Acetaminophen is a widely used medication present in hundreds of over-the-counter (OTC) and prescription (Rx) medications indicated for pain or fever as well as symptoms associated with colds, flu, and allergies. It is considered safe when dosed as directed but, in high doses, has been associated with liver injury, and overuse is reported to be responsible for over 10 000 emergency room visits annually in the USA.
Most acetaminophen- attributed liver injury is due to intentional self-harm and associated with high doses, but other cases are due to inadvertent overdosing. Although retrospective cases have reported liver injury at recommended doses, acetaminophen is considered safe when used as directed. A daily dose of 4g provides a margin of safety and has been the recommended maximum on OTC medication labels, although lower doses may be recommended by some healthcare providers for certain patients (e.g., those with known cirrhosis). Concern about acetaminophen-associated harm led the US Food and Drug Administration to convene an Advisory Committee in 2009 to recommend actions to reduce liver injury attributed to excess ingestion of acetaminophen.
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