As with any medication, there are potential side effects of rosiglitazone, including upper respiratory infections, headaches, and back pain. Most people, however, tolerate the medication well. When side effects do occur, they are generally minor. If you experience more serious side effects, such as trouble breathing, a rapid increase in weight, or vision changes, you should report them immediately to your healthcare provider.
Rosiglitazone Side Effects: An Introduction
As with any medicine, there are possible side effects of rosiglitazone maleate (Avandia®). However, not everyone who takes rosiglitazone will experience side effects. In fact, most people tolerate the medication well. When side effects do occur, in most cases they are minor and either require no treatment or can be easily treated by you or your healthcare provider.
(The side effects discussed below are not a complete list of the side effects reported with this drug. Your healthcare provider can discuss a more complete list of rosiglitazone side effects with you.)
In September 2010, the U.S. Food and Drug Administration (FDA) announced that it was severely restricting the use of rosiglitazone, due to the risk of "cardiovascular events" such as heart attacks and strokes. Only individuals who could not control their diabetes on other medications (or those who were already taking the medication and doing well) would be able to take rosiglitazone.
However, in November 2013, the FDA announced that a careful analysis of the research suggests that there is not, in fact, any increased risk, compared to treatment with standard diabetes medications and that the use of this medication will no longer be restricted.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Avandia [package insert]. Research Triangle Park, NC: GlaxoSmithKline;2011 February.
Food and Drug Administration, Center for Drug Evaluation and Research. FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines (November 25, 2013). FDA Web site. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm376389.htm. Accessed December 20, 2013.
Food and Drug Administration, Center for Drug Evaluation and Research. Avandia (rosiglitazone): REMS - risk of cardiovascular events (9/23/2010). FDA Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226994.htm. Accessed October 1, 2010.
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