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)