ORELABRUTINIB: 131 Adverse Event Reports & Safety Profile
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131
Total FAERS Reports
29 (22.1%)
Deaths Reported
12
Hospitalizations
131
As Primary/Secondary Suspect
10
Life-Threatening
4
Disabilities
First Report: 20221023 · Latest Report: 20250819
What Are the Most Common ORELABRUTINIB Side Effects?
#1 Most Reported
Anaemia
54 reports (41.2%)
#2 Most Reported
Hypokalaemia
40 reports (30.5%)
#3 Most Reported
Pneumonia
35 reports (26.7%)
All ORELABRUTINIB Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Anaemia | 54 | 41.2% | 8 | 5 |
| Hypokalaemia | 40 | 30.5% | 2 | 0 |
| Pneumonia | 35 | 26.7% | 8 | 3 |
| Neutropenia | 30 | 22.9% | 3 | 0 |
| Thrombocytopenia | 26 | 19.9% | 5 | 0 |
| Disease progression | 14 | 10.7% | 3 | 0 |
| Covid-19 | 11 | 8.4% | 8 | 0 |
| Platelet count decreased | 11 | 8.4% | 4 | 7 |
| Drug ineffective | 10 | 7.6% | 6 | 0 |
| Myelosuppression | 10 | 7.6% | 1 | 3 |
| Product use in unapproved indication | 8 | 6.1% | 1 | 0 |
| White blood cell count decreased | 8 | 6.1% | 1 | 2 |
| Atrial fibrillation | 7 | 5.3% | 1 | 0 |
| Febrile neutropenia | 7 | 5.3% | 2 | 0 |
| Neutrophil count decreased | 7 | 5.3% | 1 | 2 |
| Rash | 7 | 5.3% | 2 | 0 |
| Drug-induced liver injury | 6 | 4.6% | 0 | 0 |
| Malignant neoplasm progression | 6 | 4.6% | 4 | 0 |
| Neoplasm progression | 6 | 4.6% | 4 | 0 |
| Off label use | 6 | 4.6% | 1 | 2 |
Who Reports ORELABRUTINIB Side Effects? Age & Gender Data
Gender: 63.8% female, 36.2% male. Average age: 66.0 years. Most reports from: CN. View detailed demographics →
Is ORELABRUTINIB Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2022 | 3 | 0 | 1 |
| 2023 | 2 | 0 | 0 |
| 2024 | 12 | 1 | 4 |
| 2025 | 5 | 3 | 3 |
What Is ORELABRUTINIB Used For?
| Indication | Reports |
|---|---|
| Diffuse large b-cell lymphoma | 66 |
| Central nervous system lymphoma | 31 |
| B-cell lymphoma | 9 |
| Chronic lymphocytic leukaemia | 7 |
| Mantle cell lymphoma | 7 |
| Non-hodgkin's lymphoma | 5 |
ORELABRUTINIB vs Alternatives: Which Is Safer?
ORELABRUTINIB vs ORENCIA
ORELABRUTINIB vs ORITAVANCIN
ORELABRUTINIB vs ORITAVANCIN DIPHOSPHATE
ORELABRUTINIB vs ORLISTAT
ORELABRUTINIB vs ORNIDAZOLE
ORELABRUTINIB vs ORPHENADRINE
ORELABRUTINIB vs OSELTAMIVIR
ORELABRUTINIB vs OSILODROSTAT
ORELABRUTINIB vs OSIMERTINIB
ORELABRUTINIB vs OSPEMIFENE
Official FDA Label for ORELABRUTINIB
Official prescribing information from the FDA-approved drug label.