Avacopan side effects: what 6,343 FDA adverse event reports show

Avacopan · Tavneos · 147 reaction terms · 5,740 drug–reaction co-reports · data 2026-09-14

Drug class

Complement 5a Receptor Antagonist

FDA label (Established Pharmacologic Class)

Brand names

Tavneos

openFDA label

Who reports

6,343 reports · 73% serious · 639 with death outcome · 57% female

openFDA FAERS counts, all years, deduplication not applied

Used for

TAVNEOS is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.

FDA label, Indications and Usage

What it is

TAVNEOS (avacopan) capsules contain avacopan, a C5aR antagonist. Avacopan is a chiral molecule containing two stereocenters and has a chemical name of (2 R ,3 S )-2-[4-(cyclopentylamino)phenyl]-1-(2-fluoro-6-methylbenzoyl)- N -[4-methyl-3-(trifluoromethyl)phenyl]piperidine-3-carboxamide.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 4Labeled (related wording) 3Likely indication confounding 1Reporting / coding artifact 10Lab value / disease marker 2Not in label — unassessed 20

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 107 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Dialysis	136	31.9 27.0–37.7ROR 32.6 · χ² 4,004 / p <1e-300	31.5 EB05 27.3 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 25.7	no trial data cached
Hospitalisation	931	20.3 19.1–21.6ROR 23.6 · χ² 17,099 / p <1e-300	20.2 EB05 19.1 · IC025 +4.2 3/3 methods agree	Reporting / coding artifact	serious PRR 16.0	no trial data cached
Vasculitis	67	19.1 15.0–24.3ROR 19.3 · χ² 1,125 / p 5e-247	18.9 EB05 15.4 · IC025 +3.7 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 14.4	no trial data cached
Pneumocystis jirovecii pneumonia	45	14.9 11.2–20.0ROR 15.0 · χ² 569 / p 4e-126	14.7 EB05 11.3 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 11.5 · 93% clinician	no trial data cached
Therapy interrupted	291	14.0 12.5–15.7ROR 14.6 · χ² 3,496 / p <1e-300	13.9 EB05 12.6 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious PRR 22.4	no trial data cached
Drug-induced liver injury	108	11.6 9.6–14.0ROR 11.8 · χ² 1,035 / p 3e-227	11.4 EB05 9.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.2 · 98% clinician	no trial data cached
Hepatic function abnormal	114	10.2 8.5–12.2ROR 10.4 · χ² 935 / p 1e-205	10.0 EB05 8.5 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.1 · 98% clinician	no trial data cached
Liver disorder	122	9.1 7.7–10.9ROR 9.3 · χ² 874 / p 2e-192	8.9 EB05 7.7 · IC025 +2.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.6	no trial data cached
Jaundice (yellowing of skin/eyes)	74	9.1 7.2–11.4ROR 9.2 · χ² 524 / p 3e-116	8.8 EB05 7.2 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.3 · 90% clinician	no trial data cached
Cytomegalovirus infection	43	8.6 6.4–11.5ROR 8.6 · χ² 279 / p 5e-63	8.1 EB05 6.2 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 6.8 · ♀ 88% (drug 57%) · 95% clinician	no trial data cached
Liver function test increased	53	8.2 6.3–10.8ROR 8.3 · χ² 329 / p 8e-74	7.8 EB05 6.2 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.5	no trial data cached
Cholestasis (bile flow blockage)	41	7.1 5.2–9.6ROR 7.1 · χ² 209 / p 1e-47	6.6 EB05 5.1 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 5.7 · 100% clinician	no trial data cached
Hospice care	17	5.7 3.6–9.2ROR 5.7 · χ² 61 / p 2e-15	5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 5.7	no trial data cached
Hepatic cytolysis	21	5.7 3.7–8.7ROR 5.7 · χ² 76 / p 1e-18	5.1 EB05 3.5 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.5 · 95% clinician	no trial data cached
Covid-19 pneumonia	20	5.6 3.6–8.6ROR 5.6 · χ² 70 / p 2e-17	5.0 EB05 3.4 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.4 · 90% clinician	no trial data cached
Glomerular filtration rate decreased	19	5.2 3.3–8.1ROR 5.2 · χ² 60 / p 4e-15	4.6 EB05 3.1 · IC025 +1.5 3/3 methods agree	Lab value / disease marker	serious PRR 4.8	no trial data cached
Bacteraemia	18	5.1 3.2–8.0ROR 5.1 · χ² 55 / p 7e-14	4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 3.8	no trial data cached
Hepatic enzyme increased	95	4.6 3.8–5.6ROR 4.7 · χ² 267 / p 3e-60	4.5 EB05 3.8 · IC025 +1.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.2	no trial data cached
Therapy cessation	71	4.6 3.6–5.8ROR 4.6 · χ² 197 / p 6e-45	4.5 EB05 3.7 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 7.4	no trial data cached
Intentional dose omission	38	4.6 3.3–6.3ROR 4.6 · χ² 103 / p 1e-24	4.4 EB05 3.3 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 6.8	no trial data cached
Unevaluable event	105	4.6 3.8–5.6ROR 4.7 · χ² 292 / p 9e-66	4.5 EB05 3.8 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 2.7 · 79% consumer	no trial data cached
Pharyngeal swelling	13	4.5 2.6–7.7ROR 4.5 · χ² 32 / p 8e-9	3.9 EB05 2.5 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Renal disorder	56	4.0 3.1–5.2ROR 4.0 · χ² 122 / p 1e-28	3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 3.4	no trial data cached
Cytopenia	14	3.9 2.3–6.5ROR 3.9 · χ² 27 / p 1e-7	3.5 EB05 2.2 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 3.2	no trial data cached
Therapy change	11	3.8 2.1–6.8ROR 3.8 · χ² 20 / p 4e-6	3.3 EB05 2.0 · IC025 +0.7 3/3 methods agree	Reporting / coding artifact	serious n=10	no trial data cached
Illness	114	3.8 3.1–4.5ROR 3.8 · χ² 228 / p 7e-52	3.7 EB05 3.2 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 3.7 · 77% consumer	no trial data cached
Product dose omission in error	30	3.7 2.6–5.3ROR 3.7 · χ² 56 / p 3e-14	3.5 EB05 2.6 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 8.4	no trial data cached
Proteinuria	20	3.5 2.3–5.4ROR 3.5 · χ² 33 / p 4e-9	3.3 EB05 2.3 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 1.9	no trial data cached
Hepatocellular injury	15	3.5 2.1–5.8ROR 3.5 · χ² 24 / p 4e-7	3.2 EB05 2.1 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 2.8	no trial data cached
Surgery	60	3.4 2.7–4.4ROR 3.4 · χ² 101 / p 5e-24	3.3 EB05 2.7 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 2.9	no trial data cached
End stage renal disease	19	3.4 2.2–5.3ROR 3.4 · χ² 30 / p 2e-8	3.2 EB05 2.2 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 2.7	no trial data cached
Covid-19	172	3.2 2.8–3.7ROR 3.3 · χ² 262 / p 3e-59	3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 2.7	no trial data cached
Product use complaint	15	3.2 1.9–5.3ROR 3.2 · χ² 21 / p 3e-6	3.0 EB05 1.9 · IC025 +0.7	Reporting / coding artifact	serious n=5	no trial data cached
Blood pressure abnormal	19	3.2 2.0–5.0ROR 3.2 · χ² 26 / p 2e-7	3.0 EB05 2.0 · IC025 +0.8 3/3 methods agree	Lab value / disease marker	serious PRR 2.3	no trial data cached
Increased appetite	18	3.2 2.0–5.0ROR 3.2 · χ² 25 / p 4e-7	3.0 EB05 2.0 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 1.8	no trial data cached
Infection	138	3.2 2.7–3.7ROR 3.2 · χ² 204 / p 2e-46	3.1 EB05 2.7 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.7	no trial data cached
Renal impairment	80	3.2 2.5–3.9ROR 3.2 · χ² 117 / p 2e-27	3.1 EB05 2.6 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 2.5	no trial data cached
Lower respiratory tract infection	43	3.1 2.3–4.2ROR 3.2 · χ² 61 / p 3e-15	3.1 EB05 2.4 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 2.6 · 93% clinician	no trial data cached
Sinus disorder	17	2.8 1.8–4.6ROR 2.8 · χ² 18 / p 9e-6	2.7 EB05 1.8 · IC025 +0.6	Not in label — unassessed	serious PRR 3.7	no trial data cached
Hepatotoxicity (liver damage)	19	2.8 1.8–4.4ROR 2.8 · χ² 21 / p 3e-6	2.7 EB05 1.8 · IC025 +0.7	Labeled adverse reaction exact term	serious PRR 2.2	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Hospitalisation	931	20.3 19.1–21.6ROR 23.6 · χ² 17,099 / p <1e-300	20.2 EB05 19.1 · IC025 +4.2 3/3 methods agree	Reporting / coding artifact	serious PRR 16.0	no trial data cached
Death	381	1.5 1.3–1.6ROR 1.5 · χ² 58 / p 2e-14	1.5 EB05 1.3 · IC025 +0.4	Outcome field, not a reaction	serious PRR 1.2	no trial data cached
Therapy interrupted	291	14.0 12.5–15.7ROR 14.6 · χ² 3,496 / p <1e-300	13.9 EB05 12.6 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious PRR 22.4	no trial data cached
Pneumonia (lung infection)	223	2.3 2.0–2.6ROR 2.3 · χ² 162 / p 2e-37	2.3 EB05 2.0 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.9	no trial data cached
Covid-19	172	3.2 2.8–3.7ROR 3.3 · χ² 262 / p 3e-59	3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 2.7	no trial data cached
Product dose omission issue	155	1.8 1.5–2.1ROR 1.8 · χ² 55 / p 6e-14	1.8 EB05 1.6 · IC025 +0.6	Reporting / coding artifact	serious PRR 1.8 · 87% consumer	no trial data cached
Infection	138	3.2 2.7–3.7ROR 3.2 · χ² 204 / p 2e-46	3.1 EB05 2.7 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.7	no trial data cached
Dialysis	136	31.9 27.0–37.7ROR 32.6 · χ² 4,004 / p <1e-300	31.5 EB05 27.3 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 25.7	no trial data cached
Liver disorder	122	9.1 7.7–10.9ROR 9.3 · χ² 874 / p 2e-192	8.9 EB05 7.7 · IC025 +2.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.6	no trial data cached
Illness	114	3.8 3.1–4.5ROR 3.8 · χ² 228 / p 7e-52	3.7 EB05 3.2 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 3.7 · 77% consumer	no trial data cached
Hepatic function abnormal	114	10.2 8.5–12.2ROR 10.4 · χ² 935 / p 1e-205	10.0 EB05 8.5 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.1 · 98% clinician	no trial data cached
Drug-induced liver injury	108	11.6 9.6–14.0ROR 11.8 · χ² 1,035 / p 3e-227	11.4 EB05 9.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.2 · 98% clinician	no trial data cached
Unevaluable event	105	4.6 3.8–5.6ROR 4.7 · χ² 292 / p 9e-66	4.5 EB05 3.8 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 2.7 · 79% consumer	no trial data cached
Abdominal discomfort	98	1.9 1.6–2.4ROR 2.0 · χ² 44 / p 2e-11	1.9 EB05 1.6 · IC025 +0.6	Not in label — unassessed	serious PRR 1.1 · 73% consumer	no trial data cached
Hepatic enzyme increased	95	4.6 3.8–5.6ROR 4.7 · χ² 267 / p 3e-60	4.5 EB05 3.8 · IC025 +1.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.2	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Dialysis — n=136, PRR 31.9
Pneumocystis jirovecii pneumonia — n=45, PRR 14.9
Drug-induced liver injury — n=108, PRR 11.6
Cytomegalovirus infection — n=43, PRR 8.6
Cholestasis — n=41, PRR 7.1
Hepatic cytolysis — n=21, PRR 5.7
Covid-19 pneumonia — n=20, PRR 5.6
Renal disorder — n=56, PRR 4.0
Proteinuria — n=20, PRR 3.5
Covid-19 — n=172, PRR 3.2

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Avacopan?

In FDA FAERS, the most frequently co-reported reaction terms for Avacopan are pneumonia, covid-19, infection, dialysis, liver disorder, hepatic function abnormal. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Avacopan have an FDA boxed warning?

No. The FDA label retrieved for Avacopan has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Avacopan causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID c93cbc0b-29a3-46a5-9c85-41815ea5cf4a, effective 20260602; matched on openfda.generic_name.exact:"AVACOPAN")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 147 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.