Drug · FAERS side-effect profile with label screen
Acalabrutinib side effects: what 12,042 FDA adverse event reports show
Brand names
Calquence
openFDA label
Who reports
12,042 reports · 84% serious · 2,592 with death outcome · 37% female
openFDA FAERS counts, all years, deduplication not applied
Used for
CALQUENCE is a kinase inhibitor indicated: • In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). (1.1 ) • For the treatment of adult patients with MCL who have received at least one prior therapy.
FDA label, Indications and Usage
What it is
CALQUENCE (acalabrutinib) is a kinase 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 40 strongest signals
Labeled adverse reaction 4Labeled (related wording) 4Likely indication confounding 7Lab value / disease marker 5Not 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.
- 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. 964 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Spleen atrophy | 10 | 350.3 177.5–691.3ROR 350.6 · χ² 2,610 / p <1e-300 | 187.5 EB05 108.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Leukaemic infiltration | 10 | 134.1 70.5–255.1ROR 134.2 · χ² 1,105 / p 1e-242 | 101.0 EB05 58.7 · IC025 +3.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | no trial data cached |
| Reticulocytopenia | 10 | 129.1 67.9–245.3ROR 129.2 · χ² 1,066 / p 5e-234 | 98.2 EB05 57.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Mantle cell lymphoma recurrent | 24 | 103.2 68.4–155.8ROR 103.4 · χ² 2,197 / p <1e-300 | 90.6 EB05 64.1 · IC025 +4.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=24 | no trial data cached |
| Chronic lymphocytic leukaemia recurrent | 34 | 89.8 63.6–126.7ROR 90.0 · χ² 2,753 / p <1e-300 | 81.6 EB05 61.1 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious n=34 | no trial data cached |
| Gastroenteritis bacterial | 11 | 59.4 32.6–108.3ROR 59.4 · χ² 555 / p 5e-123 | 52.5 EB05 31.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Cerebral aspergillosis | 19 | 55.6 35.2–87.7ROR 55.6 · χ² 934 / p 2e-205 | 51.2 EB05 34.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Mantle cell lymphoma | 44 | 52.0 38.5–70.1ROR 52.2 · χ² 2,086 / p <1e-300 | 49.5 EB05 38.4 · IC025 +4.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=44 | no trial data cached |
| Spontaneous haematoma | 15 | 35.8 21.5–59.7ROR 35.9 · χ² 464 / p 4e-103 | 33.7 EB05 21.7 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=15 | no trial data cached |
| Lymphocytosis | 38 | 31.3 22.7–43.2ROR 31.4 · χ² 1,066 / p 4e-234 | 30.4 EB05 23.1 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=37 · 100% clinician | no trial data cached |
| Precancerous condition | 11 | 29.7 16.4–53.9ROR 29.8 · χ² 273 / p 2e-61 | 27.9 EB05 16.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Chronic lymphocytic leukaemia | 74 | 27.4 21.8–34.5ROR 27.6 · χ² 1,829 / p <1e-300 | 26.8 EB05 22.1 · IC025 +4.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=73 | no trial data cached |
| White blood cell count abnormal | 86 | 23.8 19.3–29.4ROR 24.0 · χ² 1,831 / p <1e-300 | 23.4 EB05 19.5 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious n=65 · 85% consumer | no trial data cached |
| Tumour lysis syndrome | 116 | 23.4 19.5–28.1ROR 23.6 · χ² 2,434 / p <1e-300 | 23.0 EB05 19.7 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.0 | no trial data cached |
| Acquired gene mutation | 13 | 17.3 10.0–29.9ROR 17.3 · χ² 182 / p 1e-41 | 16.2 EB05 9.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Red blood cell count abnormal | 14 | 16.8 9.9–28.4ROR 16.8 · χ² 191 / p 1e-43 | 15.8 EB05 9.3 · IC025 +2.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=12 | no trial data cached |
| Haematological infection | 17 | 12.8 8.0–20.7ROR 12.8 · χ² 172 / p 1e-39 | 11.8 EB05 7.2 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious n=17 | no trial data cached |
| Haemothorax | 21 | 12.7 8.2–19.4ROR 12.7 · χ² 213 / p 2e-48 | 11.8 EB05 7.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Lymphocyte count increased | 23 | 12.3 8.2–18.6ROR 12.4 · χ² 227 / p 2e-51 | 11.5 EB05 7.7 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=19 | no trial data cached |
| Gastrointestinal toxicity | 31 | 11.5 8.1–16.4ROR 11.6 · χ² 286 / p 2e-64 | 10.9 EB05 7.8 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=31 · 94% clinician | no trial data cached |
| Cryptococcosis | 10 | 10.9 5.8–20.2ROR 10.9 · χ² 79 / p 2e-19 | 8.7 EB05 4.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Blood immunoglobulin g decreased | 15 | 10.8 6.5–17.9ROR 10.8 · χ² 123 / p 8e-29 | 9.3 EB05 5.6 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious n=12 | no trial data cached |
| Splenomegaly | 65 | 9.7 7.6–12.4ROR 9.8 · χ² 497 / p 3e-110 | 9.4 EB05 7.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Cardiotoxicity | 48 | 9.5 7.1–12.6ROR 9.5 · χ² 353 / p 4e-79 | 9.0 EB05 7.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · 100% clinician | no trial data cached |
| Prostatomegaly | 21 | 9.3 6.1–14.4ROR 9.4 · χ² 148 / p 3e-34 | 8.3 EB05 5.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=18 · 81% consumer | no trial data cached |
| Haemorrhagic diathesis | 19 | 9.3 5.9–14.6ROR 9.3 · χ² 132 / p 8e-31 | 8.2 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| White blood cell disorder | 14 | 9.1 5.4–15.4ROR 9.1 · χ² 93 / p 3e-22 | 7.6 EB05 4.6 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious n=8 | no trial data cached |
| Platelet count abnormal | 30 | 8.7 6.1–12.4ROR 8.7 · χ² 196 / p 9e-45 | 8.0 EB05 5.7 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious n=25 · 83% consumer | no trial data cached |
| Aplasia pure red cell | 17 | 8.6 5.4–13.9ROR 8.6 · χ² 107 / p 3e-25 | 7.4 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Lymphadenopathy | 172 | 8.5 7.3–9.8ROR 8.6 · χ² 1,124 / p 8e-247 | 8.3 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| White blood cell count increased | 185 | 8.4 7.3–9.7ROR 8.5 · χ² 1,194 / p 5e-262 | 8.2 EB05 7.3 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 5.4 · 76% consumer | no trial data cached |
| Discouragement | 11 | 8.3 4.6–15.0ROR 8.3 · χ² 63 / p 9e-16 | 6.6 EB05 3.8 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Haemorrhage urinary tract | 11 | 7.6 4.2–13.7ROR 7.6 · χ² 56 / p 4e-14 | 6.0 EB05 3.5 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | no trial data cached |
| Aspergillus infection | 28 | 7.5 5.2–10.9ROR 7.6 · χ² 152 / p 4e-35 | 6.8 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=28 · 100% clinician | no trial data cached |
| Hepatosplenomegaly | 11 | 7.4 4.1–13.5ROR 7.5 · χ² 55 / p 6e-14 | 5.9 EB05 3.5 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Immunodeficiency | 62 | 7.4 5.7–9.4ROR 7.4 · χ² 333 / p 1e-74 | 7.0 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 85% consumer | no trial data cached |
| Blood blister | 13 | 7.2 4.2–12.5ROR 7.3 · χ² 64 / p 8e-16 | 6.0 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Leukaemia | 39 | 7.2 5.3–9.9ROR 7.2 · χ² 202 / p 4e-46 | 6.7 EB05 5.1 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.0 · 100% consumer | no trial data cached |
| Gastrointestinal stromal tumour | 11 | 7.2 4.0–13.0ROR 7.2 · χ² 52 / p 3e-13 | 5.7 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Full blood count abnormal | 43 | 7.1 5.3–9.6ROR 7.1 · χ² 219 / p 6e-50 | 6.7 EB05 5.1 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 5.1 · 84% consumer | 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 |
|---|---|---|---|---|---|---|
| Death | 2,100 | 4.3 4.1–4.4ROR 4.9 · χ² 5,429 / p <1e-300 | 4.2 EB05 4.1 · IC025 +2.0 3/3 methods agree | Outcome field, not a reaction | serious PRR 2.9 | no trial data cached |
| Fatigue (tiredness) | 677 | 1.5 1.4–1.6ROR 1.5 · χ² 123 / p 6e-29 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.4 · 78% consumer | no trial data cached |
| Headache | 623 | 1.7 1.6–1.9ROR 1.8 · χ² 198 / p 3e-45 | 1.7 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.4 · 72% consumer | no trial data cached |
| Product dose omission issue | 474 | 2.9 2.7–3.2ROR 3.0 · χ² 595 / p 8e-132 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.9 · 93% consumer | no trial data cached |
| Diarrhoea (diarrhea) | 409 | 1.1 1.0–1.2ROR 1.1 · χ² 4 / p 0.020 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.0 | no trial data cached |
| Fall | 363 | 1.9 1.7–2.1ROR 1.9 · χ² 156 / p 3e-36 | 1.9 EB05 1.7 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.6 · 86% consumer | no trial data cached |
| Contusion | 330 | 6.0 5.4–6.7ROR 6.1 · χ² 1,369 / p 7e-300 | 5.9 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 · 81% consumer | no trial data cached |
| Dyspnoea (shortness of breath) | 327 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.466 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.9 · 75% consumer | no trial data cached |
| Pneumonia (lung infection) | 320 | 1.7 1.5–1.9ROR 1.7 · χ² 98 / p 2e-23 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.2 | no trial data cached |
| Malignant neoplasm progression | 316 | 5.4 4.9–6.0ROR 5.5 · χ² 1,134 / p 6e-249 | 5.4 EB05 4.9 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.8 | no trial data cached |
| Asthenia (weakness) | 299 | 1.4 1.2–1.5ROR 1.4 · χ² 32 / p 8e-9 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.2 · 82% consumer | no trial data cached |
| Pain | 286 | 0.8 0.7–0.9ROR 0.8 · χ² 13 / p 1e-4 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.7 · 85% consumer | no trial data cached |
| Atrial fibrillation | 280 | 5.0 4.5–5.6ROR 5.1 · χ² 896 / p 4e-197 | 5.0 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial data cached |
| Off label use (used outside approved label) | 274 | 0.5 0.5–0.6ROR 0.5 · χ² 105 / p 6e-25 | 0.6 EB05 0.5 · IC025 -1.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.5 | no trial data cached |
| Nausea | 259 | 0.6 0.5–0.6ROR 0.6 · χ² 86 / p 8e-21 | 0.6 EB05 0.5 · IC025 -1.0 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.6 · 71% 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.
- Haemothorax — n=21, PRR 12.7
- Splenomegaly — n=65, PRR 9.7
- Cardiotoxicity — n=48, PRR 9.5
- Prostatomegaly — n=21, PRR 9.3
- Lymphadenopathy — n=172, PRR 8.5
- Aspergillus infection — n=28, PRR 7.5
- Immunodeficiency — n=62, PRR 7.4
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 Acalabrutinib?
In FDA FAERS, the most frequently co-reported reaction terms for Acalabrutinib are fatigue, headache, diarrhoea, fall, contusion, dyspnoea. 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 Acalabrutinib have an FDA boxed warning?
No. The FDA label retrieved for Acalabrutinib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Acalabrutinib 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 b1409184-3267-4d8c-8f17-4e01f69828b1, effective 20260219; matched on
openfda.generic_name.exact:"ACALABRUTINIB") - 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, 1,004 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.