Drug Interaction
Also known as: drug-drug interaction, drug-food interaction, DDI, medication interaction
Verified from eCFR 21 CFR 201.57 on 06-02-2026In FDA-approved prescription drug labeling, the Drug Interactions section identifies clinically significant interactions with other medications, drug classes, or foods, and provides practical instructions for prevention or management. It also describes the underlying mechanism when known, and expands on interactions already flagged in Contraindications or Warnings and Precautions. The verbatim regulatory text from the U.S. Office of the Federal Register follows below.
MedivaScan summary. The authoritative source quote follows below.eCFR 21 CFR 201.57 definition
7 Drug interactions. (i) This section must contain a description of clinically significant interactions, either observed or predicted, with other prescription or over-the-counter drugs, classes of drugs, or foods (e.g., dietary supplements, grapefruit juice), and specific practical instructions for preventing or managing them. The mechanism(s) of the interaction, if known, must be briefly described. Interactions that are described in the “Contraindications” or “Warnings and Precautions” sections must be discussed in more detail under this section. Details of drug interaction pharmacokinetic studies that are included in the “Clinical Pharmacology” section that are pertinent to clinical use of the drug must not be repeated in this section.