Drug
Risdiplam
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 | Motor Dysfunction | 33 | 16.8 | 16.9 | signal |
| 2 | Respiratory Tract Infection | 76 | 15.1 | 15.3 | signal |
| 3 | Spinal Disorder | 21 | 11.4 | 11.4 | signal |
| 4 | Atelectasis | 20 | 10.6 | 10.7 | signal |
| 5 | No Adverse Event | 347 | 10.1 | 10.9 | signal |
| 6 | Aspiration | 18 | 8.5 | 8.6 | signal |
| 7 | Respiratory Disorder | 49 | 8.4 | 8.5 | signal |
| 8 | Photosensitivity Reaction | 24 | 7.5 | 7.5 | signal |
| 9 | Pneumothorax | 22 | 7.1 | 7.2 | signal |
| 10 | Gastroenteritis | 19 | 6.7 | 6.7 | signal |
| 11 | Muscular Weakness | 145 | 6.6 | 6.8 | signal |
| 12 | Pneumonia Aspiration | 31 | 6.4 | 6.4 | signal |
| 13 | Bladder Disorder | 12 | 6.2 | 6.2 | signal |
| 14 | Nephrolithiasis | 47 | 5.3 | 5.3 | signal |
| 15 | Gastrointestinal Disorder | 90 | 5.2 | 5.3 | signal |
| 16 | Product Packaging Quantity Issue | 11 | 5.2 | 5.2 | signal |
| 17 | Salivary Hypersecretion | 10 | 5.1 | 5.2 | signal |
| 18 | Secretion Discharge | 12 | 5.0 | 5.0 | signal |
| 19 | Upper Respiratory Tract Infection | 44 | 4.9 | 4.9 | signal |
| 20 | Lower Limb Fracture | 18 | 4.8 | 4.9 | signal |
| 21 | Syringe Issue | 14 | 4.1 | 4.1 | signal |
| 22 | Product Storage Error | 65 | 3.9 | 3.9 | signal |
| 23 | Product Taste Abnormal | 10 | 3.8 | 3.8 | signal |
| 24 | Respiratory Failure | 54 | 3.8 | 3.8 | signal |
| 25 | Acute Hepatic Failure | 10 | 3.8 | 3.8 | signal |
| 26 | Viral Infection | 23 | 3.6 | 3.6 | signal |
| 27 | Pneumonia | 221 | 3.5 | 3.7 | signal |
| 28 | Ill-defined Disorder | 40 | 3.4 | 3.4 | signal |
| 29 | Respiratory Distress | 18 | 3.4 | 3.4 | signal |
| 30 | Muscle Twitching | 15 | 3.3 | 3.3 | signal |
| 31 | Femur Fracture | 20 | 3.3 | 3.3 | signal |
| 32 | Product Dispensing Error | 14 | 3.3 | 3.3 | signal |
| 33 | Influenza | 71 | 3.3 | 3.3 | signal |
| 34 | Sleep Apnoea Syndrome | 12 | 3.2 | 3.2 | signal |
| 35 | Covid-19 | 110 | 3.2 | 3.3 | signal |
| 36 | Thrombotic Microangiopathy | 6 | 3.2 | 3.2 | signal |
| 37 | Dysphagia | 57 | 3.1 | 3.1 | signal |
| 38 | Sars-cov-2 Test Positive | 8 | 3.1 | 3.1 | signal |
| 39 | Asthenia | 225 | 3.1 | 3.2 | signal |
| 40 | Brain Injury | 6 | 3.1 | 3.1 | signal |
| 41 | Gastritis | 15 | 2.9 | 2.9 | signal |
| 42 | Mouth Ulceration | 12 | 2.9 | 2.9 | signal |
| 43 | Joint Dislocation | 6 | 2.9 | 2.9 | signal |
| 44 | Ileus | 7 | 2.9 | 2.9 | signal |
| 45 | Blood Lactate Dehydrogenase Increased | 9 | 2.9 | 2.9 | signal |
| 46 | Product Complaint | 14 | 2.9 | 2.9 | signal |
| 47 | Oxygen Saturation Decreased | 31 | 2.9 | 2.9 | signal |
| 48 | Pharyngitis Streptococcal | 6 | 2.8 | 2.9 | signal |
| 49 | Status Epilepticus | 6 | 2.7 | 2.7 | signal |
| 50 | Ear Infection | 14 | 2.7 | 2.7 | signal |
| 51 | Cyanosis | 8 | 2.6 | 2.6 | signal |
| 52 | Ligament Sprain | 5 | 2.6 | 2.6 | no signal |
| 53 | Product Administration Error | 10 | 2.6 | 2.6 | signal |
| 54 | Poor Quality Product Administered | 5 | 2.5 | 2.5 | no signal |
| 55 | Gastric Disorder | 17 | 2.5 | 2.5 | signal |
| 56 | Paralysis | 7 | 2.5 | 2.5 | signal |
| 57 | Product Preparation Error | 10 | 2.5 | 2.5 | signal |
| 58 | Cold Sweat | 8 | 2.3 | 2.3 | signal |
| 59 | Cardio-respiratory Arrest | 19 | 2.3 | 2.3 | signal |
| 60 | Nasopharyngitis | 81 | 2.3 | 2.3 | signal |
| 61 | Rhinorrhoea | 28 | 2.2 | 2.2 | signal |
| 62 | Hypoglycaemia | 21 | 2.2 | 2.2 | signal |
| 63 | Post Procedural Haemorrhage | 5 | 2.2 | 2.2 | no signal |
| 64 | Epilepsy | 13 | 2.2 | 2.2 | signal |
| 65 | Proteinuria | 8 | 2.2 | 2.2 | signal |
| 66 | Fracture | 8 | 2.2 | 2.2 | no signal |
| 67 | Accident | 5 | 2.2 | 2.2 | no signal |
| 68 | Blood Urine Present | 8 | 2.2 | 2.2 | no signal |
| 69 | Lower Respiratory Tract Infection | 19 | 2.2 | 2.2 | signal |
| 70 | Spinal Operation | 5 | 2.1 | 2.1 | no signal |
| 71 | Intercepted Product Preparation Error | 5 | 2.1 | 2.1 | no signal |
| 72 | Inflammatory Bowel Disease | 4 | 2.1 | 2.1 | no signal |
| 73 | Dermatitis Allergic | 5 | 2.1 | 2.1 | no signal |
| 74 | Exposure Via Skin Contact | 9 | 2.0 | 2.0 | no signal |
| 75 | Ovarian Cyst | 4 | 2.0 | 2.0 | no signal |
| 76 | Illness | 39 | 2.0 | 2.0 | no signal |
| 77 | Dysmenorrhoea | 5 | 2.0 | 2.0 | no signal |
| 78 | Product Prescribing Error | 9 | 2.0 | 2.0 | no signal |
| 79 | Complication Associated With Device | 5 | 1.9 | 1.9 | no signal |
| 80 | Increased Appetite | 7 | 1.9 | 1.9 | no signal |
| 81 | Musculoskeletal Disorder | 7 | 1.9 | 1.9 | no signal |
| 82 | Myocarditis | 4 | 1.8 | 1.8 | no signal |
| 83 | Product Dose Omission In Error | 9 | 1.7 | 1.7 | no signal |
| 84 | Product Dose Omission Issue | 95 | 1.7 | 1.7 | no signal |
| 85 | Product Odour Abnormal | 3 | 1.5 | 1.5 | no signal |
| 86 | Menstruation Delayed | 3 | 1.5 | 1.5 | no signal |
| 87 | Expired Product Administered | 8 | 1.2 | 1.2 | no signal |
| 88 | Skin Irritation | 10 | 1.1 | 1.1 | no signal |
| 89 | Foetal Exposure During Pregnancy | 17 | 1.1 | 1.1 | no signal |
| 90 | Accidental Exposure To Product | 19 | 1.0 | 1.0 | no signal |
| 91 | Menstruation Irregular | 5 | 1.0 | 1.0 | no signal |
| 92 | Circumstance Or Information Capable Of Leading To Medication Error | 6 | 0.9 | 0.9 | no signal |
| 93 | Device Difficult To Use | 3 | 0.2 | 0.2 | no signal |