MedlinePlus Health Topics

Last uploaded: March 22, 2026
Id http://purl.bioontology.org/ontology/MEDLINEPLUS/C0678800
http://purl.bioontology.org/ontology/MEDLINEPLUS/C0678800
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Drug Safety

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<p>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 <a href="https://medlineplus.gov/overthecountermedicines.html">over-the-counter</a> drug. The FDA evaluates both the effectiveness and safety of a drug by looking at: </p> <ul> <li>How animal testing and human clinical trials affect the condition the drug is treating</li> <li>If any <a href="https://medlineplus.gov/drugreactions.html">side effects</a> occur</li> <li>How it's manufactured</li> <li>What the labeling says</li> </ul> <p>The FDA also monitors a drug's safety after approval. Health care providers and patients can report drug side effects through the FDA's <a href="https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program">MedWatch website</a>.</p> <p>For you, drug safety means buying online only from licensed pharmacies located in the United States. It also means knowing how to <a href="https://medlineplus.gov/medicationerrors.html">take your medicines correctly</a>.</p>
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