Paliperidone Palmitate

Common brands: Invega Sustenna, Invega Trinza, Invega Hafyera, Erzofri Extended-Release, Risperdal

Top reporter: Janssen Pharmaceuticals, Inc.

Atypical Antipsychotic [EPC]Benzodiazepine [EPC]Anti-epileptic Agent [EPC]Mood Stabilizer [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]
31,425
Total Reports
11,547
Serious Reports
1,160
Death Reports
30
Reported Reactions
Death Report Ratio: Moderate (3.69%)

Patient Demographics

Male
14,269
Female
9,324

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Paliperidone Palmitate.

# Reaction Reports % of Total
1 OFF LABEL USE 3,111
10.8%
2 DRUG INEFFECTIVE 2,183
7.6%
3 HOSPITALISATION 1,775
6.2%
4 WEIGHT INCREASED 1,630
5.7%
5 DRUG DOSE OMISSION 1,417
4.9%
6 PRODUCT DOSE OMISSION ISSUE 1,365
4.8%
7 SCHIZOPHRENIA 1,102
3.8%
8 GYNAECOMASTIA 1,085
3.8%
9 CONDITION AGGRAVATED 979
3.4%
10 TREATMENT NONCOMPLIANCE 935
3.3%
11 BLOOD PROLACTIN INCREASED 927
3.2%
12 PSYCHOTIC DISORDER 891
3.1%
13 INCORRECT DOSE ADMINISTERED 870
3.0%
14 INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 785
2.7%
15 THERAPEUTIC RESPONSE DECREASED 750
2.6%
16 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION 716
2.5%
17 GALACTORRHOEA 693
2.4%
18 INJECTION SITE PAIN 682
2.4%
19 HALLUCINATION, AUDITORY 668
2.3%
20 PRODUCT USE IN UNAPPROVED INDICATION 644
2.2%
21 INSOMNIA 621
2.2%
22 DEATH 613
2.1%
23 DEPRESSION 590
2.1%
24 ANXIETY 580
2.0%
25 ADVERSE EVENT 524
1.8%
26 INJECTION SITE NODULE 520
1.8%
27 FATIGUE 519
1.8%
28 AKATHISIA 518
1.8%
29 TREMOR 516
1.8%
30 SEDATION 494
1.7%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.