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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

INVEGA SUSTENNA: 656 Adverse Event Reports & Safety Profile

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656
Total FAERS Reports
11 (1.7%)
Deaths Reported
91
Hospitalizations
656
As Primary/Secondary Suspect
4
Life-Threatening
6
Disabilities

First Report: 1984 · Latest Report: 20140617

What Are the Most Common INVEGA SUSTENNA Side Effects?

#1 Most Reported
Drug dose omission
98 reports (14.9%)
#2 Most Reported
Drug ineffective
58 reports (8.8%)
#3 Most Reported
Inappropriate schedule of drug administration
39 reports (5.9%)

All INVEGA SUSTENNA Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug dose omission 98 14.9% 1 8
Drug ineffective 58 8.8% 1 11
Inappropriate schedule of drug administration 39 6.0% 0 7
Weight increased 34 5.2% 0 1
Blood prolactin increased 27 4.1% 0 0
Galactorrhoea 25 3.8% 0 1
Injection site mass 20 3.1% 0 0
Injection site nodule 19 2.9% 0 1
Injection site pain 19 2.9% 1 1
Investigation 17 2.6% 0 17
Off label use 17 2.6% 0 5
Psychotic disorder 17 2.6% 0 4
Akathisia 14 2.1% 0 3
Gynaecomastia 14 2.1% 0 2
Hallucination, auditory 14 2.1% 0 2
Injection site swelling 14 2.1% 0 0
Drug effect decreased 13 2.0% 0 1
Incorrect dose administered 13 2.0% 0 1
Treatment noncompliance 13 2.0% 0 5
Adverse event 12 1.8% 0 1

Who Reports INVEGA SUSTENNA Side Effects? Age & Gender Data

Average age: 38.8 years. Most reports from: US. View detailed demographics →

Is INVEGA SUSTENNA Getting Safer? Reports by Year

YearReportsDeathsHosp.
2010 3 0 2
2011 2 0 1
2012 9 1 3
2013 61 1 8
2014 204 2 40

View full timeline →

What Is INVEGA SUSTENNA Used For?

IndicationReports
Product used for unknown indication 366
Schizophrenia 184
Schizoaffective disorder 42
Bipolar disorder 21
Psychotic disorder 16
Schizophrenia, paranoid type 13

INVEGA SUSTENNA vs Alternatives: Which Is Safer?

INVEGA SUSTENNA vs INVESTIGATIONAL BIOSIMILARS INVEGA SUSTENNA vs INVESTIGATIONAL PRODUCT INVEGA SUSTENNA vs INVOKANA INVEGA SUSTENNA vs IOBENGUANE I-131 INVEGA SUSTENNA vs IOBITRIDOL INVEGA SUSTENNA vs IODINE INVEGA SUSTENNA vs IODINE\IOFLUPANE I-123 INVEGA SUSTENNA vs IODIXANOL INVEGA SUSTENNA vs IOHEXOL INVEGA SUSTENNA vs IOMEPROL

Official FDA Label for INVEGA SUSTENNA

Official prescribing information from the FDA-approved drug label.