RISPERDAL: 530 Adverse Event Reports & Safety Profile
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530
Total FAERS Reports
53 (10.0%)
Deaths Reported
235
Hospitalizations
530
As Primary/Secondary Suspect
22
Life-Threatening
16
Disabilities
First Report: 1984 · Latest Report: 20140616
What Are the Most Common RISPERDAL Side Effects?
#1 Most Reported
Gynaecomastia
41 reports (7.7%)
#2 Most Reported
Off label use
34 reports (6.4%)
#3 Most Reported
Intentional overdose
33 reports (6.2%)
All RISPERDAL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Gynaecomastia | 41 | 7.7% | 1 | 8 |
| Off label use | 34 | 6.4% | 6 | 11 |
| Intentional overdose | 33 | 6.2% | 1 | 8 |
| Weight increased | 32 | 6.0% | 1 | 6 |
| Self injurious behaviour | 28 | 5.3% | 0 | 5 |
| Suicide attempt | 28 | 5.3% | 0 | 10 |
| Somnolence | 26 | 4.9% | 4 | 14 |
| Fall | 24 | 4.5% | 4 | 20 |
| Sopor | 20 | 3.8% | 0 | 9 |
| Death | 19 | 3.6% | 19 | 5 |
| Drug abuse | 19 | 3.6% | 0 | 14 |
| Hyponatraemia | 19 | 3.6% | 0 | 16 |
| Speech disorder | 19 | 3.6% | 0 | 12 |
| Aggression | 17 | 3.2% | 1 | 10 |
| Anxiety | 17 | 3.2% | 1 | 5 |
| Sedation | 16 | 3.0% | 0 | 14 |
| Tachycardia | 15 | 2.8% | 0 | 8 |
| Abnormal behaviour | 14 | 2.6% | 0 | 7 |
| Altered state of consciousness | 14 | 2.6% | 0 | 14 |
| Confusional state | 14 | 2.6% | 1 | 9 |
Who Reports RISPERDAL Side Effects? Age & Gender Data
Average age: 44.7 years. Most reports from: US. View detailed demographics →
Is RISPERDAL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 1 | 0 | 1 |
| 2002 | 1 | 0 | 0 |
| 2003 | 3 | 0 | 1 |
| 2004 | 2 | 0 | 2 |
| 2005 | 1 | 1 | 0 |
| 2006 | 4 | 0 | 2 |
| 2007 | 4 | 0 | 1 |
| 2008 | 1 | 0 | 0 |
| 2009 | 6 | 1 | 4 |
| 2010 | 11 | 0 | 6 |
| 2011 | 24 | 2 | 21 |
| 2012 | 15 | 1 | 10 |
| 2013 | 122 | 18 | 76 |
| 2014 | 136 | 7 | 65 |
What Is RISPERDAL Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 222 |
| Schizophrenia | 60 |
| Bipolar disorder | 24 |
| Schizophrenia, paranoid type | 20 |
| Depression | 16 |
| Psychotic disorder | 16 |
| Abnormal behaviour | 14 |
| Attention deficit/hyperactivity disorder | 9 |
| Mental disorder | 8 |
| Autism | 7 |
RISPERDAL vs Alternatives: Which Is Safer?
RISPERDAL vs RISPERDAL CONSTA
RISPERDAL vs RISPERIDONE
RISPERDAL vs RITALIN
RISPERDAL vs RITLECITINIB
RISPERDAL vs RITODRINE
RISPERDAL vs RITONAVIR
RISPERDAL vs RITUXAN
RISPERDAL vs RITUXIMAB
RISPERDAL vs RITUXIMAB-ABBS
RISPERDAL vs RITUXIMAB-ARRX
Official FDA Label for RISPERDAL
Official prescribing information from the FDA-approved drug label.