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RISPERDAL CONSTA

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Risperdal Consta Adverse Events Reported to the FDA Over Time

How are Risperdal Consta adverse event reports trending over time?

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

Most Common Risperdal Consta Adverse Events Reported to the FDA

What are the most common Risperdal Consta adverse events reported to the FDA?

Death
277 (1.49%)
Drug Ineffective
276 (1.49%)
Weight Increased
268 (1.45%)
Psychotic Disorder
255 (1.38%)
Overdose
250 (1.35%)
Hospitalisation
248 (1.34%)
Inappropriate Schedule Of Drug Admi...
230 (1.24%)
Aggression
215 (1.16%)
Device Malfunction
188 (1.01%)
Exposure To Contaminated Device
185 (1%)
Treatment Noncompliance
173 (.93%)
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Condition Aggravated
170 (.92%)
Abnormal Behaviour
158 (.85%)
Completed Suicide
144 (.78%)
Depression
142 (.77%)
Extrapyramidal Disorder
135 (.73%)
Anxiety
129 (.7%)
Schizophrenia
128 (.69%)
Fatigue
122 (.66%)
Weight Decreased
119 (.64%)
Delusion
118 (.64%)
Suicidal Ideation
118 (.64%)
Tremor
117 (.63%)
Diabetes Mellitus
116 (.63%)
Insomnia
113 (.61%)
Musculoskeletal Stiffness
113 (.61%)
Blood Prolactin Increased
110 (.59%)
Myocardial Infarction
109 (.59%)
Hypertension
108 (.58%)
Hallucination, Auditory
106 (.57%)
Tardive Dyskinesia
104 (.56%)
Neuroleptic Malignant Syndrome
100 (.54%)
Drug Interaction
97 (.52%)
Fall
95 (.51%)
Blood Creatine Phosphokinase Increa...
94 (.51%)
Dizziness
93 (.5%)
Confusional State
92 (.5%)
Agitation
91 (.49%)
Product Quality Issue
90 (.49%)
Hallucination
88 (.47%)
Dyspnoea
87 (.47%)
Suicide Attempt
87 (.47%)
Gait Disturbance
85 (.46%)
Pulmonary Embolism
84 (.45%)
Akathisia
80 (.43%)
Dysphagia
80 (.43%)
Restlessness
80 (.43%)
Vomiting
79 (.43%)
Feeling Abnormal
78 (.42%)
Nausea
77 (.42%)
Deep Vein Thrombosis
76 (.41%)
Somnolence
75 (.4%)
Drug Exposure During Pregnancy
74 (.4%)
Leukopenia
71 (.38%)
Malaise
71 (.38%)
Pain
71 (.38%)
Pneumonia
69 (.37%)
Loss Of Consciousness
66 (.36%)
Adverse Event
65 (.35%)
Dystonia
65 (.35%)
Hyperprolactinaemia
65 (.35%)
Paranoia
65 (.35%)
Speech Disorder
65 (.35%)
Convulsion
64 (.35%)
Oedema Peripheral
64 (.35%)
Headache
62 (.33%)
Neutropenia
61 (.33%)
Cerebrovascular Accident
59 (.32%)
Coma
59 (.32%)
Drug Dose Omission
59 (.32%)
Incorrect Dose Administered
59 (.32%)
Dyskinesia
58 (.31%)
Muscle Spasms
58 (.31%)
Pyrexia
58 (.31%)
Delirium
57 (.31%)
Tachycardia
56 (.3%)
Thrombocytopenia
56 (.3%)
Vision Blurred
56 (.3%)
Back Pain
55 (.3%)
Decreased Appetite
55 (.3%)
Incorrect Route Of Drug Administrat...
55 (.3%)
Muscle Twitching
55 (.3%)
Rash
55 (.3%)
Asthenia
52 (.28%)
Cardiac Arrest
52 (.28%)
Hypotension
52 (.28%)
Chest Pain
51 (.28%)
Dissociation
51 (.28%)
Injection Site Pain
51 (.28%)
Disturbance In Attention
50 (.27%)
Sudden Death
50 (.27%)
Amnesia
49 (.26%)
Irritability
49 (.26%)
Off Label Use
49 (.26%)
Abdominal Distension
48 (.26%)
Blood Glucose Increased
48 (.26%)
Hyponatraemia
48 (.26%)
Torticollis
47 (.25%)
Unevaluable Event
47 (.25%)
Medication Error
46 (.25%)
Sedation
46 (.25%)

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This graph shows the top adverse events submitted to the FDA for Risperdal Consta, 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 Risperdal Consta 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 Risperdal Consta

What are the most common Risperdal Consta adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Risperdal Consta, 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 Risperdal Consta 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 Risperdal Consta According to Those Reporting Adverse Events

Why are people taking Risperdal Consta, according to those reporting adverse events to the FDA?

Schizophrenia
1524
Drug Use For Unknown Indication
1081
Product Used For Unknown Indication
541
Schizophrenia, Paranoid Type
319
Psychotic Disorder
315
Schizoaffective Disorder
218
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Bipolar Disorder
150
Accidental Exposure
140
Ill-defined Disorder
88
Drug Exposure During Pregnancy
25
Delusion
24
Major Depression
23
Bipolar I Disorder
22
Abnormal Behaviour
22
Mental Disorder
21
Paranoia
20
Delirium
14
Depression
14
Schizoaffective Disorder Bipolar Ty...
14
Dementia
13
Post-traumatic Stress Disorder
13
Brain Injury
12
Delusional Disorder, Persecutory Ty...
12
Schizophrenia, Disorganised Type
10
Mania
9
Mental Retardation
9
Aggression
9
Affective Disorder
9
Delusional Disorder, Unspecified Ty...
8
Persecutory Delusion
8
Personality Disorder
8
Borderline Personality Disorder
8
Injury Associated With Device
7
Antidepressant Therapy
7
Obsessive-compulsive Disorder
7
Acute Psychosis
7
Hallucination
6
Schizoid Personality Disorder
4
Learning Disability
4
Childhood Psychosis
4
Foetal Exposure During Pregnancy
4
Hallucination, Auditory
4
Agitation
4
Autism
4
Mild Mental Retardation
3
Intentional Drug Misuse
3
Affect Lability
3
Attention Deficit/hyperactivity Dis...
3
Psychiatric Symptom
3
Epilepsy
3
Schizophrenia, Residual Type
3

Drug Labels

LabelLabelerEffective
Risperdal ConstaJanssen Pharmaceuticals, Inc.29-JUN-12

Risperdal Consta Case Reports

What Risperdal Consta 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 Risperdal Consta. 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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