Patients may not begin to experience the full benefits of the drug until they have taken it for several weeks. The risk for women who take this drug during their first trimester is reportedly 30 percent. The drug is used to treat a certain type of severe acne that is not helped by other forms of treatment, like antibiotics. Some pregnant users of this drug have reported that they miscarried or gave birth to babies with a high incidence of mental retardation and deformities.

The Food & Drug Administration (FDA) sought to decrease risks of birth defects related to fetal exposure to the drug.

The medication comes in the form of a capsule and is taken by mouth with one full glass of liquid. In the general population, the risk of a birth defect is reportedly between three and five percent. Some patients have reported multiple Accutane side effects including psychological issues, Inflammatory Bowel Disease (IBD), and birth defects. It slows down the production of natural substances known to cause the formation of pimples. As a result, the Risk Minimization Action Plan (riskMAP) pertaining. A majority of the discussion surrounds conditions that are pregnancy related.

There have been ongoing regulatory and medical disputes regarding these and other Accutane side effects.