Any reaction to a black triangle drug, and serious reactions to any drug
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What to report
- Any suspected reaction to a black triangle drug, marked with an inverted black triangle to show it is under additional monitoring
- Serious suspected reactions to any established drug, including herbal and over the counter medicines, vaccines and devices
- Reactions in children, the elderly, and in pregnancy
- Delayed effects, congenital anomalies, and medication errors causing harm
“Serious” means fatal, life threatening, disabling, causing or prolonging hospitalisation, causing a congenital abnormality, or otherwise medically significant.
Who can report: anyone. Healthcare professionals, patients and carers, through the MHRA Yellow Card website or app.
“Do not wait for certainty.” A suspicion of a causal link is enough; establishing causality is the MHRA’s job, and under-reporting is the main weakness of the system.
Why it matters: licensing trials involve limited numbers of relatively healthy patients over limited periods, so rare, delayed and interaction related reactions only emerge after marketing. Yellow Card data has led to the withdrawal or restriction of numerous drugs.
What to include: the suspected drug, the reaction, the patient details and the reporter details.