Digestive Tract Cancer-Related Adverse Events Correlated with Proton Pump Inhibitors Use: A Pharmacovigilance Study of the FDA Adverse Event Reporting System

Table 2

The characteristics of digestive tract cancer adverse events of proton pump inhibitors.

Characteristics	ONM	GNM	SINM	CNM	ACNM	PNM	HNM	GBNM	BDNM	ALL
	Case (%)	Case (%)	Case (%)	Case (%)	Case (%)	Case (%)	Case (%)	Case (%)	Case (%)	Case/N
Case	327 (12.8%)	687 (26.9%)	38 (1.5%)	586 (23.0%)	20 (0.8%)	456 (17.9%)	405 (15.9%)	33 (1.3%)	83 (3.3%)	2553
Patient gender
Male	210 (64.2%)	212 (30.9%)	17 (44.7%)	268 (45.7%)	9 (45.0%)	217 (47.6%)	240 (59.3%)	10 (30.3%)	39 (47.0%)	1183 (46.3%)
Female	97 (29.7%)	180 (26.2%)	20 (52.6%)	297 (50.7%)	11 (55.0%)	221 (48.5%)	141 (34.8%)	20 (60.6%)	42 (50.6%)	993 (38.9%)
Unknown or missing	20 (6.1%)	295 (42.9%)	1 (2.6%)	21 (3.6%)	0 (0.0%)	18 (3.9%)	24 (5.9%)	3 (9.1%)	2 (2.4%)	377 (14.8%)
Patient age group (years)
<18	0 (0.0%)	0 (0.0%)	0 (0.0%)	1 (0.2%)	0 (0.0%)	0 (0.0%)	1 (0.2%)	0 (0.0%)	0 (0.0%)	2 (0.1%)
18–65	118 (36.1%)	125 (18.2%)	18 (47.4%)	203 (34.6%)	12 (60.0%)	171 (37.5%)	155 (38.3%)	14 (42.4%)	31 (37.3%)	816 (32.0%)
>65	86 (26.3%)	148 (21.5%)	14 (36.8%)	254 (43.3%)	0 (0.0%)	178 (39.0%)	154 (38.0%)	11 (33.3%)	40 (48.2%)	862 (33.8%)
Unknown or missing	123 (37.6%)	414 (60.3%)	6 (15.8%)	128 (21.8%)	8 (40.0%)	107 (23.5%)	95 (23.5%)	8 (24.2%)	12 (14.5%)	873 (34.2%)
Serious outcome of adverse events
Hospitalization	74 (22.6%)	155 (22.6%)	20 (52.6%)	295 (50.3%)	7 (35.0%)	196 (43.0%)	171 (42.2%)	21 (63.6%)	39 (47.0%)	948 (37.1%)
Disability	12 (3.7%)	11 (1.6%)	3 (7.9%)	21 (3.6%)	0 (0.0%)	25 (5.5%)	18 (4.4%)	3 (9.1%)	6 (7.2%)	95 (3.7%)
Life-threatening	38 (11.6%)	27 (3.9%)	3 (7.9%)	61 (10.4%)	0 (0.0%)	62 (13.6%)	33 (8.1%)	8 (24.2%)	11 (13.3%)	239 (9.4%)
Death	96 (29.4%)	177 (25.8%)	7 (18.4%)	157 (26.8%)	1 (5.0%)	238 (52.2%)	141 (34.8%)	9 (27.3%)	31 (37.3%)	826 (32.4%)
PPIs
Omeprazole	105 (32.1%)	368 (53.6%)	12 (31.6%)	170 (29.0%)	13 (65.0%)	170 (37.3%)	124 (30.6%)	18 (54.5%)	30 (36.1%)	966 (37.8%)
Lansoprazole	64 (19.6%)	240 (34.9%)	8 (21.1%)	121 (20.6%)	1 (5.0%)	57 (12.5%)	60 (14.8%)	5 (15.2%)	17 (20.5%)	560 (21.9%)
Pantoprazole	46 (14.1%)	228 (33.2%)	8 (21.1%)	144 (24.6%)	3 (15.0%)	121 (26.5%)	109 (26.9%)	3 (9.1%)	19 (22.9%)	659 (25.8%)
Rabeprazole	11 (3.4%)	36 (5.2%)	6 (15.8%)	29 (4.9%)	0 (0.0%)	21 (4.6%)	26 (6.4%)	1 (3.0%)	6 (7.2%)	127 (5.0%)
Esomeprazole	162 (49.5%)	346 (50.4%)	10 (26.3%)	166 (28.3%)	5 (25.0%)	121 (26.5%)	98 (24.2%)	7 (21.2%)	14 (16.9%)	893 (35.0%)
Dexlansoprazole	9 (2.8%)	59 (8.6%)	2 (5.3%)	4 (0.7%)	1 (5.0%)	7 (1.5%)	5 (1.2%)	0 (0.0%)	0 (0.0%)	82 (3.2%)

PPIs, proton pump inhibitors; ONM, oesophageal neoplasms malignant; GNM, gastric neoplasms malignant; SINM, small intestinal neoplasms malignant; CNM, colorectal neoplasms malignant; ACNM, anal canal neoplasms malignant; PNM, pancreatic neoplasms malignant; HNM, hepatic neoplasms malignant; GBNM, gallbladder neoplasms malignant; BDNM, bile duct neoplasms malignant.