Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Avacopan
Drug ID BADD_D02530
Description Anti-neutrophil cytoplasmic (auto)antibody (ANCA)-associated vasculitis (AAV) is a rare (estimated incidence of 3 cases per 100,000 per year) form of "pauci-immune" systemic small-vessel vasculitis typified by the presence of ANCAs in the serum.[A240249, A240254, A227003] The full spectrum of AAV includes granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), eosinophilic granulomatosis with polyangiitis (EGPA), and drug-induced AAV. AAV may be associated with necrotizing and crescentic glomerulonephritis (NCGN).[A240249, A240254] Despite complex pathophysiology, studies over the past ~2 decades have identified a key role for the alternative complement pathway and, in particular, the interaction between the anaphylatoxin fragment C5a and its cognate C5aR receptor in AAV.[A240254, A240259, A240264, A240269] Avacopan (formerly CCX168) is an allosteric C5aR antagonist indicated for use in AAV.[A240269, A240329, L38919] Avacopan was granted FDA approval on October 8, 2021, and is currently marketed under the name TAVNEOS by ChemoCentryx, Inc.[L38919]
Indications and Usage Avacopan is indicated for the adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis; GPA/MPA) in combination with standard therapy including glucocorticoids. Avacopan does not eliminate the need for glucocorticoids.[L38919]
Marketing Status approved; investigational
ATC Code L04AA59
DrugBank ID DB15011
KEGG ID D11093
MeSH ID C000620232
PubChem ID 49841217
TTD Drug ID D0MR4Q
NDC Product Code 73556-168; 49187-0834; 67651-0363; 67651-0364
UNII O880NM097T
Synonyms avacopan | CCX168
Chemical Information
Molecular Formula C33H35F4N3O2
CAS Registry Number 1346623-17-3
SMILES CC1=C(C(=CC=C1)F)C(=O)N2CCCC(C2C3=CC=C(C=C3)NC4CCCC4)C(=O)NC5=CC(=C(C=C5)C)C(F)( F)F
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain upper07.01.05.0030.000820%
Death08.04.01.0010.000723%
Diarrhoea07.02.01.0010.002001%
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.0030.000940%
Dry skin23.03.03.0010.000530%
Dyspnoea02.11.05.003; 22.02.01.0040.001181%
Gastrointestinal disorder07.11.01.0010.000530%Not Available
Headache17.14.01.0010.001350%
Hepatic function abnormal09.01.02.0010.002990%Not Available
Hypertension24.08.02.0010.000530%
Jaundice09.01.01.004; 01.06.04.004; 23.03.03.0300.000820%Not Available
Pancreatitis07.18.01.0010.000241%
Pulmonary embolism24.01.06.001; 22.06.02.0010.000241%Not Available
Rash23.03.13.0010.000940%Not Available
Swelling08.01.03.0150.000530%Not Available
Vasculitis24.12.04.027; 10.02.02.0060.000530%
Unevaluable event08.01.03.0510.003110%Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.0230.000241%Not Available
Steroid diabetes14.06.01.019; 05.06.01.0190.000241%Not Available
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