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INVEGA SUSTENNA

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Invega Sustenna Adverse Events Reported to the FDA Over Time

How are Invega Sustenna adverse event reports trending over time?

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

Most Common Invega Sustenna Adverse Events Reported to the FDA

What are the most common Invega Sustenna adverse events reported to the FDA?

Product Quality Issue
337 (3.7%)
Drug Dose Omission
316 (3.47%)
Drug Ineffective
253 (2.78%)
Inappropriate Schedule Of Drug Admi...
226 (2.48%)
Weight Increased
172 (1.89%)
Injection Site Nodule
158 (1.73%)
Psychotic Disorder
148 (1.62%)
Injection Site Pain
144 (1.58%)
Condition Aggravated
132 (1.45%)
Incorrect Dose Administered
119 (1.31%)
Device Leakage
115 (1.26%)
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Aggression
105 (1.15%)
Hospitalisation
103 (1.13%)
Schizophrenia
103 (1.13%)
Galactorrhoea
102 (1.12%)
Injection Site Mass
96 (1.05%)
Blood Prolactin Increased
95 (1.04%)
Akathisia
87 (.95%)
Agitation
85 (.93%)
Dizziness
81 (.89%)
Paranoia
78 (.86%)
Injection Site Reaction
77 (.84%)
Extrapyramidal Disorder
74 (.81%)
Hallucination, Auditory
70 (.77%)
Therapeutic Response Decreased
69 (.76%)
Musculoskeletal Stiffness
65 (.71%)
Tremor
65 (.71%)
Delusion
63 (.69%)
Drug Effect Decreased
63 (.69%)
Insomnia
63 (.69%)
Confusional State
61 (.67%)
Depression
57 (.63%)
Treatment Noncompliance
57 (.63%)
Adverse Event
56 (.61%)
Feeling Abnormal
55 (.6%)
Hallucination
55 (.6%)
Sedation
55 (.6%)
Dyspnoea
54 (.59%)
Abnormal Behaviour
53 (.58%)
Amenorrhoea
53 (.58%)
Drug Administered At Inappropriate ...
53 (.58%)
Anxiety
52 (.57%)
Injection Site Erythema
52 (.57%)
Fatigue
51 (.56%)
Tardive Dyskinesia
50 (.55%)
Malaise
49 (.54%)
Accidental Exposure
48 (.53%)
Underdose
48 (.53%)
Suicidal Ideation
47 (.52%)
Weight Decreased
46 (.5%)
Anger
45 (.49%)
Dyskinesia
45 (.49%)
Pain In Extremity
45 (.49%)
Neuroleptic Malignant Syndrome
44 (.48%)
Syringe Issue
44 (.48%)
Injection Site Swelling
42 (.46%)
Overdose
41 (.45%)
Restlessness
38 (.42%)
Dystonia
37 (.41%)
Headache
37 (.41%)
Oedema Peripheral
37 (.41%)
Asthenia
36 (.39%)
Device Malfunction
36 (.39%)
Drooling
35 (.38%)
Wrong Technique In Drug Usage Proce...
33 (.36%)
Convulsion
32 (.35%)
Vision Blurred
32 (.35%)
Blood Glucose Increased
31 (.34%)
Erectile Dysfunction
30 (.33%)
Rash
30 (.33%)
Adverse Drug Reaction
29 (.32%)
Completed Suicide
29 (.32%)
Gait Disturbance
29 (.32%)
Pain
28 (.31%)
Muscle Rigidity
27 (.3%)
Vomiting
27 (.3%)
Nausea
26 (.29%)
Somnolence
26 (.29%)
Injection Site Cellulitis
25 (.27%)
Lethargy
25 (.27%)
Pyrexia
25 (.27%)
Suicide Attempt
25 (.27%)
Eye Movement Disorder
24 (.26%)
Fall
24 (.26%)
Heart Rate Increased
24 (.26%)
Needle Issue
24 (.26%)
Swollen Tongue
24 (.26%)
Chest Pain
23 (.25%)
Refusal Of Treatment By Patient
23 (.25%)
Syncope
23 (.25%)
Cellulitis
22 (.24%)
Death
22 (.24%)
Incorrect Route Of Drug Administrat...
22 (.24%)
Mental Disorder
22 (.24%)
Disorientation
21 (.23%)
Hypersensitivity
21 (.23%)
Mania
21 (.23%)
Medication Error
21 (.23%)
Mental Impairment
21 (.23%)
Muscular Weakness
21 (.23%)
Parkinsonism
21 (.23%)

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

What are the most common Invega Sustenna adverse events reported to the FDA?

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

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

Product Used For Unknown Indication
1285
Schizophrenia
1094
Schizoaffective Disorder
232
Drug Use For Unknown Indication
168
Bipolar Disorder
150
Psychotic Disorder
114
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Schizophrenia, Paranoid Type
64
Ill-defined Disorder
48
Bipolar I Disorder
25
Accidental Exposure
20
Major Depression
13
Schizoaffective Disorder Bipolar Ty...
9
Hallucination, Auditory
8
Mental Disorder
8
Autism
6
Paranoia
5
Obsessive-compulsive Disorder
5
Post-traumatic Stress Disorder
4
Depression
3
Delusion
3
Mania
3
Panic Disorder
3
Anxiety
3
Aggression
3
Schizophrenia, Undifferentiated Typ...
2
Affective Disorder
2
Drug Dependence
2
Learning Disability
2
Delusional Disorder, Unspecified Ty...
2
Mental Retardation
2
Aspergers Disorder
2
Anger
2
Schizophrenia, Disorganised Type
2
Mood Swings
2
Somatoform Disorder
1
Intentional Self-injury
1
Traumatic Brain Injury
1
Tachyphrenia
1
Cognitive Disorder
1
Cerebral Disorder
1
Psychotic Behaviour
1
Abnormal Behaviour
1
Treatment Noncompliance
1
Emotional Disorder
1
Exposure During Breast Feeding
1
Psychiatric Symptom
1
Mental Impairment
1
Substance Use
1
Hallucination, Tactile
1
Unevaluable Event
1
Schizophreniform Disorder
1

Drug Labels

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

Invega Sustenna Case Reports

What Invega Sustenna 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 Invega Sustenna. 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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