Drug
Pralsetinib
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 | Product Prescribing Issue | 181 | 105.2 | 117.0 | signal |
| 2 | Pneumonitis | 44 | 19.1 | 19.6 | signal |
| 3 | Taste Disorder | 26 | 15.2 | 15.4 | signal |
| 4 | Face Oedema | 20 | 13.9 | 14.0 | signal |
| 5 | Hepatic Function Abnormal | 42 | 13.3 | 13.6 | signal |
| 6 | Myelosuppression | 38 | 13.1 | 13.4 | signal |
| 7 | Hypoaesthesia Oral | 16 | 12.5 | 12.6 | signal |
| 8 | Pneumocystis Jirovecii Pneumonia | 10 | 11.7 | 11.8 | signal |
| 9 | Mouth Ulceration | 21 | 11.7 | 11.8 | signal |
| 10 | Metastases To Central Nervous System | 12 | 11.0 | 11.1 | signal |
| 11 | Red Blood Cell Count Decreased | 26 | 10.7 | 10.8 | signal |
| 12 | Transaminases Increased | 19 | 10.0 | 10.1 | signal |
| 13 | Blood Test Abnormal | 12 | 10.0 | 10.1 | signal |
| 14 | Ageusia | 21 | 9.9 | 10.0 | signal |
| 15 | White Blood Cell Count Decreased | 85 | 9.2 | 9.6 | signal |
| 16 | Disease Progression | 91 | 9.1 | 9.5 | signal |
| 17 | Liver Injury | 16 | 7.8 | 7.8 | signal |
| 18 | Blood Creatine Phosphokinase Increased | 19 | 7.6 | 7.7 | signal |
| 19 | Interstitial Lung Disease | 31 | 7.5 | 7.6 | signal |
| 20 | Dry Mouth | 50 | 7.2 | 7.4 | signal |
| 21 | Eyelid Oedema | 7 | 7.0 | 7.0 | signal |
| 22 | Blood Pressure Increased | 90 | 6.9 | 7.2 | signal |
| 23 | Blood Count Abnormal | 9 | 6.9 | 6.9 | signal |
| 24 | Petechiae | 6 | 6.8 | 6.8 | signal |
| 25 | Platelet Count Increased | 7 | 6.3 | 6.3 | signal |
| 26 | Platelet Count Decreased | 56 | 6.2 | 6.3 | signal |
| 27 | Lymphopenia | 7 | 5.8 | 5.9 | signal |
| 28 | Neutrophil Count Decreased | 20 | 5.8 | 5.8 | signal |
| 29 | Metastases To Bone | 8 | 5.7 | 5.8 | signal |
| 30 | Immunodeficiency | 7 | 5.6 | 5.6 | signal |
| 31 | Head Discomfort | 8 | 5.3 | 5.3 | signal |
| 32 | Brain Neoplasm | 4 | 5.1 | 5.1 | signal |
| 33 | Drug Resistance | 10 | 4.6 | 4.6 | signal |
| 34 | Nephropathy Toxic | 4 | 4.2 | 4.2 | signal |
| 35 | Metastases To Liver | 6 | 4.0 | 4.0 | signal |
| 36 | Spinal Operation | 4 | 3.9 | 3.9 | signal |
| 37 | Tendon Rupture | 4 | 3.8 | 3.8 | signal |
| 38 | No Adverse Event | 52 | 3.4 | 3.5 | signal |
| 39 | Thyroid Cancer | 3 | 2.9 | 2.9 | no signal |
| 40 | Cytomegalovirus Infection | 4 | 2.8 | 2.8 | no signal |
| 41 | Hair Colour Changes | 3 | 2.8 | 2.8 | no signal |
| 42 | Tuberculosis | 3 | 2.7 | 2.7 | no signal |