What should be reported?
Please report All suspected reactions to new drugs and vaccines (Black triangle drugs ▼)
Report All serious reactions to established drugs
Established drugs and vaccines continue to be monitored under the Yellow Card Scheme in order to identify previously unidentified adverse reactions and provide a better understanding of well known side effects.
Established drugs and vaccines are products which no longer require intensive monitoring as ‘black triangle’ products, because the safety of the product has been well established. However, previously unrecognised side effects (in particular, rare or delayed effects) may still be identified when a medicine has been available for many years. For instance, Reyes syndrome was associated with aspirin in the 1980's, 8 decades after it was first marketed. For this reason, all established drugs and vaccines are continually monitored under the Yellow Card Scheme
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Adverse Reactions in Children
The reporting of ALL suspected adverse drug reactions in children is strongly encouraged through the Yellow Card Scheme even if the intensive monitoring symbol (▼) has been removed, because experience in children may still be limited.
The identification and reporting of adverse reactions to drugs in children is particularly important because:-
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the action of the drug and its pharmacokinetics in children (especially in the very young) may be different from that in adults
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drugs are not extensively tested in children
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many drugs are not specifically licensed for use in children and are used ‘off-label’
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suitable formulations may not be available to allow precise dosing in children
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the nature and course of illnesses and adverse drug reactions may differ between adults and children