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RISPERIDONE

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Risperidone Adverse Events Reported to the FDA Over Time

How are Risperidone adverse event reports trending over time?

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

Most Common Risperidone Adverse Events Reported to the FDA

What are the most common Risperidone adverse events reported to the FDA?

Drug Interaction
482 (1.78%)
Psychotic Disorder
392 (1.45%)
Neuroleptic Malignant Syndrome
371 (1.37%)
Drug Ineffective
328 (1.21%)
Weight Increased
310 (1.14%)
Anxiety
282 (1.04%)
Completed Suicide
280 (1.03%)
Tremor
266 (.98%)
Extrapyramidal Disorder
265 (.98%)
Somnolence
233 (.86%)
Aggression
228 (.84%)
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Condition Aggravated
196 (.72%)
Confusional State
193 (.71%)
Overdose
189 (.7%)
Depression
188 (.69%)
Agitation
185 (.68%)
Hyperprolactinaemia
184 (.68%)
Suicidal Ideation
180 (.66%)
Abnormal Behaviour
176 (.65%)
Suicide Attempt
176 (.65%)
Insomnia
167 (.62%)
Neutropenia
156 (.58%)
Vomiting
156 (.58%)
Death
154 (.57%)
Dyskinesia
153 (.56%)
Treatment Noncompliance
153 (.56%)
Dystonia
152 (.56%)
Tachycardia
150 (.55%)
Fall
149 (.55%)
Weight Decreased
147 (.54%)
Schizophrenia
143 (.53%)
Salivary Hypersecretion
140 (.52%)
Blood Creatine Phosphokinase Increa...
138 (.51%)
Hallucination, Auditory
138 (.51%)
Nausea
137 (.51%)
Pyrexia
136 (.5%)
Rhabdomyolysis
128 (.47%)
Fatigue
127 (.47%)
Electrocardiogram Qt Prolonged
126 (.46%)
Headache
125 (.46%)
Malaise
121 (.45%)
Convulsion
118 (.44%)
Tardive Dyskinesia
117 (.43%)
Dizziness
116 (.43%)
Hypotension
115 (.42%)
Loss Of Consciousness
115 (.42%)
Serotonin Syndrome
112 (.41%)
Musculoskeletal Stiffness
111 (.41%)
Hyperhidrosis
110 (.41%)
Muscle Rigidity
109 (.4%)
Thrombocytopenia
108 (.4%)
Drug Toxicity
107 (.39%)
Sedation
103 (.38%)
Delusion
98 (.36%)
Blood Prolactin Increased
97 (.36%)
Off Label Use
97 (.36%)
Restlessness
95 (.35%)
Parkinsonism
94 (.35%)
Akathisia
91 (.34%)
Hyponatraemia
91 (.34%)
Urinary Incontinence
90 (.33%)
Cardiac Arrest
89 (.33%)
Lethargy
89 (.33%)
Multiple Drug Overdose Intentional
89 (.33%)
Dyspnoea
88 (.32%)
Respiratory Arrest
88 (.32%)
Speech Disorder
87 (.32%)
Catatonia
85 (.31%)
Disorientation
85 (.31%)
Feeling Abnormal
85 (.31%)
Hallucination
84 (.31%)
Pulmonary Embolism
84 (.31%)
Gait Disturbance
83 (.31%)
Galactorrhoea
83 (.31%)
Coma
82 (.3%)
Paranoia
82 (.3%)
Asthenia
81 (.3%)
Product Substitution Issue
81 (.3%)
Mental Impairment
79 (.29%)
Dysphagia
76 (.28%)
Diarrhoea
75 (.28%)
Pain
75 (.28%)
White Blood Cell Count Decreased
74 (.27%)
Alanine Aminotransferase Increased
73 (.27%)
Drug Exposure During Pregnancy
73 (.27%)
Heart Rate Increased
71 (.26%)
Multiple Drug Overdose
70 (.26%)
Cardio-respiratory Arrest
69 (.25%)
Hospitalisation
69 (.25%)
Mental Status Changes
69 (.25%)
Priapism
69 (.25%)
Irritability
67 (.25%)
Dysarthria
66 (.24%)
Hypertension
65 (.24%)
Respiratory Failure
65 (.24%)
Amenorrhoea
64 (.24%)
Hypothermia
64 (.24%)
Decreased Appetite
63 (.23%)
Obsessive-compulsive Disorder
62 (.23%)
Constipation
61 (.23%)
Dehydration
61 (.23%)

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

What are the most common Risperidone adverse events reported to the FDA?

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

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

Schizophrenia
1197
Product Used For Unknown Indication
811
Drug Use For Unknown Indication
774
Psychotic Disorder
645
Bipolar Disorder
374
Schizophrenia, Paranoid Type
240
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Depression
235
Schizoaffective Disorder
204
Agitation
144
Anxiety
124
Attention Deficit/hyperactivity Dis...
107
Aggression
103
Obsessive-compulsive Disorder
102
Dementia
91
Autism
89
Abnormal Behaviour
89
Ill-defined Disorder
80
Major Depression
76
Bipolar I Disorder
73
Affective Disorder
54
Insomnia
54
Dementia Alzheimers Type
49
Mania
47
Mental Disorder
44
Drug Exposure During Pregnancy
40
Acute Psychosis
38
Tourettes Disorder
38
Hallucination
36
Suicide Attempt
35
Delusion
32
Post-traumatic Stress Disorder
31
Disturbance In Social Behaviour
31
Parkinsons Disease
28
Delirium
27
Psychomotor Hyperactivity
27
Paranoia
24
Sleep Disorder
23
Hallucination, Auditory
22
Psychiatric Symptom
22
Restlessness
20
Delusional Disorder, Unspecified Ty...
18
Psychotic Behaviour
18
Conduct Disorder
16
Aspergers Disorder
15
Schizophreniform Disorder
15
Confusional State
15
Mood Altered
12
Epilepsy
12
Hypomania
12
Schizoaffective Disorder Bipolar Ty...
12
Oppositional Defiant Disorder
12

Drug Labels

LabelLabelerEffective
RisperidoneWest-ward Pharmaceutical Corp31-AUG-09
RisperidoneWOCKHARDT USA LLC.14-OCT-09
RisperidonePhysicians Total Care, Inc29-OCT-09
RisperidoneGreenstone LLC12-NOV-09
RisperidoneState of Florida DOH Central Pharmacy20-MAY-10
RisperidoneState of Florida DOH Central Pharmacy20-MAY-10
RisperidoneState of Florida DOH Central Pharmacy21-MAY-10
Risperidone Ratiopharm Inc31-MAY-10
RisperidonePD-Rx Pharmaceuticals, Inc.23-JUN-10
Risperidone Oral Disintegrate TabletsRanbaxy Pharmaceuticals Inc.18-AUG-10
RisperidoneContract Pharmacy Services-PA25-AUG-10
RisperidoneBayPharma Inc30-AUG-10
RisperdalPhysicians Total Care, Inc.14-OCT-10
RisperidoneContract Pharmacy Services-PA22-OCT-10
RisperidoneREMEDYREPACK INC. 08-NOV-10
RisperidoneWOCKHARDT LIMITED10-NOV-10
RisperidoneRebel Distributors Corp11-NOV-10
RisperdalRebel Distributors Corp27-DEC-10
RisperidoneCobalt Laboratories04-FEB-11
RisperidoneMylan Institutional Inc.11-FEB-11
Risperidone REMEDYREPACK INC. 28-MAR-11
Risperidone REMEDYREPACK INC. 11-APR-11
Risperidone Atlantic Biologicals Corps31-MAY-11
RisperidoneCardinal Health10-JUN-11
RisperidoneGen-Source Rx22-JUN-11
RisperidoneRoxane Laboratories, Inc01-AUG-11
RisperidoneRoxane Laboratories, Inc01-AUG-11
RisperidoneHikma Pharmaceutical09-AUG-11
RisperdalPD-Rx Pharmaceuticals, Inc.01-SEP-11
RisperdalPD-Rx Pharmaceuticals, Inc.01-SEP-11
RisperdalPD-Rx Pharmaceuticals, Inc.01-SEP-11
RisperdalPD-Rx Pharmaceuticals, Inc.01-SEP-11
RisperidoneCardinal Health26-SEP-11
RisperidoneSTAT Rx USA LLC06-OCT-11
RisperidoneMylan Institutional Inc.04-NOV-11
RisperidoneDr. Reddy's Laboratories Limited05-NOV-11
RisperidoneDr. Reddy's Laboratories Limited05-NOV-11
RisperidoneTaro Pharmaceuticals U.S.A., Inc.11-JAN-12
RisperidoneH.J. Harkins Company, Inc.19-JAN-12
RisperidoneCadila Healthcare Limited27-JAN-12
RisperidoneMcKesson Packaging Services a business unit of McKesson Corporation13-FEB-12
RisperidoneSandoz Inc20-MAR-12
RisperidoneAurolife Pharma LLC11-MAY-12
RisperidoneMcKesson Contract Packaging11-MAY-12
RisperdalCardinal Health17-MAY-12
RisperidoneMajor Pharmaceuticals22-JUN-12
Risperdal ConstaJanssen Pharmaceuticals, Inc.29-JUN-12
RisperidonePar Pharmaceutical Companies, Inc.25-JUL-12
RisperidoneTeva Pharmaceuticals USA Inc25-JUL-12
RisperidoneAmneal Pharmaceuticals27-JUL-12
RisperidoneQualitest Pharmaceuticals01-AUG-12
RisperidoneQualitest Pharmaceuticals01-AUG-12
RisperidoneBreckenridge Pharmaceutical, Inc.14-AUG-12
RisperdalJanssen Pharmaceuticals, Inc.15-AUG-12
Risperdal M-tabJanssen Pharmaceuticals, Inc.15-AUG-12
RisperidoneJanssen Pharmaceutical, Inc.31-AUG-12
Risperidone M-tabJanssen Pharmaceutical, Inc.31-AUG-12
RisperidoneAmerican Health Packaging01-SEP-12
RisperidoneAurobindo Pharma Limited15-OCT-12
Risperidone WOCKHARDT LIMITED18-OCT-12
Risperidone WOCKHARDT USA LLC18-OCT-12
RisperidoneDr. Reddy's Laboratories Limited19-OCT-12
RisperidoneZydus Pharmaceuticals (USA) Inc.24-OCT-12
RisperidoneTorrent Pharmaceuticals Limited26-OCT-12
Risperidone Jubilant Cadista Pharmaceuticals Inc.06-NOV-12
RisperidoneAurobindo Pharma Limited26-NOV-12
RisperidoneCadila Healthcare Limited28-NOV-12
RisperidoneTris Pharma Inc12-DEC-12
RisperidoneApotex Corp.01-JAN-13
RisperidoneMylan Pharmaceuticals Inc.10-JAN-13
RisperidoneMylan Pharmaceuticals Inc.15-JAN-13
RisperidoneBryant Ranch Prepack17-JAN-13
RisperidoneBryant Ranch Prepack17-JAN-13
RisperidoneBryant Ranch Prepack17-JAN-13
RisperidoneBryant Ranch Prepack17-JAN-13
RisperidoneBryant Ranch Prepack17-JAN-13
RisperidoneBryant Ranch Prepack18-JAN-13
RisperidoneZydus Pharmaceuticals (USA) Inc.21-JAN-13
RisperidoneApotex Corp01-FEB-13
RisperidoneNCS HealthCare of KY, Inc dba Vangard Labs19-FEB-13
RisperidoneREMEDYREPACK INC. 05-MAR-13
RisperidoneREMEDYREPACK INC. 18-MAR-13
RisperidoneCardinal Health20-MAR-13
RisperidoneSun Pharmaceutical Industries Limited 13-APR-13
RisperidoneSandoz Inc23-APR-13
RisperidoneREMEDYREPACK INC. 23-APR-13
RisperidoneREMEDYREPACK INC. 23-APR-13
RisperidoneREMEDYREPACK INC. 23-APR-13
RisperidoneREMEDYREPACK INC. 24-APR-13
RisperidoneREMEDYREPACK INC. 24-APR-13
RisperidoneREMEDYREPACK INC. 24-APR-13
RisperidoneCardinal Health26-APR-13
RisperidoneREMEDYREPACK INC. 30-APR-13
RisperidoneREMEDYREPACK INC. 01-MAY-13
RisperidoneREMEDYREPACK INC. 01-MAY-13
RisperidoneREMEDYREPACK INC. 01-MAY-13
RisperidoneREMEDYREPACK INC. 01-MAY-13
RisperidoneREMEDYREPACK INC. 01-MAY-13
RisperidoneREMEDYREPACK INC. 06-MAY-13

Risperidone Case Reports

What Risperidone 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 Risperidone. 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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