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Purpose: This study aims to investigate how gender-based differences are actually reflected on drug approval. Methods: Data on gender-based differences of drugs were analyzed by searching PDR (Physician’s Desk Reference) with the keyword, “GENDER”. Results: There were descriptions related to gender in product directions of 361 drugs in 2009 PDR, out of which 63 items actually showed gender-related differences. Drug categories showing comparatively high gender-based differences were nervous system, cardiovascular system, and alimentary tract and metabolism. Pharmacokinetic differences between genders were observed most frequently; compared to men, 32 drugs showed higher absorption while 18 drugs revealed lower clearance in women. There were 2 drugs which gender should be considered before prescribing, and 5 drugs which showed different severity of adverse effects according to gender. Conclusions: It is necessary to establish domestic policies for drug approval and use which reflects gender-based differences through sufficient researches.