Drug
Tetrabenazine
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 | Parkinsonism | 113 | 33.7 | 34.2 | signal |
| 2 | Prescribed Overdose | 195 | 29.2 | 30.0 | signal |
| 3 | Drug Administration Error | 241 | 22.4 | 23.1 | signal |
| 4 | Dystonia | 130 | 19.3 | 19.6 | signal |
| 5 | Hospice Care | 62 | 18.2 | 18.3 | signal |
| 6 | Movement Disorder | 189 | 16.9 | 17.3 | signal |
| 7 | Tardive Dyskinesia | 162 | 16.4 | 16.8 | signal |
| 8 | Dyskinesia | 223 | 15.9 | 16.3 | signal |
| 9 | Restlessness | 133 | 10.5 | 10.6 | signal |
| 10 | Treatment Noncompliance | 196 | 10.4 | 10.7 | signal |
| 11 | Akathisia | 43 | 9.1 | 9.1 | signal |
| 12 | Sedation | 82 | 9.1 | 9.2 | signal |
| 13 | Intentional Product Use Issue | 274 | 9.0 | 9.3 | signal |
| 14 | Salivary Hypersecretion | 29 | 8.4 | 8.4 | signal |
| 15 | Muscle Rigidity | 32 | 7.7 | 7.7 | signal |
| 16 | Neuroleptic Malignant Syndrome | 31 | 7.5 | 7.5 | signal |
| 17 | Hypersomnia | 69 | 6.9 | 7.0 | signal |
| 18 | Crying | 87 | 6.9 | 6.9 | signal |
| 19 | Anger | 80 | 6.8 | 6.8 | signal |
| 20 | Aspiration | 25 | 6.6 | 6.7 | signal |
| 21 | Drug Ineffective For Unapproved Indication | 126 | 6.5 | 6.6 | signal |
| 22 | Somnolence | 451 | 6.5 | 6.8 | signal |
| 23 | Abnormal Behaviour | 89 | 6.4 | 6.5 | signal |
| 24 | Depression | 475 | 6.0 | 6.3 | signal |
| 25 | Hospitalisation | 299 | 5.6 | 5.8 | signal |
| 26 | Suicidal Ideation | 179 | 5.6 | 5.7 | signal |
| 27 | Aggression | 95 | 5.4 | 5.5 | signal |
| 28 | Agitation | 138 | 5.4 | 5.5 | signal |
| 29 | Extrapyramidal Disorder | 46 | 5.3 | 5.3 | signal |
| 30 | Eating Disorder | 39 | 5.2 | 5.3 | signal |
| 31 | Muscle Twitching | 42 | 5.2 | 5.3 | signal |
| 32 | Medication Error | 97 | 5.0 | 5.1 | signal |
| 33 | Dysphagia | 164 | 5.0 | 5.1 | signal |
| 34 | Pneumonia Aspiration | 43 | 5.0 | 5.0 | signal |
| 35 | Apathy | 24 | 4.8 | 4.8 | signal |
| 36 | Activities Of Daily Living Impaired | 33 | 4.7 | 4.7 | signal |
| 37 | Speech Disorder | 86 | 4.7 | 4.8 | signal |
| 38 | No Therapeutic Response | 19 | 4.4 | 4.4 | signal |
| 39 | Psychomotor Hyperactivity | 25 | 4.3 | 4.3 | signal |
| 40 | Choking | 29 | 4.3 | 4.3 | signal |
| 41 | Emotional Disorder | 46 | 4.3 | 4.3 | signal |
| 42 | Mood Altered | 40 | 4.2 | 4.2 | signal |
| 43 | Death | 1,219 | 4.1 | 4.7 | signal |
| 44 | Dysarthria | 53 | 4.1 | 4.1 | signal |
| 45 | Depressed Mood | 73 | 4.0 | 4.0 | signal |
| 46 | Drug Dose Omission | 224 | 3.8 | 3.9 | signal |
| 47 | Tremor | 221 | 3.8 | 3.9 | signal |
| 48 | Micturition Urgency | 15 | 3.8 | 3.8 | signal |
| 49 | Off Label Use | 1,135 | 3.8 | 4.3 | signal |
| 50 | Hypokinesia | 19 | 3.8 | 3.8 | signal |
| 51 | Balance Disorder | 112 | 3.7 | 3.8 | signal |
| 52 | Thinking Abnormal | 24 | 3.7 | 3.7 | signal |
| 53 | Irritability | 75 | 3.6 | 3.6 | signal |
| 54 | Decreased Activity | 13 | 3.5 | 3.5 | signal |
| 55 | Bipolar Disorder | 13 | 3.4 | 3.4 | signal |
| 56 | Economic Problem | 18 | 3.4 | 3.4 | signal |
| 57 | Restless Legs Syndrome | 21 | 3.3 | 3.3 | signal |
| 58 | Lethargy | 66 | 3.3 | 3.3 | signal |
| 59 | Feeding Disorder | 22 | 3.2 | 3.2 | signal |
| 60 | Mood Swings | 35 | 3.2 | 3.2 | signal |
| 61 | Personality Change | 10 | 3.1 | 3.1 | signal |
| 62 | Laceration | 10 | 3.0 | 3.0 | signal |
| 63 | Incontinence | 11 | 3.0 | 3.0 | signal |
| 64 | Insomnia | 276 | 3.0 | 3.1 | signal |
| 65 | Affect Lability | 10 | 3.0 | 3.0 | signal |
| 66 | Mental Status Changes | 28 | 2.9 | 2.9 | signal |
| 67 | Initial Insomnia | 10 | 2.8 | 2.8 | signal |
| 68 | Disturbance In Attention | 52 | 2.8 | 2.8 | signal |
| 69 | Fall | 318 | 2.7 | 2.8 | signal |
| 70 | Hallucination, Auditory | 15 | 2.7 | 2.7 | signal |
| 71 | Musculoskeletal Stiffness | 81 | 2.7 | 2.7 | signal |
| 72 | Paranoia | 16 | 2.7 | 2.7 | signal |
| 73 | Ataxia | 11 | 2.7 | 2.7 | signal |
| 74 | Anxiety | 263 | 2.6 | 2.7 | signal |
| 75 | Hallucination | 69 | 2.6 | 2.7 | signal |
| 76 | Malnutrition | 10 | 2.6 | 2.6 | signal |
| 77 | Hunger | 12 | 2.6 | 2.6 | signal |
| 78 | Head Injury | 28 | 2.5 | 2.6 | signal |
| 79 | Cognitive Disorder | 41 | 2.5 | 2.5 | signal |
| 80 | Drug Prescribing Error | 17 | 2.5 | 2.5 | signal |
| 81 | Mental Impairment | 21 | 2.5 | 2.5 | signal |
| 82 | Electrocardiogram Qt Prolonged | 30 | 2.4 | 2.4 | signal |
| 83 | Gait Disturbance | 158 | 2.4 | 2.4 | signal |
| 84 | Unevaluable Event | 62 | 2.4 | 2.4 | signal |
| 85 | Unresponsive To Stimuli | 21 | 2.3 | 2.3 | signal |
| 86 | Drug Effect Incomplete | 30 | 2.3 | 2.3 | signal |
| 87 | Panic Attack | 29 | 2.3 | 2.3 | signal |
| 88 | Feeling Jittery | 15 | 2.3 | 2.3 | signal |
| 89 | Bedridden | 10 | 2.2 | 2.2 | signal |
| 90 | Condition Aggravated | 228 | 2.2 | 2.2 | signal |
| 91 | Dementia | 21 | 2.2 | 2.2 | signal |
| 92 | Muscle Tightness | 12 | 2.1 | 2.1 | signal |
| 93 | Therapy Change | 7 | 2.1 | 2.1 | no signal |
| 94 | Therapy Cessation | 37 | 2.1 | 2.1 | signal |
| 95 | Sinus Bradycardia | 7 | 2.1 | 2.1 | no signal |
| 96 | Abasia | 18 | 2.1 | 2.1 | signal |
| 97 | Sleep Disorder | 50 | 2.1 | 2.1 | signal |
| 98 | Hypophagia | 18 | 2.0 | 2.0 | signal |
| 99 | Hypotonia | 7 | 2.0 | 2.0 | no signal |
| 100 | Increased Appetite | 13 | 2.0 | 2.0 | no signal |
| 101 | Hip Fracture | 22 | 2.0 | 2.0 | no signal |
| 102 | Poor Quality Sleep | 14 | 1.9 | 1.9 | no signal |
| 103 | Nervousness | 34 | 1.9 | 1.9 | no signal |
| 104 | Confusional State | 104 | 1.8 | 1.9 | no signal |
| 105 | Aphasia | 19 | 1.8 | 1.8 | no signal |
| 106 | Feeling Abnormal | 149 | 1.8 | 1.8 | no signal |
| 107 | Mental Disorder | 27 | 1.8 | 1.8 | no signal |
| 108 | Adverse Event | 57 | 1.8 | 1.8 | no signal |
| 109 | Rebound Effect | 7 | 1.8 | 1.8 | no signal |
| 110 | Impaired Driving Ability | 7 | 1.8 | 1.8 | no signal |
| 111 | Dysstasia | 18 | 1.8 | 1.8 | no signal |
| 112 | Therapeutic Response Unexpected | 27 | 1.7 | 1.7 | no signal |
| 113 | Intentional Self-injury | 12 | 1.7 | 1.7 | no signal |
| 114 | Sluggishness | 6 | 1.7 | 1.7 | no signal |
| 115 | Memory Impairment | 80 | 1.7 | 1.7 | no signal |
| 116 | Adverse Drug Reaction | 52 | 1.7 | 1.7 | no signal |
| 117 | Delusion | 9 | 1.7 | 1.7 | no signal |
| 118 | Schizophrenia | 7 | 1.7 | 1.7 | no signal |
| 119 | Psychotic Disorder | 17 | 1.7 | 1.7 | no signal |
| 120 | Respiratory Depression | 7 | 1.6 | 1.6 | no signal |
| 121 | Coordination Abnormal | 8 | 1.6 | 1.6 | no signal |
| 122 | Visual Acuity Reduced | 19 | 1.6 | 1.6 | no signal |
| 123 | Drug Effect Decreased | 31 | 1.6 | 1.6 | no signal |
| 124 | Amnesia | 37 | 1.6 | 1.6 | no signal |
| 125 | Diabetes Mellitus Inadequate Control | 10 | 1.6 | 1.6 | no signal |
| 126 | Retching | 12 | 1.6 | 1.6 | no signal |
| 127 | Subdural Haematoma | 8 | 1.6 | 1.6 | no signal |
| 128 | Rhabdomyolysis | 23 | 1.6 | 1.6 | no signal |
| 129 | Upper Limb Fracture | 11 | 1.6 | 1.6 | no signal |
| 130 | Suicide Attempt | 33 | 1.6 | 1.6 | no signal |
| 131 | Urinary Incontinence | 16 | 1.6 | 1.6 | no signal |
| 132 | Insurance Issue | 8 | 1.5 | 1.5 | no signal |
| 133 | Hyperhidrosis | 69 | 1.5 | 1.5 | no signal |
| 134 | Drug Ineffective | 703 | 1.5 | 1.6 | no signal |
| 135 | Deformity | 5 | 1.5 | 1.5 | no signal |
| 136 | Disorientation | 21 | 1.5 | 1.5 | no signal |
| 137 | Adverse Reaction | 7 | 1.5 | 1.5 | no signal |
| 138 | Epilepsy | 16 | 1.5 | 1.5 | no signal |
| 139 | Neck Pain | 29 | 1.5 | 1.5 | no signal |
| 140 | Impaired Work Ability | 11 | 1.5 | 1.5 | no signal |
| 141 | Myoclonus | 6 | 1.4 | 1.4 | no signal |
| 142 | Eyelid Ptosis | 5 | 1.4 | 1.4 | no signal |
| 143 | Impaired Quality Of Life | 7 | 1.4 | 1.4 | no signal |
| 144 | Euphoric Mood | 5 | 1.4 | 1.4 | no signal |
| 145 | Disease Recurrence | 23 | 1.4 | 1.4 | no signal |
| 146 | Pollakiuria | 20 | 1.4 | 1.4 | no signal |
| 147 | Drug Resistance | 12 | 1.3 | 1.3 | no signal |
| 148 | Product Administration Error | 9 | 1.3 | 1.3 | no signal |
| 149 | Convulsion | 26 | 1.3 | 1.3 | no signal |
| 150 | Blood Creatine Phosphokinase Increased | 13 | 1.3 | 1.3 | no signal |
| 151 | Fear | 12 | 1.3 | 1.3 | no signal |
| 152 | Muscle Spasms | 81 | 1.3 | 1.3 | no signal |
| 153 | Nightmare | 15 | 1.2 | 1.2 | no signal |
| 154 | Hallucination, Visual | 9 | 1.2 | 1.2 | no signal |
| 155 | Grand Mal Convulsion | 4 | 1.2 | 1.2 | no signal |
| 156 | Pain In Jaw | 12 | 1.2 | 1.2 | no signal |
| 157 | Seizure | 47 | 1.2 | 1.2 | no signal |
| 158 | Therapy Partial Responder | 6 | 1.1 | 1.1 | no signal |
| 159 | Heart Rate Irregular | 9 | 1.1 | 1.1 | no signal |
| 160 | No Adverse Event | 69 | 1.1 | 1.1 | no signal |
| 161 | Product Substitution Issue | 22 | 1.1 | 1.1 | no signal |
| 162 | Coma | 18 | 1.1 | 1.1 | no signal |
| 163 | Middle Insomnia | 7 | 1.1 | 1.1 | no signal |
| 164 | Incorrect Dose Administered | 84 | 1.1 | 1.1 | no signal |
| 165 | Acute Hepatic Failure | 5 | 1.1 | 1.1 | no signal |
| 166 | Disease Progression | 42 | 1.0 | 1.0 | no signal |
| 167 | Myocarditis | 4 | 1.0 | 1.0 | no signal |
| 168 | Therapy Interrupted | 24 | 1.0 | 1.0 | no signal |
| 169 | Local Swelling | 6 | 1.0 | 1.0 | no signal |
| 170 | Abnormal Dreams | 9 | 0.9 | 0.9 | no signal |
| 171 | Drug Dispensing Error | 5 | 0.9 | 0.9 | no signal |
| 172 | Sopor | 4 | 0.9 | 0.9 | no signal |
| 173 | Wrong Technique In Drug Usage Process | 10 | 0.8 | 0.8 | no signal |
| 174 | Neoplasm Malignant | 18 | 0.8 | 0.8 | no signal |
| 175 | Device Failure | 4 | 0.8 | 0.8 | no signal |
| 176 | Intentional Overdose | 16 | 0.7 | 0.7 | no signal |
| 177 | Overdose | 50 | 0.7 | 0.7 | no signal |
| 178 | Withdrawal Syndrome | 9 | 0.6 | 0.6 | no signal |
| 179 | Product Quality Issue | 28 | 0.6 | 0.6 | no signal |
| 180 | Hepatic Cancer | 4 | 0.5 | 0.5 | no signal |
| 181 | Drug Withdrawal Syndrome | 14 | 0.5 | 0.5 | no signal |
| 182 | Completed Suicide | 13 | 0.4 | 0.4 | no signal |
| 183 | Incorrect Drug Administration Duration | 4 | 0.4 | 0.4 | no signal |
| 184 | Menstruation Irregular | 3 | 0.3 | 0.3 | no signal |
| 185 | Drug Abuse | 8 | 0.3 | 0.3 | no signal |