URSODIOL for Product used for unknown indication: Side Effects & Safety Data

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There are 1,357 adverse event reports in the FDA FAERS database where URSODIOL was used for Product used for unknown indication.

Most Reported Side Effects for URSODIOL

Side Effect	Reports	%	Deaths	Hosp.
Off label use	444	12.3%	75	136
Drug ineffective	383	10.6%	89	142
Foetal exposure during pregnancy	262	7.2%	19	59
Maternal exposure during pregnancy	210	5.8%	2	63
Pruritus	197	5.4%	8	47
Premature baby	176	4.9%	12	58
Exposure during pregnancy	162	4.5%	2	72
Nausea	149	4.1%	13	67
Product use in unapproved indication	135	3.7%	38	33
Death	124	3.4%	124	19
Diarrhoea	115	3.2%	9	38
Condition aggravated	97	2.7%	14	60
Pneumonia	96	2.7%	15	44
Drug ineffective for unapproved indication	92	2.5%	12	32
Pyrexia	91	2.5%	14	69