First trimester in utero exposure to methylphenidate

Basic Clin Pharmacol Toxicol. 2013 Feb;112(2):73-6. doi: 10.1111/bcpt.12034.


Methylphenidate is a centrally acting sympathomimetic used for the treatment of attention deficit/hyperactivity disorder in children and adolescents and for narcolepsy in adults. Despite the growing use among adult women, no reliable data on the prevalence of use during pregnancy have been published, and safety during pregnancy has not been established. We systematically reviewed available data on birth outcome after human in utero exposure to methylphenidate. Systematic searches in PubMed/Embase were performed from origin to August 2012, and data from Michigan Medicaid recipients, The Collaborative Perinatal Project and the Swedish Birth Registry were evaluated. Excluding three case reports, a total of 180 children exposed to methylphenidate in utero during first trimester were identified, among whom, four children with major malformations were observed. Methylphenidate exposure during pregnancy does not appear to be associated with a substantially (i.e. more than twofold) increased risk of congenital malformations.

Publication types

  • Review

MeSH terms

  • Adult
  • Animals
  • Attention Deficit Disorder with Hyperactivity / drug therapy*
  • Central Nervous System Stimulants / administration & dosage
  • Central Nervous System Stimulants / adverse effects*
  • Female
  • Humans
  • Infant, Newborn
  • Methylphenidate / administration & dosage
  • Methylphenidate / adverse effects*
  • Pregnancy
  • Pregnancy Complications / drug therapy
  • Pregnancy Outcome
  • Pregnancy Trimester, First


  • Central Nervous System Stimulants
  • Methylphenidate