Drug
Eteplirsen
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 | Poor Venous Access | 187 | 161.8 | 175.5 | signal |
| 2 | Intentional Dose Omission | 279 | 90.4 | 102.2 | signal |
| 3 | No Adverse Event | 550 | 27.3 | 35.1 | signal |
| 4 | Product Dose Omission Issue | 696 | 21.5 | 29.9 | signal |
| 5 | Device Issue | 182 | 18.3 | 19.8 | signal |
| 6 | Gastroenteritis Viral | 18 | 8.7 | 8.8 | signal |
| 7 | Insurance Issue | 14 | 8.3 | 8.3 | signal |
| 8 | Device Occlusion | 13 | 8.2 | 8.2 | signal |
| 9 | Pharyngitis Streptococcal | 10 | 8.1 | 8.1 | signal |
| 10 | Acute Respiratory Failure | 15 | 6.9 | 6.9 | signal |
| 11 | Femur Fracture | 24 | 6.8 | 6.8 | signal |
| 12 | Product Dose Omission | 41 | 5.4 | 5.5 | signal |
| 13 | Pneumothorax | 9 | 5.0 | 5.0 | signal |
| 14 | Illness | 55 | 4.8 | 4.9 | signal |
| 15 | Increased Appetite | 10 | 4.7 | 4.7 | signal |
| 16 | Lower Limb Fracture | 10 | 4.6 | 4.6 | signal |
| 17 | Device Related Infection | 8 | 4.5 | 4.6 | signal |
| 18 | Covid-19 | 87 | 4.3 | 4.4 | signal |
| 19 | Influenza | 52 | 4.1 | 4.1 | signal |
| 20 | Underdose | 33 | 4.0 | 4.0 | signal |
| 21 | Therapy Cessation | 23 | 3.9 | 4.0 | signal |
| 22 | Accidental Underdose | 5 | 3.0 | 3.0 | signal |
| 23 | Sars-cov-2 Test Positive | 4 | 2.6 | 2.6 | no signal |
| 24 | Product Preparation Error | 6 | 2.5 | 2.5 | signal |
| 25 | Sickle Cell Anaemia With Crisis | 4 | 2.2 | 2.2 | no signal |
| 26 | Device Dislocation | 9 | 1.8 | 1.8 | no signal |
| 27 | Device Leakage | 6 | 1.2 | 1.2 | no signal |