RISPERIDONE for Off label use: Side Effects & Safety Data
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There are 26 adverse event reports in the FDA FAERS database where RISPERIDONE was used for Off label use.
Most Reported Side Effects for RISPERIDONE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Gynaecomastia | 24,453 | 30.8% | 47 | 371 |
| Off label use | 10,376 | 13.1% | 245 | 1,621 |
| Abnormal weight gain | 9,418 | 11.9% | 20 | 83 |
| Weight increased | 6,885 | 8.7% | 56 | 804 |
| Emotional disorder | 5,809 | 7.3% | 4 | 76 |
| Product use in unapproved indication | 5,551 | 7.0% | 69 | 686 |
| Drug ineffective | 5,232 | 6.6% | 121 | 1,840 |
| Injury | 4,447 | 5.6% | 10 | 35 |
| Hyperprolactinaemia | 4,124 | 5.2% | 22 | 257 |
| Galactorrhoea | 3,513 | 4.4% | 16 | 170 |
| Emotional distress | 3,195 | 4.0% | 7 | 72 |
| Obesity | 3,039 | 3.8% | 27 | 207 |
| Extrapyramidal disorder | 2,613 | 3.3% | 107 | 912 |
| Product use issue | 2,567 | 3.2% | 38 | 272 |
| Somnolence | 2,496 | 3.2% | 129 | 1,005 |
Other Indications for RISPERIDONE
Product used for unknown indication (36,691)
Schizophrenia (11,506)
Bipolar disorder (6,866)
Attention deficit/hyperactivity disorder (6,071)
Psychotic disorder (4,372)
Depression (3,356)
Autism spectrum disorder (2,370)
Affective disorder (2,096)
Attention deficit hyperactivity disorder (1,928)
Aggression (1,813)
Other Drugs Used for Off label use
LENALIDOMIDE (5,767)
ECULIZUMAB (3,550)
CERTOLIZUMAB PEGOL (2,256)
ABOBOTULINUMTOXINA (2,170)
LEVETIRACETAM (2,161)
APREMILAST (1,995)
PROPRANOLOL (1,576)
CETIRIZINE (1,416)
HUMAN IMMUNOGLOBULIN G (1,129)
THALIDOMIDE (1,033)