Table 4.

The signal strength of AEs of Alprazolam at the SOC level.

System organ class	SOC code	Case reports	ROR (95% CI)	PRR (95% CI)	χ2	IC (IC025)	EBGM (EBGM05)
Psychiatric disorders	10,037,175	19,010	5.44 (5.35–5.53)	4.34 (4.29–4.40)	51,536.65	2.11 (2.09)	4.32 (4.25)
General disorders and administration site conditions	10,018,065	11,490	0.83 (0.81–0.85)	0.86 (0.84–0.87)	337.35	−0.22 (− 0.25)	0.86 (0.84)
Nervous system disorders	10,029,205	10,865	1.74 (1.70–1.77)	1.63 (1.60–1.66)	2903.67	0.71 (0.68)	1.63 (1.60)
Injury, poisoning and procedural complications	10,022,117	10,139	1.38 (1.35–1.41)	1.33 (1.30–1.35)	911.54	0.41 (0.38)	1.33 (1.30)
Gastrointestinal disorders	10,017,947	3303	0.48 (0.46–0.49)	0.50 (0.48–0.52)	1804.74	− 1.00 (− 1.05)	0.50 (0.48)
Respiratory, thoracic and mediastinal disorders	10,038,738	2898	0.79 (0.76–0.82)	0.80 (0.77–0.82)	158.98	− 0.33 (− 0.38)	0.80 (0.77)
Cardiac disorders	10,007,541	2830	1.36 (1.31–1.42)	1.35 (1.30–1.40)	265.26	0.43 (0.38)	1.35 (1.30)
Investigations	10,022,891	2698	0.55 (0.53–0.57)	0.56 (0.54–0.58)	978.76	− 0.83 (− 0.89)	0.56 (0.54)
Musculoskeletal and connective tissue disorders	10,028,395	1636	0.39 (0.37–0.41)	0.41 (0.39–0.43)	1499.56	− 1.30 (− 1.37)	0.41 (0.39)
Skin and subcutaneous tissue disorders	10,040,785	1448	0.34 (0.32–0.35)	0.35 (0.33–0.37)	1861.21	− 1.52 (− 1.59)	0.35 (0.33)
Vascular disorders	10,047,065	1243	0.74 (0.70–0.78)	0.74 (0.70–0.78)	115.23	− 0.43 (− 0.51)	0.74 (0.70)
Eye disorders	10,015,919	1201	0.79 (0.74–0.83)	0.79 (0.75–0.83)	69.26	− 0.34 (− 0.43)	0.79 (0.75)
Product issues	10,077,536	1139	0.95 (0.90–1.01)	0.95 (0.90–1.01)	2.48	− 0.07 (− 0.15)	0.95 (0.90)
Metabolism and nutrition disorders	10,027,433	1095	0.64 (0.61–0.68)	0.65 (0.61–0.69)	213.34	− 0.62 (− 0.71)	0.65 (0.61)
Infections and infestations	10,021,881	1018	0.24 (0.23–0.26)	0.25 (0.24–0.27)	2345.19	− 1.97 (− 2.06)	0.25 (0.24)
Social circumstances	10,041,244	865	2.44 (2.28–2.61)	2.43 (2.27–2.59)	726.22	1.27 (1.17)	2.42 (2.26)
Immune system disorders	10,021,428	794	0.94 (0.88–1.01)	0.94 (0.88–1.01)	2.66	− 0.08 (− 0.19)	0.94 (0.88)
Renal and urinary disorders	10,038,359	673	0.44 (0.41–0.48)	0.45 (0.41–0.48)	470.14	− 1.16 (− 1.27)	0.45 (0.41)
Hepatobiliary disorders	10,019,805	518	0.73 (0.67–0.80)	0.73 (0.67–0.80)	51.17	− 0.45 (− 0.58)	0.73 (0.67)
Ear and labyrinth disorders	10,013,993	479	1.43 (1.30–1.56)	1.42 (1.30–1.56)	60.34	0.51 (0.37)	1.42 (1.30)
Blood and lymphatic system disorders	10,005,329	398	0.30 (0.28–0.34)	0.31 (0.28–0.34)	631.01	− 1.70 (− 1.84)	0.31 (0.28)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)	10,029,104	379	0.18 (0.16–0.19)	0.18 (0.16–0.20)	1455.74	− 2.47 (− 2.62)	0.18 (0.16)
Surgical and medical procedures	10,042,613	259	0.26 (0.23–0.29)	0.26 (0.23–0.29)	558.37	− 1.95 (− 2.13)	0.26 (0.23)
Congenital, familial and genetic disorders	10,010,331	230	0.96 (0.84–1.09)	0.96 (0.84–1.09)	0.43	− 0.06 (− 0.25)	0.96 (0.84)
Pregnancy, puerperium and perinatal conditions	10,036,585	224	0.65 (0.57–0.75)	0.66 (0.58–0.75)	40.68	− 0.61 (− 0.80)	0.66 (0.58)
Reproductive system and breast disorders	10,038,604	164	0.23 (0.20–0.27)	0.23 (0.20–0.27)	427.43	− 2.11 (− 2.34)	0.23 (0.20)
Endocrine disorders	10,014,698	141	0.74 (0.62–0.87)	0.74 (0.62–0.87)	13.30	− 0.44 (− 0.68)	0.74 (0.62)