Drugs approved by the U.S. Food and Drug Administration (FDA) for sale in the United States must be safe and effective - which means that the benefits of the drug must be greater than the known risks. However, both prescription and over-the-counter (OTC) drugs have side effects. Side effects, also known as adverse reactions, are unwanted undesirable effects that are possibly related to a drug. Side effects can vary from minor problems like a runny nose to life-threatening events, such as a heart attack or liver damage.
Several things can affect who does and does not have a side effect when taking a drug – age; use of other drugs, vitamins, or dietary supplements; or other underlying diseases or conditions (for example, diseases that weaken the immune system or effect the function of the kidneys or liver).
Common side effects include upset stomach, dry mouth, and drowsiness. A side effect is considered serious if the result is: death; life-threatening; hospitalization; disability or permanent damage; or exposure prior to conception or during pregnancy caused birth defect.
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