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RISPERDAL

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Risperdal Adverse Events Reported to the FDA Over Time

How are Risperdal adverse event reports trending over time?

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

Most Common Risperdal Adverse Events Reported to the FDA

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

Weight Increased
1218 (1.65%)
Diabetes Mellitus
1118 (1.52%)
Somnolence
870 (1.18%)
Death
821 (1.11%)
Suicide Attempt
723 (.98%)
Drug Interaction
648 (.88%)
Drug Ineffective
631 (.86%)
Aggression
602 (.82%)
Fall
593 (.81%)
Overdose
584 (.79%)
Neuroleptic Malignant Syndrome
557 (.76%)
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Extrapyramidal Disorder
553 (.75%)
Type 2 Diabetes Mellitus
545 (.74%)
Psychotic Disorder
518 (.7%)
Tremor
512 (.7%)
Fatigue
474 (.64%)
Hospitalisation
474 (.64%)
Tardive Dyskinesia
474 (.64%)
Abnormal Behaviour
461 (.63%)
Insomnia
447 (.61%)
Confusional State
442 (.6%)
Self Injurious Behaviour
439 (.6%)
Treatment Noncompliance
437 (.59%)
Anxiety
433 (.59%)
Depression
431 (.59%)
Agitation
429 (.58%)
Suicidal Ideation
426 (.58%)
Intentional Overdose
415 (.56%)
Dizziness
408 (.55%)
Convulsion
396 (.54%)
Condition Aggravated
395 (.54%)
Pneumonia
395 (.54%)
Tachycardia
389 (.53%)
Leukopenia
386 (.52%)
Pyrexia
368 (.5%)
Hallucination
362 (.49%)
Rhabdomyolysis
361 (.49%)
Vomiting
359 (.49%)
Hypotension
354 (.48%)
Restlessness
349 (.47%)
Blood Prolactin Increased
345 (.47%)
Blood Creatine Phosphokinase Increa...
338 (.46%)
Dyskinesia
328 (.45%)
Completed Suicide
327 (.44%)
Off Label Use
322 (.44%)
Akathisia
320 (.43%)
Dysphagia
319 (.43%)
Delusion
317 (.43%)
Gait Disturbance
316 (.43%)
Hyponatraemia
309 (.42%)
Inappropriate Schedule Of Drug Admi...
309 (.42%)
Thrombocytopenia
308 (.42%)
Weight Decreased
308 (.42%)
Neutropenia
298 (.4%)
Drug Exposure During Pregnancy
294 (.4%)
Myocardial Infarction
294 (.4%)
Malaise
292 (.4%)
Coma
290 (.39%)
Loss Of Consciousness
289 (.39%)
Sedation
287 (.39%)
Dyspnoea
284 (.39%)
Schizophrenia
282 (.38%)
Pulmonary Embolism
281 (.38%)
Musculoskeletal Stiffness
277 (.38%)
Hypertension
276 (.37%)
Nausea
276 (.37%)
Feeling Abnormal
267 (.36%)
Multiple Drug Overdose Intentional
265 (.36%)
Depressed Level Of Consciousness
259 (.35%)
Asthenia
258 (.35%)
Hyperprolactinaemia
253 (.34%)
Headache
249 (.34%)
White Blood Cell Count Decreased
238 (.32%)
Speech Disorder
237 (.32%)
Galactorrhoea
231 (.31%)
Blood Glucose Increased
230 (.31%)
Medication Error
227 (.31%)
Cerebrovascular Accident
225 (.31%)
Bradycardia
223 (.3%)
Dehydration
219 (.3%)
Hallucination, Auditory
218 (.3%)
Anaemia
217 (.29%)
Constipation
206 (.28%)
Delirium
206 (.28%)
Rash
204 (.28%)
Pain
203 (.28%)
Parkinsonism
202 (.27%)
Device Malfunction
200 (.27%)
Incorrect Dose Administered
200 (.27%)
Electrocardiogram Qt Prolonged
199 (.27%)
Exposure To Contaminated Device
196 (.27%)
Dystonia
192 (.26%)
General Physical Health Deteriorati...
186 (.25%)
Oedema Peripheral
186 (.25%)
Muscle Rigidity
182 (.25%)
Cardiac Failure
178 (.24%)
Syncope
177 (.24%)
Diabetic Ketoacidosis
174 (.24%)
Deep Vein Thrombosis
169 (.23%)
Pneumonia Aspiration
169 (.23%)
Paranoia
168 (.23%)

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

What are the most common Risperdal 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, 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 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 According to Those Reporting Adverse Events

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

Drug Use For Unknown Indication
4628
Schizophrenia
4279
Product Used For Unknown Indication
1999
Psychotic Disorder
1244
Bipolar Disorder
1189
Depression
1065
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Schizoaffective Disorder
638
Schizophrenia, Paranoid Type
628
Anxiety
419
Ill-defined Disorder
325
Dementia
264
Agitation
255
Abnormal Behaviour
251
Delirium
219
Aggression
207
Autism
197
Hallucination
185
Accidental Exposure
182
Attention Deficit/hyperactivity Dis...
165
Bipolar I Disorder
163
Mental Disorder
155
Delusion
147
Paranoia
143
Major Depression
139
Post-traumatic Stress Disorder
124
Insomnia
122
Affective Disorder
116
Restlessness
110
Mania
109
Drug Exposure During Pregnancy
105
Obsessive-compulsive Disorder
100
Sleep Disorder
95
Dementia Alzheimers Type
89
Sleep Disorder Therapy
71
Hallucination, Auditory
66
Personality Disorder
58
Self Injurious Behaviour
52
Delusional Disorder, Unspecified Ty...
45
Tourettes Disorder
42
Borderline Personality Disorder
39
Autism Spectrum Disorder
38
Aspergers Disorder
37
Anxiety Disorder
34
Persecutory Delusion
33
Delusional Disorder, Persecutory Ty...
32
Acute Psychosis
31
Behavioural And Psychiatric Symptom...
29
Impulsive Behaviour
29
Parkinsons Disease
29
Psychomotor Hyperactivity
28
Brain Injury
27

Drug Labels

LabelLabelerEffective
RisperdalPhysicians Total Care, Inc.14-OCT-10
RisperdalRebel Distributors Corp27-DEC-10
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
RisperdalCardinal Health17-MAY-12
Risperdal ConstaJanssen Pharmaceuticals, Inc.29-JUN-12
Risperdal M-tabJanssen Pharmaceuticals, Inc.15-AUG-12
RisperdalJanssen Pharmaceuticals, Inc.15-AUG-12
RisperdalREMEDYREPACK INC. 06-MAY-13

Risperdal Case Reports

What Risperdal 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. 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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