AVACOPAN for Off label use: Side Effects & Safety Data
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There are 79 adverse event reports in the FDA FAERS database where AVACOPAN was used for Off label use.
Most Reported Side Effects for AVACOPAN
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Hospitalisation | 520 | 11.7% | 13 | 507 |
| Off label use | 264 | 5.9% | 27 | 61 |
| Death | 254 | 5.7% | 252 | 30 |
| Fatigue | 214 | 4.8% | 2 | 29 |
| Diarrhoea | 211 | 4.7% | 8 | 38 |
| Nausea | 200 | 4.5% | 6 | 39 |
| Headache | 149 | 3.3% | 2 | 23 |
| Product dose omission issue | 145 | 3.3% | 1 | 30 |
| Pneumonia | 143 | 3.2% | 30 | 98 |
| Covid-19 | 139 | 3.1% | 18 | 46 |
| Drug ineffective | 111 | 2.5% | 1 | 29 |
| Therapy interrupted | 110 | 2.5% | 2 | 71 |
| Infection | 100 | 2.2% | 31 | 43 |
| Rash | 98 | 2.2% | 2 | 24 |
| Dizziness | 95 | 2.1% | 1 | 17 |
Other Indications for AVACOPAN
Product used for unknown indication (966)
Granulomatosis with polyangiitis (931)
Anti-neutrophil cytoplasmic antibody positive vasculitis (873)
Microscopic polyangiitis (667)
Vasculitis (118)
Renal disorder (83)
Arteritis (78)
Antineutrophil cytoplasmic antibody (41)
Antineutrophil cytoplasmic antibody positive (26)
Lung disorder (16)
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)