AVACOPAN for Granulomatosis with polyangiitis: Side Effects & Safety Data
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There are 931 adverse event reports in the FDA FAERS database where AVACOPAN was used for Granulomatosis with polyangiitis.
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)
Anti-neutrophil cytoplasmic antibody positive vasculitis (873)
Microscopic polyangiitis (667)
Vasculitis (118)
Renal disorder (83)
Off label use (79)
Arteritis (78)
Antineutrophil cytoplasmic antibody (41)
Antineutrophil cytoplasmic antibody positive (26)
Lung disorder (16)
Other Drugs Used for Granulomatosis with polyangiitis
RITUXIMAB (3,222)
RITUXIMAB-PVVR (745)
METHOTREXATE (456)
CYCLOPHOSPHAMIDE (438)
PREDNISONE (410)
PREDNISOLONE (299)
AZATHIOPRINE (265)
MYCOPHENOLATE MOFETIL (237)
METHYLPREDNISOLONE (210)
MYCOPHENOLATE MOFETIL\MYCOPHENOLATE MOFETIL (63)