Duvelisib side effects: what 765 FDA adverse event reports show
Drug class
Kinase inhibitor
Brand names
Copiktra
Who reports
765 reports · 61% serious · 173 with death outcome · 38% female
Used for
COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy. Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality.
What it is
COPIKTRA (duvelisib) is a kinase inhibitor. Duvelisib is a white-to-off-white crystalline solid with the empirical formula C 22 H 17 ClN 6 O•H 2 O and a molecular weight of 434.88 g/mol. Hydration can vary with relative humidity. Duvelisib contains a single chiral center as ( S ) enantiomer.
Boxed warning
TREATMENT-RELATED MORTALITY AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, AND PNEUMONITIS Treatment-related mortality occurred in 15% of COPIKTRA-treated patients [see Warnings and Precautions ( 5.1 )] . Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection.
Causality screen of the 8 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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.
- 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.
- 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. 1 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 |
|---|---|---|---|---|---|---|
| Prescribed underdose | 65 | 89.6 71.0–113.1ROR 97.8 · χ² 5,594 / p <1e-300 | 87.1 EB05 70.7 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 55.5 | no trial data cached |
| Prescribed overdose | 15 | 21.3 12.9–35.1ROR 21.7 · χ² 270 / p 6e-61 | 20.6 EB05 13.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 18.3 | no trial data cached |
| Product use in unapproved indication | 181 | 20.3 17.9–23.1ROR 26.3 · χ² 3,343 / p <1e-300 | 20.3 EB05 17.9 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 24.9 | no trial data cached |
| Cytopenia | 7 | 16.1 7.7–33.6ROR 16.2 · χ² 84 / p 2e-20 | 13.3 EB05 5.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.7 | no trial data cached |
| Colitis | 20 | 14.6 9.4–22.4ROR 14.9 · χ² 240 / p 3e-54 | 14.0 EB05 9.1 · IC025 +2.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.8 | no trial data cached |
| Hospice care | 5 | 13.9 5.8–33.4ROR 14.0 · χ² 48 / p 2e-12 | 9.5 EB05 3.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Mucosal inflammation | 12 | 12.6 7.2–22.1ROR 12.8 · χ² 117 / p 1e-27 | 11.0 EB05 6.0 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.7 | no trial data cached |
| Malignant neoplasm progression | 40 | 10.8 8.0–14.6ROR 11.3 · χ² 346 / p 1e-77 | 10.3 EB05 7.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 8.3 | 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 |
|---|---|---|---|---|---|---|
| Product use in unapproved indication | 181 | 20.3 17.9–23.1ROR 26.3 · χ² 3,343 / p <1e-300 | 20.3 EB05 17.9 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 24.9 | no trial data cached |
| Prescribed underdose | 65 | 89.6 71.0–113.1ROR 97.8 · χ² 5,594 / p <1e-300 | 87.1 EB05 70.7 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 55.5 | no trial data cached |
| Malignant neoplasm progression | 40 | 10.8 8.0–14.6ROR 11.3 · χ² 346 / p 1e-77 | 10.3 EB05 7.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 8.3 | no trial data cached |
| Colitis | 20 | 14.6 9.4–22.4ROR 14.9 · χ² 240 / p 3e-54 | 14.0 EB05 9.1 · IC025 +2.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.8 | no trial data cached |
| Prescribed overdose | 15 | 21.3 12.9–35.1ROR 21.7 · χ² 270 / p 6e-61 | 20.6 EB05 13.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 18.3 | no trial data cached |
| Mucosal inflammation | 12 | 12.6 7.2–22.1ROR 12.8 · χ² 117 / p 1e-27 | 11.0 EB05 6.0 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.7 | no trial data cached |
| Cytopenia | 7 | 16.1 7.7–33.6ROR 16.2 · χ² 84 / p 2e-20 | 13.3 EB05 5.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.7 | no trial data cached |
| Hospice care | 5 | 13.9 5.8–33.4ROR 14.0 · χ² 48 / p 2e-12 | 9.5 EB05 3.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Pneumocystis jirovecii pneumonia | 4 | 11.0 4.1–29.2ROR 11.0 · χ² 27 / p 1e-7 | 6.4 EB05 2.4 · IC025 +0.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.4 | 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.
- Prescribed underdose — n=65, PRR 89.6
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 Duvelisib?
In FDA FAERS, the most frequently co-reported reaction terms for Duvelisib are prescribed underdose, colitis, prescribed overdose, mucosal inflammation, cytopenia, hospice care. 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 Duvelisib have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: TREATMENT-RELATED MORTALITY AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, AND PNEUMONITIS Treatment-related mortality occurred in 15% of COPIKTRA-treated patients [see Warnings and Precautions ( 5.1 )] . Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection.
Do FAERS signals prove that Duvelisib 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 e3c5ac56-e1f6-473a-bc73-687836534780, effective 20251218; matched on
openfda.generic_name.exact:"DUVELISIB") - 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, 9 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.