Risperdal Drug Warnings:

There have been 26 drug regulatory agency warnings from six countries (Australia, Canada, New Zealand, South Africa, United Kingdom and United States) on Risperdal (or risperidone). These include the following (note that some warnings cite more than one side effect, so the list below may not be equal to the total number of warnings):

8 warnings on Risperdal causing cardiovascular disorders
6 warnings on Risperdal causing death or increased risk of death
4 warnings on Risperdal causing stroke
3 warnings on Risperdal causing muscle problems
3 warnings on Risperdal causing blood disorders
3 warnings on Risperdal causing weight gain
3 warnings on Risperdal causing metabolic disorders
2 warnings on Risperdal causing blood pressure changes or high or low blood pressure
2 warnings on Risperdal causing newborn complications (including infant withdrawal symptoms)
2 warnings on Risperdal causing nervous system disorders
2 warnings on Risperdal causing involuntary movements
2 warnings on Risperdal causing allergic reactions
2 warnings on Risperdal causing sleep problems
2 warnings on Risperdal causing diabetes
1 warning on Risperdal causing swelling
1 warning on Risperdal causing gastrointestinal problems
1 warning on Risperdal causing risk of fractures
1 warning on Risperdal causing sexual dysfunction
1 warning on Risperdal causing Neuroleptic Malignant Syndrome (a life-threatening neurological disorder)
1 warning on Risperdal causing abnormal bleeding

Risperdal Drug Studies:

There have been 67 studies done in 18 countries (Australia, Bosnia and Herzegovina, Brazil, Canada, China, Denmark, Finland, France, Italy, Japan, Netherlands, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and United States) on Risperdal (or risperidone). These include the following (note that some studies cite more than one side effect, so the list below may not be equal to the total number of studies):

16 studies on Risperdal causing death or increased risk of death
16 studies on Risperdal causing cardiovascular disorders
8 studies on Risperdal causing weight gain
7 studies on Risperdal causing heart problems
7 studies on Risperdal causing metabolic disorders
6 studies on Risperdal causing nervous system disorders
6 studies on Risperdal causing diabetes
5 studies on Risperdal causing involuntary movements
3 studies on Risperdal causing heart attacks
3 studies on Risperdal causing stroke
3 studies on Risperdal causing lack of efficacy
3 studies on Risperdal causing blood pressure changes or high or low blood pressure
2 studies on Risperdal causing muscle problems
2 studies on Risperdal causing skin conditions
2 studies on Risperdal causing pregnancy complications
2 studies on Risperdal causing pneumonia
2 studies on Risperdal causing lowered bone mass
2 studies on Risperdal causing sexual dysfunction
2 studies on Risperdal causing sedation
1 study on Risperdal causing newborn complications
1 study on Risperdal causing Neuroleptic Malignant Syndrome (a life-threatening neurological disorder)
1 study on Risperdal causing allergic reactions
1 study on Risperdal causing premature birth
1 study on Risperdal causing infant withdrawal symptoms
1 study on Risperdal causing brain shrinkage or other structural brain changes
1 study on Risperdal causing violence
1 study on Risperdal causing homicidal ideation
1 study on Risperdal causing gastrointestinal problems
1 study on Risperdal causing coma
1 study on Risperdal causing birth defects
1 study on Risperdal causing suicide risk or completed suicide
1 study on Risperdal causing swelling
1 study on Risperdal causing risk of fractures
1 study on Risperdal causing cognitive impairment
1 study on Risperdal causing Parkinson’s Disease
1 study on Risperdal causing reproductive system disorders

Adverse Reaction Reports Filed with the US FDA: There have been 12,883 adverse reactions reported to the US FDA in connection with Risperdal (risperidone).

The FDA estimates that less than 1% of all serious events are ever reported to it, so the actual number of side effects occurring are most certainly higher.

• 635 cases of weight increased
• 532 cases of death
• 467 cases of diabetes mellitus
• 443 cases of suicide attempt
• 438 cases of somnolence
• 408 cases of psychotic disorder
• 384 cases of the drug being ineffective
• 370 cases of aggression
• 364 cases of neuroleptic malignant syndrome (life-threatening neurological disorder)
• 343 cases of extrapyramidal disorder (movement syndromes)

Documented Side Effects of Risperdal:
Source: Physicians Desk Reference, National Institutes of Health’s Medline Plus, and/or the drug label.