Sex and racial differences in pharmacological response: where is the evidence? Pharmacogenetics, pharmacokinetics, and pharmacodynamics

J Womens Health (Larchmt). 2005 Jan-Feb;14(1):19-29. doi: 10.1089/jwh.2005.14.19.


The Food and Drug Administration (FDA) reviewed 300 new drug applications between 1995 and 2000. Of the 163 that included a sex analysis, 11 drugs showed a >40% difference in pharmacokinetics between males and females, which was listed on the product label, yet no dosing recommendations were made based on sex. Female sex has been shown to be a risk factor for clinically relevant adverse drug reactions. Would simply dosing females based on their different pharmacokinetics decrease the incidence of adverse events? The answer is not known. Sex-dependent pharmacodynamic effects have been identified. The role of pharmacokinetics vs. pharmacodynamics is unclear, as is the impact of pharmacogenetics on both. This review highlights a few specific examples in each area in which sex differences in pharmacokinetics and pharmacodynamics are important and provides recommendations for additional needed research.

Publication types

  • Review

MeSH terms

  • Biological Availability
  • Biological Transport
  • Biotransformation
  • Dose-Response Relationship, Drug
  • Drug Administration Routes
  • Drug Delivery Systems
  • Drug Prescriptions / standards
  • Evidence-Based Medicine
  • Female
  • Humans
  • Metabolic Clearance Rate
  • Pharmacogenetics*
  • Pharmacokinetics*
  • Racial Groups* / genetics
  • Sex Characteristics*
  • Therapeutic Uses
  • Tissue Distribution
  • United States
  • Women's Health*


  • Therapeutic Uses