Drug · FAERS side-effect profile with label screen
Ibrutinib side effects: what 80,310 FDA adverse event reports show
Brand names
Imbruvica
openFDA label
Who reports
80,310 reports · 78% serious · 13,715 with death outcome · 38% female
openFDA FAERS counts, all years, deduplication not applied
Used for
IMBRUVICA is a kinase inhibitor indicated for the treatment of: Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) ( 1.1 ). Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion ( 1.2 ). Adult patients with Waldenström’s macroglobulinemia (WM) ( 1.3 ).
FDA label, Indications and Usage
What it is
Ibrutinib is a kinase inhibitor. It is a white to off-white solid with the empirical formula C 25 H 24 N 6 O 2 and a molecular weight 440.50. Ibrutinib is freely soluble in dimethyl sulfoxide, soluble in methanol and practically insoluble in water.
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 3Labeled (related wording) 7Likely indication confounding 4Reporting / coding artifact 3Lab value / disease marker 7Not in label — unassessed 16
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,167 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 |
|---|---|---|---|---|---|---|
| Haematotympanum | 35 | 183.3 118.8–282.9ROR 183.4 · calibrated p 4e-9 ✓ | 101.5 EB05 76.3 · IC025 +4.9 3/3 methods agree vs other Kinase Inhibitors: PRR 528.3 (187.8–1,486.5) | Not in label — unassessed | serious n=32 | not reported in cached trials |
| Chronic lymphocytic leukaemia refractory | 37 | 169.6 112.0–256.9ROR 169.7 · calibrated p 7e-9 ✓ | 97.5 EB05 73.9 · IC025 +4.9 3/3 methods agree vs other Kinase Inhibitors: only this drug | Labeled (related wording) related wording | serious n=36 · 100% clinician | not reported in cached trials |
| Mantle cell lymphoma recurrent | 162 | 159.3 131.0–193.8ROR 159.6 · calibrated p 4e-9 ✓ | 97.6 EB05 85.6 · IC025 +6.0 3/3 methods agree vs other Kinase Inhibitors: PRR 407.6 (265.5–625.6) | Likely indication confounding shares a disease stem with the indications wording | serious n=162 | not reported in cached trials |
| Micrographic skin surgery | 61 | 107.2 79.5–144.6ROR 107.3 · calibrated p 1e-7 ✓ | 74.2 EB05 59.9 · IC025 +5.1 3/3 methods agree vs other Kinase Inhibitors: only this drug | Not in label — unassessed | serious n=61 · 100% consumer | not reported in cached trials |
| Blood immunoglobulin m abnormal | 30 | 105.5 69.0–161.3ROR 105.5 · calibrated p 3e-7 ✓ | 71.8 EB05 52.7 · IC025 +4.5 3/3 methods agree vs other Kinase Inhibitors: only this drug | Lab value / disease marker | ♀ 0% (drug 38%) · 100% consumer | not reported in cached trials |
| Mantle cell lymphoma | 389 | 90.1 80.3–101.1ROR 90.5 · calibrated p 3e-7 ✓ | 66.7 EB05 61.4 · IC025 +5.8 3/3 methods agree vs other Kinase Inhibitors: PRR 533.8 (391.0–728.9) | Likely indication confounding shares a disease stem with the indications wording | serious n=388 | NCT03734016: 1/324 (0.3%) on Ibrutinib (serious AE) |
| Angina bullosa haemorrhagica | 50 | 70.5 51.6–96.4ROR 70.6 · calibrated p 2e-6 ✓ | 54.4 EB05 42.9 · IC025 +4.7 3/3 methods agree vs other Kinase Inhibitors: only this drug | Not in label — unassessed | serious n=41 · 72% consumer | not reported in cached trials |
| Blood immunoglobulin m increased | 130 | 70.4 58.0–85.5ROR 70.5 · calibrated p 2e-6 ✓ | 55.0 EB05 47.5 · IC025 +5.2 3/3 methods agree vs other Kinase Inhibitors: only this drug | Lab value / disease marker | serious n=92 · 78% consumer | not reported in cached trials |
| Chronic lymphocytic leukaemia | 901 | 60.8 56.5–65.3ROR 61.5 · calibrated p 4e-6 ✓ | 49.3 EB05 46.6 · IC025 +5.5 3/3 methods agree vs other Kinase Inhibitors: PRR 499.1 (409.3–608.6) | Likely indication confounding term in indications; also in warnings | serious n=900 | not reported in cached trials |
| Medical procedure | 288 | 55.6 49.0–63.2ROR 55.8 · calibrated p 7e-6 ✓ | 45.8 EB05 41.5 · IC025 +5.2 3/3 methods agree vs other Kinase Inhibitors: PRR 1,337.7 (767.5–2,331.6) | Reporting / coding artifact | serious n=286 · 100% consumer | not reported in cached trials |
| Cerebral aspergillosis | 107 | 55.0 44.7–67.8ROR 55.1 · calibrated p 9e-6 ✓ | 45.2 EB05 38.4 · IC025 +4.9 3/3 methods agree vs other Kinase Inhibitors: PRR 208.4 (139.8–310.8) | Not in label — unassessed | serious n=107 · 100% clinician | NCT01855750: 1/416 (0.2%) on Ibrutinib (serious AE) |
| Chronic lymphocytic leukaemia recurrent | 118 | 53.5 43.9–65.2ROR 53.6 · calibrated p 1e-5 ✓ | 44.2 EB05 37.9 · IC025 +4.9 3/3 methods agree vs other Kinase Inhibitors: PRR 209.6 (143.1–306.8) | Labeled (related wording) related wording | serious n=118 | not reported in cached trials |
| Chronic lymphocytic leukaemia transformation | 36 | 53.4 37.3–76.5ROR 53.4 · calibrated p 2e-5 ✓ | 43.4 EB05 32.8 · IC025 +4.2 3/3 methods agree vs other Kinase Inhibitors: only this drug | Labeled (related wording) related wording | serious n=36 · ♀ 0% (drug 38%) · 100% clinician | not reported in cached trials |
| Microsporidia infection | 50 | 42.6 31.6–57.5ROR 42.7 · calibrated p 5e-5 ✓ | 36.2 EB05 28.6 · IC025 +4.3 3/3 methods agree vs other Kinase Inhibitors: PRR 44.4 (30.8–64.0) | Not in label — unassessed | serious n=50 · ♀ 0% (drug 38%) · 100% clinician | not reported in cached trials |
| B-cell small lymphocytic lymphoma | 31 | 41.2 28.2–60.2ROR 41.2 · calibrated p 8e-5 ✓ | 35.0 EB05 25.8 · IC025 +3.9 3/3 methods agree vs other Kinase Inhibitors: PRR 234.0 (107.6–509.0) | Labeled (related wording) related wording | serious n=31 | not reported in cached trials |
| Lymphocytosis | 285 | 39.9 35.2–45.2ROR 40.0 · calibrated p 6e-5 ✓ | 34.6 EB05 31.3 · IC025 +4.8 3/3 methods agree vs other Kinase Inhibitors: PRR 452.9 (322.9–635.1) | Likely indication confounding shares a disease stem with the indications wording | serious n=250 | NCT03734016: 1/324 (0.3%) on Ibrutinib (serious AE) |
| Blood viscosity decreased | 42 | 37.2 26.9–51.4ROR 37.2 · calibrated p 1e-4 ✓ | 32.2 EB05 24.8 · IC025 +4.1 3/3 methods agree vs other Kinase Inhibitors: PRR 422.7 (179.7–994.2) | Lab value / disease marker | serious n=36 · ♀ 0% (drug 38%) · 100% consumer | not reported in cached trials |
| Post procedural contusion | 34 | 30.8 21.6–44.0ROR 30.8 · calibrated p 3e-4 ✓ | 27.3 EB05 20.4 · IC025 +3.7 3/3 methods agree vs other Kinase Inhibitors: PRR 342.2 (143.7–814.9) | Reporting / coding artifact | serious n=32 · 100% consumer | not reported in cached trials |
| Prostatic operation | 114 | 27.6 22.7–33.4ROR 27.6 · calibrated p 5e-4 ✓ | 24.9 EB05 21.3 · IC025 +4.2 3/3 methods agree vs other Kinase Inhibitors: only this drug | Reporting / coding artifact | serious n=114 · ♀ 0% (drug 38%) · 81% consumer | not reported in cached trials |
| Onychoclasis | 638 | 26.7 24.6–28.9ROR 26.9 · calibrated p 5e-4 ✓ | 24.2 EB05 22.7 · IC025 +4.4 3/3 methods agree vs other Kinase Inhibitors: PRR 79.3 (70.5–89.1) | Labeled adverse reaction exact term | serious n=350 · 86% consumer | not reported in cached trials |
| Blood immunoglobulin m decreased | 88 | 25.2 20.2–31.3ROR 25.2 · calibrated p 7e-4 ✓ | 22.9 EB05 19.2 · IC025 +4.0 3/3 methods agree vs other Kinase Inhibitors: PRR 1,062.7 (431.6–2,616.5) | Lab value / disease marker | serious n=58 · 83% consumer | not reported in cached trials |
| Aspergillus infection | 548 | 24.0 22.0–26.2ROR 24.2 · calibrated p 8e-4 ✓ | 22.0 EB05 20.5 · IC025 +4.3 3/3 methods agree vs other Kinase Inhibitors: PRR 127.8 (110.3–148.0) | Not in label — unassessed | serious n=542 | NCT01855750: 2/416 (0.5%) on Ibrutinib (serious AE) |
| Lymphocyte count increased | 259 | 22.4 19.7–25.4ROR 22.5 · calibrated p 0.001 ✓ | 20.7 EB05 18.6 · IC025 +4.1 3/3 methods agree vs other Kinase Inhibitors: PRR 188.4 (147.2–241.2) | Lab value / disease marker | serious n=208 | NCT01855750: 44/416 (10.6%) on Ibrutinib; 42/418 (10.0%) control |
| Increased tendency to bruise | 709 | 21.7 20.1–23.4ROR 21.9 · calibrated p 0.001 ✓ | 20.1 EB05 18.9 · IC025 +4.2 3/3 methods agree vs other Kinase Inhibitors: PRR 89.6 (79.8–100.5) | Not in label — unassessed | serious n=493 · 85% consumer | not reported in cached trials |
| White blood cell count abnormal | 469 | 20.7 18.8–22.7ROR 20.8 · calibrated p 0.002 ✓ | 19.2 EB05 17.8 · IC025 +4.1 3/3 methods agree vs other Kinase Inhibitors: PRR 30.0 (26.9–33.5) | Lab value / disease marker | serious n=345 · 86% consumer | NCT01855750: 3/416 (0.7%) on Ibrutinib (serious AE) |
| Nail growth abnormal | 76 | 19.2 15.2–24.3ROR 19.2 · calibrated p 0.003 ✓ | 17.9 EB05 14.7 · IC025 +3.6 3/3 methods agree vs other Kinase Inhibitors: PRR 127.5 (85.8–189.5) | Not in label — unassessed | serious n=43 · ♀ 68% (drug 38%) · 100% consumer | not reported in cached trials |
| Haemorrhagic diathesis | 243 | 19.0 16.7–21.6ROR 19.0 · calibrated p 0.003 ✓ | 17.7 EB05 15.9 · IC025 +3.9 3/3 methods agree vs other Kinase Inhibitors: PRR 145.3 (115.2–183.2) | Not in label — unassessed | serious n=202 | not reported in cached trials |
| Blood blister | 211 | 18.8 16.3–21.6ROR 18.8 · calibrated p 0.003 ✓ | 17.6 EB05 15.6 · IC025 +3.9 3/3 methods agree vs other Kinase Inhibitors: PRR 205.5 (154.9–272.7) | Not in label — unassessed | serious n=158 · 77% consumer | not reported in cached trials |
| Ear haemorrhage | 134 | 18.5 15.5–22.0ROR 18.5 · calibrated p 0.003 ✓ | 17.3 EB05 14.9 · IC025 +3.7 3/3 methods agree vs other Kinase Inhibitors: PRR 899.0 (457.8–1,765.4) | Labeled (related wording) related wording | serious n=123 · 74% consumer | NCT01855750: 1/416 (0.2%) on Ibrutinib (serious AE) |
| Vasogenic cerebral oedema | 41 | 16.0 11.7–22.0ROR 16.0 · calibrated p 0.006 ✓ | 14.9 EB05 11.4 · IC025 +3.2 3/3 methods agree vs other Kinase Inhibitors: PRR 176.8 (96.4–324.3) | Not in label — unassessed | serious n=41 · ♀ 100% (drug 38%) · 100% clinician | not reported in cached trials |
| Central nervous system lymphoma | 78 | 15.7 12.5–19.7ROR 15.7 · calibrated p 0.006 ✓ | 14.7 EB05 12.2 · IC025 +3.4 3/3 methods agree vs other Kinase Inhibitors: only this drug | Labeled (related wording) related wording | serious n=78 · 100% clinician | not reported in cached trials |
| Hospice care | 528 | 14.7 13.5–16.1ROR 14.8 · calibrated p 0.007 ✓ | 14.0 EB05 13.0 · IC025 +3.6 3/3 methods agree vs other Kinase Inhibitors: PRR 48.2 (43.0–54.0) | Not in label — unassessed | serious PRR 15.0 | not reported in cached trials |
| Abdominal lymphadenopathy | 46 | 14.7 11.0–19.8ROR 14.7 · calibrated p 0.009 ✓ | 13.8 EB05 10.6 · IC025 +3.1 3/3 methods agree vs other Kinase Inhibitors: PRR 39.1 (27.0–56.7) | Not in label — unassessed | serious n=43 | not reported in cached trials |
| Haemothorax | 155 | 14.7 12.5–17.2ROR 14.7 · calibrated p 0.008 ✓ | 13.9 EB05 12.1 · IC025 +3.5 3/3 methods agree vs other Kinase Inhibitors: PRR 146.2 (109.3–195.6) | Not in label — unassessed | serious n=153 | NCT03734016: 1/324 (0.3%) on Ibrutinib (serious AE) |
| Campylobacter infection | 41 | 13.5 9.8–18.4ROR 13.5 · calibrated p 0.013 ✓ | 12.5 EB05 9.5 · IC025 +3.0 3/3 methods agree vs other Kinase Inhibitors: only this drug | Not in label — unassessed | serious n=39 · 100% clinician | not reported in cached trials |
| Oral surgery | 114 | 13.4 11.1–16.2ROR 13.4 · calibrated p 0.011 ✓ | 12.7 EB05 10.8 · IC025 +3.3 3/3 methods agree vs other Kinase Inhibitors: PRR 245.8 (162.6–371.6) | Labeled (related wording) related wording | serious n=114 · 100% consumer | not reported in cached trials |
| Lymphocyte count abnormal | 55 | 13.3 10.2–17.5ROR 13.3 · calibrated p 0.013 ✓ | 12.5 EB05 9.9 · IC025 +3.1 3/3 methods agree vs other Kinase Inhibitors: PRR 474.4 (216.1–1,041.6) | Lab value / disease marker | serious n=48 | NCT01855750: 44/416 (10.6%) on Ibrutinib; 42/418 (10.0%) control |
| Infective exacerbation of chronic obstructive airways disease | 31 | 13.2 9.2–18.9ROR 13.2 · calibrated p 0.015 ✓ | 12.1 EB05 8.7 · IC025 +2.8 3/3 methods agree vs other Kinase Inhibitors: only this drug | Not in label — unassessed | serious n=31 · ♀ 0% (drug 38%) · 100% clinician | not reported in cached trials |
| Petechiae | 498 | 13.1 12.0–14.3ROR 13.2 · calibrated p 0.012 ✓ | 12.5 EB05 11.6 · IC025 +3.5 3/3 methods agree vs other Kinase Inhibitors: PRR 81.3 (71.1–92.9) | Labeled adverse reaction exact term | age-adj. PRR 13.5 · serious PRR 8.2 | NCT03734016: 19/324 (5.9%) on Ibrutinib |
| Cytopenia | 546 | 12.5 11.4–13.6ROR 12.5 · calibrated p 0.014 ✓ | 11.9 EB05 11.1 · IC025 +3.4 3/3 methods agree vs other Kinase Inhibitors: PRR 31.5 (28.4–34.9) | Labeled adverse reaction exact term | serious PRR 8.9 | NCT01855750: 1/418 (0.2%) control (serious AE) |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Arrhythmia / qt | 4,357 | 6.05.8–6.2 | signal |
| Thrombocytopenia | 3,107 | 3.73.6–3.9 | signal |
| Neutropenia / agranulocytosis | 2,522 | 2.72.6–2.8 | signal |
| Anaemia | 3,011 | 2.62.5–2.7 | signal |
| Serious infection | 7,015 | 2.42.3–2.4 | signal |
| Heart failure | 1,343 | 2.01.9–2.1 | raised |
| Fall / fracture | 2,808 | 1.91.9–2.0 | raised |
| Opportunistic infection | 936 | 1.81.7–1.9 | raised |
| Hyponatraemia | 463 | 1.51.4–1.6 | raised |
| Interstitial lung disease | 527 | 1.41.3–1.6 | raised |
| Stroke | 1,362 | 1.41.4–1.5 | raised |
| Gi bleeding | 922 | 1.31.2–1.4 | raised |
| Malignancy | 1,817 | 1.31.2–1.3 | raised |
| Myocardial infarction | 764 | 1.00.9–1.0 | no difference |
| Venous thromboembolism | 748 | 0.90.8–1.0 | lower than other drugs |
| Kidney injury | 1,563 | 0.90.9–0.9 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Ibrutinib as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (11 of 40 signal terms matched).
- NCT01855750 — A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclo (N=838, PHASE3; 283 AE terms posted; arms: Treatment Arm B: Ibrutinib+R-CHOP; Treatment Arm A: Placebo+R-CHOP)
- NCT03734016 — A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocyt (N=652, PHASE3; 400 AE terms posted; arms: Zanubrutinib; Ibrutinib)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 | 8,579 | 2.6 2.6–2.7ROR 2.8 · calibrated p 0.691 | 2.6 EB05 2.6 · IC025 +1.3 3/3 methods agree vs other Kinase Inhibitors: PRR 12.8 (12.6–13.1) | Outcome field, not a reaction | age-adj. PRR 2.0 · serious PRR 1.9 | NCT01855750: 2/416 (0.5%) on Ibrutinib; 2/418 (0.5%) control (serious AE) |
| Off label use (used outside approved label) | 6,002 | 1.8 1.8–1.9ROR 1.9 · calibrated p 0.875 | 1.8 EB05 1.8 · IC025 +0.8 vs other Kinase Inhibitors: PRR 12.9 (12.6–13.2) | Reporting / coding artifact | age-adj. PRR 2.3 · serious PRR 1.8 | not reported in cached trials |
| Fatigue (tiredness) | 4,752 | 1.6 1.6–1.6ROR 1.6 · calibrated p 0.731 | 1.6 EB05 1.6 · IC025 +0.6 vs other Kinase Inhibitors: PRR 7.7 (7.5–7.9) | Labeled adverse reaction exact term | age-adj. PRR 1.6 · serious PRR 1.5 · 75% consumer | NCT01855750: 5/416 (1.2%) on Ibrutinib; 1/418 (0.2%) control (serious AE) |
| Diarrhoea (diarrhea) | 4,191 | 1.7 1.7–1.8ROR 1.7 · calibrated p 0.797 | 1.7 EB05 1.7 · IC025 +0.7 vs other Kinase Inhibitors: PRR 8.7 (8.4–8.9) | Labeled adverse reaction exact term | age-adj. PRR 1.6 · serious PRR 1.6 | NCT01855750: 15/416 (3.6%) on Ibrutinib; 4/418 (1.0%) control (serious AE) |
| Atrial fibrillation | 3,894 | 10.8 10.5–11.2ROR 11.3 · calibrated p 0.021 ✓ | 10.4 EB05 10.1 · IC025 +3.3 3/3 methods agree vs other Kinase Inhibitors: PRR 139.2 (131.7–147.2) | Labeled adverse reaction exact term | age-adj. PRR 6.2 · serious PRR 7.1 | NCT01855750: 13/416 (3.1%) on Ibrutinib; 2/418 (0.5%) control (serious AE) |
| Pneumonia (lung infection) | 3,263 | 2.7 2.6–2.7ROR 2.7 · calibrated p 0.724 | 2.6 EB05 2.6 · IC025 +1.3 3/3 methods agree vs other Kinase Inhibitors: PRR 24.3 (23.3–25.2) | Labeled adverse reaction exact term | age-adj. PRR 2.3 · serious PRR 1.9 | NCT01855750: 1/416 (0.2%) on Ibrutinib (serious AE) |
| Contusion | 2,820 | 7.9 7.6–8.2ROR 8.1 · calibrated p 0.064 | 7.7 EB05 7.4 · IC025 +2.9 3/3 methods agree vs other Kinase Inhibitors: PRR 54.4 (51.8–57.1) | Labeled adverse reaction exact term | age-adj. PRR 7.5 · serious PRR 6.6 · 78% consumer | NCT03734016: 38/324 (11.7%) on Ibrutinib |
| Incorrect dose administered | 2,778 | 3.3 3.1–3.4ROR 3.3 · calibrated p 0.527 | 3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree vs other Kinase Inhibitors: PRR 135.4 (126.8–144.6) | Reporting / coding artifact | age-adj. PRR 4.6 · serious PRR 5.4 · 80% consumer | not reported in cached trials |
| Fall | 2,527 | 2.0 1.9–2.1ROR 2.0 · calibrated p 0.957 | 2.0 EB05 1.9 · IC025 +0.9 vs other Kinase Inhibitors: PRR 31.7 (30.3–33.2) | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.6 · 77% consumer | NCT03734016: 2/324 (0.6%) on Ibrutinib (serious AE) |
| Asthenia (weakness) | 2,358 | 1.6 1.6–1.7ROR 1.7 · calibrated p 0.745 | 1.6 EB05 1.6 · IC025 +0.6 vs other Kinase Inhibitors: PRR 10.7 (10.2–11.1) | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.4 · 73% consumer | NCT01855750: 2/416 (0.5%) on Ibrutinib; 1/418 (0.2%) control (serious AE) |
| Nausea | 2,317 | 0.8 0.7–0.8ROR 0.8 · calibrated p 0.161 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC vs other Kinase Inhibitors: PRR 6.2 (5.9–6.4) | Labeled adverse reaction exact term | age-adj. PRR 0.8 · serious PRR 0.8 · 70% consumer | NCT01855750: 6/416 (1.4%) on Ibrutinib; 3/418 (0.7%) control (serious AE) |
| Arthralgia (joint pain) | 2,209 | 1.4 1.3–1.5ROR 1.4 · calibrated p 0.579 | 1.4 EB05 1.3 · IC025 +0.4 vs other Kinase Inhibitors: PRR 16.2 (15.5–16.9) | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.3 · 71% consumer | NCT01855750: 1/416 (0.2%) on Ibrutinib (serious AE) |
| Rash | 2,147 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.510 | 1.3 EB05 1.2 · IC025 +0.3 vs other Kinase Inhibitors: PRR 11.5 (11.0–12.1) | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.2 | NCT01855750: 22/416 (5.3%) on Ibrutinib; 21/418 (5.0%) control |
| Haemorrhage | 2,015 | 5.1 4.9–5.3ROR 5.2 · calibrated p 0.212 | 5.0 EB05 4.8 · IC025 +2.3 3/3 methods agree vs other Kinase Inhibitors: PRR 62.6 (58.9–66.5) | Labeled adverse reaction exact term | age-adj. PRR 3.1 · serious PRR 4.1 | NCT01855750: 1/416 (0.2%) on Ibrutinib (serious AE) |
| Disease progression | 1,981 | 4.4 4.3–4.6ROR 4.5 · calibrated p 0.292 | 4.4 EB05 4.2 · IC025 +2.1 3/3 methods agree vs other Kinase Inhibitors: PRR 9.6 (9.2–10.1) | Reporting / coding artifact | age-adj. PRR 3.9 · serious PRR 3.4 | not reported in cached trials |
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.
- Haematotympanum — n=35, PRR 183.3
- Micrographic skin surgery — n=61, PRR 107.2
- Angina bullosa haemorrhagica — n=50, PRR 70.5
- Cerebral aspergillosis — n=107, PRR 55.0 (also seen in trial arm)
- Microsporidia infection — n=50, PRR 42.6
- Aspergillus infection — n=548, PRR 24.0 (also seen in trial arm)
- Increased tendency to bruise — n=709, PRR 21.7
- Nail growth abnormal — n=76, PRR 19.2
- Haemorrhagic diathesis — n=243, PRR 19.0
- Blood blister — n=211, PRR 18.8
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 Ibrutinib?
In FDA FAERS, the most frequently co-reported reaction terms for Ibrutinib are fatigue, diarrhoea, atrial fibrillation, pneumonia, contusion, fall. 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 Ibrutinib have an FDA boxed warning?
No. The FDA label retrieved for Ibrutinib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ibrutinib 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 0dfd0279-ff17-4ea9-89be-9803c71bab44, effective 20251021; matched on
openfda.generic_name.exact:"IBRUTINIB") - 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, 1,207 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 - ClinicalTrials.gov API v2 (query
IBRUTINIB, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.