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PALIPERIDONE PALMITATE

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Paliperidone Palmitate Adverse Events Reported to the FDA Over Time

How are Paliperidone Palmitate adverse event reports trending over time?

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

Most Common Paliperidone Palmitate Adverse Events Reported to the FDA

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

Weight Increased
455 (2.03%)
Drug Ineffective
430 (1.92%)
Product Quality Issue
383 (1.71%)
Drug Dose Omission
338 (1.51%)
Galactorrhoea
334 (1.49%)
Blood Prolactin Increased
290 (1.3%)
Psychotic Disorder
283 (1.27%)
Inappropriate Schedule Of Drug Admi...
279 (1.25%)
Extrapyramidal Disorder
267 (1.19%)
Dizziness
228 (1.02%)
Tremor
224 (1%)
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Insomnia
209 (.93%)
Anxiety
200 (.89%)
Akathisia
198 (.89%)
Schizophrenia
193 (.86%)
Condition Aggravated
186 (.83%)
Agitation
185 (.83%)
Aggression
184 (.82%)
Dystonia
184 (.82%)
Dyspnoea
181 (.81%)
Depression
170 (.76%)
Tardive Dyskinesia
166 (.74%)
Somnolence
163 (.73%)
Injection Site Nodule
160 (.72%)
Suicidal Ideation
160 (.72%)
Neuroleptic Malignant Syndrome
158 (.71%)
Suicide Attempt
157 (.7%)
Amenorrhoea
156 (.7%)
Incorrect Dose Administered
153 (.68%)
Hospitalisation
150 (.67%)
Injection Site Pain
148 (.66%)
Dyskinesia
145 (.65%)
Headache
144 (.64%)
Fatigue
143 (.64%)
Hallucination, Auditory
140 (.63%)
Musculoskeletal Stiffness
138 (.62%)
Restlessness
135 (.6%)
Oedema Peripheral
128 (.57%)
Convulsion
126 (.56%)
Abnormal Behaviour
125 (.56%)
Paranoia
124 (.55%)
Sedation
124 (.55%)
Confusional State
120 (.54%)
Weight Decreased
119 (.53%)
Delusion
118 (.53%)
Device Leakage
115 (.51%)
Tachycardia
110 (.49%)
Asthenia
108 (.48%)
Vomiting
108 (.48%)
Nausea
107 (.48%)
Feeling Abnormal
104 (.46%)
Rash
103 (.46%)
Treatment Noncompliance
101 (.45%)
Injection Site Mass
98 (.44%)
Wrong Technique In Drug Usage Proce...
98 (.44%)
Malaise
95 (.42%)
Adverse Event
94 (.42%)
Completed Suicide
94 (.42%)
Hallucination
93 (.42%)
Hyperprolactinaemia
93 (.42%)
Pain In Extremity
92 (.41%)
Blood Glucose Increased
89 (.4%)
Overdose
88 (.39%)
Gait Disturbance
86 (.38%)
Therapeutic Response Decreased
82 (.37%)
Intentional Overdose
81 (.36%)
Mania
81 (.36%)
Pain
81 (.36%)
Drug Effect Decreased
80 (.36%)
Anger
79 (.35%)
Injection Site Reaction
79 (.35%)
Drooling
78 (.35%)
Hypertension
78 (.35%)
Pyrexia
77 (.34%)
Syncope
76 (.34%)
Dysphagia
75 (.34%)
Off Label Use
75 (.34%)
Vision Blurred
75 (.34%)
Rhabdomyolysis
73 (.33%)
Swollen Tongue
73 (.33%)
Muscle Twitching
72 (.32%)
Palpitations
72 (.32%)
Death
71 (.32%)
Fall
71 (.32%)
Drug Interaction
68 (.3%)
Self Injurious Behaviour
68 (.3%)
Chest Pain
67 (.3%)
Diarrhoea
66 (.3%)
Muscle Spasms
66 (.3%)
Drug Administered At Inappropriate ...
65 (.29%)
Erectile Dysfunction
64 (.29%)
Myalgia
64 (.29%)
Hypotension
62 (.28%)
Irritability
62 (.28%)
Muscle Rigidity
62 (.28%)
Drug Administration Error
59 (.26%)
Injection Site Erythema
59 (.26%)
Muscular Weakness
59 (.26%)
Blood Creatine Phosphokinase Increa...
58 (.26%)
Hypersensitivity
58 (.26%)
Hypoaesthesia
58 (.26%)

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

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

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

Schizophrenia
2253
Product Used For Unknown Indication
1808
Drug Use For Unknown Indication
1148
Bipolar Disorder
555
Schizoaffective Disorder
466
Psychotic Disorder
331
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Schizophrenia, Paranoid Type
227
Ill-defined Disorder
82
Bipolar I Disorder
79
Depression
67
Major Depression
44
Affective Disorder
40
Paranoia
37
Anxiety
35
Drug Therapy
29
Attention Deficit/hyperactivity Dis...
28
Accidental Exposure
24
Obsessive-compulsive Disorder
23
Mental Disorder
21
Autism
21
Hallucination
21
Hallucination, Auditory
20
Schizophrenia, Disorganised Type
20
Delusion
19
Post-traumatic Stress Disorder
19
Mania
14
Schizoaffective Disorder Bipolar Ty...
13
Aggression
13
Abnormal Behaviour
12
Agitation
12
Borderline Personality Disorder
10
Bipolar Ii Disorder
10
Aspergers Disorder
9
Delusional Disorder, Unspecified Ty...
9
Oppositional Defiant Disorder
9
Mood Swings
8
Delusional Disorder, Persecutory Ty...
7
Schizophrenia, Undifferentiated Typ...
6
Autism Spectrum Disorder
6
Schizophrenia, Residual Type
6
Dementia
6
Anxiety Disorder
6
Mental Retardation Severity Unspeci...
6
Tourettes Disorder
5
Mental Impairment
5
Unevaluable Event
5
Panic Disorder
5
Thinking Abnormal
5
Intentional Overdose
5
Delirium
5
Suicidal Ideation
4

Drug Labels

LabelLabelerEffective
Invega SustennaJanssen Pharmaceuticals, Inc.22-OCT-12

Paliperidone Palmitate Case Reports

What Paliperidone Palmitate 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 Palmitate. 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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