Drug Interactions & Labeling

November 2020 Update: The FDA announces new regulatory guidance on assessing pH-dependent drug interactions

Preventing and Mitigating Drug Interactions

Patients frequently use more than one drug at a time. One type of drug-drug interaction (DDI) can occur when a co-administered drug alters the drug concentrations (pharmacokinetics) of another drug.

These changes could result in reduced efficacy or increased side effects for the affected drug(s). Thus, evaluating the risk of a DDI is a critical aspect of the benefit-risk assessment of new drugs prior to market approval and during the postmarketing period.

The assessment of DDIs also informs drug labeling that is often used by healthcare providers to aid in therapeutic decision-making. This Website provides resources relevant to DDIs. Visit the pages below to learn more.

Topics

Table of Substrates, Inhibitors and Inducers

Examples of CYP enzymes and transporters

Guidances, Policies & Procedures

Drug Interactions—relevant regulatory guidance and policy documents

Resources

Possible models for decision making, advisory committee meetings, presentations, and preventable adverse reactions

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Office of Translational Sciences | Office of Clinical Pharmacology