After a drug has been approved, big ADRs are reported to MEDRA, but smaller side effects are not usually reported. While some may be known and in the drug label, novel side effects may occur in populations not included in the original trials. Small effects may lead to discontinuation or poor compliance.. Collecting better data about side effects and combining with genomic data could give improved pharmacogenomic prediction of side effects and allow for better selection of drugs for a patient.
Idea No. 363