Drug
Deutetrabenazine
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 | 119 | 35.8 | 36.4 | signal |
| 2 | Dyskinesia | 468 | 33.8 | 36.1 | signal |
| 3 | Tardive Dyskinesia | 260 | 26.7 | 27.6 | signal |
| 4 | Akathisia | 70 | 14.9 | 15.1 | signal |
| 5 | Therapy Change | 43 | 13.0 | 13.1 | signal |
| 6 | Bipolar Disorder | 47 | 12.5 | 12.6 | signal |
| 7 | Suicidal Ideation | 343 | 10.9 | 11.4 | signal |
| 8 | Insurance Issue | 55 | 10.8 | 10.8 | signal |
| 9 | Restlessness | 121 | 9.6 | 9.7 | signal |
| 10 | Loss Of Personal Independence In Daily Activities | 149 | 9.1 | 9.3 | signal |
| 11 | Drug Effect Less Than Expected | 42 | 8.7 | 8.7 | signal |
| 12 | Inability To Afford Medication | 28 | 8.3 | 8.3 | signal |
| 13 | Initial Insomnia | 27 | 7.7 | 7.7 | signal |
| 14 | Muscle Twitching | 55 | 6.9 | 7.0 | signal |
| 15 | Salivary Hypersecretion | 23 | 6.7 | 6.7 | signal |
| 16 | Depression | 521 | 6.6 | 7.1 | signal |
| 17 | Tremor | 365 | 6.4 | 6.7 | signal |
| 18 | Speech Disorder | 115 | 6.4 | 6.5 | signal |
| 19 | Movement Disorder | 70 | 6.3 | 6.4 | signal |
| 20 | Product Use Issue | 390 | 6.1 | 6.3 | signal |
| 21 | Hallucination, Auditory | 33 | 6.0 | 6.0 | signal |
| 22 | Schizophrenia | 25 | 6.0 | 6.0 | signal |
| 23 | Sedation | 53 | 5.9 | 5.9 | signal |
| 24 | Hypersomnia | 57 | 5.8 | 5.8 | signal |
| 25 | Hospice Care | 18 | 5.3 | 5.3 | signal |
| 26 | Mood Altered | 49 | 5.2 | 5.3 | signal |
| 27 | Somnolence | 350 | 5.1 | 5.3 | signal |
| 28 | Aggression | 87 | 5.0 | 5.1 | signal |
| 29 | Product Prescribing Error | 41 | 5.0 | 5.0 | signal |
| 30 | Restless Legs Syndrome | 30 | 4.8 | 4.8 | signal |
| 31 | Crying | 60 | 4.8 | 4.8 | signal |
| 32 | Mania | 27 | 4.8 | 4.8 | signal |
| 33 | Dry Mouth | 124 | 4.4 | 4.5 | signal |
| 34 | Product Prescribing Issue | 31 | 4.4 | 4.4 | signal |
| 35 | Balance Disorder | 131 | 4.4 | 4.5 | signal |
| 36 | Gait Inability | 49 | 4.3 | 4.3 | signal |
| 37 | Choking | 28 | 4.2 | 4.2 | signal |
| 38 | Therapeutic Product Effect Incomplete | 101 | 4.1 | 4.2 | signal |
| 39 | Impaired Driving Ability | 16 | 4.1 | 4.1 | signal |
| 40 | Aspiration | 15 | 4.0 | 4.0 | signal |
| 41 | Agitation | 101 | 4.0 | 4.0 | signal |
| 42 | Product Dose Omission In Error | 36 | 3.9 | 3.9 | signal |
| 43 | Therapy Cessation | 67 | 3.8 | 3.8 | signal |
| 44 | Dysarthria | 49 | 3.8 | 3.8 | signal |
| 45 | Depressed Mood | 68 | 3.7 | 3.8 | signal |
| 46 | Sluggishness | 13 | 3.7 | 3.7 | signal |
| 47 | Product Use In Unapproved Indication | 310 | 3.7 | 3.8 | signal |
| 48 | Ataxia | 15 | 3.7 | 3.7 | signal |
| 49 | Dementia | 35 | 3.6 | 3.7 | signal |
| 50 | Feeding Disorder | 25 | 3.6 | 3.6 | signal |
| 51 | Anger | 42 | 3.6 | 3.6 | signal |
| 52 | Insomnia | 322 | 3.5 | 3.6 | signal |
| 53 | Motor Dysfunction | 12 | 3.4 | 3.4 | signal |
| 54 | Apathy | 17 | 3.4 | 3.4 | signal |
| 55 | Product Dispensing Error | 25 | 3.3 | 3.3 | signal |
| 56 | Psychomotor Hyperactivity | 19 | 3.3 | 3.3 | signal |
| 57 | Hallucination | 85 | 3.3 | 3.3 | signal |
| 58 | Disturbance In Attention | 61 | 3.3 | 3.3 | signal |
| 59 | Thinking Abnormal | 21 | 3.3 | 3.3 | signal |
| 60 | Dysphagia | 103 | 3.2 | 3.2 | signal |
| 61 | Mental Impairment | 26 | 3.1 | 3.1 | signal |
| 62 | Diabetes Mellitus | 82 | 3.1 | 3.1 | signal |
| 63 | Muscle Tightness | 17 | 3.0 | 3.1 | signal |
| 64 | Psychotic Disorder | 31 | 3.0 | 3.1 | signal |
| 65 | Feeling Jittery | 20 | 3.0 | 3.0 | signal |
| 66 | Mental Disorder | 45 | 3.0 | 3.0 | signal |
| 67 | Neuroleptic Malignant Syndrome | 12 | 2.9 | 2.9 | signal |
| 68 | Eating Disorder | 21 | 2.8 | 2.9 | signal |
| 69 | Therapeutic Product Effect Decreased | 43 | 2.8 | 2.8 | signal |
| 70 | Aphasia | 29 | 2.8 | 2.8 | signal |
| 71 | Confusional State | 152 | 2.7 | 2.8 | signal |
| 72 | Fall | 311 | 2.7 | 2.8 | signal |
| 73 | Rhinorrhoea | 60 | 2.7 | 2.7 | signal |
| 74 | Head Injury | 29 | 2.7 | 2.7 | signal |
| 75 | Adverse Drug Reaction | 82 | 2.7 | 2.7 | signal |
| 76 | Bedridden | 12 | 2.7 | 2.7 | signal |
| 77 | Middle Insomnia | 17 | 2.7 | 2.7 | signal |
| 78 | Adverse Event | 83 | 2.6 | 2.6 | signal |
| 79 | Brain Fog | 13 | 2.6 | 2.6 | signal |
| 80 | Hospitalisation | 134 | 2.6 | 2.6 | signal |
| 81 | Abnormal Behaviour | 35 | 2.5 | 2.6 | signal |
| 82 | Swollen Tongue | 27 | 2.5 | 2.5 | signal |
| 83 | Therapeutic Response Shortened | 27 | 2.5 | 2.5 | signal |
| 84 | Urinary Incontinence | 25 | 2.4 | 2.5 | signal |
| 85 | Delusion | 13 | 2.4 | 2.4 | signal |
| 86 | Dizziness Postural | 8 | 2.4 | 2.4 | signal |
| 87 | Hunger | 11 | 2.4 | 2.4 | signal |
| 88 | Paranoia | 14 | 2.3 | 2.3 | signal |
| 89 | Oral Pain | 18 | 2.3 | 2.3 | signal |
| 90 | Therapy Interrupted | 55 | 2.3 | 2.3 | signal |
| 91 | Panic Attack | 29 | 2.3 | 2.3 | signal |
| 92 | Impaired Gastric Emptying | 10 | 2.3 | 2.3 | signal |
| 93 | Anxiety | 220 | 2.2 | 2.3 | signal |
| 94 | Memory Impairment | 106 | 2.2 | 2.3 | signal |
| 95 | Dystonia | 15 | 2.2 | 2.2 | signal |
| 96 | Drug Ineffective | 1,012 | 2.2 | 2.4 | signal |
| 97 | Feeling Abnormal | 184 | 2.2 | 2.2 | signal |
| 98 | Disability | 15 | 2.2 | 2.2 | signal |
| 99 | Incontinence | 8 | 2.2 | 2.2 | signal |
| 100 | Cognitive Disorder | 35 | 2.2 | 2.2 | signal |
| 101 | Mood Swings | 24 | 2.2 | 2.2 | signal |
| 102 | Gait Disturbance | 144 | 2.2 | 2.2 | signal |
| 103 | Blood Sodium Decreased | 14 | 2.2 | 2.2 | signal |
| 104 | Pharyngeal Swelling | 7 | 2.1 | 2.1 | no signal |
| 105 | Irritability | 44 | 2.1 | 2.1 | signal |
| 106 | Lethargy | 42 | 2.1 | 2.1 | signal |
| 107 | Electrocardiogram Qt Prolonged | 26 | 2.1 | 2.1 | signal |
| 108 | Product Use Complaint | 11 | 2.1 | 2.1 | signal |
| 109 | Heart Rate Irregular | 16 | 2.0 | 2.0 | signal |
| 110 | Sleep Disorder | 49 | 2.0 | 2.0 | signal |
| 111 | Impaired Work Ability | 15 | 2.0 | 2.0 | signal |
| 112 | Inappropriate Schedule Of Product Administration | 122 | 2.0 | 2.0 | signal |
| 113 | Head Discomfort | 12 | 2.0 | 2.0 | no signal |
| 114 | Muscle Rigidity | 8 | 1.9 | 1.9 | no signal |
| 115 | Joint Dislocation | 7 | 1.9 | 1.9 | no signal |
| 116 | Contraindicated Product Administered | 20 | 1.9 | 1.9 | no signal |
| 117 | Increased Appetite | 12 | 1.9 | 1.9 | no signal |
| 118 | Tooth Fracture | 7 | 1.8 | 1.8 | no signal |
| 119 | Intentional Dose Omission | 17 | 1.8 | 1.8 | no signal |
| 120 | Product Administration Error | 12 | 1.7 | 1.7 | no signal |
| 121 | Death | 512 | 1.7 | 1.8 | no signal |
| 122 | Musculoskeletal Stiffness | 52 | 1.7 | 1.7 | no signal |
| 123 | Euphoric Mood | 6 | 1.7 | 1.7 | no signal |
| 124 | Product Dose Omission Issue | 165 | 1.7 | 1.7 | no signal |
| 125 | Lower Limb Fracture | 11 | 1.7 | 1.7 | no signal |
| 126 | Nightmare | 20 | 1.7 | 1.7 | no signal |
| 127 | Coordination Abnormal | 8 | 1.7 | 1.7 | no signal |
| 128 | Thirst | 10 | 1.6 | 1.6 | no signal |
| 129 | Stress | 40 | 1.6 | 1.6 | no signal |
| 130 | Throat Tightness | 15 | 1.6 | 1.6 | no signal |
| 131 | Sinus Disorder | 11 | 1.6 | 1.6 | no signal |
| 132 | Pharyngitis Streptococcal | 6 | 1.6 | 1.6 | no signal |
| 133 | Back Injury | 6 | 1.6 | 1.6 | no signal |
| 134 | Withdrawal Syndrome | 23 | 1.6 | 1.6 | no signal |
| 135 | Amnesia | 35 | 1.6 | 1.6 | no signal |
| 136 | Personality Change | 5 | 1.6 | 1.6 | no signal |
| 137 | Wrong Technique In Product Usage Process | 104 | 1.5 | 1.5 | no signal |
| 138 | Knee Operation | 5 | 1.5 | 1.5 | no signal |
| 139 | Nervousness | 27 | 1.5 | 1.5 | no signal |
| 140 | Dysstasia | 15 | 1.5 | 1.5 | no signal |
| 141 | Palpitations | 59 | 1.5 | 1.5 | no signal |
| 142 | Abnormal Dreams | 14 | 1.5 | 1.5 | no signal |
| 143 | Brain Injury | 5 | 1.4 | 1.4 | no signal |
| 144 | Illness | 50 | 1.4 | 1.4 | no signal |
| 145 | Intentional Self-injury | 10 | 1.4 | 1.4 | no signal |
| 146 | Pain In Jaw | 14 | 1.4 | 1.4 | no signal |
| 147 | Suicide Attempt | 30 | 1.4 | 1.4 | no signal |
| 148 | Glossodynia | 11 | 1.4 | 1.4 | no signal |
| 149 | Blindness | 20 | 1.4 | 1.4 | no signal |
| 150 | Dizziness | 240 | 1.4 | 1.4 | no signal |
| 151 | Hypokinesia | 7 | 1.4 | 1.4 | no signal |
| 152 | Hallucination, Visual | 10 | 1.4 | 1.4 | no signal |
| 153 | Incorrect Route Of Product Administration | 8 | 1.4 | 1.4 | no signal |
| 154 | Hip Fracture | 15 | 1.4 | 1.4 | no signal |
| 155 | Therapeutic Response Unexpected | 21 | 1.4 | 1.4 | no signal |
| 156 | Hypoacusis | 20 | 1.3 | 1.4 | no signal |
| 157 | Gastrointestinal Pain | 5 | 1.3 | 1.3 | no signal |
| 158 | Ankle Fracture | 7 | 1.3 | 1.3 | no signal |
| 159 | Sinus Congestion | 6 | 1.3 | 1.3 | no signal |
| 160 | Seizure | 50 | 1.3 | 1.3 | no signal |
| 161 | Unresponsive To Stimuli | 11 | 1.2 | 1.2 | no signal |
| 162 | Loss Of Consciousness | 54 | 1.2 | 1.2 | no signal |
| 163 | Impaired Quality Of Life | 6 | 1.2 | 1.2 | no signal |
| 164 | Spinal Operation | 5 | 1.2 | 1.2 | no signal |
| 165 | Nasal Congestion | 24 | 1.2 | 1.2 | no signal |
| 166 | Incorrect Dose Administered | 91 | 1.2 | 1.2 | no signal |
| 167 | Platelet Count Increased | 5 | 1.1 | 1.1 | no signal |
| 168 | Hair Texture Abnormal | 5 | 1.1 | 1.1 | no signal |
| 169 | Pulmonary Thrombosis | 4 | 1.1 | 1.1 | no signal |
| 170 | Sneezing | 8 | 1.0 | 1.0 | no signal |
| 171 | Knee Arthroplasty | 7 | 1.0 | 1.0 | no signal |
| 172 | Tendon Rupture | 4 | 0.9 | 0.9 | no signal |
| 173 | Muscle Spasticity | 4 | 0.9 | 0.9 | no signal |
| 174 | Emotional Disorder | 10 | 0.9 | 0.9 | no signal |
| 175 | Product Dose Omission | 20 | 0.9 | 0.9 | no signal |
| 176 | Surgery | 17 | 0.9 | 0.8 | no signal |
| 177 | Cerebrovascular Accident | 48 | 0.8 | 0.8 | no signal |
| 178 | Product Availability Issue | 6 | 0.8 | 0.8 | no signal |
| 179 | Rebound Effect | 3 | 0.8 | 0.8 | no signal |
| 180 | Internal Haemorrhage | 3 | 0.8 | 0.8 | no signal |
| 181 | Completed Suicide | 21 | 0.7 | 0.7 | no signal |
| 182 | Hepatitis C | 3 | 0.7 | 0.7 | no signal |
| 183 | Multiple Fractures | 4 | 0.7 | 0.7 | no signal |
| 184 | Drug Effective For Unapproved Indication | 7 | 0.7 | 0.7 | no signal |
| 185 | Serotonin Syndrome | 4 | 0.6 | 0.6 | no signal |
| 186 | Extrapyramidal Disorder | 5 | 0.6 | 0.6 | no signal |
| 187 | Drug Effect Incomplete | 6 | 0.5 | 0.5 | no signal |
| 188 | Circumstance Or Information Capable Of Leading To Medication Error | 5 | 0.4 | 0.4 | no signal |
| 189 | Product Preparation Error | 3 | 0.4 | 0.4 | no signal |