Drug Safety

On this page

Basics

• Summary
• Start Here

Learn More

• Related Issues
• Specifics

See, Play and Learn

• No links available

Research

• Journal Articles

Resources

• Find an Expert

For You

• No links available

Summary

Before any drug can be sold in the United States, it must be approved by the U.S. Food and Drug Administration (FDA). This is true whether it's a prescription or an over-the-counter drug. The FDA evaluates both the effectiveness and safety of a drug by looking at:

• How animal testing and human clinical trials affect the condition the drug is treating
• If any side effects occur
• How it's manufactured
• What the labeling says

The FDA also monitors a drug's safety after approval. Health care providers and patients can report drug side effects through the FDA's MedWatch website.

For you, drug safety means buying online only from licensed pharmacies located in the United States. It also means knowing how to take your medicines correctly.

Start Here

• Buying and Using Medicine Safely (Food and Drug Administration)
• FDA Pharmacists Help You Use Medicines Safely (Food and Drug Administration) Also in Spanish

Related Issues

• Drug Development Process (Food and Drug Administration)
• Is It Really FDA Approved? (Food and Drug Administration) Also in Spanish
• MedWatch, the FDA Safety Information and Adverse Event Reporting Program (Food and Drug Administration)
• Postmarket Drug Safety Information for Patients and Providers (Food and Drug Administration)
• Recalls, Market Withdrawals and Safety Alerts (Food and Drug Administration)

Specifics

• 10 Facts about What FDA Does and Does Not Approve (Food and Drug Administration) Also in Spanish
• Generic Drugs Undergo Rigorous FDA Review (Food and Drug Administration) Also in Spanish
• Generic Drugs: Questions & Answers (Food and Drug Administration)
• How to Buy Medicines Safely from an Online Pharmacy (Food and Drug Administration) Also in Spanish
• Quick Tips for Buying Medicines Over the Internet (Food and Drug Administration)
• What Does FDA Approve? Part 2 (Food and Drug Administration) Also in Spanish

Journal Articles References and abstracts from MEDLINE/PubMed (National Library of Medicine)

• Article: Quantitative evaluation and obstacle factor diagnosis of drug regulatory capacity in...
• Article: Substandard and falsified antibiotics are associated with antimicrobial resistance: a retrospective...
• Article: A proportionality approach to the ethics of drug policy.
• Drug Safety -- see more articles

Find an Expert

• Food and Drug Administration