Drug
Belumosudil
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Inappropriate Schedule Of Product Administration | 440 | 16.4 | 18.9 | signal |
| 2 | Product Use In Unapproved Indication | 454 | 12.3 | 14.1 | signal |
| 3 | Decreased Activity | 17 | 10.5 | 10.5 | signal |
| 4 | Product Dose Omission In Error | 30 | 7.4 | 7.4 | signal |
| 5 | Dry Eye | 54 | 7.3 | 7.5 | signal |
| 6 | Hospitalisation | 145 | 6.3 | 6.5 | signal |
| 7 | Cytopenia | 11 | 6.1 | 6.1 | signal |
| 8 | Liver Function Test Increased | 19 | 5.9 | 5.9 | signal |
| 9 | Emotional Disorder | 26 | 5.5 | 5.6 | signal |
| 10 | Depressed Mood | 40 | 5.0 | 5.1 | signal |
| 11 | Bacterial Infection | 14 | 5.0 | 5.0 | signal |
| 12 | Full Blood Count Decreased | 15 | 4.9 | 4.9 | signal |
| 13 | Muscle Tightness | 12 | 4.9 | 4.9 | signal |
| 14 | Hospice Care | 7 | 4.7 | 4.7 | signal |
| 15 | Blood Bilirubin Increased | 19 | 4.6 | 4.6 | signal |
| 16 | Platelet Count Increased | 9 | 4.5 | 4.6 | signal |
| 17 | Hepatic Enzyme Increased | 45 | 4.4 | 4.4 | signal |
| 18 | Disease Progression | 77 | 4.3 | 4.4 | signal |
| 19 | Loss Of Personal Independence In Daily Activities | 31 | 4.3 | 4.3 | signal |
| 20 | Acute Myeloid Leukaemia | 10 | 4.2 | 4.2 | signal |
| 21 | Oesophagitis | 7 | 4.2 | 4.2 | signal |
| 22 | Musculoskeletal Discomfort | 11 | 4.2 | 4.2 | signal |
| 23 | Leukaemia | 6 | 4.2 | 4.2 | signal |
| 24 | Thrombotic Microangiopathy | 6 | 4.1 | 4.1 | signal |
| 25 | Immunodeficiency | 9 | 4.0 | 4.0 | signal |
| 26 | Hepatomegaly | 6 | 4.0 | 4.0 | signal |
| 27 | Pulmonary Mass | 9 | 4.0 | 4.0 | signal |
| 28 | Therapy Partial Responder | 9 | 3.9 | 3.9 | signal |
| 29 | Blood Sodium Decreased | 11 | 3.9 | 3.9 | signal |
| 30 | Skin Disorder | 19 | 3.8 | 3.8 | signal |
| 31 | Skin Laceration | 6 | 3.7 | 3.7 | signal |
| 32 | Product Dose Omission Issue | 158 | 3.7 | 3.8 | signal |
| 33 | Gastroenteritis Viral | 10 | 3.6 | 3.6 | signal |
| 34 | Pulmonary Thrombosis | 6 | 3.6 | 3.6 | signal |
| 35 | Brain Fog | 8 | 3.6 | 3.6 | signal |
| 36 | Influenza | 61 | 3.6 | 3.6 | signal |
| 37 | Skin Ulcer | 14 | 3.6 | 3.6 | signal |
| 38 | Viral Infection | 18 | 3.6 | 3.6 | signal |
| 39 | Cytomegalovirus Infection | 9 | 3.6 | 3.6 | signal |
| 40 | Eating Disorder | 11 | 3.4 | 3.4 | signal |
| 41 | Spinal Pain | 6 | 3.4 | 3.4 | signal |
| 42 | Basal Cell Carcinoma | 8 | 3.4 | 3.4 | signal |
| 43 | Blood Pressure Abnormal | 10 | 3.3 | 3.3 | signal |
| 44 | Emphysema | 5 | 3.3 | 3.3 | signal |
| 45 | Red Blood Cell Count Decreased | 14 | 3.2 | 3.2 | signal |
| 46 | Drug Ineffective For Unapproved Indication | 27 | 3.2 | 3.2 | signal |
| 47 | Transfusion | 5 | 3.1 | 3.1 | signal |
| 48 | Full Blood Count Abnormal | 5 | 3.1 | 3.1 | signal |
| 49 | Clostridium Difficile Infection | 10 | 3.0 | 3.0 | signal |
| 50 | Covid-19 | 81 | 3.0 | 3.1 | signal |
| 51 | Dental Caries | 5 | 3.0 | 3.0 | signal |
| 52 | Nerve Compression | 4 | 2.9 | 2.9 | no signal |
| 53 | Blood Test Abnormal | 6 | 2.8 | 2.8 | signal |
| 54 | Squamous Cell Carcinoma | 4 | 2.8 | 2.8 | no signal |
| 55 | Osteonecrosis | 14 | 2.8 | 2.8 | signal |
| 56 | Limb Discomfort | 13 | 2.8 | 2.8 | signal |
| 57 | Spinal Fracture | 8 | 2.6 | 2.6 | signal |
| 58 | Hip Arthroplasty | 6 | 2.6 | 2.6 | signal |
| 59 | Bone Pain | 23 | 2.6 | 2.6 | signal |
| 60 | Tooth Infection | 5 | 2.5 | 2.5 | no signal |
| 61 | Respiratory Tract Congestion | 6 | 2.5 | 2.5 | no signal |
| 62 | Skin Cancer | 8 | 2.4 | 2.4 | signal |
| 63 | Illness | 37 | 2.4 | 2.4 | signal |
| 64 | Eye Disorder | 12 | 2.4 | 2.4 | signal |
| 65 | Oral Discomfort | 5 | 2.4 | 2.4 | no signal |
| 66 | Nephropathy Toxic | 4 | 2.4 | 2.4 | no signal |
| 67 | Schizophrenia | 4 | 2.2 | 2.2 | no signal |
| 68 | Upper Limb Fracture | 6 | 2.0 | 2.0 | no signal |
| 69 | Malignant Melanoma | 4 | 2.0 | 2.0 | no signal |
| 70 | Product Prescribing Issue | 6 | 1.9 | 1.9 | no signal |
| 71 | Eye Discharge | 3 | 1.9 | 1.9 | no signal |
| 72 | Blood Glucose Fluctuation | 3 | 1.8 | 1.8 | no signal |
| 73 | Product Availability Issue | 5 | 1.5 | 1.5 | no signal |