Drug
Opicapone
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 | Dyskinesia | 306 | 70.5 | 81.4 | signal |
| 2 | Muscle Rigidity | 78 | 60.9 | 63.1 | signal |
| 3 | Hypokinesia | 79 | 50.7 | 52.5 | signal |
| 4 | Hallucination, Visual | 95 | 42.2 | 44.0 | signal |
| 5 | Dystonia | 85 | 40.7 | 42.2 | signal |
| 6 | Delusion | 67 | 40.3 | 41.5 | signal |
| 7 | Hallucination | 314 | 39.0 | 45.1 | signal |
| 8 | Orthostatic Hypotension | 44 | 23.4 | 23.9 | signal |
| 9 | Therapeutic Response Shortened | 74 | 21.6 | 22.3 | signal |
| 10 | Joint Dislocation | 22 | 19.4 | 19.6 | signal |
| 11 | Infusion Site Pain | 26 | 18.9 | 19.1 | signal |
| 12 | Delirium | 64 | 17.2 | 17.7 | signal |
| 13 | Device Occlusion | 25 | 16.7 | 16.9 | signal |
| 14 | Anosmia | 25 | 16.0 | 16.2 | signal |
| 15 | Psychotic Disorder | 49 | 15.4 | 15.7 | signal |
| 16 | Dementia | 44 | 14.7 | 14.9 | signal |
| 17 | Movement Disorder | 47 | 13.5 | 13.8 | signal |
| 18 | Pneumonia Aspiration | 33 | 12.3 | 12.5 | signal |
| 19 | Hallucination, Auditory | 21 | 12.3 | 12.4 | signal |
| 20 | Mobility Decreased | 93 | 12.1 | 12.5 | signal |
| 21 | Upper Limb Fracture | 25 | 11.6 | 11.7 | signal |
| 22 | Motor Dysfunction | 12 | 11.0 | 11.1 | signal |
| 23 | Paranoia | 20 | 10.7 | 10.8 | signal |
| 24 | Gait Inability | 35 | 9.8 | 10.0 | signal |
| 25 | Aggression | 51 | 9.4 | 9.6 | signal |
| 26 | Speech Disorder | 52 | 9.2 | 9.4 | signal |
| 27 | Initial Insomnia | 10 | 9.1 | 9.1 | signal |
| 28 | Urinary Retention | 32 | 8.9 | 9.0 | signal |
| 29 | Drug Effect Less Than Expected | 13 | 8.6 | 8.6 | signal |
| 30 | Mania | 15 | 8.5 | 8.5 | signal |
| 31 | Dysphagia | 86 | 8.4 | 8.7 | signal |
| 32 | Dysarthria | 34 | 8.4 | 8.5 | signal |
| 33 | Poor Quality Sleep | 19 | 8.2 | 8.3 | signal |
| 34 | Balance Disorder | 76 | 8.1 | 8.4 | signal |
| 35 | Restlessness | 32 | 8.1 | 8.2 | signal |
| 36 | Hypophagia | 22 | 8.0 | 8.1 | signal |
| 37 | Tremor | 143 | 8.0 | 8.5 | signal |
| 38 | Cognitive Disorder | 40 | 8.0 | 8.1 | signal |
| 39 | Sputum Discoloured | 8 | 7.9 | 7.9 | signal |
| 40 | Skin Laceration | 9 | 7.7 | 7.8 | signal |
| 41 | Disorientation | 33 | 7.7 | 7.8 | signal |
| 42 | Aspiration | 9 | 7.7 | 7.7 | signal |
| 43 | Ligament Sprain | 8 | 7.5 | 7.5 | signal |
| 44 | Device Dislocation | 35 | 7.5 | 7.6 | signal |
| 45 | Salivary Hypersecretion | 8 | 7.4 | 7.5 | signal |
| 46 | Dry Throat | 8 | 7.3 | 7.3 | signal |
| 47 | Fall | 258 | 7.2 | 8.0 | signal |
| 48 | Treatment Noncompliance | 42 | 7.2 | 7.3 | signal |
| 49 | Device Use Issue | 13 | 7.0 | 7.0 | signal |
| 50 | Nocturia | 9 | 6.9 | 6.9 | signal |
| 51 | Confusional State | 120 | 6.9 | 7.2 | signal |
| 52 | Depressed Mood | 39 | 6.9 | 7.0 | signal |
| 53 | Unresponsive To Stimuli | 19 | 6.9 | 6.9 | signal |
| 54 | Dysphonia | 43 | 6.8 | 6.9 | signal |
| 55 | Agitation | 54 | 6.8 | 6.9 | signal |
| 56 | Sleep Disorder | 51 | 6.8 | 6.9 | signal |
| 57 | Parkinsonism | 7 | 6.7 | 6.7 | signal |
| 58 | Product Use Complaint | 11 | 6.6 | 6.6 | signal |
| 59 | Device Issue | 61 | 6.5 | 6.6 | signal |
| 60 | Therapeutic Product Effect Incomplete | 49 | 6.4 | 6.6 | signal |
| 61 | Nightmare | 24 | 6.4 | 6.5 | signal |
| 62 | Gait Disturbance | 131 | 6.3 | 6.7 | signal |
| 63 | Serotonin Syndrome | 13 | 6.3 | 6.3 | signal |
| 64 | Product Prescribing Error | 16 | 6.3 | 6.3 | signal |
| 65 | Neuroleptic Malignant Syndrome | 8 | 6.2 | 6.3 | signal |
| 66 | Polyneuropathy | 8 | 6.2 | 6.3 | signal |
| 67 | Blood Pressure Fluctuation | 16 | 6.2 | 6.2 | signal |
| 68 | Psychomotor Hyperactivity | 11 | 6.1 | 6.1 | signal |
| 69 | Therapeutic Product Effect Decreased | 29 | 6.1 | 6.1 | signal |
| 70 | Knee Operation | 6 | 5.7 | 5.7 | signal |
| 71 | Micturition Urgency | 7 | 5.7 | 5.7 | signal |
| 72 | Incorrect Route Of Product Administration | 10 | 5.5 | 5.5 | signal |
| 73 | Rib Fracture | 12 | 5.4 | 5.4 | signal |
| 74 | Euphoric Mood | 6 | 5.4 | 5.4 | signal |
| 75 | Fracture | 11 | 5.4 | 5.4 | signal |
| 76 | Oral Discomfort | 8 | 5.3 | 5.3 | signal |
| 77 | Unevaluable Event | 43 | 5.3 | 5.4 | signal |
| 78 | Contraindicated Product Administered | 17 | 5.2 | 5.3 | signal |
| 79 | Blood Pressure Abnormal | 11 | 5.2 | 5.2 | signal |
| 80 | Product Physical Issue | 11 | 5.1 | 5.1 | signal |
| 81 | Abnormal Dreams | 15 | 5.0 | 5.0 | signal |
| 82 | Personality Change | 5 | 5.0 | 5.0 | signal |
| 83 | Deformity | 5 | 4.9 | 5.0 | signal |
| 84 | Bedridden | 7 | 4.9 | 5.0 | signal |
| 85 | Abnormal Behaviour | 21 | 4.9 | 4.9 | signal |
| 86 | Embedded Device | 5 | 4.7 | 4.7 | signal |
| 87 | Urinary Incontinence | 15 | 4.7 | 4.7 | signal |
| 88 | Musculoskeletal Stiffness | 44 | 4.7 | 4.7 | signal |
| 89 | Restless Legs Syndrome | 9 | 4.6 | 4.6 | signal |
| 90 | Hypothermia | 5 | 4.6 | 4.6 | signal |
| 91 | Eyelid Ptosis | 5 | 4.6 | 4.6 | signal |
| 92 | Therapy Cessation | 25 | 4.5 | 4.6 | signal |
| 93 | Subdural Haematoma | 7 | 4.5 | 4.5 | signal |
| 94 | Nervousness | 25 | 4.4 | 4.5 | signal |
| 95 | Somnolence | 94 | 4.3 | 4.5 | signal |
| 96 | Nodule | 6 | 4.3 | 4.3 | signal |
| 97 | Depressed Level Of Consciousness | 18 | 4.2 | 4.3 | signal |
| 98 | Malignant Melanoma | 6 | 4.1 | 4.2 | signal |
| 99 | Unintentional Medical Device Removal | 5 | 4.0 | 4.0 | signal |
| 100 | Sedation | 11 | 3.9 | 3.9 | signal |
| 101 | Musculoskeletal Disorder | 8 | 3.9 | 3.9 | signal |
| 102 | Wrist Fracture | 5 | 3.9 | 3.9 | signal |
| 103 | Wrong Technique In Device Usage Process | 19 | 3.9 | 3.9 | signal |
| 104 | Therapy Change | 4 | 3.8 | 3.9 | signal |
| 105 | Apathy | 6 | 3.8 | 3.8 | signal |
| 106 | Choking | 8 | 3.8 | 3.8 | signal |
| 107 | Adverse Drug Reaction | 34 | 3.5 | 3.6 | signal |
| 108 | Sars-cov-2 Test Positive | 5 | 3.5 | 3.5 | signal |
| 109 | Akathisia | 5 | 3.4 | 3.4 | signal |
| 110 | Hip Fracture | 11 | 3.2 | 3.2 | signal |
| 111 | Madarosis | 4 | 3.2 | 3.2 | no signal |
| 112 | Device Breakage | 13 | 3.1 | 3.1 | signal |
| 113 | Device Leakage | 14 | 3.1 | 3.1 | signal |
| 114 | Spinal Operation | 4 | 3.1 | 3.1 | no signal |
| 115 | Tardive Dyskinesia | 9 | 2.9 | 2.9 | signal |
| 116 | Hospitalisation | 48 | 2.9 | 3.0 | signal |
| 117 | Incorrect Dose Administered By Device | 8 | 2.9 | 2.9 | signal |
| 118 | Suicide Attempt | 19 | 2.9 | 2.9 | signal |
| 119 | Device Delivery System Issue | 8 | 2.8 | 2.8 | signal |
| 120 | Femur Fracture | 9 | 2.7 | 2.7 | signal |
| 121 | Wrong Technique In Product Usage Process | 55 | 2.5 | 2.6 | signal |
| 122 | Underdose | 19 | 2.4 | 2.4 | signal |
| 123 | Device Difficult To Use | 17 | 2.4 | 2.4 | signal |
| 124 | Intentional Self-injury | 5 | 2.3 | 2.3 | no signal |
| 125 | Schizophrenia | 3 | 2.3 | 2.3 | no signal |
| 126 | Hand Deformity | 3 | 2.1 | 2.1 | no signal |
| 127 | Sopor | 3 | 2.1 | 2.1 | no signal |
| 128 | Device Defective | 3 | 1.7 | 1.7 | no signal |
| 129 | Device Use Error | 4 | 1.1 | 1.1 | no signal |
| 130 | Drug Dose Omission By Device | 4 | 0.5 | 0.5 | no signal |