Table 1. Dapagliflozin KAERS signals meeting disproportionality analysis criteria.

AEs		Number of AE reports		Disproportionality analysis
		Dapagliflozin	All other OHAs	PRR	ROR	IC	χ 2
Skin and appendages disorders
	Pruritus genital	166	216	10.62	11.29	2.42	826.60
Musculo-skeletal system disorders
	Muscle weakness	10	45	3.07	3.08	0.59	11.45
Central & peripheral nervous system disorders
	Dysaesthesia	4	2	27.65	27.69	1.71	34.25
	Hypoaesthesia	25	35	9.87	9.96	1.98	116.49
Vision disorders
	Retinal disorder	8	39	2.46	2.47	0.23	5.80
Hearing and vestibular disorders
	Tinnitus	6	25	3.32	3.32	0.49	7.84
Psychiatric disorders
	Appetite increased	14	55	3.52	3.53	0.84	20.16
Gastro-intestinal system disorders
	Increased stool frequency	3	3	13.82	13.84	1.27	17.85
	Mouth dry	65	244	3.68	3.75	1.26	101.12
Liver and biliary system disorders
	Gallbladder disorder	4	5	11.06	11.07	1.31	20.34
	Liver fatty	9	14	8.89	8.91	1.54	38.37
	SGOT increased	10	61	2.27	2.27	0.24	6.09
Metabolic and nutritional disorders
	Dehydration	9	16	7.78	7.80	1.44	34.03
	Ketosis	14	24	8.06	8.10	1.63	54.77
	Polydipsia	12	2	82.94	83.33	2.59	138.83
	Thirst	70	102	9.49	9.73	2.19	316.60
	Weight decrease	214	387	7.64	8.25	2.17	808.57
Cardiovascular disorders, general
	Hypotension postural	7	24	4.03	4.04	0.75	12.37
Vascular (extracardiac) disorders
	Transient ischaemic attack	4	8	6.91	6.92	0.99	13.49
Urinary system disorders
	Cystitis	35	74	6.54	6.61	1.72	111.79
	Dysuria	24	64	5.18	5.22	1.40	59.08
	Micturition disorder	6	20	4.15	4.15	0.72	11.03
	Micturition frequency	113	169	9.24	9.62	2.25	501.54
	Nocturia	44	31	19.62	19.95	2.59	322.02
	Polyuria	106	82	17.87	18.60	2.72	739.96
	Pyelonephritis	10	23	6.01	6.03	1.26	29.14
	Urethritis	6	10	8.29	8.31	1.31	24.07
	Urinary incontinence	8	32	3.46	3.46	0.64	11.18
	Urinary retention	10	9	15.36	15.42	1.94	63.62
	Urinary tract infection	39	68	7.93	8.04	1.92	150.48
	Urine abnormal	15	49	4.23	4.25	1.06	28.39
Reproductive disorders, male
	Genital infection	36	10	49.76	50.46	2.91	374.42
Reproductive disorders, female
	Leukorrhoea	8	1	110.59	110.93	2.41	96.55
	Menstrual disorder	3	6	6.91	6.92	0.86	10.12
	Vaginitis	65	99	9.08	9.29	2.14	283.20
Body as a whole—general disorders
	Asthenia	41	271	2.09	2.11	0.51	20.45
	Leg pain	11	59	2.24	2.24	0.23	6.40
Resistance mechanism disorders
	Moniliasis genital	9	9	13.82	13.87	1.83	53.56

AE, adverse event; IC, information component; KAERS, Korea adverse event reporting system; OHAs, oral hypoglycaemic agents; PRR, proportional reporting ratio; ROR, reporting odds ratio; SGOT, serum glutamic oxaloacetic transaminase.