Paracetamol, otherwise known as acetaminophen, is the active ingredient in over 600 prescription and nonprescription analgesic and antipyretic medications. Worldwide and in the United States, more than 50% and 65% of pregnant women use acetaminophen, respectively. Currently, acetaminophen is considered to be of minimal risk and appropriate for use during pregnancy by the US Food and Drug Administration and European Medicines Agency. Despite this, there exists concern that environmental exposure to pharmaceuticals including acetaminophen during fetal life may contribute to the increased rates of neurological, urogenital, and reproductive disorders.

This consensus statement aimed to provide an evidence-based summary of the literature relating to neurological, urogenital, and reproductive outcomes that have been associated with maternal and perinatal use of acetaminophen. This consensus statement was created by an international multidisciplinary group consisting of experts in neurology, obstetrics/gynecologists, pediatrics, epidemiology, toxicology, endocrinology, reproductive medicine, and neurodevelopment. A literature review was conducted for studies published between 1995 and 2020, including only those with acetaminophen as an independent exposure. There is a limitation in the existing epidemiological literature addressing these questions, and future efforts are required.

This consensus statement and systematic review finds evidence of significant neurodevelopmental and reproductive adverse effects of acetaminophen prenatal exposure, particularly with long-term use. It is recommended by this document that acetaminophen be used by pregnant women cautiously at the lowest effective dose for the shortest possible time and longer or higher-dose use be discussed with a health professional. It is also advised that packaging display warning labels related to the evidence discussed here.