Drug · FAERS side-effect profile with label screen
Abemaciclib side effects: what 5,327 FDA adverse event reports show
Drug class
No validated FDA label found
Who reports
5,327 reports · 97% serious · 561 with death outcome · 95% 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 4No label text to screen 34
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. 993 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 |
|---|---|---|---|---|---|---|
| Metastases to spinal cord | 12 | 69.4 38.7–124.4ROR 69.4 · χ² 695 / p 2e-153 | 59.3 EB05 36.1 · IC025 +3.2 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Pik3ca-activated mutation | 20 | 68.9 43.8–108.3ROR 69.0 · χ² 1,192 / p 1e-261 | 61.1 EB05 41.8 · IC025 +3.9 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Pseudocirrhosis | 20 | 68.4 43.5–107.6ROR 68.5 · χ² 1,185 / p 7e-260 | 60.7 EB05 41.5 · IC025 +3.9 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Hormone receptor positive her2 negative breast cancer | 18 | 64.1 39.9–103.2ROR 64.2 · χ² 995 / p 1e-218 | 57.0 EB05 38.2 · IC025 +3.7 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Mucosal toxicity | 11 | 44.4 24.3–81.1ROR 44.4 · χ² 406 / p 1e-90 | 39.9 EB05 23.8 · IC025 +2.9 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Tumour marker abnormal | 13 | 42.5 24.4–74.0ROR 42.6 · χ² 467 / p 6e-104 | 38.8 EB05 24.1 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Carbohydrate antigen 15-3 increased | 29 | 41.7 28.8–60.5ROR 41.8 · χ² 1,070 / p 7e-235 | 39.2 EB05 28.6 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Bone marrow infiltration | 12 | 33.8 19.0–60.1ROR 33.9 · χ² 339 / p 5e-76 | 31.3 EB05 19.0 · IC025 +2.9 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Metastases to breast | 10 | 33.2 17.7–62.4ROR 33.3 · χ² 273 / p 2e-61 | 30.5 EB05 17.6 · IC025 +2.6 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Metastases to pleura | 27 | 28.1 19.2–41.1ROR 28.1 · χ² 660 / p 7e-146 | 26.9 EB05 19.4 · IC025 +3.6 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Tumour marker increased | 98 | 21.9 18.0–26.8ROR 22.0 · χ² 1,897 / p <1e-300 | 21.4 EB05 18.1 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Motor neurone disease | 10 | 21.9 11.7–41.0ROR 21.9 · χ² 175 / p 2e-40 | 20.3 EB05 11.1 · IC025 +2.4 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Thirst decreased | 11 | 19.1 10.5–34.6ROR 19.1 · χ² 168 / p 1e-38 | 17.7 EB05 9.7 · IC025 +2.4 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Dysbiosis | 13 | 17.4 10.1–30.1ROR 17.4 · χ² 182 / p 1e-41 | 16.2 EB05 9.3 · IC025 +2.5 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Tumour flare | 11 | 17.3 9.5–31.3ROR 17.3 · χ² 150 / p 8e-35 | 15.8 EB05 8.4 · IC025 +2.3 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Myelosuppression | 530 | 16.7 15.3–18.2ROR 17.1 · χ² 7,690 / p <1e-300 | 16.4 EB05 15.3 · IC025 +3.9 3/3 methods agree | No label text to screen | – | NCT05288166: 1/460 (0.2%) on Abemaciclib (serious AE) |
| Radiation pneumonitis | 32 | 16.0 11.3–22.6ROR 16.0 · χ² 428 / p 2e-95 | 15.5 EB05 11.3 · IC025 +3.1 3/3 methods agree | No label text to screen | – | NCT03155997: 3/2,791 (0.1%) on Abemaciclib (serious AE) |
| Superficial vein thrombosis | 12 | 15.9 9.0–28.2ROR 16.0 · χ² 151 / p 5e-35 | 14.5 EB05 7.9 · IC025 +2.3 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Embolism venous | 44 | 15.5 11.5–20.9ROR 15.5 · χ² 574 / p 3e-127 | 15.1 EB05 11.6 · IC025 +3.2 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Lymphangiosis carcinomatosa | 15 | 15.4 9.2–25.6ROR 15.4 · χ² 185 / p 2e-42 | 14.3 EB05 8.5 · IC025 +2.5 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Decreased immune responsiveness | 133 | 14.5 12.3–17.3ROR 14.6 · χ² 1,642 / p <1e-300 | 14.3 EB05 12.4 · IC025 +3.5 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Gastric ph decreased | 14 | 14.5 8.6–24.6ROR 14.5 · χ² 161 / p 4e-37 | 13.3 EB05 7.6 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Gastrointestinal toxicity | 64 | 14.5 11.4–18.6ROR 14.6 · χ² 782 / p 2e-172 | 14.2 EB05 11.5 · IC025 +3.3 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Seroma | 17 | 14.3 8.8–23.0ROR 14.3 · χ² 194 / p 2e-44 | 13.3 EB05 8.2 · IC025 +2.5 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 83 | 13.8 11.1–17.1ROR 13.8 · χ² 958 / p 1e-210 | 13.5 EB05 11.2 · IC025 +3.3 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Lung opacity | 33 | 13.7 9.7–19.3ROR 13.7 · χ² 371 / p 6e-83 | 13.2 EB05 9.6 · IC025 +2.9 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Choroidal effusion | 10 | 13.4 7.2–24.9ROR 13.4 · χ² 101 / p 5e-24 | 11.3 EB05 5.6 · IC025 +2.0 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Onychoclasis | 83 | 12.9 10.4–16.0ROR 12.9 · χ² 888 / p 2e-195 | 12.6 EB05 10.4 · IC025 +3.2 3/3 methods agree | No label text to screen | – | NCT03155997: 46/2,791 (1.6%) on Abemaciclib |
| Taste disorder | 239 | 12.7 11.2–14.4ROR 12.9 · χ² 2,542 / p <1e-300 | 12.5 EB05 11.3 · IC025 +3.4 3/3 methods agree | No label text to screen | – | NCT03155997: 36/2,791 (1.3%) on Abemaciclib |
| Radiation injury | 12 | 12.0 6.8–21.2ROR 12.0 · χ² 109 / p 7e-26 | 10.2 EB05 5.6 · IC025 +2.1 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Malignant neoplasm progression | 1,095 | 11.5 10.8–12.1ROR 12.1 · χ² 10,378 / p <1e-300 | 11.3 EB05 10.8 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | – | NCT05288166: 1/460 (0.2%) control (serious AE) |
| Cancer pain | 27 | 11.2 7.7–16.4ROR 11.2 · χ² 238 / p 5e-54 | 10.4 EB05 7.2 · IC025 +2.6 3/3 methods agree | No label text to screen | – | NCT05288166: 1/460 (0.2%) control (serious AE) |
| Lymphoedema | 71 | 11.0 8.7–13.8ROR 11.0 · χ² 626 / p 2e-138 | 10.6 EB05 8.6 · IC025 +3.0 3/3 methods agree | No label text to screen | – | NCT03155997: 5/2,791 (0.2%) on Abemaciclib (serious AE) |
| Onychalgia | 10 | 10.6 5.7–19.8ROR 10.6 · χ² 77 / p 8e-19 | 8.4 EB05 4.5 · IC025 +1.8 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Vulvovaginal dryness | 31 | 10.3 7.2–14.6ROR 10.3 · χ² 248 / p 4e-56 | 9.5 EB05 6.8 · IC025 +2.6 3/3 methods agree | No label text to screen | – | NCT03155997: 78/2,770 (2.8%) on Abemaciclib |
| Diarrhoea (diarrhea) | 6,094 | 10.1 9.9–10.3ROR 14.1 · χ² 50,954 / p <1e-300 | 10.0 EB05 9.8 · IC025 +3.3 3/3 methods agree | No label text to screen | – | NCT03155997: 15/2,791 (0.5%) on Abemaciclib (serious AE) |
| Metastases to bone | 153 | 10.0 8.5–11.7ROR 10.0 · χ² 1,213 / p 5e-266 | 9.7 EB05 8.5 · IC025 +3.0 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Pneumonitis | 249 | 9.8 8.7–11.1ROR 9.9 · χ² 1,943 / p <1e-300 | 9.6 EB05 8.7 · IC025 +3.0 3/3 methods agree | No label text to screen | – | NCT03155997: 3/2,791 (0.1%) on Abemaciclib (serious AE) |
| Therapy change | 85 | 9.4 7.6–11.6ROR 9.4 · χ² 622 / p 1e-137 | 9.1 EB05 7.5 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | – | not reported in cached trials |
| Hepatotoxicity (liver damage) | 192 | 9.2 8.0–10.6ROR 9.3 · χ² 1,387 / p <1e-300 | 9.0 EB05 8.0 · IC025 +2.9 3/3 methods agree | No label text to screen | – | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Abemaciclib 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 (10 of 40 signal terms matched).
- NCT03155997 — Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer (N=5637, PHASE3; 424 AE terms posted; arms: 150 mg Abemaciclib + Endocrine Therapy; Endocrine Therapy)
- NCT05288166 — A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts (N=925, PHASE3; 202 AE terms posted; arms: Abemaciclib; Placebo)
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 |
|---|---|---|---|---|---|---|
| Diarrhoea (diarrhea) | 6,094 | 10.1 9.9–10.3ROR 14.1 · χ² 50,954 / p <1e-300 | 10.0 EB05 9.8 · IC025 +3.3 3/3 methods agree | No label text to screen | – | NCT03155997: 15/2,791 (0.5%) on Abemaciclib (serious AE) |
| Fatigue (tiredness) | 2,551 | 3.5 3.3–3.6ROR 3.8 · χ² 4,649 / p <1e-300 | 3.5 EB05 3.4 · IC025 +1.7 3/3 methods agree | No label text to screen | – | NCT03155997: 2/2,791 (0.1%) on Abemaciclib (serious AE) |
| Nausea | 2,124 | 2.8 2.7–3.0ROR 3.1 · χ² 2,634 / p <1e-300 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree | No label text to screen | – | NCT03155997: 3/2,791 (0.1%) on Abemaciclib (serious AE) |
| Vomiting | 1,119 | 2.5 2.4–2.7ROR 2.6 · χ² 1,048 / p 4e-230 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | No label text to screen | – | NCT03155997: 3/2,791 (0.1%) on Abemaciclib (serious AE) |
| Malignant neoplasm progression | 1,095 | 11.5 10.8–12.1ROR 12.1 · χ² 10,378 / p <1e-300 | 11.3 EB05 10.8 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | – | NCT05288166: 1/460 (0.2%) control (serious AE) |
| Decreased appetite (loss of appetite) | 952 | 4.4 4.1–4.6ROR 4.5 · χ² 2,471 / p <1e-300 | 4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree | No label text to screen | – | NCT03155997: 312/2,791 (11.2%) on Abemaciclib |
| Asthenia (weakness) | 863 | 2.4 2.3–2.6ROR 2.5 · χ² 733 / p 1e-161 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Death | 784 | 1.0 0.9–1.0ROR 1.0 · χ² 1 / p 0.129 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | – | NCT03155997: 1/2,800 (0.0%) on Abemaciclib (serious AE) |
| Drug ineffective (drug did not work) | 734 | 0.6 0.5–0.6ROR 0.6 · χ² 225 / p 3e-51 | 0.6 EB05 0.6 · IC025 -0.9 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | – | not reported in cached trials |
| White blood cell count decreased | 712 | 7.0 6.5–7.5ROR 7.2 · χ² 3,625 / p <1e-300 | 6.9 EB05 6.5 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Constipation | 697 | 3.4 3.2–3.7ROR 3.5 · χ² 1,191 / p 3e-261 | 3.4 EB05 3.2 · IC025 +1.6 3/3 methods agree | No label text to screen | – | NCT03155997: 288/2,791 (10.3%) on Abemaciclib |
| Anaemia (low red blood cells) | 692 | 3.8 3.6–4.1ROR 3.9 · χ² 1,457 / p <1e-300 | 3.8 EB05 3.6 · IC025 +1.8 3/3 methods agree | No label text to screen | – | NCT03155997: 8/2,791 (0.3%) on Abemaciclib (serious AE) |
| Abdominal pain upper | 676 | 3.5 3.2–3.7ROR 3.6 · χ² 1,201 / p 2e-263 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree | No label text to screen | – | NCT03155997: 6/2,791 (0.2%) on Abemaciclib (serious AE) |
| Neutropenia (low neutrophils (infection-fighting cells)) | 635 | 5.0 4.6–5.4ROR 5.1 · χ² 2,010 / p <1e-300 | 4.9 EB05 4.6 · IC025 +2.2 3/3 methods agree | No label text to screen | – | NCT03155997: 4/2,791 (0.1%) on Abemaciclib (serious AE) |
| Off label use (used outside approved label) | 594 | 0.7 0.7–0.8ROR 0.7 · χ² 66 / p 2e-16 | 0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | – | not reported in cached trials |
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 Abemaciclib?
In FDA FAERS, the most frequently co-reported reaction terms for Abemaciclib are diarrhoea, fatigue, nausea, vomiting, decreased appetite, asthenia. 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 Abemaciclib 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 Abemaciclib 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, fieldpatient.drug.openfda.generic_name.exact, 1,033 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
ABEMACICLIB, results-bearing studies sorted by enrollment)
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.