Paliperidone

Common brands: Invega, Risperdal, Risperdal Consta, Risperdal M-Tab, Uzedy

Top reporter: Janssen Pharmaceuticals, Inc.

Atypical Antipsychotic [EPC]Benzodiazepine [EPC]Mood Stabilizer [EPC]Anti-epileptic Agent [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]
22,987
Total Reports
5,463
Serious Reports
814
Death Reports
30
Reported Reactions
Death Report Ratio: Moderate (3.54%)

Patient Demographics

Male
13,028
Female
6,049

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Paliperidone.

# Reaction Reports % of Total
1 INJURY 4,329
15.0%
2 GYNAECOMASTIA 3,665
12.7%
3 DRUG INEFFECTIVE 1,748
6.1%
4 ABNORMAL WEIGHT GAIN 1,660
5.8%
5 OFF LABEL USE 1,527
5.3%
6 WEIGHT INCREASED 1,371
4.8%
7 HYPERPROLACTINAEMIA 1,259
4.4%
8 GALACTORRHOEA 1,051
3.6%
9 SEDATION 742
2.6%
10 DYSTONIA 709
2.5%
11 DYSKINESIA 701
2.4%
12 SUICIDE ATTEMPT 666
2.3%
13 TREATMENT NONCOMPLIANCE 661
2.3%
14 SCHIZOPHRENIA 655
2.3%
15 PRODUCT USE IN UNAPPROVED INDICATION 622
2.2%
16 EXTRAPYRAMIDAL DISORDER 591
2.1%
17 EMOTIONAL DISORDER 589
2.0%
18 SOMNOLENCE 582
2.0%
19 TREMOR 525
1.8%
20 OBESITY 514
1.8%
21 CONDITION AGGRAVATED 513
1.8%
22 HOSPITALISATION 505
1.8%
23 BLOOD GLUCOSE INCREASED 489
1.7%
24 SEXUAL DYSFUNCTION 478
1.7%
25 PSYCHOTIC DISORDER 467
1.6%
26 INSOMNIA 459
1.6%
27 FATIGUE 449
1.6%
28 ANXIETY 446
1.5%
29 DRUG INTERACTION 420
1.5%
30 BLOOD PROLACTIN ABNORMAL 410
1.4%

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.