LOTEPREDNOL ETABONATE for Off label use: Side Effects & Safety Data

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There are 45 adverse event reports in the FDA FAERS database where LOTEPREDNOL ETABONATE was used for Off label use.

Most Reported Side Effects for LOTEPREDNOL ETABONATE

Side Effect	Reports	%	Deaths	Hosp.
Off label use	255	15.6%	0	10
Eye irritation	211	12.9%	0	0
Vision blurred	179	11.0%	0	0
Eye pain	170	10.4%	0	1
Drug ineffective	168	10.3%	0	14
Ocular hyperaemia	133	8.2%	0	0
Product use in unapproved indication	129	7.9%	1	4
Visual impairment	75	4.6%	0	1
Eye pruritus	71	4.4%	0	0
Intraocular pressure increased	70	4.3%	0	0
Foreign body sensation in eyes	66	4.1%	0	0
Headache	66	4.1%	0	4
Lacrimation increased	66	4.1%	0	0
Dry eye	65	4.0%	0	0
Eye swelling	64	3.9%	0	0