CROFELEMER for Colitis: Side Effects & Safety Data

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There are 6 adverse event reports in the FDA FAERS database where CROFELEMER was used for Colitis.

Most Reported Side Effects for CROFELEMER

Side Effect	Reports	%	Deaths	Hosp.
Off label use	52	29.4%	3	5
Drug ineffective	42	23.7%	1	1
Diarrhoea	23	13.0%	0	2
Death	19	10.7%	19	1
Product dose omission issue	19	10.7%	1	4
Constipation	11	6.2%	0	2
Fatigue	8	4.5%	0	1
Flatulence	7	4.0%	0	0
Abdominal discomfort	5	2.8%	0	0
Back pain	5	2.8%	0	0
Cough	5	2.8%	0	0
Dizziness	5	2.8%	0	0