Pegcetacoplan side effects: what 1,779 FDA adverse event reports show
Brand names
Empaveli
Who reports
1,779 reports · 66% serious · 103 with death outcome · 63% female
Used for
EMPAVELI is a complement inhibitor indicated: for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). ( 1.1 ) for the treatment of adult and pediatric patients aged 12 years and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), to reduce proteinuria and the loss of kidney function.
What it is
EMPAVELI contains pegcetacoplan, a complement inhibitor. Pegcetacoplan is a symmetrical molecule comprised of two identical pentadecapeptides covalently bound to the ends of a linear 40-kiloDalton (kDa) PEG molecule.
Boxed warning
SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA EMPAVELI, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae , Neisseria meningitidis , and Haemophilus influenzae type B [see Warnings and Precautions (5.1) ] .
Causality screen of the 36 strongest signals
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. 26 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Vitreous floaters | 112 | 137.1 114.5–164.2ROR 146.3 · χ² 14,832 / p <1e-300 | 132.5 EB05 113.2 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=55 | no trial data cached |
| Eye inflammation | 66 | 83.0 65.5–105.3ROR 86.2 · χ² 5,233 / p <1e-300 | 80.6 EB05 65.6 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=39 | no trial data cached |
| Uveitis | 78 | 68.5 55.1–85.1ROR 71.5 · χ² 5,090 / p <1e-300 | 67.0 EB05 55.4 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 60.5 · 97% clinician | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 53 | 48.8 37.4–63.7ROR 50.3 · χ² 2,428 / p <1e-300 | 47.9 EB05 38.0 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious PRR 49.5 | no trial data cached |
| Blood lactate dehydrogenase increased | 42 | 31.1 23.1–42.0ROR 31.9 · χ² 1,192 / p 1e-261 | 30.7 EB05 23.6 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious PRR 24.6 | no trial data cached |
| Infusion site pain | 21 | 19.4 12.7–29.7ROR 19.6 · χ² 348 / p 5e-78 | 19.0 EB05 13.0 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=17 · 76% consumer | no trial data cached |
| Ocular discomfort | 16 | 17.4 10.7–28.3ROR 17.5 · χ² 231 / p 2e-52 | 16.7 EB05 10.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Eye haemorrhage | 19 | 16.8 10.7–26.2ROR 16.9 · χ² 266 / p 4e-60 | 16.3 EB05 10.6 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.7 | no trial data cached |
| Chromaturia | 29 | 15.1 10.6–21.7ROR 15.4 · χ² 369 / p 1e-82 | 14.8 EB05 10.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 18.6 | no trial data cached |
| Haemoglobin decreased | 124 | 14.2 12.0–16.9ROR 15.2 · χ² 1,516 / p <1e-300 | 14.1 EB05 12.2 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 12.0 | no trial data cached |
| Blindness | 47 | 13.6 10.3–18.1ROR 14.0 · χ² 538 / p 3e-119 | 13.4 EB05 10.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 | no trial data cached |
| Visual impairment | 137 | 13.1 11.2–15.4ROR 14.2 · χ² 1,532 / p <1e-300 | 13.1 EB05 11.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 15.6 | no trial data cached |
| Photophobia (light sensitivity) | 19 | 12.0 7.7–18.8ROR 12.1 · χ² 181 / p 2e-41 | 11.1 EB05 7.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 | no trial data cached |
| Visual acuity reduced | 33 | 11.6 8.3–16.3ROR 11.8 · χ² 310 / p 1e-69 | 11.1 EB05 8.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.7 | no trial data cached |
| Cytopenia | 11 | 10.9 6.0–19.6ROR 10.9 · χ² 89 / p 2e-21 | 8.9 EB05 4.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.7 | no trial data cached |
| Myelodysplastic syndrome | 13 | 10.6 6.2–18.2ROR 10.7 · χ² 104 / p 1e-24 | 9.0 EB05 5.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Eye infection | 10 | 10.5 5.7–19.5ROR 10.6 · χ² 77 / p 9e-19 | 8.4 EB05 4.4 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious n=4 | no trial data cached |
| Brain fog | 13 | 10.5 6.1–18.1ROR 10.6 · χ² 103 / p 2e-24 | 8.9 EB05 5.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Eye pain | 47 | 10.0 7.6–13.3ROR 10.3 · χ² 374 / p 1e-83 | 9.6 EB05 7.4 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.8 | no trial data cached |
| Incorrect product administration duration | 16 | 9.3 5.7–15.1ROR 9.4 · χ² 110 / p 4e-26 | 8.0 EB05 5.0 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious n=2 | no trial data cached |
| Blood urine present | 15 | 9.3 5.6–15.4ROR 9.4 · χ² 103 / p 2e-24 | 7.9 EB05 4.8 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 7.7 | no trial data cached |
| Bone marrow failure | 16 | 9.2 5.7–15.0ROR 9.3 · χ² 109 / p 7e-26 | 7.9 EB05 4.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Injection site induration | 10 | 9.1 4.9–16.9ROR 9.1 · χ² 64 / p 6e-16 | 7.1 EB05 3.9 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious n=7 | no trial data cached |
| Ocular hyperaemia | 33 | 8.3 5.9–11.7ROR 8.5 · χ² 206 / p 5e-47 | 7.7 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 14.8 | no trial data cached |
| Glaucoma | 13 | 8.0 4.6–13.7ROR 8.0 · χ² 72 / p 9e-18 | 6.5 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Viral infection | 17 | 6.0 3.8–9.7ROR 6.1 · χ² 66 / p 2e-16 | 5.2 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 | no trial data cached |
| Intentional dose omission | 13 | 5.6 3.3–9.6ROR 5.6 · χ² 45 / p 1e-11 | 4.7 EB05 3.0 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 | no trial data cached |
| Platelet count decreased | 50 | 5.5 4.2–7.3ROR 5.7 · χ² 182 / p 8e-42 | 5.3 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.4 · 80% consumer | no trial data cached |
| Vision blurred (blurred vision) | 63 | 5.4 4.3–6.9ROR 5.6 · χ² 225 / p 3e-51 | 5.2 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Injection site swelling | 32 | 5.0 3.5–7.0ROR 5.1 · χ² 98 / p 2e-23 | 4.7 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.7 | no trial data cached |
| Dry eye | 19 | 4.6 3.0–7.2ROR 4.7 · χ² 50 / p 6e-13 | 4.2 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Injection site pruritus | 24 | 4.3 2.9–6.3ROR 4.3 · χ² 57 / p 3e-14 | 4.0 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.9 · 79% consumer | no trial data cached |
| Needle issue | 10 | 4.1 2.2–7.6ROR 4.1 · χ² 21 / p 3e-6 | 3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Injection site pain (pain where injected) | 57 | 2.2 1.7–2.9ROR 2.3 · χ² 37 / p 5e-10 | 2.2 EB05 1.8 · IC025 +0.7 | Labeled (related wording) related wording | serious PRR 6.3 · 70% consumer | no trial data cached |
| Injection site haemorrhage | 14 | 2.1 1.2–3.5ROR 2.1 · χ² 7 / p 0.004 | 2.0 EB05 1.3 · IC025 +0.1 | Labeled (related wording) related wording | serious PRR 10.6 | no trial data cached |
| Injection site erythema (redness where injected) | 21 | 2.0 1.3–3.1ROR 2.0 · χ² 10 / p 9e-4 | 2.0 EB05 1.4 · IC025 +0.2 | Labeled (related wording) related wording | serious PRR 6.6 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Visual impairment | 137 | 13.1 11.2–15.4ROR 14.2 · χ² 1,532 / p <1e-300 | 13.1 EB05 11.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 15.6 | no trial data cached |
| Haemoglobin decreased | 124 | 14.2 12.0–16.9ROR 15.2 · χ² 1,516 / p <1e-300 | 14.1 EB05 12.2 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 12.0 | no trial data cached |
| Vitreous floaters | 112 | 137.1 114.5–164.2ROR 146.3 · χ² 14,832 / p <1e-300 | 132.5 EB05 113.2 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=55 | no trial data cached |
| Uveitis | 78 | 68.5 55.1–85.1ROR 71.5 · χ² 5,090 / p <1e-300 | 67.0 EB05 55.4 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 60.5 · 97% clinician | no trial data cached |
| Eye inflammation | 66 | 83.0 65.5–105.3ROR 86.2 · χ² 5,233 / p <1e-300 | 80.6 EB05 65.6 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=39 | no trial data cached |
| Vision blurred (blurred vision) | 63 | 5.4 4.3–6.9ROR 5.6 · χ² 225 / p 3e-51 | 5.2 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Injection site pain (pain where injected) | 57 | 2.2 1.7–2.9ROR 2.3 · χ² 37 / p 5e-10 | 2.2 EB05 1.8 · IC025 +0.7 | Labeled (related wording) related wording | serious PRR 6.3 · 70% consumer | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 53 | 48.8 37.4–63.7ROR 50.3 · χ² 2,428 / p <1e-300 | 47.9 EB05 38.0 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious PRR 49.5 | no trial data cached |
| Platelet count decreased | 50 | 5.5 4.2–7.3ROR 5.7 · χ² 182 / p 8e-42 | 5.3 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.4 · 80% consumer | no trial data cached |
| Eye pain | 47 | 10.0 7.6–13.3ROR 10.3 · χ² 374 / p 1e-83 | 9.6 EB05 7.4 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.8 | no trial data cached |
| Blindness | 47 | 13.6 10.3–18.1ROR 14.0 · χ² 538 / p 3e-119 | 13.4 EB05 10.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 | no trial data cached |
| Blood lactate dehydrogenase increased | 42 | 31.1 23.1–42.0ROR 31.9 · χ² 1,192 / p 1e-261 | 30.7 EB05 23.6 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious PRR 24.6 | no trial data cached |
| Ocular hyperaemia | 33 | 8.3 5.9–11.7ROR 8.5 · χ² 206 / p 5e-47 | 7.7 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 14.8 | no trial data cached |
| Visual acuity reduced | 33 | 11.6 8.3–16.3ROR 11.8 · χ² 310 / p 1e-69 | 11.1 EB05 8.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.7 | no trial data cached |
| Injection site swelling | 32 | 5.0 3.5–7.0ROR 5.1 · χ² 98 / p 2e-23 | 4.7 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.7 | 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.
- Vitreous floaters — n=112, PRR 137.1
- Eye inflammation — n=66, PRR 83.0
- Uveitis — n=78, PRR 68.5
- Chromaturia — n=29, PRR 15.1
- Blindness — n=47, PRR 13.6
- Visual impairment — n=137, PRR 13.1
- Visual acuity reduced — n=33, PRR 11.6
- Ocular hyperaemia — n=33, PRR 8.3
- Vision blurred — n=63, PRR 5.4
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 Pegcetacoplan?
In FDA FAERS, the most frequently co-reported reaction terms for Pegcetacoplan are visual impairment, haemoglobin decreased, vitreous floaters, uveitis, eye inflammation, vision blurred. 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 Pegcetacoplan have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA EMPAVELI, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae , Neisseria meningitidis , and Haemophilus influenzae type B [see Warnings and Precautions (5.1) ] .
Do FAERS signals prove that Pegcetacoplan 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 c23d89e9-b00b-4520-e053-2995a90a95af, effective 20260821; matched on
openfda.generic_name.exact:"PEGCETACOPLAN") - 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, fieldpatient.drug.openfda.generic_name.exact, 62 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.