Table 4.

OR of reporting AEs by medication class of pregnancy in FAERS-US, categorized based on system organ class (SOC)

	Class 1 n=2,079	Class 2 n=1,734	Class 3 n=1,297	Class 4 n=571	Class 5 n=1,080	Class 6 n=364	Class 7 n=438	Class 8 n=364	Class 9 n=367	Class 10 n=268	Class 11 n=173	Reports in pregnancy without psychiatric medications, n=43,807
SOC	# reports OR (95%CI)	# reports OR (95%CI)	# reports OR (95%CI)	# reports OR (95%CI)	# reports OR (95%CI)	# reports OR (95%CI)	# reports OR (95%CI)	# reports OR (95%CI)	# reports OR (95%CI)	# reports OR (95%CI)	# reports OR (95%CI)	n (reference)
Preg	447	615	549	214	98	189	139	147	145	53	103	20,376
	0.3 (0.3,0.4)	0.6 (0.6,0.7)	0.8 (0.8,0.9)	0.7 (0.6,0.8)	0.1 (<0.1,0.1)	1.2 (1.0,1.5)	0.5 (0.4,0.7)	0.8 (0.6,1.0)	0.8 (0.6,0.9)	0.3 (0.2,0.4)	1.7 (1.2,2.3)	1.0
Cong	711	629	319	210	931	88	65	33	156	35	29	7,337
	2.6 (2.4,2.8)	2.8 (2.6,3.1)	1.6 (1.4,1.8)	2.9 (2.4,3.4)	31.1 (26.1,37.0)	1.6 (1.2,2.0)	0.9 (0.7,1.1)	0.5 (0.3,0.7)	3.7 (3.0,4.5)	0.7 (0.5,1.1)	1.0 (0.7,1.5)	1.0
Resp	61	283	130	117	97	3	47	9	43	23	23	3,192
	0.4 (0.3,0.5)	2.5 (2.2,2.8)	1.4 (1.2,1.7)	3.3 (2.7,4.0)	1.3 (1.0,1.6)	-	1.5 (1.1,2.1)	0.3 (0.2,0.6)	1.7 (1.2,2.3)	1.2 (0.8,1.8)	2.0 (1.3,3.0)	1.0
Genrl	328	549	304	165	103	59	123	42	97	174	44	12,315
	0.5 (0.4,0.5)	1.2 (1.1,1.3)	0.8 (0.7,0.9)	1.0 (0.9,1.2)	0.3 (0.2,0.3)	0.5 (0.4,0.7)	1.0 (0.8,1.2)	0.3 (0.2,0.5)	0.9 (0.7,1.2)	4.7 (3.7,6.1)	0.9 (0.6,1.2)	1.0
Nerv	459	379	219	129	110	89	215	24	44	44	33	3,394
	3.4 (3.0,3.8)	3.3 (3.0,3.8)	2.4 (2.1,2.8)	3.5 (2.8,4.2)	1.4 (1.1,1.7)	3.9 (3.0,4.9)	11.5 (9.5,13.9)	0.8 (0.6,1.3)	1.6 (1.2,2.2)	2.3 (1.7,3.2)	2.8 (1.9,4.1)	1.0
Psych	253	344	250	122	108	31	81	40	46	36	46	3,251
	1.7 (1.5,2.0)	3.1 (2.7,3.5)	3.0 (2.6,3.4)	3.4 (2.8,4.2)	1.4 (1.1,1.7)	1.2 (0.8,1.7)	2.8 (2.2,3.6)	1.5 (1.1,2.1)	1.8 (1.3,2.4)	1.9 (1.4,2.8)	4.5 (3.2,6.3)	1.0
Inv	95	277	143	101	130	24	33	16	33	17	32	3,502
	0.6 (0.4,0.7)	2.2 (1.9,2.5)	1.4 (1.2,1.7)	2.5 (2.0,3.1)	1.6 (1.3,1.9)	0.8 (0.5,1.2)	0.9 (0.7,1.3)	0.5 (0.3,0.9)	1.1 (0.8,1.6)	0.8 (0.5,1.3)	2.6 (1.8,3.8)	1.0
Metab	73	177	76	62	30	6	38	5	21	10	42	1,878
	0.8 (0.6,1.0)	2.5 (2.2,3.0)	1.4 (1.1,1.8)	2.7 (2.1,3.6)	0.6 (0.4,0.9)	0.4 (0.2,0.8)	2.1 (1.5,3.0)	-	1.4 (0.9,2.1)	0.9 (0.5,1.6)	7.2 (5.0,10.2)	1.0
Inj&P	1654	1170	1034	423	1064	269	251	324	296	196	136	25,556
	2.8 (2.5,3.1)	1.5 (1.3,1.6)	2.8 (2.4,3.2)	2.0 (1.7,2.5)	47.3 (28.9,77.4)	2.0 (1.6,2.6)	1.0 (0.8,1.2)	5.8 (4.2,8.0)	3.0 (2.3,3.9)	1.9 (1.5,2.5)	2.6 (1.8,3.8)	1.0
Card	66	179	86	89	153	8	21	2	55	30	13	1,770
	0.8 (0.6,1.0)	2.7 (2.3,3.2)	1.7 (1.3,2.1)	4.4 (3.5,5.5)	3.9 (3.3,4.7)	0.5 (0.3,1.1)	1.2 (0.8,1.9)	-	4.2 (3.1,5.6)	3.0 (2.0,4.4)	1.9 (1.1,3.4)	1.0
Musc	43	226	79	73	52	12	19	2	34	25	8	2,430
	0.4 (0.3,0.5)	2.6 (2.2,3.0)	1.1 (0.9,1.4)	2.5 (1.9,3.2)	0.9 (0.6,1.1)	0.6 (0.3,1.0)	0.8 (0.5,1.2)	-	1.7 (1.2,2.5)	1.8 (1.2,2.6)	0.8 (0.4,1.7)	1.0
Gastr	145	350	153	91	56	19	73	3	33	39	33	4,137
	0.7 (0.6,0.9)	2.4 (2.1,2.7)	1.3 (1.1,1.5)	1.8 (1.4,2.3)	0.5 (0.4,0.7)	0.5 (0.3,0.8)	1.9 (1.5,2.5)	-	0.9 (0.7,1.4)	1.6 (1.2,2.3)	2.3 (1.5,3.3)	1.0
Surg	36	112	83	39	10	10	15	27	14	13	37	2,348
	0.3 (0.2,0.4)	1.2 (1.0,1.5)	1.2 (1.0,1.5)	1.3 (0.9,1.8)	0.2 (<0.1,0.3)	0.5 (0.3,0.9)	0.6 (0.4,1.0)	1.4 (1.0,2.1)	0.7 (0.4,1.2)	0.9 (0.5,1.6)	4.8 (3.3,6.9)	1.0
Blood	4	144	31	34	5	2	10	0	11	9	2	1,458
	-	2.6 (2.2,3.1)	0.7 (0.5,1.0)	1.8 (1.3,2.6)	-	-	0.7 (0.4,1.3)	-	0.9 (0.5,1.6)	1.0 (0.5,2.0)	-	1.0
Skin	23	126	46	29	9	2	15	1	16	6	0	2,015
	0.2 (0.2,0.4)	1.6 (1.3,2.0)	0.8 (0.6,1.0)	1.1 (0.8,1.6)	0.2 (<0.1,0.3)	-	0.7 (0.4,1.2)	-	0.9 (0.6,1.6)	0.5 (0.2,1.1)	-	1.0
Hepat	11	49	26	22	21	2	3	1	7	2	15	657
	0.3 (0.2,0.6)	1.9 (1.4,2.6)	1.3 (0.9,2.0)	2.6 (1.7,4.1)	1.3 (0.8,2.0)	-	-	-	1.3 (0.6,2.7)	-	6.2 (3.7,10.6)	1.0
Infec	38	264	79	68	60	8	33	8	79	5	15	3,181
	0.2 (0.2,0.3)	2.3 (2.0,2.6)	0.8 (0.7,1.0)	1.7 (1.3,2.2)	0.8 (0.6,1.0)	0.3 (0.1,0.6)	1.0 (0.7,1.5)	0.3 (0.1,0.6)	3.5 (2.7,4.5)	-	1.2 (0.7,2.1)	1.0
Immun	3	48	11	13	3	2	2	1	23	0	0	550
	-	2.2 (1.7,3.0)	0.7 (0.4,1.2)	1.8 (1.1,3.2)	-	-	-	-	5.3 (3.4,8.1)	-	-	1.0
Eye	31	60	32	24	24	4	11	2	8	18	4	725
	0.9 (0.6,1.3)	2.1 (1.6,2.8)	1.5 (1.1,2.2)	2.6 (1.7,3.9)	1.4 (0.9,2.0)	-	1.5 (0.8,2.8)	-	1.3 (0.7,2.7)	4.3 (2.6,6.9)	-	1.0
Repro	46	131	88	36	13	7	10	10	24	5	6	2,944
	0.3 (0.2,0.4)	1.1 (0.9,1.4)	1.0 (0.8,1.3)	0.9 (0.7,1.3)	0.2 (<0.1,0.3)	0.3 (0.1,0.6)	0.3 (0.2,0.6)	0.4 (0.2,0.7)	1.0 (0.6,1.5)	-	0.5 (0.2,1.1)	1.0
Vasc	24	144	61	55	30	5	14	1	22	8	4	1,675
	0.3 (0.2,0.4)	2.3 (1.9,2.7)	1.2 (1.0,1.6)	2.7 (2.0,3.6)	0.7 (0.5,1.0)	-	0.8 (0.5,1.4)	-	1.6 (1.0,2.5)	0.8 (0.4,1.6)	-	1.0
Neopl	8	60	20	12	10	2	7	0	4	3	2	668
	0.2 (0.1,0.5)	2.3 (1.8,3.0)	1.0 (0.6,1.6)	1.4 (0.8,2.5)	0.6 (0.3,1.1)	-	1.1 (0.5,2.2)	-	-	-	-	1.0
Endo	18	40	9	9	3	0	1	0	3	0	3	339
	1.1 (0.7,1.8)	3.0 (2.2,4.2)	0.9 (0.5,1.7)	2.1 (1.1,4.0)	-	-	-	-	-	-	-	1.0
Ear	17	44	14	11	18	2	4	1	10	1	1	422
	0.8 (0.5,1.4)	2.7 (2.0,3.7)	1.1 (0.7,1.9)	2.0 (1.1,3.7)	1.7 (1.1,2.8)	-	-	-	2.9 (1.5,5.4)	-	-	1.0
Renal	10	99	33	28	32	4	6	3	11	4	5	1,037
	0.2 (0.1,0.4)	2.5 (2.0,3.1)	1.1 (0.8,1.5)	2.1 (1.4,3.1)	1.3 (0.9,1.8)	-	0.6 (0.3,1.3)	-	1.3 (0.7,2.3)	-	-	1.0
SocCi	124	50	38	8	4	13	10	37	6	4	8	517
	5.3 (4.3,6.5)	2.5 (1.9,3.3)	2.5 (1.8,3.5)	1.2 (0.6,2.4)	-	3.1 (1.8,5.4)	2.0 (1.0,3.7)	9.5 (6.7,13.5)	1.4 (0.6,3.1)	-	4.1 (2.0,8.3)	1.0
Prod	11	59	38	15	2	2	7	0	12	1	1	1,627
	0.1 (<0.1,0.3)	0.9 (0.7,1.2)	0.8 (0.6,1.1)	0.7 (0.4,1.2)	-	-	0.4 (0.2,0.9)	-	0.9 (0.5,1.6)	-	-	1.0

Significant results with p<0.05 in boldface

OR was estimated in cells with > 5 events

AE Adverse event, OR Odds ratio, SOC System organ class, Blood Blood and lymphatic system disorders, Card Cardiac disorders, Cong Congenital, familial and genetic disorders, Ear Ear and labyrinth disorders, Endo Endocrine disorders, Eye Eye disorders, Gastr Gastrointestinal disorders, Genrl General disorders and administration site conditions, Hepat Hepatobiliary disorders, Immun Immune system disorders, Infec Infections and infestations, Inj&P Injury, poisoning and procedural complications, Inv Investigations, Metab Metabolism and nutrition disorders, Musc Musculoskeletal and connective tissue disorders, Neopl Neoplasms benign, malignant and unspecified (incl cysts and polyps), Nerv Nervous system disorders, Preg Pregnancy, puerperium and perinatal conditions, Prod Product issues, Psych Psychiatric disorders, Renal Renal and urinary disorders, Repro Reproductive system and breast disorders, Resp Respiratory, thoracic and mediastinal disorders, Skin Skin and subcutaneous tissue disorders, SocCi Social circumstances, Surg Surgical and medical procedures, Vasc Vascular disorders