ODEVIXIBAT for Off label use: Side Effects & Safety Data

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There are 16 adverse event reports in the FDA FAERS database where ODEVIXIBAT was used for Off label use.

Most Reported Side Effects for ODEVIXIBAT

Side Effect	Reports	%	Deaths	Hosp.
Diarrhoea	65	29.2%	0	10
Pruritus	55	24.7%	0	5
Off label use	33	14.8%	3	6
Drug ineffective	26	11.7%	1	5
Abdominal pain	17	7.6%	0	4
Abdominal pain upper	17	7.6%	0	2
Product dose omission issue	16	7.2%	0	2
Vomiting	14	6.3%	0	4
Blood bilirubin increased	10	4.5%	0	3
Hepatic enzyme increased	10	4.5%	0	1
Nausea	10	4.5%	0	3
Abdominal discomfort	7	3.1%	0	1
Bile acids increased	7	3.1%	0	0
Product use issue	7	3.1%	0	2
Alanine aminotransferase increased	6	2.7%	0	1