Drug
Cerliponase Alfa
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 | Device Related Infection | 30 | 77.6 | 82.3 | signal |
| 2 | Device Occlusion | 16 | 45.9 | 47.3 | signal |
| 3 | Myoclonus | 13 | 43.5 | 44.6 | signal |
| 4 | Dystonia | 15 | 30.7 | 31.6 | signal |
| 5 | Device Leakage | 28 | 26.4 | 27.8 | signal |
| 6 | Seizure | 75 | 26.1 | 30.2 | signal |
| 7 | Status Epilepticus | 7 | 24.7 | 25.0 | signal |
| 8 | Cyanosis | 7 | 17.7 | 17.9 | signal |
| 9 | Generalised Tonic-clonic Seizure | 7 | 17.1 | 17.3 | signal |
| 10 | Hypotonia | 4 | 15.9 | 16.0 | signal |
| 11 | Complication Associated With Device | 4 | 12.1 | 12.1 | signal |
| 12 | Needle Issue | 8 | 11.2 | 11.3 | signal |
| 13 | Device Dislocation | 8 | 7.3 | 7.4 | signal |
| 14 | Device Breakage | 6 | 6.1 | 6.1 | signal |
| 15 | Device Issue | 11 | 5.0 | 5.1 | signal |