Drug
Leniolisib
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 | Ear Infection | 26 | 24.6 | 25.3 | signal |
| 2 | Infection | 131 | 22.8 | 26.8 | signal |
| 3 | Sinusitis | 58 | 14.1 | 15.1 | signal |
| 4 | Insurance Issue | 8 | 13.5 | 13.6 | signal |
| 5 | Product Dose Omission Issue | 121 | 10.7 | 12.3 | signal |