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Outcome Labels

What are Outcome Labels?

Comprehensive, evidence-based information about the effects of interventions on health

Outcome Labels provide standardized, quantitative information about how foods, drugs, supplements, and other interventions affect all measurable aspects of human health. They go beyond traditional drug labels by showing:

  • Comprehensive effects - Not just the primary outcome, but all measurable effects on health
  • Comparative effectiveness - How interventions compare to alternatives, not just to placebo
  • Absolute risk reduction - Real-world impact expressed in ways patients can understand
  • Side effect profiles - Detailed information about potential negative effects and their frequency
  • Evidence quality - Transparency about the strength of evidence behind each claim

Why Outcome Labels Matter

Traditional drug labels focus primarily on whether a treatment is better than placebo for a single outcome. Outcome Labels provide a complete picture of all health effects, helping patients and providers make truly informed decisions based on what matters most to them.

For Patients

Make informed health decisions

Find What Works

Compare treatments based on outcomes that matter most to you

Understand Trade-offs

See both benefits and risks in clear, quantitative terms

Share with Providers

Facilitate better conversations with your healthcare team

For Healthcare Providers

Evidence-based clinical decision support

Comprehensive Data

Access aggregated trial data and real-world evidence in one place

Integration Tools

Download or integrate with EHR systems for point-of-care access

Contribute Data

Help improve labels by contributing clinical observations

Explore Outcome Labels

Browse by category or search for specific interventions

Data updated: June 2025

Contribute to Outcome Labels

Outcome Labels are continuously improved through new clinical trials, real-world evidence, and patient-reported outcomes. Join the Decentralized FDA to contribute data and help create the most comprehensive health information resource available.