Bile Acid [EPC] — Common Side Effects

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Side Effect	Total Reports	Drugs	Deaths	Hosp.	Life-Threat.
Off label use	449	2	76	139	12
Drug ineffective	399	3	89	142	38
Foetal exposure during pregnancy	262	1	19	59	10
Maternal exposure during pregnancy	210	1	2	63	3
Diarrhoea	210	3	11	44	10
Pruritus	203	2	8	48	16
Death	178	3	178	28	12
Premature baby	176	1	12	58	6
Nausea	165	3	13	70	31
Exposure during pregnancy	162	1	2	72	13
Product use in unapproved indication	135	1	38	33	16
Vomiting	122	3	5	46	7
Pyrexia	116	3	15	81	26
Pneumonia	106	3	16	52	4
Decreased appetite	100	3	10	42	9
Condition aggravated	97	1	14	60	2
Drug ineffective for unapproved indication	92	1	12	32	2
Weight decreased	91	3	5	39	8
Alanine aminotransferase increased	91	2	9	45	11
Fatigue	90	1	2	23	0
Cholestasis	90	1	10	57	5
Dyspnoea	88	2	10	45	30
Aspartate aminotransferase increased	88	2	9	47	11
Rash	87	2	2	40	21
Abdominal discomfort	86	3	1	36	20
Abdominal pain	85	3	22	41	4
Drug-induced liver injury	82	1	11	53	14
Constipation	82	3	2	10	2
Multiple organ dysfunction syndrome	80	1	72	51	9
Blood alkaline phosphatase increased	77	2	1	25	6