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Drug

Haloperidol Decanoate

172 flagged reaction(s) · 4,877 total co-reports · max PRR 80.0
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