Freedom of Information request on the adverse reactions reported relating to Aripiprazole (FOI 22/694)
Published 27 March 2023
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FOI 22/694
19th May 2022
Dear
Thank you for your email on 12th May 2022, in which you requested “information on the drug Aripiprazole” and that we provide “the frequency or how often the following side effects or death occurred due to use of this drug on patients:
Blood Clots, Priapism, Parkinsonism, Dystoniam, Tardive dyskinesia, Dystonia, Incontinence, Convulsing, Low blood pressure, Pneumonia, Increase in CPK, Erectile dysfunction, Development of breasts in men, Shaking of head, Dangerously low white blood cells, Increased insulin, Tumours and cancers, Death”
For suspected side effects being reported, the MHRA publishes this information in the form of interactive Drug Analysis Profiles (iDAPs). There is an iDAP for each licensed medicine and drug substance. Within an iDAP you can see all suspected side effects, known as suspected adverse drug reactions, that are reported to the MHRA. The iDAP for Paliperidone may be found here: https://info.mhra.gov.uk/drug-analysis-profiles/dap.html?drug=./UK_EXTERNAL/NONCOMBINED/UK_NON_000830181335.zip&agency=MHRA. Furthermore, iDAPs for all drug substances can be found here: https://yellowcard.mhra.gov.uk/idaps.
iDAPs enable you to interact with the data so you can understand more about the types of reactions that have been reported, and at a high level about who experienced the side effects.
Each iDAP contains complete data for all spontaneous side effects, known as suspected adverse drug reactions via the Yellow Card scheme from healthcare professionals and members of the public. They also include reports from pharmaceutical companies. Information regarding suspected adverse reactions to vaccines is not currently available via the iDAPs but is available upon request.
iDAPs provided on this website are regularly updated. Please be aware, however, that if you have reported a suspected adverse drug reaction it may not immediately appear on this website. There is a time lag of around one month from receipt of a report to it appearing in the iDAP.
When reviewing the data within an iDAP it is important to do so in the context of the essential guidance at the bottom of the report and before to ensure that you do not misinterpret the data.
I hope the information provided is helpful; however, if you are dissatisfied with the handling of your
request, you have the right to ask for an internal review. Internal review requests should be submitted
within two months of the date of this response; and can be addressed to this email address.
Please remember to quote the reference number above in any future communications.
Kind regards,
FOI Team