and brain defects that the label now lists.

Pregnancies still happen under iPLEDGE

The FDA says the iPLEDGE program was first put in place in early 2005 and became a formal FDA safety program in 2010. A 2019 study in JAMA Dermatology counted 6,740 pregnancies in women taking isotretinoin reported to the FDA from 1997 to 2017. Reports peaked in 2006 at 768 and settled at 218 to 310 a year after 2011. Among women who could get pregnant, the yearly rate ranged from 0.33 to 0.65 percent. The authors, who date iPLEDGE's start to 2006, wrote that pregnancies, abortions and birth defects have decreased since then, and all three persist.

A 2014 study from the Netherlands, which has its own prevention program, found 51 exposed pregnancies among 203,962. In 60 percent of them, the woman started isotretinoin while already pregnant.

The rules for anyone who can get pregnant

These rules come from the August 2026 FDA label. MedlinePlus says they apply even to someone who has not started having periods or has had their tubes tied. The exceptions it lists are surgery to remove the uterus or both ovaries, and menopause confirmed by a doctor after 12 months in a row without a period.

When	What the label requires
Before the first prescription	Two negative pregnancy tests in a medical setting, the second at least 30 days after the first. Two forms of birth control, or a commitment to no sexual contact that could cause pregnancy, for at least 30 days first
Every month of treatment	A negative pregnancy test within 7 days before each prescription. Two forms of birth control. Answer the iPLEDGE questions, and pick up the prescription within 7 days of the test
After the last dose	Two forms of birth control for 1 month. A pregnancy test at the end of treatment and another 1 month later

Two forms of birth control, at the same time. At least one must be a primary form. The label lists these primary forms: tubal sterilization, a partner's vasectomy, an intrauterine device, and hormonal methods (combined pills, rings, inserts, patches, shots or implants). Secondary forms are barrier methods such as a male latex condom, or a diaphragm or cervical cap used with spermicide, and the vaginal sponge.

The progestin-only "minipill" does not count. The label calls it an inadequate form of birth control during isotretinoin treatment.

Any method can fail. The label says pregnancies have been reported in patients using combined pills, rings, patches and shots, and that these reports are more frequent in patients using only one method. MedlinePlus warns against St. John's wort, an herbal supplement, with hormonal birth control, and the older Accutane label says pregnancies have been reported in people who used both.

A free birth control visit. The Medication Guide says your prescriber can arrange a free visit with another doctor or family planning expert to talk about birth control, paid for by the drug's maker. The older label's enrollment form also records that the patient received information on emergency birth control.

If you have sex without two forms of birth control

The label sets out four steps if unprotected sex happens at any time from 1 month before to 1 month after treatment:

1. Stop isotretinoin immediately, if you are taking it.
2. Have a pregnancy test at least 19 days after the last unprotected sex.
3. Use two forms of birth control again for 1 month before restarting.
4. Have a second pregnancy test after that month.

Call your prescriber first. Ask about emergency birth control at the same call.

If you become pregnant

Stop the drug and tell your prescriber right away. The label asks that every suspected exposure during treatment or within 1 month after be reported to FDA MedWatch at 1-800-FDA-1088 and to the iPLEDGE pregnancy registry at 1-866-495-0654. The prescriber will refer you to an obstetrician who can explain the risks for your pregnancy.

Changes to iPLEDGE in 2026

The FDA approved changes on February 9, 2026 and has set November 15, 2026 as the date they take effect. Prescribers may then let patients use home pregnancy tests during and after treatment, and a patient who misses the 7-day pickup period can repeat the test right away. Until then, the FDA says it will not object if prescribers rely on home tests during and after treatment, as it announced in October 2023. The FDA says the tests before treatment must still be done in a medical setting, because making sure a patient is not pregnant before starting is critically important. Older labels still on DailyMed describe the earlier rules, with 19 days between the two tests before treatment and monthly tests in a specially certified lab, so ask your prescriber which rules apply to you. The how to get Accutane guide lists every change.

Men and pregnancy

Men do not need pregnancy tests, and they still enroll in iPLEDGE. The older Accutane label says isotretinoin is found in semen, and estimates the amount a partner could receive at one millionth of a 40 mg oral dose. It says 20 years of reports after approval included four with isolated defects like those seen after isotretinoin exposure, and that two of those reports were incomplete and two had other possible explanations. MedlinePlus says it is not known whether this small amount can harm a baby, and asks men to tell their doctor if a partner is pregnant or plans to be.

Breastfeeding

The August 2026 label says breastfeeding is not recommended during treatment and for at least 8 days after the last dose, because of the risk of serious side effects in the baby. It adds that no data exist on isotretinoin in breast milk. MedlinePlus, last revised in 2018, says not to breastfeed for 1 month after stopping, and so does the Medication Guide in the older Accutane label. The NHS says you must not take isotretinoin while breastfeeding. Where these sources differ, Skinli follows the newest label, and your doctor can say what applies to you.

Fertility and later pregnancies

The labels report no clear change in sperm count or movement in studies of 66 men and 50 men. A newer label describes a study of 79 women in which measures of egg supply fell by the end of treatment and returned to normal 12 months after it ended, and it lists the study's limits: small size, no comparison group, and results that may not apply to everyone.

For pregnancies after treatment ends, the label's rule is 1 month. A 1989 report by the drug safety department of the original maker looked at 88 pregnancies conceived after stopping and found miscarriage and birth defect rates in line with the general population. It is old and industry-written, so ask your doctor to go over your plans.

Blood donation

Every patient, whether or not they can get pregnant, must not donate blood during treatment and for 1 month after. The label explains that the blood might be given to a pregnant patient.

Acne treatment during pregnancy

The AAD's page on acne treatment during pregnancy lists isotretinoin among the medicines to stop immediately if you are pregnant, because they can cause serious birth defects. For acne while pregnant or breastfeeding, see retinoids during pregnancy and breastfeeding and azelaic acid during pregnancy, and ask your obstetrician. The Accutane side effects guide covers the risks that apply to everyone.