Drug Safety Information for RISPERDAL (Risperidone)

Safety-related Labeling Changes for RISPERDAL (RISPERIDONE) Rx Drug: FDA Link

Safety-related Labeling Changes for RISPERDAL CONSTA (RISPERIDONE) Rx Drug: FDA Link

Adverse Drug Reactions for RISPERDAL* (Risperidone)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with RISPERDAL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Gynaecomastia4035
2Weight increased*2810
3Diabetes mellitus2568
4Hyperprolactinaemia2474
5Abnormal weight gain2211
6Galactorrhoea1984
7Type 2 diabetes mellitus1782
8Drug ineffective1592
9Drug interaction1510
10Somnolence*1474
11Depression1256
12Anxiety*1229
13Death1216
14Insomnia*1148
15Suicide attempt1118
16Drug dose omission1115
17Aggression1112
18Psychotic disorder1112
19Overdose1096
20Fall1072

* This side effect also appears in "Top 10 Side Effects of RISPERDAL " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking RISPERDAL
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication39239
2Schizophrenia*18074
3Psychotic disorder*6182
4Bipolar disorder*5354
5Depression*4462
6Schizophrenia, paranoid type*2669
7Schizoaffective disorder*2471
8Attention deficit/hyperactivity disorder1745
9Agitation1374
10Anxiety*1310

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for RISPERDAL

Total Reports Filed with FDA: 184501


Number of FDA Adverse Event Reports by Patient Age for RISPERDAL

Total Reports Filed with FDA: 184501*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Risperidone (Risperidone m-tab, Risperdal m-tab, Risperdal, Risperdal consta, Risperidone)

Charts are based on 184501 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and RISPERDAL Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.