Contraindication
Also known as: contraindicated use, do not use
Verified from eCFR 21 CFR 201.57 on 06-02-2026Contraindication is a section of an FDA-approved drug label that identifies specific situations where a product should not be used at all. These situations include patient characteristics such as age, sex, concomitant therapy, disease state, or other conditions under which the risk of harm clearly outweighs any potential benefit. The federal regulation governing this label section is reproduced verbatim below.
MedivaScan summary. The authoritative source quote follows below.eCFR 21 CFR 201.57 definition
4 Contraindications. This section must describe any situations in which the drug should not be used because the risk of use (e.g., certain potentially fatal adverse reactions) clearly outweighs any possible therapeutic benefit. Those situations include use of the drug in patients who, because of their particular age, sex, concomitant therapy, disease state, or other condition, have a substantial risk of being harmed by the drug and for whom no potential benefit makes the risk acceptable. Known hazards and not theoretical possibilities must be listed (e.g., if severe hypersensitivity to the drug has not been demonstrated, it should not be listed as a contraindication). If no contraindications are known, this section must state “None.”