ISOTRETINOIN for Rosacea: Side Effects & Safety Data

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There are 105 adverse event reports in the FDA FAERS database where ISOTRETINOIN was used for Rosacea.

Most Reported Side Effects for ISOTRETINOIN

Side Effect	Reports	%	Deaths	Hosp.
Depression	2,985	8.5%	34	237
Exposure during pregnancy	1,825	5.2%	0	19
Off label use	1,731	5.0%	19	95
Headache	1,693	4.9%	5	61
Dry skin	1,688	4.8%	11	62
Product dose omission issue	1,673	4.8%	0	5
Arthralgia	1,616	4.6%	1	64
Mood altered	1,367	3.9%	4	13
Adverse drug reaction	1,269	3.6%	1	4
Suicidal ideation	1,120	3.2%	13	147
Anxiety	1,112	3.2%	14	59
Drug ineffective	1,074	3.1%	6	53
Unintended pregnancy	1,011	2.9%	0	7
Lip dry	946	2.7%	11	48
Colitis ulcerative	932	2.7%	3	200