Table 2.

Concordance between sex-biased PKs and VigiBase sex ratios

WHO ATC category	Drug name/PK biasa	PK measureb	VB ratioc	Concordance
Alimentary tract, metabolism	Ondansetron	AUC, Cmax	2.14	Concordant
Blood and blood forming organs	Icatibant	AUC, Cmax	3.18	Concordant
Cardiovascular system	Metoprolol	AUC, Cmax	1.26	Concordant
	Labetalol	Cmax, ClT	1.50	Concordant
	Nifedipine	ClT	1.29	Discordant1
	Pitavastatin	AUC, Cmax	1.12	Discordant2
Systemic hormonal preparations	Methylprednisolone	AUC, t1/2, ClT	1.38	Discordant1
Musculoskeletal	Ibuprofen	AUC,Cmax, t1/2, ClT	1.46	Discordant1
Anesthetics, analgesics	Lignocaine	ClT	1.64	Condordant
	Propofol	AUC,ClT	1.45	Concordant
	Butorphanol	AUC, Cmax	3.23	Concordant
	Paracetamol	ClT	1.68	Concordant
Anti-epileptics	Ezogabine	AUC, Cmax, ClT	0.90	Discordant2
Psycholeptics	Clobazam	t1/2	1.11	Discordant2
	Sertindole	AUC, Cmax	1.06	Discordant2
	Thiothixene	ClT	1.35	Concordant
	Oxazepam	ClT	1.31	Concordant
	Temazepam	t1/2, ClT	1.34	Concordant
	Zopiclone	AUC, Cmax	1.55	Concordant
Psychoanaleptics	Memantine	SysExp	1.50	Condordant
	Desipramine	AUC, ClT	1.59	Concordant
	Clomipramine	ClT	1.57	Concordant
	Paroxetine	ClT	2.00	Concordant
	Fluvoxamine	ClT	1.73	Concordant
	Mirtazapine	ClT	1.53	Concordant
Respiratory	Cetirizine	ClT	1.76	Concordant

PK abbreviations: AUC area under the curve, Cmax maximum circulating concentration, Tmax time required to reach Cmax value, t1/2 elimination half-life, ClT clearance time, exposure, or plasma concentration after a fixed time interval, SysExp systemic exposure, DurAbs duration of absorption

^aFont style of drug name indicates direction of PK drug exposure bias: (normal: F > M; bold: M > F)

^bFont style of PK measure indicates direction of greater PK drug exposure: (normal: F > M; bold: M > F; italic: inconsistent)

^cF-to-M reporting ratio of suspected ADRs. Threshold for designation of sex bias = ± 20%

¹False positive

²False negative