Drug
Patisiran
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 | Intentional Dose Omission | 114 | 31.2 | 32.5 | signal |
| 2 | Infusion Related Reaction | 129 | 14.6 | 15.3 | signal |
| 3 | Hospice Care | 15 | 11.4 | 11.4 | signal |
| 4 | Poor Venous Access | 15 | 10.9 | 10.9 | signal |
| 5 | Product Preparation Error | 29 | 10.5 | 10.6 | signal |
| 6 | Cardiac Failure | 100 | 9.3 | 9.6 | signal |
| 7 | Therapy Change | 12 | 9.3 | 9.3 | signal |
| 8 | Carpal Tunnel Syndrome | 16 | 8.5 | 8.6 | signal |
| 9 | Therapy Interrupted | 76 | 8.2 | 8.4 | signal |
| 10 | Infusion Site Pain | 14 | 8.2 | 8.2 | signal |
| 11 | Insurance Issue | 16 | 8.0 | 8.1 | signal |
| 12 | Intercepted Product Preparation Error | 13 | 8.0 | 8.0 | signal |
| 13 | Hospitalisation | 132 | 6.5 | 6.7 | signal |
| 14 | Polyneuropathy | 10 | 6.3 | 6.3 | signal |
| 15 | Generalised Oedema | 10 | 6.1 | 6.1 | signal |
| 16 | Product Administration Error | 16 | 6.0 | 6.0 | signal |
| 17 | Fluid Overload | 11 | 5.6 | 5.6 | signal |
| 18 | Localised Infection | 18 | 5.6 | 5.6 | signal |
| 19 | Neuralgia | 18 | 5.5 | 5.6 | signal |
| 20 | Malnutrition | 8 | 5.4 | 5.4 | signal |
| 21 | Motor Dysfunction | 7 | 5.2 | 5.2 | signal |
| 22 | Weight Fluctuation | 7 | 5.0 | 5.0 | signal |
| 23 | Ischaemic Stroke | 12 | 5.0 | 5.0 | signal |
| 24 | Product Dose Omission | 44 | 5.0 | 5.0 | signal |
| 25 | Spinal Operation | 8 | 4.9 | 4.9 | signal |
| 26 | Sudden Death | 7 | 4.9 | 4.9 | signal |
| 27 | Fluid Retention | 33 | 4.8 | 4.9 | signal |
| 28 | Unevaluable Event | 48 | 4.7 | 4.8 | signal |
| 29 | Ill-defined Disorder | 38 | 4.7 | 4.7 | signal |
| 30 | Product Dose Omission Issue | 176 | 4.6 | 4.9 | signal |
| 31 | Blood Pressure Decreased | 40 | 4.5 | 4.6 | signal |
| 32 | Medication Error | 33 | 4.4 | 4.5 | signal |
| 33 | Orthostatic Hypotension | 10 | 4.3 | 4.3 | signal |
| 34 | Dysstasia | 16 | 4.1 | 4.1 | signal |
| 35 | Intraocular Pressure Increased | 7 | 4.1 | 4.1 | signal |
| 36 | Atrial Fibrillation | 51 | 3.9 | 4.0 | signal |
| 37 | Neuropathy Peripheral | 49 | 3.9 | 3.9 | signal |
| 38 | Peripheral Coldness | 7 | 3.8 | 3.8 | signal |
| 39 | Restless Legs Syndrome | 9 | 3.7 | 3.7 | signal |
| 40 | Dialysis | 7 | 3.7 | 3.7 | signal |
| 41 | Heart Rate Decreased | 17 | 3.6 | 3.6 | signal |
| 42 | Muscle Atrophy | 6 | 3.6 | 3.6 | signal |
| 43 | Inappropriate Schedule Of Product Administration | 84 | 3.5 | 3.6 | signal |
| 44 | Balance Disorder | 41 | 3.5 | 3.6 | signal |
| 45 | Incorrect Product Administration Duration | 9 | 3.3 | 3.3 | signal |
| 46 | Impaired Driving Ability | 5 | 3.3 | 3.3 | signal |
| 47 | Cardiac Disorder | 39 | 3.1 | 3.1 | signal |
| 48 | Injection Site Irritation | 5 | 2.9 | 3.0 | signal |
| 49 | Disease Progression | 45 | 2.8 | 2.9 | signal |
| 50 | Cholecystectomy | 4 | 2.6 | 2.6 | no signal |
| 51 | Leukaemia | 3 | 2.4 | 2.4 | no signal |
| 52 | Death | 269 | 2.3 | 2.5 | signal |
| 53 | Knee Operation | 3 | 2.3 | 2.3 | no signal |
| 54 | Blindness | 12 | 2.2 | 2.2 | signal |
| 55 | Cerebrovascular Accident | 50 | 2.2 | 2.2 | signal |
| 56 | No Adverse Event | 51 | 2.1 | 2.2 | signal |
| 57 | Product Availability Issue | 6 | 2.0 | 2.0 | no signal |
| 58 | Hand Deformity | 3 | 1.7 | 1.7 | no signal |
| 59 | Prostate Cancer | 7 | 0.6 | 0.6 | no signal |
| 60 | Renal Cancer | 3 | 0.5 | 0.5 | no signal |