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Drug

Opicapone

130 flagged reaction(s) · 4,290 total co-reports · max PRR 70.5
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