An Overview of Concerta Sexual Side Effects

Concerta^® (methylphenidate extended release) is a prescription medication that has been licensed to treat attention deficit hyperactivity disorder (ADHD). In clinical studies prior to the approval of Concerta, there were no reported sexual side effects. Since Concerta was approved, sexual problems also have not been reported.

 

Understanding Clinical Trials

Before medicines are approved, they must go through several clinical studies where thousands of people are given a particular medicine and are then compared to a group of people not given the medicine. In these studies, the side effects are always documented. As a result, it is possible to see what side effects occur, how often they appear, and how they compare to the group not taking the medicine. Side effects are then usually separated into those side effects that occur in more than 1 percent of people and those that occur in less than 1 percent of people. Sexual side effects, such as a decrease in sex drive (libido) or impotence, were not reported as either  common or rare side effects with Concerta during these studies.

 

Yet, clinical trials are designed to factor out as many variables possible in order to understand whether the medicine works and to document its possible side effects. This means that once a medicine is approved, it is possible that new side effects may occur since a wider range of people are now taking the medicine and for longer periods of time.

 

However, once a medicine is approved, a drug does not usually continue to be studied, so certain side effects that occur very rarely may never be documented, especially if it is not a serious side effect. The bottom line: for an individual person, it is very difficult to say with complete assurance that a particular complaint is not due to a medicine, even though the complaint is not a reported side effect.