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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ISOTRETINOIN for Off label use: Side Effects & Safety Data

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There are 31 adverse event reports in the FDA FAERS database where ISOTRETINOIN was used for Off label use.

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

Other Indications for ISOTRETINOIN

Product used for unknown indication (15,784) Acne (9,184) Acne cystic (1,441) Neuroblastoma (234) Hidradenitis (194) Acne conglobata (112) Rosacea (105) Scar (71) Alopecia scarring (44) Acne fulminans (41)

Other Drugs Used for Off label use

LENALIDOMIDE (5,767) ECULIZUMAB (3,550) CERTOLIZUMAB PEGOL (2,256) ABOBOTULINUMTOXINA (2,170) LEVETIRACETAM (2,161) APREMILAST (1,995) PROPRANOLOL (1,576) CETIRIZINE (1,416) HUMAN IMMUNOGLOBULIN G (1,129) THALIDOMIDE (1,033)

Related Pages

ISOTRETINOIN Full Profile All Off label use Drugs ISOTRETINOIN Demographics ISOTRETINOIN Timeline