ADALIMUMAB for Off label use: Side Effects & Safety Data
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There are 220 adverse event reports in the FDA FAERS database where ADALIMUMAB was used for Off label use.
Most Reported Side Effects for ADALIMUMAB
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 71,926 | 14.4% | 1,675 | 11,783 |
| Pain | 37,514 | 7.5% | 2,020 | 9,822 |
| Arthralgia | 35,592 | 7.1% | 1,893 | 8,782 |
| Rheumatoid arthritis | 29,817 | 6.0% | 2,076 | 6,523 |
| Fatigue | 29,420 | 5.9% | 2,196 | 7,284 |
| Injection site pain | 28,679 | 5.7% | 43 | 1,849 |
| Headache | 19,891 | 4.0% | 1,906 | 5,361 |
| Nausea | 19,299 | 3.9% | 1,450 | 6,570 |
| Rash | 18,690 | 3.7% | 1,953 | 4,915 |
| Pain in extremity | 18,319 | 3.7% | 1,156 | 4,915 |
| Joint swelling | 18,266 | 3.7% | 2,037 | 5,007 |
| Diarrhoea | 18,120 | 3.6% | 1,815 | 7,132 |
| Device issue | 17,630 | 3.5% | 19 | 1,191 |
| Psoriasis | 16,698 | 3.3% | 555 | 3,143 |
| Off label use | 16,417 | 3.3% | 2,187 | 5,051 |
Other Indications for ADALIMUMAB
Rheumatoid arthritis (154,287)
Crohn's disease (99,540)
Product used for unknown indication (63,549)
Psoriasis (56,634)
Psoriatic arthropathy (47,183)
Colitis ulcerative (34,530)
Ankylosing spondylitis (25,131)
Hidradenitis (18,344)
Uveitis (5,600)
Juvenile idiopathic arthritis (4,658)
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)