Drug
Haloperidol Decanoate
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 | Akathisia | 141 | 80.0 | 84.3 | signal |
| 2 | Neuroleptic Malignant Syndrome | 112 | 72.9 | 76.0 | signal |
| 3 | Extrapyramidal Disorder | 182 | 56.0 | 60.0 | signal |
| 4 | Euphoric Mood | 70 | 52.4 | 53.8 | signal |
| 5 | Schizophrenia | 72 | 45.7 | 46.9 | signal |
| 6 | Parkinsonism | 50 | 39.5 | 40.2 | signal |
| 7 | Salivary Hypersecretion | 42 | 32.4 | 32.9 | signal |
| 8 | Obesity | 66 | 31.8 | 32.6 | signal |
| 9 | Increased Appetite | 72 | 29.5 | 30.2 | signal |
| 10 | Muscle Rigidity | 41 | 26.4 | 26.8 | signal |
| 11 | Leukaemia | 31 | 25.3 | 25.6 | signal |
| 12 | Hallucination, Auditory | 49 | 23.7 | 24.1 | signal |
| 13 | Sedation | 79 | 23.3 | 24.0 | signal |
| 14 | Dystonia | 58 | 22.9 | 23.4 | signal |
| 15 | Prescribed Overdose | 53 | 21.1 | 21.4 | signal |
| 16 | Psychotic Disorder | 77 | 20.0 | 20.6 | signal |
| 17 | Delusion | 40 | 19.9 | 20.1 | signal |
| 18 | Tardive Dyskinesia | 70 | 18.9 | 19.4 | signal |
| 19 | Leukopenia | 105 | 16.2 | 16.8 | signal |
| 20 | Treatment Noncompliance | 110 | 15.6 | 16.2 | signal |
| 21 | Suicide Attempt | 123 | 15.5 | 16.2 | signal |
| 22 | Sexual Dysfunction | 23 | 15.1 | 15.2 | signal |
| 23 | Inappropriate Antidiuretic Hormone Secretion | 15 | 11.3 | 11.4 | signal |
| 24 | Sudden Death | 15 | 10.8 | 10.8 | signal |
| 25 | Hypothermia | 14 | 10.6 | 10.6 | signal |
| 26 | Dyskinesia | 52 | 9.8 | 10.0 | signal |
| 27 | Drug Resistance | 32 | 9.6 | 9.7 | signal |
| 28 | Muscle Tightness | 20 | 9.5 | 9.6 | signal |
| 29 | Weight Increased | 272 | 9.4 | 10.3 | signal |
| 30 | Aggression | 60 | 9.2 | 9.4 | signal |
| 31 | Psychomotor Hyperactivity | 19 | 8.7 | 8.8 | signal |
| 32 | Agitation | 80 | 8.3 | 8.6 | signal |
| 33 | Agranulocytosis | 20 | 8.3 | 8.4 | signal |
| 34 | Laceration | 10 | 8.0 | 8.1 | signal |
| 35 | Restlessness | 38 | 8.0 | 8.1 | signal |
| 36 | Abnormal Behaviour | 41 | 7.9 | 8.0 | signal |
| 37 | Electrocardiogram Qt Prolonged | 37 | 7.9 | 8.0 | signal |
| 38 | Incorrect Route Of Product Administration | 17 | 7.8 | 7.8 | signal |
| 39 | Irritability | 59 | 7.5 | 7.7 | signal |
| 40 | Therapeutic Product Effect Incomplete | 69 | 7.5 | 7.7 | signal |
| 41 | Serotonin Syndrome | 18 | 7.2 | 7.3 | signal |
| 42 | Cardiovascular Disorder | 24 | 7.2 | 7.3 | signal |
| 43 | Muscle Twitching | 21 | 7.0 | 7.0 | signal |
| 44 | Hepatic Cytolysis | 11 | 6.9 | 6.9 | signal |
| 45 | Sopor | 12 | 6.9 | 6.9 | signal |
| 46 | Delirium | 31 | 6.9 | 6.9 | signal |
| 47 | Altered State Of Consciousness | 19 | 6.8 | 6.8 | signal |
| 48 | Gynaecomastia | 27 | 6.6 | 6.7 | signal |
| 49 | Sinus Tachycardia | 12 | 6.5 | 6.5 | signal |
| 50 | Blood Creatine Phosphokinase Increased | 24 | 6.3 | 6.3 | signal |
| 51 | Drug Interaction | 129 | 6.2 | 6.5 | signal |
| 52 | Paranoia | 14 | 6.2 | 6.2 | signal |
| 53 | Thinking Abnormal | 15 | 6.1 | 6.2 | signal |
| 54 | Dysarthria | 30 | 6.1 | 6.2 | signal |
| 55 | Myocarditis | 9 | 6.1 | 6.1 | signal |
| 56 | Intentional Self-injury | 16 | 6.1 | 6.1 | signal |
| 57 | Mental Impairment | 19 | 6.0 | 6.0 | signal |
| 58 | Mental Status Changes | 21 | 5.8 | 5.8 | signal |
| 59 | Incontinence | 8 | 5.8 | 5.8 | signal |
| 60 | Breast Pain | 8 | 5.8 | 5.8 | signal |
| 61 | Erectile Dysfunction | 19 | 5.7 | 5.7 | signal |
| 62 | Coma | 35 | 5.6 | 5.7 | signal |
| 63 | Hypercholesterolaemia | 7 | 5.6 | 5.6 | signal |
| 64 | Ventricular Fibrillation | 8 | 5.5 | 5.5 | signal |
| 65 | Cognitive Disorder | 32 | 5.3 | 5.3 | signal |
| 66 | Speech Disorder | 36 | 5.3 | 5.3 | signal |
| 67 | Medication Error | 37 | 5.1 | 5.2 | signal |
| 68 | Leukocytosis | 12 | 5.1 | 5.1 | signal |
| 69 | Tremor | 109 | 5.0 | 5.2 | signal |
| 70 | Eating Disorder | 14 | 5.0 | 5.0 | signal |
| 71 | Lactic Acidosis | 21 | 5.0 | 5.1 | signal |
| 72 | Generalised Oedema | 8 | 5.0 | 5.0 | signal |
| 73 | Aspiration | 7 | 5.0 | 5.0 | signal |
| 74 | Incorrect Route Of Drug Administration | 23 | 4.9 | 4.9 | signal |
| 75 | Suicidal Ideation | 57 | 4.8 | 4.9 | signal |
| 76 | Injection Site Induration | 8 | 4.7 | 4.7 | signal |
| 77 | Impaired Work Ability | 13 | 4.6 | 4.7 | signal |
| 78 | Therapy Non-responder | 27 | 4.6 | 4.7 | signal |
| 79 | Toxicity To Various Agents | 101 | 4.6 | 4.8 | signal |
| 80 | Hospitalisation | 91 | 4.6 | 4.7 | signal |
| 81 | Cardio-respiratory Arrest | 25 | 4.6 | 4.6 | signal |
| 82 | Hallucination | 44 | 4.5 | 4.6 | signal |
| 83 | Blood Sodium Decreased | 11 | 4.5 | 4.5 | signal |
| 84 | Rhabdomyolysis | 24 | 4.4 | 4.5 | signal |
| 85 | Coordination Abnormal | 8 | 4.4 | 4.4 | signal |
| 86 | Abnormal Weight Gain | 7 | 4.3 | 4.3 | signal |
| 87 | Generalised Tonic-clonic Seizure | 9 | 4.2 | 4.2 | signal |
| 88 | Product Packaging Quantity Issue | 6 | 4.2 | 4.2 | signal |
| 89 | Cardiomyopathy | 8 | 4.1 | 4.2 | signal |
| 90 | Sinus Bradycardia | 5 | 4.0 | 4.0 | signal |
| 91 | Depressed Level Of Consciousness | 20 | 3.9 | 3.9 | signal |
| 92 | Myoclonus | 6 | 3.9 | 3.9 | signal |
| 93 | Pulmonary Embolism | 48 | 3.9 | 3.9 | signal |
| 94 | Product Availability Issue | 11 | 3.8 | 3.8 | signal |
| 95 | Small Intestinal Obstruction | 6 | 3.7 | 3.8 | signal |
| 96 | Treatment Failure | 40 | 3.7 | 3.8 | signal |
| 97 | Mania | 8 | 3.7 | 3.7 | signal |
| 98 | Hypercalcaemia | 6 | 3.7 | 3.7 | signal |
| 99 | Drug-induced Liver Injury | 15 | 3.7 | 3.7 | signal |
| 100 | Drug Level Increased | 8 | 3.7 | 3.7 | signal |
| 101 | Shock | 11 | 3.7 | 3.7 | signal |
| 102 | Renal Pain | 5 | 3.6 | 3.6 | signal |
| 103 | Mydriasis | 6 | 3.6 | 3.6 | signal |
| 104 | Adverse Event | 43 | 3.6 | 3.6 | signal |
| 105 | Unresponsive To Stimuli | 12 | 3.6 | 3.6 | signal |
| 106 | Bedridden | 6 | 3.5 | 3.5 | signal |
| 107 | Intestinal Obstruction | 17 | 3.5 | 3.5 | signal |
| 108 | Blood Triglycerides Increased | 8 | 3.5 | 3.5 | signal |
| 109 | Product Prescribing Issue | 9 | 3.4 | 3.4 | signal |
| 110 | Blood Lactate Dehydrogenase Increased | 7 | 3.4 | 3.4 | signal |
| 111 | Central Nervous System Lesion | 6 | 3.3 | 3.3 | signal |
| 112 | Product Packaging Issue | 4 | 3.3 | 3.3 | signal |
| 113 | Diabetes Mellitus | 33 | 3.3 | 3.3 | signal |
| 114 | Pericarditis | 7 | 3.2 | 3.2 | signal |
| 115 | Drug Administration Error | 13 | 3.2 | 3.2 | signal |
| 116 | Neutropenia | 56 | 3.2 | 3.2 | signal |
| 117 | Apathy | 6 | 3.2 | 3.2 | signal |
| 118 | Hypokinesia | 6 | 3.2 | 3.2 | signal |
| 119 | Panic Attack | 15 | 3.2 | 3.2 | signal |
| 120 | Product Administration Error | 8 | 3.1 | 3.1 | signal |
| 121 | Syringe Issue | 7 | 3.1 | 3.1 | signal |
| 122 | Metastases To Liver | 7 | 3.1 | 3.1 | signal |
| 123 | Hypotonia | 4 | 3.1 | 3.1 | no signal |
| 124 | Brain Injury | 4 | 3.1 | 3.1 | no signal |
| 125 | Drug Abuse | 33 | 3.0 | 3.0 | signal |
| 126 | Drug Level Decreased | 4 | 3.0 | 3.0 | no signal |
| 127 | Adverse Drug Reaction | 34 | 2.9 | 2.9 | signal |
| 128 | Withdrawal Syndrome | 16 | 2.9 | 2.9 | signal |
| 129 | Intentional Overdose | 24 | 2.9 | 2.9 | signal |
| 130 | Drug Administered At Inappropriate Site | 4 | 2.9 | 2.9 | no signal |
| 131 | Acute Hepatic Failure | 5 | 2.8 | 2.8 | signal |
| 132 | Mental Disorder | 16 | 2.8 | 2.8 | signal |
| 133 | Drug Dose Omission | 61 | 2.8 | 2.8 | signal |
| 134 | Vaginal Haemorrhage | 15 | 2.7 | 2.7 | signal |
| 135 | Anaphylactic Shock | 9 | 2.7 | 2.7 | signal |
| 136 | Nightmare | 12 | 2.6 | 2.7 | signal |
| 137 | Accidental Overdose | 12 | 2.5 | 2.5 | signal |
| 138 | Respiratory Depression | 4 | 2.5 | 2.5 | no signal |
| 139 | Libido Decreased | 4 | 2.5 | 2.5 | no signal |
| 140 | Drug Dispensing Error | 5 | 2.5 | 2.5 | no signal |
| 141 | Grand Mal Convulsion | 3 | 2.5 | 2.5 | no signal |
| 142 | Deformity | 3 | 2.5 | 2.5 | no signal |
| 143 | Inappropriate Schedule Of Drug Administration | 21 | 2.2 | 2.2 | signal |
| 144 | Underdose | 20 | 2.1 | 2.1 | signal |
| 145 | Injection Site Nodule | 3 | 2.1 | 2.1 | no signal |
| 146 | Blood Glucose Abnormal | 5 | 2.1 | 2.1 | no signal |
| 147 | Drug Prescribing Error | 5 | 2.0 | 2.0 | no signal |
| 148 | Caesarean Section | 3 | 2.0 | 2.0 | no signal |
| 149 | Overdose | 55 | 1.9 | 2.0 | no signal |
| 150 | Injection Site Reaction | 17 | 1.9 | 1.9 | no signal |
| 151 | Product Quality Issue | 33 | 1.9 | 1.9 | no signal |
| 152 | Injection Site Mass | 9 | 1.9 | 1.9 | no signal |
| 153 | Injection Site Extravasation | 3 | 1.8 | 1.8 | no signal |
| 154 | Amenorrhoea | 4 | 1.8 | 1.8 | no signal |
| 155 | Poisoning | 3 | 1.8 | 1.8 | no signal |
| 156 | Accidental Exposure To Product | 23 | 1.8 | 1.8 | no signal |
| 157 | Drug Toxicity | 3 | 1.7 | 1.7 | no signal |
| 158 | Expired Product Administered | 7 | 1.6 | 1.6 | no signal |
| 159 | Drug Effect Decreased | 11 | 1.5 | 1.5 | no signal |
| 160 | Drug Withdrawal Syndrome Neonatal | 3 | 1.5 | 1.5 | no signal |
| 161 | Drug Effect Incomplete | 7 | 1.5 | 1.5 | no signal |
| 162 | Needle Issue | 5 | 1.3 | 1.3 | no signal |
| 163 | Injection Site Warmth | 3 | 1.1 | 1.1 | no signal |
| 164 | Drug Effective For Unapproved Indication | 4 | 1.0 | 1.0 | no signal |
| 165 | Wrong Technique In Drug Usage Process | 5 | 1.0 | 1.0 | no signal |
| 166 | Injection Site Swelling | 10 | 1.0 | 1.0 | no signal |
| 167 | Completed Suicide | 10 | 0.9 | 0.9 | no signal |
| 168 | Injection Site Pain | 36 | 0.9 | 0.9 | no signal |
| 169 | Pharmaceutical Product Complaint | 3 | 0.9 | 0.9 | no signal |
| 170 | Drug Exposure During Pregnancy | 3 | 0.7 | 0.7 | no signal |
| 171 | Drug Dependence | 12 | 0.6 | 0.6 | no signal |
| 172 | Dependence | 3 | 0.4 | 0.4 | no signal |