Final answer:
Side effects are unintended reactions to a drug or treatment, while an adverse reaction is a more serious and sometimes life-threatening effect. Severe adverse reactions should be reported to the FDA through the MedWatch program. The sponsor of a drug must report serious adverse events within 15 days, and other events quarterly.
Step-by-step explanation:
Side effects are unintended consequences or reactions that occur in addition to the desired therapeutic effect of a drug or medical treatment. These can vary from mild to serious and may include symptoms like nausea, headache, or dizziness. On the other hand, an adverse reaction is a harmful and undesired effect resulting from a medication or other intervention such as surgery. An adverse reaction is generally more serious than a side effect and can sometimes be life-threatening.
When it comes to reporting severe adverse reactions, it is critical to report them to the Food and Drug Administration (FDA) through its MedWatch program. This program allows health professionals and consumers to report voluntarily on serious adverse events, product quality problems, product use errors, or therapeutic failures for human medical products, including drugs and medical devices.
Specifically, after New Drug Application (NDA) approval, the sponsor of the drug must review and report to the FDA every serious adverse drug experience they learn about. They are required to report unexpected serious and fatal adverse drug events within 15 days, and other events on a quarterly basis. In cases of the most severe allergic reactions, such as anaphylaxis, which is life-threatening and caused by a massive release of histamines, emergency medical treatment is necessary.