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U.S. Department of Health and Human Services

Safety

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Stimulants Used for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

December 2013

Summary View

Concerta (methylphenidate HCl) Extended-Release Tablets
Daytrana (methylphenidate transdermal system)
Focalin (dexmethylphenidate) tablets and Focalin XR (Dexmethylphenidate Hydrochloride) extended-release tablets
Metadate CD (methylphenidate HCl) Extended-Release Capsules
Methylin (methylphenidate) Oral Solution and Chewable Tablets
Quillivant XR (methylphenidate) extended-release oral suspension
Ritalin (methylphenidate hydrochloride) Tablets, Ritalin SR (Sustained-Release Tablets, and Ritalin LA Extended-Release Capsules

WARNINGS AND PRECAUTIONS

Priapism
  • Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both pediatric and adult patients. Priapism was not reported with drug initiation but developed after some time on the drug, often subsequent to an increase in dose. Priapism has also appeared during a period of drug withdrawal (drug holidays or during discontinuation). Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.

ADVERSE REACTIONS

Postmarketing Experience
  • libido changes

MEDICATION GUIDE

Other serious side effects include:

  • Painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develop priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately.
  • FDA Drug Safety Communication: FDA warns of rare risk of long-lasting erections in males taking methylphenidate ADHD medications and has approved label changes http://www.fda.gov/Drugs/DrugSafety/ucm375796.htm