No reports of permanent liver damage associated with Accutane (isotretinoin) could be found in the literature but temporary increases in liver test abnormalities are estimated to occur in up to 15% of people taking isotretinoin. Significant increases, such as those more than three times the upper limit of normal (ULN) or increases that require people to stop taking Accutane are exceedingly rare and occur in less than 1% of people taking Accutane.

Liver test abnormalities caused by Accutane do not usually cause any symptoms and can resolve even when people keep taking Accutane. Accutane is unlikely to cause acute liver injury with signs of hypersensitivity that have been described with similar medicines such as etretinate and acitretin, and no case reports describing this could be found. Rarely, vitamin A-like effects on the liver with lipid accumulation in certain liver cells have occurred in people taking isotretinoin therapy, but it wasn’t clear whether they had also been taking supplementary vitamin A. So the majority of liver effects occurring with Accutane have caused minimal or no symptoms and have resolved either on stopping the medication or with continued use.

Close monitoring of liver function tests is required for people taking Accutane and it should be stopped with signs of significant elevations (more than 3 to 5 times ULN) in liver enzymes, or if there are symptoms such as jaundice. One case study in the literature described a 16-year-old male whose ALT levels rose from 13 to 288 U/L after 20 weeks of isotretinoin therapy and these did not return to normal limits for 8 months after discontinuation. However, when isotretinoin was readministered 3 years later, his liver enzymes remained normal throughout treatment.