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For Consumers

October 11: What is in generic Plavix that makes me break out in whelps?

CDER Director's Mailbag

A generic drug is the same as a brand-name drug in dosage, safety, strength, how it is taken, quality, performance, and intended use. Before approving a generic drug product, FDA requires many rigorous tests and procedures to assure that the generic drug can be substituted for the brand name drug.

Breaking out in whelps has not been a reported side effect of the generic form of Plavix. The active component(s)/ingredient(s) of a generic drug must be equivalent to the innovator product. However, other components/inactive ingredients–such as binders or inactive substances–can vary from the innovator product. But they must also be approved by FDA and be present at the same or lower levels than approved in other innovator products. Sometimes people can have sensitivities or allergic-type reactions to these other components. If this is the case, trying another generic–if available–may be a good option. Talk to your doctor about this possibility.

If you notice an adverse reaction when using any drug product, contact your health care professional. In addition, you or your health care provider can report adverse reactions or quality problems experienced with the use of any product to FDA's MedWatch Adverse Event Reporting program.

Page Last Updated: 02/26/2016
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