Drug
Entacapone
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 | Muscle Rigidity | 152 | 65.0 | 67.5 | signal |
| 2 | Dyskinesia | 481 | 60.6 | 68.4 | signal |
| 3 | Hallucination, Visual | 192 | 46.6 | 48.8 | signal |
| 4 | Delusion | 110 | 36.1 | 37.1 | signal |
| 5 | Hallucination | 496 | 33.6 | 38.0 | signal |
| 6 | Dystonia | 123 | 32.1 | 33.0 | signal |
| 7 | Orthostatic Hypotension | 87 | 25.3 | 25.8 | signal |
| 8 | Nocturia | 58 | 24.3 | 24.6 | signal |
| 9 | Device Occlusion | 60 | 21.9 | 22.2 | signal |
| 10 | Neuroleptic Malignant Syndrome | 49 | 20.9 | 21.1 | signal |
| 11 | Therapeutic Response Shortened | 116 | 18.5 | 19.0 | signal |
| 12 | Psychotic Disorder | 97 | 16.6 | 17.0 | signal |
| 13 | Paranoia | 52 | 15.2 | 15.4 | signal |
| 14 | Abnormal Dreams | 71 | 12.9 | 13.1 | signal |
| 15 | Dementia | 71 | 12.9 | 13.1 | signal |
| 16 | Initial Insomnia | 26 | 12.9 | 13.0 | signal |
| 17 | Motor Dysfunction | 25 | 12.5 | 12.6 | signal |
| 18 | Joint Dislocation | 26 | 12.5 | 12.6 | signal |
| 19 | Hypokinesia | 35 | 12.2 | 12.3 | signal |
| 20 | Parkinsonism | 23 | 11.9 | 12.0 | signal |
| 21 | Device Use Issue | 40 | 11.7 | 11.8 | signal |
| 22 | Cognitive Disorder | 105 | 11.4 | 11.7 | signal |
| 23 | Poor Quality Sleep | 48 | 11.3 | 11.5 | signal |
| 24 | Hospice Care | 22 | 11.3 | 11.4 | signal |
| 25 | Delirium | 74 | 10.8 | 11.0 | signal |
| 26 | Mania | 35 | 10.8 | 10.9 | signal |
| 27 | Psychomotor Hyperactivity | 34 | 10.3 | 10.4 | signal |
| 28 | Salivary Hypersecretion | 20 | 10.1 | 10.2 | signal |
| 29 | Device Dislocation | 86 | 10.0 | 10.2 | signal |
| 30 | Aggression | 96 | 9.7 | 9.9 | signal |
| 31 | Restlessness | 68 | 9.4 | 9.5 | signal |
| 32 | Abnormal Behaviour | 73 | 9.3 | 9.4 | signal |
| 33 | Balance Disorder | 157 | 9.2 | 9.5 | signal |
| 34 | Agitation | 132 | 9.1 | 9.3 | signal |
| 35 | Gait Inability | 58 | 8.9 | 9.0 | signal |
| 36 | Choking | 34 | 8.9 | 8.9 | signal |
| 37 | Mobility Decreased | 124 | 8.8 | 9.0 | signal |
| 38 | Speech Disorder | 89 | 8.6 | 8.8 | signal |
| 39 | Confusional State | 270 | 8.4 | 8.9 | signal |
| 40 | Hip Fracture | 52 | 8.2 | 8.3 | signal |
| 41 | Loss Of Personal Independence In Daily Activities | 77 | 8.2 | 8.3 | signal |
| 42 | Middle Insomnia | 30 | 8.2 | 8.2 | signal |
| 43 | Tremor | 265 | 8.1 | 8.5 | signal |
| 44 | Device Issue | 139 | 8.1 | 8.3 | signal |
| 45 | Sputum Discoloured | 15 | 8.0 | 8.0 | signal |
| 46 | Serotonin Syndrome | 30 | 7.9 | 8.0 | signal |
| 47 | Quality Of Life Decreased | 21 | 7.9 | 7.9 | signal |
| 48 | Urinary Retention | 51 | 7.7 | 7.8 | signal |
| 49 | Hypophagia | 38 | 7.6 | 7.6 | signal |
| 50 | Therapeutic Product Effect Incomplete | 104 | 7.4 | 7.6 | signal |
| 51 | Nightmare | 51 | 7.4 | 7.5 | signal |
| 52 | Fall | 475 | 7.2 | 8.0 | signal |
| 53 | Restless Legs Syndrome | 26 | 7.2 | 7.3 | signal |
| 54 | Gait Disturbance | 268 | 7.1 | 7.5 | signal |
| 55 | Pneumonia Aspiration | 34 | 6.9 | 6.9 | signal |
| 56 | Musculoskeletal Stiffness | 119 | 6.9 | 7.0 | signal |
| 57 | Movement Disorder | 43 | 6.7 | 6.8 | signal |
| 58 | Ileus | 16 | 6.6 | 6.6 | signal |
| 59 | Upper Limb Fracture | 26 | 6.6 | 6.6 | signal |
| 60 | Head Injury | 40 | 6.4 | 6.5 | signal |
| 61 | Hypersomnia | 36 | 6.4 | 6.4 | signal |
| 62 | Depressed Level Of Consciousness | 49 | 6.3 | 6.3 | signal |
| 63 | Incontinence | 13 | 6.2 | 6.2 | signal |
| 64 | Eating Disorder | 26 | 6.1 | 6.2 | signal |
| 65 | Prescribed Underdose | 24 | 6.1 | 6.1 | signal |
| 66 | Micturition Urgency | 13 | 5.8 | 5.8 | signal |
| 67 | Depressed Mood | 59 | 5.7 | 5.7 | signal |
| 68 | Sleep Disorder | 76 | 5.5 | 5.6 | signal |
| 69 | Pancreatitis Acute | 24 | 5.4 | 5.5 | signal |
| 70 | Bedridden | 14 | 5.4 | 5.4 | signal |
| 71 | Dysstasia | 31 | 5.3 | 5.4 | signal |
| 72 | Sensory Disturbance | 17 | 5.3 | 5.3 | signal |
| 73 | Unevaluable Event | 78 | 5.2 | 5.3 | signal |
| 74 | Aphasia | 31 | 5.2 | 5.2 | signal |
| 75 | Polyneuropathy | 12 | 5.1 | 5.1 | signal |
| 76 | Somnolence | 201 | 5.1 | 5.3 | signal |
| 77 | Dysphagia | 93 | 5.0 | 5.1 | signal |
| 78 | Inappropriate Antidiuretic Hormone Secretion | 10 | 5.0 | 5.0 | signal |
| 79 | Euphoric Mood | 10 | 4.9 | 4.9 | signal |
| 80 | Disturbance In Attention | 52 | 4.9 | 4.9 | signal |
| 81 | Disorientation | 38 | 4.8 | 4.9 | signal |
| 82 | Hallucination, Auditory | 15 | 4.8 | 4.8 | signal |
| 83 | Memory Impairment | 129 | 4.7 | 4.9 | signal |
| 84 | Mydriasis | 12 | 4.7 | 4.7 | signal |
| 85 | Skin Laceration | 10 | 4.7 | 4.7 | signal |
| 86 | Embedded Device | 9 | 4.6 | 4.6 | signal |
| 87 | Foot Deformity | 10 | 4.6 | 4.6 | signal |
| 88 | Constipation | 193 | 4.5 | 4.7 | signal |
| 89 | Fear | 24 | 4.5 | 4.5 | signal |
| 90 | Mood Altered | 24 | 4.5 | 4.5 | signal |
| 91 | Rib Fracture | 18 | 4.4 | 4.4 | signal |
| 92 | Cystitis | 28 | 4.4 | 4.4 | signal |
| 93 | Personality Change | 8 | 4.3 | 4.3 | signal |
| 94 | Blood Creatine Phosphokinase Increased | 25 | 4.3 | 4.3 | signal |
| 95 | Irritability | 51 | 4.3 | 4.3 | signal |
| 96 | Urinary Tract Infection | 143 | 4.2 | 4.4 | signal |
| 97 | Posterior Reversible Encephalopathy Syndrome | 8 | 4.2 | 4.3 | signal |
| 98 | Limb Discomfort | 26 | 4.2 | 4.3 | signal |
| 99 | Dizziness Postural | 8 | 4.2 | 4.2 | signal |
| 100 | Shock | 19 | 4.2 | 4.2 | signal |
| 101 | Apathy | 12 | 4.2 | 4.2 | signal |
| 102 | Dysarthria | 31 | 4.2 | 4.2 | signal |
| 103 | Device Difficult To Use | 54 | 4.1 | 4.2 | signal |
| 104 | Encephalopathy | 20 | 4.1 | 4.1 | signal |
| 105 | Device Breakage | 32 | 4.1 | 4.1 | signal |
| 106 | Malnutrition | 9 | 4.1 | 4.1 | signal |
| 107 | Mitral Valve Incompetence | 9 | 4.0 | 4.0 | signal |
| 108 | Oral Discomfort | 11 | 4.0 | 4.0 | signal |
| 109 | Mental Disorder | 34 | 3.9 | 4.0 | signal |
| 110 | General Physical Health Deterioration | 89 | 3.9 | 4.0 | signal |
| 111 | Emotional Disorder | 24 | 3.9 | 3.9 | signal |
| 112 | Incorrect Route Of Product Administration | 13 | 3.9 | 3.9 | signal |
| 113 | Therapeutic Product Effect Decreased | 34 | 3.9 | 3.9 | signal |
| 114 | Urosepsis | 7 | 3.8 | 3.8 | signal |
| 115 | Chromaturia | 17 | 3.8 | 3.8 | signal |
| 116 | Product Administration Error | 15 | 3.8 | 3.8 | signal |
| 117 | Sudden Death | 8 | 3.8 | 3.8 | signal |
| 118 | Unresponsive To Stimuli | 19 | 3.7 | 3.7 | signal |
| 119 | Transient Ischaemic Attack | 25 | 3.7 | 3.7 | signal |
| 120 | Product Prescribing Issue | 15 | 3.7 | 3.7 | signal |
| 121 | Generalised Tonic-clonic Seizure | 12 | 3.7 | 3.7 | signal |
| 122 | Musculoskeletal Disorder | 14 | 3.7 | 3.7 | signal |
| 123 | Mental Status Changes | 20 | 3.6 | 3.6 | signal |
| 124 | Hyponatraemia | 40 | 3.6 | 3.6 | signal |
| 125 | Urinary Incontinence | 21 | 3.6 | 3.6 | signal |
| 126 | Brain Injury | 7 | 3.5 | 3.5 | signal |
| 127 | Skin Haemorrhage | 10 | 3.5 | 3.5 | signal |
| 128 | Device Leakage | 29 | 3.5 | 3.5 | signal |
| 129 | Dysphonia | 40 | 3.5 | 3.5 | signal |
| 130 | Stress | 49 | 3.4 | 3.5 | signal |
| 131 | Wrong Technique In Device Usage Process | 31 | 3.4 | 3.4 | signal |
| 132 | Drug Effect Decreased | 37 | 3.4 | 3.4 | signal |
| 133 | Ventricular Extrasystoles | 7 | 3.4 | 3.4 | signal |
| 134 | Weight Fluctuation | 7 | 3.4 | 3.4 | signal |
| 135 | Prescribed Overdose | 13 | 3.4 | 3.4 | signal |
| 136 | Drug Effect Less Than Expected | 9 | 3.2 | 3.2 | signal |
| 137 | Extrapyramidal Disorder | 16 | 3.2 | 3.2 | signal |
| 138 | Infusion Site Pain | 8 | 3.2 | 3.2 | signal |
| 139 | Paralysis | 9 | 3.2 | 3.2 | signal |
| 140 | Rotator Cuff Syndrome | 8 | 3.1 | 3.1 | signal |
| 141 | Dry Throat | 6 | 3.0 | 3.0 | signal |
| 142 | Insomnia | 157 | 3.0 | 3.0 | signal |
| 143 | Myoclonus | 7 | 3.0 | 3.0 | signal |
| 144 | Drug Interaction | 92 | 2.9 | 3.0 | signal |
| 145 | Mental Impairment | 14 | 2.9 | 2.9 | signal |
| 146 | Muscular Weakness | 65 | 2.9 | 2.9 | signal |
| 147 | Treatment Noncompliance | 31 | 2.9 | 2.9 | signal |
| 148 | Contraindicated Product Administered | 17 | 2.8 | 2.9 | signal |
| 149 | Subdural Haematoma | 8 | 2.8 | 2.8 | signal |
| 150 | Muscle Tightness | 9 | 2.8 | 2.8 | signal |
| 151 | Impaired Quality Of Life | 8 | 2.8 | 2.8 | signal |
| 152 | Blood Pressure Abnormal | 11 | 2.8 | 2.8 | signal |
| 153 | Body Height Decreased | 6 | 2.8 | 2.8 | signal |
| 154 | Product Physical Issue | 11 | 2.8 | 2.8 | signal |
| 155 | Incorrect Dose Administered By Device | 14 | 2.8 | 2.8 | signal |
| 156 | Product Prescribing Error | 13 | 2.8 | 2.8 | signal |
| 157 | Impaired Gastric Emptying | 7 | 2.8 | 2.8 | signal |
| 158 | Panic Attack | 20 | 2.8 | 2.8 | signal |
| 159 | Adverse Drug Reaction | 49 | 2.8 | 2.8 | signal |
| 160 | Gastrointestinal Pain | 6 | 2.8 | 2.8 | signal |
| 161 | Diplopia | 14 | 2.7 | 2.7 | signal |
| 162 | Anxiety | 153 | 2.7 | 2.8 | signal |
| 163 | Thinking Abnormal | 10 | 2.7 | 2.7 | signal |
| 164 | Underdose | 39 | 2.7 | 2.7 | signal |
| 165 | Dry Mouth | 43 | 2.7 | 2.7 | signal |
| 166 | Foot Fracture | 10 | 2.7 | 2.7 | signal |
| 167 | Gastric Ulcer | 10 | 2.7 | 2.7 | signal |
| 168 | Sars-cov-2 Test Positive | 7 | 2.6 | 2.6 | signal |
| 169 | Muscle Twitching | 12 | 2.6 | 2.6 | signal |
| 170 | Throat Irritation | 23 | 2.6 | 2.6 | signal |
| 171 | Product Dose Omission | 34 | 2.6 | 2.6 | signal |
| 172 | Unintentional Medical Device Removal | 6 | 2.6 | 2.6 | signal |
| 173 | Hyperhidrosis | 66 | 2.6 | 2.6 | signal |
| 174 | Head Discomfort | 9 | 2.6 | 2.6 | signal |
| 175 | Abscess | 8 | 2.5 | 2.5 | signal |
| 176 | Feeding Disorder | 10 | 2.5 | 2.5 | signal |
| 177 | Wrist Fracture | 6 | 2.5 | 2.5 | signal |
| 178 | Blood Pressure Fluctuation | 12 | 2.5 | 2.5 | signal |
| 179 | Carpal Tunnel Syndrome | 7 | 2.5 | 2.5 | signal |
| 180 | Spinal Operation | 6 | 2.5 | 2.5 | signal |
| 181 | Hypothermia | 5 | 2.5 | 2.5 | no signal |
| 182 | Sluggishness | 5 | 2.5 | 2.5 | no signal |
| 183 | Loss Of Consciousness | 62 | 2.4 | 2.5 | signal |
| 184 | Cough | 134 | 2.4 | 2.5 | signal |
| 185 | Altered State Of Consciousness | 10 | 2.3 | 2.3 | signal |
| 186 | Back Injury | 5 | 2.3 | 2.3 | no signal |
| 187 | Hip Arthroplasty | 7 | 2.3 | 2.3 | signal |
| 188 | Feeling Abnormal | 109 | 2.3 | 2.3 | signal |
| 189 | Therapeutic Response Unexpected | 20 | 2.2 | 2.2 | signal |
| 190 | Anger | 15 | 2.2 | 2.2 | signal |
| 191 | Gastric Haemorrhage | 5 | 2.2 | 2.2 | no signal |
| 192 | Coordination Abnormal | 6 | 2.2 | 2.2 | no signal |
| 193 | Increased Appetite | 8 | 2.1 | 2.2 | no signal |
| 194 | Fracture | 8 | 2.1 | 2.1 | no signal |
| 195 | Product Dose Omission Issue | 117 | 2.1 | 2.1 | signal |
| 196 | Neurotoxicity | 7 | 2.0 | 2.0 | no signal |
| 197 | Bladder Disorder | 4 | 2.0 | 2.0 | no signal |
| 198 | Death | 345 | 2.0 | 2.1 | signal |
| 199 | Expired Product Administered | 13 | 2.0 | 2.0 | no signal |
| 200 | Economic Problem | 6 | 2.0 | 2.0 | no signal |
| 201 | Product Use Complaint | 6 | 2.0 | 2.0 | no signal |
| 202 | Haematoma | 10 | 1.9 | 1.9 | no signal |
| 203 | Rhabdomyolysis | 16 | 1.9 | 1.9 | no signal |
| 204 | Coma | 18 | 1.9 | 1.9 | no signal |
| 205 | Product Packaging Quantity Issue | 4 | 1.9 | 1.9 | no signal |
| 206 | Injection Site Nodule | 4 | 1.8 | 1.8 | no signal |
| 207 | Ageusia | 9 | 1.8 | 1.8 | no signal |
| 208 | Stevens-johnson Syndrome | 8 | 1.8 | 1.8 | no signal |
| 209 | Cardiovascular Disorder | 9 | 1.8 | 1.8 | no signal |
| 210 | Impaired Driving Ability | 4 | 1.8 | 1.8 | no signal |
| 211 | Activities Of Daily Living Impaired | 7 | 1.8 | 1.8 | no signal |
| 212 | Sedation | 9 | 1.7 | 1.7 | no signal |
| 213 | Anosmia | 5 | 1.7 | 1.7 | no signal |
| 214 | Device Delivery System Issue | 9 | 1.7 | 1.7 | no signal |
| 215 | Accident | 4 | 1.7 | 1.7 | no signal |
| 216 | Therapy Cessation | 17 | 1.7 | 1.7 | no signal |
| 217 | Intentional Dose Omission | 9 | 1.7 | 1.7 | no signal |
| 218 | Femur Fracture | 10 | 1.6 | 1.6 | no signal |
| 219 | Hospitalisation | 48 | 1.6 | 1.6 | no signal |
| 220 | Laceration | 3 | 1.6 | 1.6 | no signal |
| 221 | Hernia | 6 | 1.6 | 1.6 | no signal |
| 222 | Knee Operation | 3 | 1.6 | 1.6 | no signal |
| 223 | Withdrawal Syndrome | 13 | 1.6 | 1.6 | no signal |
| 224 | Inability To Afford Medication | 3 | 1.5 | 1.5 | no signal |
| 225 | Malignant Melanoma | 4 | 1.5 | 1.5 | no signal |
| 226 | Product Dose Omission In Error | 8 | 1.5 | 1.5 | no signal |
| 227 | Breast Pain | 3 | 1.4 | 1.4 | no signal |
| 228 | Nephropathy Toxic | 3 | 1.4 | 1.4 | no signal |
| 229 | Drug Abuse | 22 | 1.3 | 1.3 | no signal |
| 230 | Suicidal Ideation | 24 | 1.3 | 1.3 | no signal |
| 231 | Incorrect Dose Administered | 58 | 1.3 | 1.3 | no signal |
| 232 | Tardive Dyskinesia | 7 | 1.2 | 1.2 | no signal |
| 233 | Suicide Attempt | 14 | 1.2 | 1.2 | no signal |
| 234 | Product Dispensing Error | 5 | 1.2 | 1.2 | no signal |
| 235 | Anorexia | 3 | 1.2 | 1.2 | no signal |
| 236 | Extra Dose Administered | 9 | 1.1 | 1.1 | no signal |
| 237 | Drug Administration Error | 7 | 1.1 | 1.1 | no signal |
| 238 | Drug Effect Incomplete | 8 | 1.1 | 1.1 | no signal |
| 239 | Drug Withdrawal Syndrome | 19 | 1.1 | 1.1 | no signal |
| 240 | Device Defective | 3 | 0.9 | 0.9 | no signal |
| 241 | Wrong Technique In Product Usage Process | 36 | 0.9 | 0.9 | no signal |
| 242 | Device Use Error | 6 | 0.9 | 0.9 | no signal |
| 243 | Drug Dose Omission | 29 | 0.9 | 0.9 | no signal |
| 244 | Intentional Self-injury | 3 | 0.8 | 0.8 | no signal |
| 245 | Drug Effective For Unapproved Indication | 4 | 0.7 | 0.7 | no signal |
| 246 | Device Malfunction | 9 | 0.7 | 0.7 | no signal |
| 247 | Intentional Overdose | 8 | 0.6 | 0.6 | no signal |
| 248 | Hepatic Cancer | 3 | 0.6 | 0.6 | no signal |
| 249 | Device Expulsion | 8 | 0.6 | 0.6 | no signal |
| 250 | Product Adhesion Issue | 4 | 0.6 | 0.6 | no signal |
| 251 | Injection Site Mass | 4 | 0.5 | 0.5 | no signal |
| 252 | Injection Site Pruritus | 7 | 0.5 | 0.5 | no signal |
| 253 | Pancreatic Carcinoma | 3 | 0.5 | 0.5 | no signal |
| 254 | Incorrect Route Of Drug Administration | 3 | 0.4 | 0.4 | no signal |
| 255 | Prostate Cancer | 6 | 0.4 | 0.4 | no signal |
| 256 | Dependence | 4 | 0.4 | 0.4 | no signal |