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PALIPERIDONE

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Paliperidone Adverse Events Reported to the FDA Over Time

How are Paliperidone adverse event reports trending over time?

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

Most Common Paliperidone Adverse Events Reported to the FDA

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

Weight Increased
487 (1.89%)
Drug Ineffective
481 (1.87%)
Psychotic Disorder
459 (1.78%)
Product Quality Issue
383 (1.49%)
Drug Dose Omission
350 (1.36%)
Galactorrhoea
345 (1.34%)
Schizophrenia
314 (1.22%)
Inappropriate Schedule Of Drug Admi...
296 (1.15%)
Blood Prolactin Increased
295 (1.14%)
Extrapyramidal Disorder
288 (1.12%)
Aggression
277 (1.08%)
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Depression
274 (1.06%)
Anxiety
273 (1.06%)
Insomnia
270 (1.05%)
Suicidal Ideation
267 (1.04%)
Dizziness
253 (.98%)
Akathisia
249 (.97%)
Tremor
248 (.96%)
Suicide Attempt
237 (.92%)
Agitation
229 (.89%)
Condition Aggravated
216 (.84%)
Dystonia
202 (.78%)
Dyspnoea
195 (.76%)
Somnolence
180 (.7%)
Fatigue
174 (.68%)
Hallucination, Auditory
174 (.68%)
Neuroleptic Malignant Syndrome
169 (.66%)
Incorrect Dose Administered
168 (.65%)
Tardive Dyskinesia
167 (.65%)
Hospitalisation
166 (.64%)
Amenorrhoea
163 (.63%)
Injection Site Nodule
163 (.63%)
Musculoskeletal Stiffness
162 (.63%)
Headache
161 (.62%)
Restlessness
160 (.62%)
Dyskinesia
156 (.61%)
Injection Site Pain
154 (.6%)
Delusion
148 (.57%)
Completed Suicide
146 (.57%)
Paranoia
145 (.56%)
Sedation
142 (.55%)
Abnormal Behaviour
140 (.54%)
Weight Decreased
138 (.54%)
Confusional State
137 (.53%)
Oedema Peripheral
137 (.53%)
Mania
135 (.52%)
Convulsion
134 (.52%)
Treatment Noncompliance
128 (.5%)
Vomiting
126 (.49%)
Tachycardia
125 (.49%)
Device Leakage
121 (.47%)
Asthenia
120 (.47%)
Nausea
120 (.47%)
Hallucination
114 (.44%)
Malaise
112 (.43%)
Hyperprolactinaemia
111 (.43%)
Overdose
109 (.42%)
Feeling Abnormal
108 (.42%)
Intentional Overdose
107 (.42%)
Rash
103 (.4%)
Death
101 (.39%)
Injection Site Mass
100 (.39%)
Wrong Technique In Drug Usage Proce...
100 (.39%)
Pain In Extremity
99 (.38%)
Adverse Event
98 (.38%)
Blood Glucose Increased
91 (.35%)
Hypertension
91 (.35%)
Gait Disturbance
87 (.34%)
Anger
85 (.33%)
Pain
85 (.33%)
Pyrexia
84 (.33%)
Dysphagia
83 (.32%)
Drug Interaction
82 (.32%)
Therapeutic Response Decreased
82 (.32%)
Drooling
80 (.31%)
Drug Effect Decreased
80 (.31%)
Fall
80 (.31%)
Syncope
80 (.31%)
Injection Site Reaction
79 (.31%)
Rhabdomyolysis
78 (.3%)
Off Label Use
77 (.3%)
Swollen Tongue
77 (.3%)
Vision Blurred
77 (.3%)
Hypotension
76 (.29%)
Self Injurious Behaviour
76 (.29%)
Muscle Rigidity
75 (.29%)
Palpitations
75 (.29%)
Diarrhoea
74 (.29%)
Muscle Twitching
72 (.28%)
Chest Pain
70 (.27%)
Drug Administered At Inappropriate ...
69 (.27%)
Irritability
69 (.27%)
Muscle Spasms
68 (.26%)
Erectile Dysfunction
67 (.26%)
Myalgia
67 (.26%)
Blood Creatine Phosphokinase Increa...
66 (.26%)
Constipation
62 (.24%)
Hyponatraemia
61 (.24%)
Injection Site Erythema
61 (.24%)
Muscular Weakness
61 (.24%)
Drug Administration Error
60 (.23%)

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

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

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

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

Schizophrenia
2811
Product Used For Unknown Indication
1959
Drug Use For Unknown Indication
1169
Bipolar Disorder
574
Schizoaffective Disorder
525
Psychotic Disorder
392
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Schizophrenia, Paranoid Type
305
Bipolar I Disorder
124
Ill-defined Disorder
84
Depression
73
Major Depression
47
Paranoia
41
Affective Disorder
41
Anxiety
37
Attention Deficit/hyperactivity Dis...
30
Drug Therapy
29
Hallucination, Auditory
24
Accidental Exposure
24
Autism
23
Obsessive-compulsive Disorder
23
Schizophrenia, Disorganised Type
23
Delusion
22
Hallucination
22
Mental Disorder
21
Post-traumatic Stress Disorder
19
Abnormal Behaviour
15
Mania
15
Schizoaffective Disorder Bipolar Ty...
14
Aggression
13
Agitation
12
Delusional Disorder, Unspecified Ty...
11
Bipolar Ii Disorder
10
Borderline Personality Disorder
10
Aspergers Disorder
9
Oppositional Defiant Disorder
9
Mood Swings
8
Delusional Disorder, Persecutory Ty...
7
Schizophrenia, Residual Type
7
Intentional Overdose
7
Dementia
6
Anxiety Disorder
6
Autism Spectrum Disorder
6
Schizophrenia, Undifferentiated Typ...
6
Mental Retardation Severity Unspeci...
6
Panic Disorder
5
Thinking Abnormal
5
Delirium
5
Suicidal Ideation
5
Mental Impairment
5
Unevaluable Event
5
Tourettes Disorder
5

Drug Labels

LabelLabelerEffective
InvegaRebel Distributors Corp28-DEC-10
InvegaJanssen Pharmaceuticals, Inc.01-JUN-11
Invega SustennaJanssen Pharmaceuticals, Inc.22-OCT-12
InvegaREMEDYREPACK INC. 27-MAR-13

Paliperidone Case Reports

What Paliperidone 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 Paliperidone. 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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