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HALOPERIDOL DECANOATE

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Haloperidol Decanoate Adverse Events Reported to the FDA Over Time

How are Haloperidol Decanoate adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Haloperidol Decanoate, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Haloperidol Decanoate is flagged as the suspect drug causing the adverse event.

Most Common Haloperidol Decanoate Adverse Events Reported to the FDA

What are the most common Haloperidol Decanoate adverse events reported to the FDA?

Somnolence
302 (1.89%)
Extrapyramidal Disorder
268 (1.67%)
Weight Increased
254 (1.59%)
Drug Interaction
238 (1.49%)
Self Injurious Behaviour
195 (1.22%)
Suicide Attempt
195 (1.22%)
Tremor
193 (1.21%)
Agitation
188 (1.17%)
Fall
183 (1.14%)
Neuroleptic Malignant Syndrome
181 (1.13%)
Overdose
141 (.88%)
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Confusional State
137 (.86%)
Aggression
131 (.82%)
Dyskinesia
131 (.82%)
Tachycardia
126 (.79%)
Death
124 (.77%)
Pyrexia
120 (.75%)
Psychotic Disorder
119 (.74%)
Parkinsonism
111 (.69%)
Coma
110 (.69%)
Convulsion
106 (.66%)
Dyspnoea
106 (.66%)
Multiple Drug Overdose Intentional
93 (.58%)
Blood Creatine Phosphokinase Increa...
92 (.57%)
Incorrect Route Of Drug Administrat...
91 (.57%)
Tardive Dyskinesia
91 (.57%)
Fatigue
90 (.56%)
Gait Disturbance
88 (.55%)
Dehydration
87 (.54%)
Dysphagia
86 (.54%)
Sopor
86 (.54%)
Restlessness
85 (.53%)
Abnormal Behaviour
84 (.52%)
Vomiting
84 (.52%)
Medication Error
80 (.5%)
Muscle Rigidity
78 (.49%)
Hypotension
77 (.48%)
Cardiac Arrest
75 (.47%)
Delirium
75 (.47%)
Intentional Overdose
75 (.47%)
Pneumonia
75 (.47%)
Salivary Hypersecretion
74 (.46%)
Sluggishness
74 (.46%)
Hospitalisation
73 (.46%)
Depression
72 (.45%)
Drug Ineffective
72 (.45%)
Drug Exposure During Pregnancy
71 (.44%)
Disorientation
70 (.44%)
Suicidal Ideation
70 (.44%)
Dystonia
69 (.43%)
Accidental Exposure
68 (.42%)
Electrocardiogram Qt Prolonged
68 (.42%)
Anxiety
66 (.41%)
Hypertension
63 (.39%)
Malaise
63 (.39%)
Asthenia
62 (.39%)
Speech Disorder
62 (.39%)
Hallucination
61 (.38%)
Insomnia
61 (.38%)
Sedation
61 (.38%)
Bradycardia
58 (.36%)
Dizziness
58 (.36%)
Rhabdomyolysis
58 (.36%)
Headache
56 (.35%)
Urinary Retention
55 (.34%)
Hallucination, Auditory
54 (.34%)
Weight Decreased
54 (.34%)
Pulmonary Embolism
53 (.33%)
Dysarthria
52 (.32%)
Loss Of Consciousness
52 (.32%)
Akathisia
51 (.32%)
Musculoskeletal Stiffness
50 (.31%)
Condition Aggravated
49 (.31%)
Depressed Level Of Consciousness
49 (.31%)
General Physical Health Deteriorati...
48 (.3%)
Hyponatraemia
48 (.3%)
Diabetes Mellitus
47 (.29%)
Hyperhidrosis
46 (.29%)
Nausea
46 (.29%)
Oedema Peripheral
45 (.28%)
Treatment Noncompliance
45 (.28%)
Accidental Overdose
44 (.27%)
Alanine Aminotransferase Increased
44 (.27%)
Cognitive Disorder
44 (.27%)
Disturbance In Attention
44 (.27%)
Hypothermia
44 (.27%)
Incorrect Dose Administered
44 (.27%)
Thinking Abnormal
44 (.27%)
Off Label Use
43 (.27%)
Accidental Drug Intake By Child
42 (.26%)
Delusion
41 (.26%)
Completed Suicide
40 (.25%)
Constipation
40 (.25%)
Pleurothotonus
40 (.25%)
Aspartate Aminotransferase Increase...
39 (.24%)
Cardio-respiratory Arrest
39 (.24%)
Mutism
39 (.24%)
Myocardial Infarction
39 (.24%)
Neutropenia
39 (.24%)
Respiratory Failure
39 (.24%)
Feeling Abnormal
38 (.24%)

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This graph shows the top adverse events submitted to the FDA for Haloperidol Decanoate, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Haloperidol Decanoate is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Haloperidol Decanoate

What are the most common Haloperidol Decanoate adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Haloperidol Decanoate, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Haloperidol Decanoate is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Haloperidol Decanoate According to Those Reporting Adverse Events

Why are people taking Haloperidol Decanoate, according to those reporting adverse events to the FDA?

Drug Use For Unknown Indication
965
Product Used For Unknown Indication
600
Schizophrenia
541
Psychotic Disorder
292
Agitation
224
Schizophrenia, Paranoid Type
123
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Bipolar Disorder
113
Mental Disorder
103
Schizoaffective Disorder
101
Depression
96
Delirium
72
Anxiety
62
Hallucination
61
Nausea
56
Ill-defined Disorder
53
Abnormal Behaviour
48
Bipolar I Disorder
47
Aggression
42
Accidental Exposure
41
Restlessness
40
Drug Exposure During Pregnancy
34
Delusion
33
Self Injurious Behaviour
32
Confusional State
28
Suicide Attempt
26
Sedation
22
Mania
22
Dementia
20
Acute Psychosis
19
Insomnia
16
Nervousness
14
Psychomotor Hyperactivity
13
Delusional Disorder, Unspecified Ty...
13
Alcohol Withdrawal Syndrome
13
Paranoia
12
Major Depression
12
Personality Disorder
11
Vomiting
10
Hiccups
8
Tourettes Disorder
8
Schizophrenia, Disorganised Type
7
Anger
7
Pain
7
Affective Disorder
6
Hallucination, Visual
6
Hallucination, Auditory
5
Schizophrenia, Undifferentiated Typ...
5
Adverse Event
5
Schizotypal Personality Disorder
5
Irritability
5
Convulsion
5

Drug Labels

LabelLabelerEffective
Haloperidol DecanoateBedford Laboratories04-JUN-10
Haloperidol DecanoatePatriot Pharmaceuticals LLC06-JUN-11
Haloperidol DecanoateAPP Pharmaceuticals, LLC19-MAR-12
Haloperidol DecanoateTeva Parenteral Medicines, Inc.08-AUG-12
Haloperidol DecanoateAmneal-Agila, LLC31-JAN-13
Haloperidol DecanoateAGILA SPECIALTIES PRIVATE LIMITED25-APR-13

Haloperidol Decanoate Case Reports

What Haloperidol Decanoate safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Haloperidol Decanoate. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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