Brensocatib side effects: what 2,017 FDA adverse event reports show

Brensocatib · Brinsupri · 39 reaction terms · 1,686 drug–reaction co-reports · data 2026-09-14

Drug class

Dipeptidyl peptidase 1 (dpp1) inhibitor

FDA label, Indications wording

Brand names

Brinsupri

openFDA label

Who reports

2,017 reports · 31% serious · 62 with death outcome · 75% female

openFDA FAERS counts, all years, deduplication not applied

Used for

BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older. BRINSUPRI is a dipeptidyl peptidase 1 (DPP1) inhibitor indicated for the treatment of non-cystic fibrosis bronchiectasis in adult and pediatric patients 12 years of age and older. ( 1 )

FDA label, Indications and Usage

What it is

BRINSUPRI (brensocatib) is a dipeptidyl peptidase 1 (DPP1) inhibitor.

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 28 strongest signals

Labeled adverse reaction 3Labeled (related wording) 1Reporting / coding artifact 9Not in label — unassessed 15

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.
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. 11 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
Secretion discharge	50	42.2 32.1–55.6ROR 43.3 · χ² 1,965 / p <1e-300	41.5 EB05 32.7 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 46.8 · 94% consumer	no trial data cached
Sputum discoloured	37	40.8 29.7–56.2ROR 41.6 · χ² 1,394 / p <1e-300	39.9 EB05 30.2 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 43.3 · 97% consumer	no trial data cached
Therapy interrupted	234	35.4 31.4–39.9ROR 39.9 · χ² 7,782 / p <1e-300	35.2 EB05 31.5 · IC025 +4.8 3/3 methods agree	Reporting / coding artifact	serious PRR 79.0 · 93% consumer	no trial data cached
Insurance issue	39	27.4 20.0–37.3ROR 27.9 · χ² 962 / p 1e-211	27.0 EB05 20.6 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 21.8 · 97% consumer	no trial data cached
Productive cough (cough with phlegm)	77	16.9 13.6–21.1ROR 17.6 · χ² 1,139 / p 4e-250	16.8 EB05 13.9 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 19.7 · 95% consumer	no trial data cached
Intentional dose omission	40	15.2 11.2–20.7ROR 15.5 · χ² 517 / p 8e-115	15.0 EB05 11.4 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 25.0 · 95% consumer	no trial data cached
Respiratory tract congestion	18	11.8 7.4–18.7ROR 11.9 · χ² 167 / p 2e-38	10.7 EB05 6.7 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 17.1	no trial data cached
Hospice care	11	11.6 6.4–21.0ROR 11.7 · χ² 96 / p 5e-23	9.7 EB05 5.2 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 17.3	no trial data cached
Adverse drug reaction	95	11.1 9.1–13.4ROR 11.5 · χ² 861 / p 1e-189	10.9 EB05 9.1 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious PRR 24.6 · 93% consumer	no trial data cached
Haemoptysis	29	10.8 7.5–15.5ROR 10.9 · χ² 248 / p 3e-56	10.1 EB05 7.2 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 16.5 · 90% consumer	no trial data cached
Inability to afford medication	10	10.6 5.7–19.6ROR 10.6 · χ² 77 / p 7e-19	8.5 EB05 4.5 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Product dose omission in error	25	9.7 6.6–14.3ROR 9.8 · χ² 186 / p 1e-42	8.8 EB05 6.1 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 17.2 · 96% consumer	no trial data cached
Cough	221	8.2 7.3–9.3ROR 9.1 · χ² 1,411 / p <1e-300	8.1 EB05 7.2 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 11.0 · 92% consumer	no trial data cached
Aphonia	11	8.2 4.5–14.8ROR 8.2 · χ² 63 / p 1e-15	6.5 EB05 3.8 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 20.9	no trial data cached
Dry skin	96	7.6 6.2–9.2ROR 7.9 · χ² 546 / p 5e-121	7.4 EB05 6.2 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 17.4 · 94% consumer	no trial data cached
Hospitalisation	106	7.2 6.0–8.7ROR 7.6 · χ² 567 / p 1e-125	7.0 EB05 6.0 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 13.9 · 86% consumer	no trial data cached
Tooth disorder	15	7.0 4.2–11.6ROR 7.0 · χ² 71 / p 2e-17	5.9 EB05 3.8 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 3.0	no trial data cached
Unevaluable event	49	6.7 5.1–8.9ROR 6.9 · χ² 234 / p 3e-53	6.4 EB05 5.0 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 11.0 · 98% consumer	no trial data cached
Toothache	11	6.3 3.5–11.4ROR 6.4 · χ² 44 / p 2e-11	5.1 EB05 3.0 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 6.1	no trial data cached
Illness	53	5.5 4.2–7.2ROR 5.6 · χ² 191 / p 1e-43	5.2 EB05 4.2 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 12.1 · 91% consumer	no trial data cached
Dysphonia	30	5.3 3.7–7.6ROR 5.4 · χ² 102 / p 3e-24	5.0 EB05 3.6 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 13.9 · ♀ 97% (drug 75%) · 93% consumer	no trial data cached
Skin disorder	17	5.3 3.3–8.5ROR 5.3 · χ² 55 / p 5e-14	4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.1	no trial data cached
Dyspnoea exertional	19	5.3 3.4–8.2ROR 5.3 · χ² 62 / p 2e-15	4.7 EB05 3.2 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.9	no trial data cached
Alopecia (hair loss)	96	5.1 4.2–6.2ROR 5.3 · χ² 313 / p 3e-70	5.0 EB05 4.2 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.3 · 83% consumer	no trial data cached
Product storage error	42	5.0 3.7–6.8ROR 5.1 · χ² 133 / p 5e-31	4.8 EB05 3.7 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 41.3 · 95% consumer	no trial data cached
Product dose omission issue	138	5.0 4.3–5.9ROR 5.3 · χ² 449 / p 6e-100	5.0 EB05 4.3 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 13.5 · 95% consumer	no trial data cached
Skin exfoliation	31	3.9 2.7–5.5ROR 3.9 · χ² 64 / p 8e-16	3.7 EB05 2.7 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.8 · 87% consumer	no trial data cached
Throat irritation	16	3.7 2.3–6.1ROR 3.7 · χ² 29 / p 3e-8	3.4 EB05 2.2 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 4.1	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
Therapy interrupted	234	35.4 31.4–39.9ROR 39.9 · χ² 7,782 / p <1e-300	35.2 EB05 31.5 · IC025 +4.8 3/3 methods agree	Reporting / coding artifact	serious PRR 79.0 · 93% consumer	no trial data cached
Cough	221	8.2 7.3–9.3ROR 9.1 · χ² 1,411 / p <1e-300	8.1 EB05 7.2 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 11.0 · 92% consumer	no trial data cached
Product dose omission issue	138	5.0 4.3–5.9ROR 5.3 · χ² 449 / p 6e-100	5.0 EB05 4.3 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 13.5 · 95% consumer	no trial data cached
Hospitalisation	106	7.2 6.0–8.7ROR 7.6 · χ² 567 / p 1e-125	7.0 EB05 6.0 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 13.9 · 86% consumer	no trial data cached
Alopecia (hair loss)	96	5.1 4.2–6.2ROR 5.3 · χ² 313 / p 3e-70	5.0 EB05 4.2 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.3 · 83% consumer	no trial data cached
Dry skin	96	7.6 6.2–9.2ROR 7.9 · χ² 546 / p 5e-121	7.4 EB05 6.2 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 17.4 · 94% consumer	no trial data cached
Adverse drug reaction	95	11.1 9.1–13.4ROR 11.5 · χ² 861 / p 1e-189	10.9 EB05 9.1 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious PRR 24.6 · 93% consumer	no trial data cached
Productive cough (cough with phlegm)	77	16.9 13.6–21.1ROR 17.6 · χ² 1,139 / p 4e-250	16.8 EB05 13.9 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 19.7 · 95% consumer	no trial data cached
Illness	53	5.5 4.2–7.2ROR 5.6 · χ² 191 / p 1e-43	5.2 EB05 4.2 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 12.1 · 91% consumer	no trial data cached
Secretion discharge	50	42.2 32.1–55.6ROR 43.3 · χ² 1,965 / p <1e-300	41.5 EB05 32.7 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 46.8 · 94% consumer	no trial data cached
Unevaluable event	49	6.7 5.1–8.9ROR 6.9 · χ² 234 / p 3e-53	6.4 EB05 5.0 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 11.0 · 98% consumer	no trial data cached
Product storage error	42	5.0 3.7–6.8ROR 5.1 · χ² 133 / p 5e-31	4.8 EB05 3.7 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 41.3 · 95% consumer	no trial data cached
Intentional dose omission	40	15.2 11.2–20.7ROR 15.5 · χ² 517 / p 8e-115	15.0 EB05 11.4 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 25.0 · 95% consumer	no trial data cached
Insurance issue	39	27.4 20.0–37.3ROR 27.9 · χ² 962 / p 1e-211	27.0 EB05 20.6 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 21.8 · 97% consumer	no trial data cached
Sputum discoloured	37	40.8 29.7–56.2ROR 41.6 · χ² 1,394 / p <1e-300	39.9 EB05 30.2 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 43.3 · 97% consumer	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.

Secretion discharge — n=50, PRR 42.2
Sputum discoloured — n=37, PRR 40.8
Insurance issue — n=39, PRR 27.4
Productive cough — n=77, PRR 16.9
Haemoptysis — n=29, PRR 10.8
Cough — n=221, PRR 8.2
Dysphonia — n=30, PRR 5.3

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 Brensocatib?

In FDA FAERS, the most frequently co-reported reaction terms for Brensocatib are cough, alopecia, dry skin, productive cough, secretion discharge, insurance issue. 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 Brensocatib have an FDA boxed warning?

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

Do FAERS signals prove that Brensocatib 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 b56986ae-e7db-421e-b622-a7f41e321f3d, effective 20260316; matched on openfda.generic_name.exact:"BRENSOCATIB")
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, 39 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.