Zanubrutinib side effects: what 846 FDA adverse event reports show

Zanubrutinib · 136 reaction terms · 5,879 drug–reaction co-reports · data 2026-09-14

Drug class

No validated FDA label found

Who reports

846 reports · 93% serious · 144 with death outcome · 42% female

openFDA FAERS counts, all years, deduplication not applied

Used for

—

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

Reporting / coding artifact 2Lab value / disease marker 12No label text to screen 26

What the badges mean

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.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

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. 96 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
Myelosuppression	240	35.7 31.5–40.4ROR 37.8 · χ² 8,012 / p <1e-300	35.3 EB05 31.8 · IC025 +4.8 3/3 methods agree	No label text to screen	–	no trial data cached
Lymphocyte count decreased	101	28.8 23.8–35.0ROR 29.5 · χ² 2,674 / p <1e-300	28.5 EB05 24.2 · IC025 +4.3 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Petechiae	51	24.7 18.8–32.5ROR 25.0 · χ² 1,133 / p 9e-249	24.4 EB05 19.3 · IC025 +3.9 3/3 methods agree	No label text to screen	–	no trial data cached
Cytokine release syndrome	87	23.0 18.7–28.4ROR 23.5 · χ² 1,805 / p <1e-300	22.8 EB05 19.1 · IC025 +4.0 3/3 methods agree	No label text to screen	–	no trial data cached
Hypomagnesaemia	52	18.9 14.4–24.8ROR 19.1 · χ² 861 / p 2e-189	18.7 EB05 14.8 · IC025 +3.5 3/3 methods agree	No label text to screen	–	no trial data cached
Neutrophil count decreased	145	18.0 15.4–21.2ROR 18.7 · χ² 2,313 / p <1e-300	17.9 EB05 15.6 · IC025 +3.8 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Increased tendency to bruise	31	16.9 11.9–24.1ROR 17.1 · χ² 448 / p 1e-99	16.7 EB05 12.2 · IC025 +3.2 3/3 methods agree	No label text to screen	–	no trial data cached
Hypocalcaemia (low calcium)	54	14.4 11.1–18.8ROR 14.6 · χ² 659 / p 1e-145	14.2 EB05 11.2 · IC025 +3.2 3/3 methods agree	No label text to screen	–	no trial data cached
Disease progression	296	12.6 11.3–14.1ROR 13.5 · χ² 3,171 / p <1e-300	12.6 EB05 11.4 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Prescribed underdose	48	12.1 9.1–16.1ROR 12.2 · χ² 478 / p 3e-106	11.8 EB05 9.1 · IC025 +3.0 3/3 methods agree	No label text to screen	–	no trial data cached
Contusion	227	11.9 10.5–13.5ROR 12.5 · χ² 2,258 / p <1e-300	11.8 EB05 10.6 · IC025 +3.3 3/3 methods agree	No label text to screen	–	no trial data cached
Lymphadenopathy	81	11.5 9.3–14.3ROR 11.7 · χ² 766 / p 6e-169	11.3 EB05 9.3 · IC025 +3.1 3/3 methods agree	No label text to screen	–	no trial data cached
White blood cell count decreased	237	11.0 9.7–12.4ROR 11.6 · χ² 2,150 / p <1e-300	10.9 EB05 9.8 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Splenomegaly	25	10.7 7.3–15.9ROR 10.8 · χ² 211 / p 4e-48	10.0 EB05 6.8 · IC025 +2.5 3/3 methods agree	No label text to screen	–	no trial data cached
C-reactive protein increased	76	10.5 8.4–13.1ROR 10.7 · χ² 645 / p 1e-142	10.3 EB05 8.4 · IC025 +2.9 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Skin infection	23	10.4 6.9–15.6ROR 10.4 · χ² 185 / p 2e-42	9.5 EB05 6.4 · IC025 +2.4 3/3 methods agree	No label text to screen	–	no trial data cached
Hypokalaemia (low potassium)	94	10.3 8.4–12.6ROR 10.5 · χ² 781 / p 4e-172	10.1 EB05 8.4 · IC025 +3.0 3/3 methods agree	No label text to screen	–	no trial data cached
Platelet count decreased	214	10.1 8.9–11.5ROR 10.6 · χ² 1,753 / p <1e-300	10.0 EB05 8.9 · IC025 +3.1 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Gamma-glutamyltransferase increased	44	10.0 7.4–13.4ROR 10.1 · χ² 346 / p 1e-77	9.5 EB05 7.3 · IC025 +2.7 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Covid-19 pneumonia	21	8.9 5.8–13.6ROR 8.9 · χ² 139 / p 2e-32	7.9 EB05 5.3 · IC025 +2.2 3/3 methods agree	No label text to screen	–	no trial data cached
Cytopenia	21	8.8 5.8–13.6ROR 8.9 · χ² 138 / p 3e-32	7.8 EB05 5.2 · IC025 +2.2 3/3 methods agree	No label text to screen	–	no trial data cached
Product use complaint	26	8.4 5.8–12.4ROR 8.5 · χ² 163 / p 1e-37	7.6 EB05 5.4 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
White blood cell count increased	61	8.0 6.2–10.2ROR 8.1 · χ² 365 / p 1e-81	7.6 EB05 6.1 · IC025 +2.5 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Blood alkaline phosphatase increased	36	7.3 5.3–10.1ROR 7.3 · χ² 189 / p 3e-43	6.7 EB05 5.1 · IC025 +2.2 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Blood lactate dehydrogenase increased	23	7.3 4.8–10.9ROR 7.3 · χ² 118 / p 1e-27	6.5 EB05 4.5 · IC025 +2.0 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Anaemia (low red blood cells)	236	6.2 5.5–7.0ROR 6.5 · χ² 1,036 / p 1e-227	6.1 EB05 5.5 · IC025 +2.4 3/3 methods agree	No label text to screen	–	no trial data cached
Lymphoma	19	6.2 3.9–9.7ROR 6.2 · χ² 77 / p 8e-19	5.4 EB05 3.7 · IC025 +1.7 3/3 methods agree	No label text to screen	–	no trial data cached
Aspartate aminotransferase increased	65	6.2 4.8–7.8ROR 6.2 · χ² 276 / p 3e-62	5.9 EB05 4.8 · IC025 +2.2 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Ankylosing spondylitis	15	5.8 3.5–9.6ROR 5.8 · χ² 55 / p 7e-14	5.0 EB05 3.2 · IC025 +1.5 3/3 methods agree	No label text to screen	–	no trial data cached
Internal haemorrhage	13	5.7 3.3–9.8ROR 5.7 · χ² 46 / p 6e-12	4.8 EB05 3.0 · IC025 +1.3 3/3 methods agree	No label text to screen	–	no trial data cached
Sinus tachycardia	16	5.7 3.5–9.3ROR 5.7 · χ² 57 / p 2e-14	4.9 EB05 3.2 · IC025 +1.5 3/3 methods agree	No label text to screen	–	no trial data cached
Skin lesion	30	5.5 3.9–7.9ROR 5.6 · χ² 107 / p 2e-25	5.1 EB05 3.8 · IC025 +1.8 3/3 methods agree	No label text to screen	–	no trial data cached
Pneumocystis jirovecii pneumonia	11	5.5 3.1–10.0ROR 5.5 · χ² 36 / p 8e-10	4.6 EB05 2.7 · IC025 +1.2 3/3 methods agree	No label text to screen	–	no trial data cached
Atrial fibrillation	106	5.5 4.5–6.6ROR 5.6 · χ² 384 / p 1e-85	5.3 EB05 4.5 · IC025 +2.1 3/3 methods agree	No label text to screen	–	no trial data cached
Skin haemorrhage	15	5.2 3.2–8.7ROR 5.2 · χ² 47 / p 3e-12	4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree	No label text to screen	–	no trial data cached
Blood iron decreased	12	5.1 2.9–9.0ROR 5.1 · χ² 36 / p 1e-9	4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Alanine aminotransferase increased	62	5.1 4.0–6.5ROR 5.1 · χ² 199 / p 2e-45	4.9 EB05 4.0 · IC025 +1.9 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Pericardial effusion	23	5.0 3.3–7.6ROR 5.0 · χ² 70 / p 3e-17	4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree	No label text to screen	–	no trial data cached
Pleural effusion	60	5.0 3.9–6.4ROR 5.0 · χ² 186 / p 1e-42	4.8 EB05 3.8 · IC025 +1.8 3/3 methods agree	No label text to screen	–	no trial data cached
Subarachnoid haemorrhage	10	4.9 2.6–9.1ROR 4.9 · χ² 27 / p 8e-8	4.1 EB05 2.4 · IC025 +1.0 3/3 methods agree	No label text to screen	–	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
Off label use (used outside approved label)	553	3.2 3.0–3.5ROR 3.5 · χ² 871 / p 1e-191	3.2 EB05 3.0 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Disease progression	296	12.6 11.3–14.1ROR 13.5 · χ² 3,171 / p <1e-300	12.6 EB05 11.4 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Myelosuppression	240	35.7 31.5–40.4ROR 37.8 · χ² 8,012 / p <1e-300	35.3 EB05 31.8 · IC025 +4.8 3/3 methods agree	No label text to screen	–	no trial data cached
White blood cell count decreased	237	11.0 9.7–12.4ROR 11.6 · χ² 2,150 / p <1e-300	10.9 EB05 9.8 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Anaemia (low red blood cells)	236	6.2 5.5–7.0ROR 6.5 · χ² 1,036 / p 1e-227	6.1 EB05 5.5 · IC025 +2.4 3/3 methods agree	No label text to screen	–	no trial data cached
Contusion	227	11.9 10.5–13.5ROR 12.5 · χ² 2,258 / p <1e-300	11.8 EB05 10.6 · IC025 +3.3 3/3 methods agree	No label text to screen	–	no trial data cached
Platelet count decreased	214	10.1 8.9–11.5ROR 10.6 · χ² 1,753 / p <1e-300	10.0 EB05 8.9 · IC025 +3.1 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Rash	202	2.3 2.0–2.7ROR 2.4 · χ² 157 / p 3e-36	2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree	No label text to screen	–	no trial data cached
Neutrophil count decreased	145	18.0 15.4–21.2ROR 18.7 · χ² 2,313 / p <1e-300	17.9 EB05 15.6 · IC025 +3.8 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Covid-19	127	3.6 3.0–4.3ROR 3.7 · χ² 239 / p 4e-54	3.6 EB05 3.1 · IC025 +1.5 3/3 methods agree	No label text to screen	–	no trial data cached
Atrial fibrillation	106	5.5 4.5–6.6ROR 5.6 · χ² 384 / p 1e-85	5.3 EB05 4.5 · IC025 +2.1 3/3 methods agree	No label text to screen	–	no trial data cached
Thrombocytopenia (low platelets)	101	4.6 3.8–5.5ROR 4.6 · χ² 278 / p 1e-62	4.5 EB05 3.8 · IC025 +1.8 3/3 methods agree	No label text to screen	–	no trial data cached
Lymphocyte count decreased	101	28.8 23.8–35.0ROR 29.5 · χ² 2,674 / p <1e-300	28.5 EB05 24.2 · IC025 +4.3 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Product dose omission issue	99	1.7 1.4–2.1ROR 1.8 · χ² 31 / p 1e-8	1.7 EB05 1.5 · IC025 +0.5	Reporting / coding artifact	–	no trial data cached
Hypokalaemia (low potassium)	94	10.3 8.4–12.6ROR 10.5 · χ² 781 / p 4e-172	10.1 EB05 8.4 · IC025 +3.0 3/3 methods agree	No label text to screen	–	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Zanubrutinib?

In FDA FAERS, the most frequently co-reported reaction terms for Zanubrutinib are myelosuppression, white blood cell count decreased, anaemia, contusion, platelet count decreased, rash. 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 Zanubrutinib have an FDA boxed warning?

No validated FDA label could be retrieved for this product name, so this page cannot say.

Do FAERS signals prove that Zanubrutinib 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

No FDA label passed the name-validation check for this product string, so label-based screening was skipped
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, 136 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.