What does “Adverse event” mean?
Any unwanted medical occurrence in someone taking a medicine, whether or not the medicine caused it.
Adverse event in plain English
Any unwanted medical occurrence in someone taking a medicine, whether or not the medicine caused it.
The definition is deliberately broad. Deciding whether the medicine was responsible is a separate judgement made afterwards, which is why reports do not require certainty.
Suspected adverse reactions should be reported to the MHRA through the Yellow Card scheme as well as to the prescriber.
Frequently asked questions
What does adverse event mean?
Any unwanted medical occurrence in someone taking a medicine, whether or not the medicine caused it.
Sources and further reading
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