BDNFBrain Paracetamol (acetaminophen) remains the first line for the treatment of pain and fever in pregnancy. Recently published epidemiological studies suggested a possible association between paracetamol exposure in utero and attention-deficit-hyperactivity disorder/hyperkinetic disorder (ADHD/HKD) or adverse development issues in children. However, the effects observed are in the weak to moderate range, and limitations in the studies' design prevent inference on a causal association with ADHD/HKD or child neurological development. In parallel, recent animal data showed that cognition and behaviour may be altered following exposure to therapeutic doses of paracetamol during early development. These effects may be mediated by interference of paracetamol with brain-derived neurotrophic factor, neurotransmitter systems (including serotonergic, dopaminergic, adrenergic, as well as the endogenous endocannabinoid systems), or cyclooxygenase-2. However, no firm conclusion can be made on the relevance of these observations to humans. We conclude that additional well-designed cohort studies are necessary to confirm or disprove the association. In the context of current knowledge, paracetamol is still to be considered safe in pregnancy and should remain the first-line treatment for pain and fever.Information on safety of the fetus exposed to drugs during pregnancy is generally limited. 1 Among 172 medications approved in the USA between 2000 and 2010, 73% had no data on the safety in pregnancy and 98% had insufficient data to evaluate teratogenic risk. 2 In the European Union (EU), 68% of marketed product via the EU centralized procedure, and published on the European Medicines Agency (EMA) website, indicate in their Summary of Product Characteristics that there is no clinical experience during pregnancy.3 Pregnant females are typically excluded from clinical trials, thus, there is often an absence of evidence-based information in this group of patients at the time of marketing authorization. The EMA recently conducted an analysis of data sources on drug exposure during pregnancy and has noted several issues in obtaining high quality data. 4 However, use of medication during pregnancy is extremely common. Over-the-counter drugs, in particular, are the most common medications used 5 with about 67% of females reporting the use of over-the-counter medication during pregnancy in Europe. 6 Figures are probably more variable in developing countries. A recent pharmacovigilance study conducted on 994 pregnant females using the platform of the Rufiji Health and Demographic Surveillance System in Tanzania, found that more than 98% of these females reported taking at least one medication during pregnancy.7 Analgesics were among the most frequently reported medications (24%).Paracetamol (acetaminophen) is a widely used analgesic and antipyretic. It is also an active substance in a series of readily available over-the-counter medicines. Taken during pregnancy, paracetamol is generally considered safe and effective when used at the ...