All serious suspected reactions must be reported via the Yellow Card Scheme, regardless of whether a product is a black triangle drug or vaccine. The side-effects of an established drug may be well known but if a serious reaction occurs it should always be reported so that rare or delayed effects can be identified.
Serious reactions include those that are:
- Disabling or incapacitating
- Result in or prolong hospitalisation
- Congenital abnormalities
- Medically significant