Reported signals
abemaciclib
Registration status unknownDrugalgemeen
18,718
reports (FAERS)
52.3%
reported as serious
1,114
fatal reports (6.0%)
30
signals above threshold
2026-07
last updated
Signal ranking · ROR
What stands out in the reports.
On the labelNew signalUnknown & frequent
Symptom
0.1110100
ROR [95% CI]
Myelosuppression
17.8 [16.3–19.5]
Diarrhoea
13.9 [13.5–14.4]
Malignant neoplasm progression
12.2 [11.5–13.0]
Pneumonitis
10.2 [9.0–11.6]
Interstitial lung disease
8.4 [7.6–9.3]
Blood creatinine increased
7.1 [6.4–7.9]
White blood cell count decreased
7.0 [6.5–7.6]
Neutrophil count decreased
6.4 [5.6–7.3]
Therapy cessation
5.3 [4.7–6.1]
Neutropenia
5.1 [4.7–5.5]
Decreased appetite
Intended effect
4.4 [4.1–4.7]
Dehydration
4.4 [4.0–4.8]
Anaemia
3.9 [3.6–4.2]
Therapy interrupted
3.8 [3.3–4.3]
Fatigue
3.7 [3.5–3.8]
ROR = reporting odds ratio (log scale). A value above 1 means the symptom is reported more often for this product than for all other products combined. This measures how much it stands out in reports — not cause, not risk.
Interpretation
Summary not yet available — will be auto-generated.
Label versus report
On the label
No signals currently mapped to the label.
Newly reported
Myelosuppression
Diarrhoea
Malignant neoplasm progression
Pneumonitis
Interstitial lung disease
Blood creatinine increased
White blood cell count decreased
Neutrophil count decreased
Recall history · 0 on record
No recalls on record.
Compare within ALGEMEEN
Source & citation
HealthProves. abemaciclib — reported signals. Retrieved 2026-07-05. Source: openFDA (FAERS). healthproves.com/abemaciclib/
FAERS18,718 records
Retrieved2026-07-05
MethodROR / disproportionality