Some Focalin warnings and precautions to be aware of include:
Stimulants (including Focalin) are often abused. Taking high doses of Focalin for long periods of time can lead to dependence on Focalin (see Dexmethylphenidate Abuse). Because Focalin is so commonly abused, there are special rules for prescribing Focalin (see Focalin: A Controlled Substance for more information).
In people with psychotic disorders (such as schizophrenia or schizoaffective disorder), Focalin can worsen psychotic symptoms, including thought disorders and behavior problems. Also, Focalin may make bipolar symptoms -- especially manic symptoms -- worse.
Sudden death has been reported in children and adolescents with heart problems who took normal doses of Focalin. If your child has heart problems, talk with your healthcare provider about whether it is appropriate for him or her to take Focalin. Also, let your healthcare provider know if your child develops any chest tightness, chest pain, shortness of breath, or fainting while taking Focalin.
Sudden death, stroke, and heart attacks have also been reported in adults taking normal doses of medications similar to Focalin. These events seem to occur more often in adults with heart problems. If you have heart problems, talk with your healthcare provider about whether Focalin is appropriate in your situation. Also, let your healthcare provider know if you develop any chest tightness, chest pain, shortness of breath, or fainting while on Focalin.
Focalin can cause an increase in blood pressure and heart rate. In most cases, the increase is small and does not cause problems. However, there is an increased risk for people who already have high blood pressure, congestive heart failure, certain irregular heart rhythms (arrhythmias), or a recent history of a heart attack.
Focalin can cause a temporary slowing of growth in children. This slowing of growth is usually small (less that one inch and less than two pounds); and, in time, children usually catch up to within normal limits.
Focalin may cause an increase in aggressive behavior in people with ADHD. Let your healthcare provider know of you have any increase in aggressive behavior while on Focalin.
Focalin can increase the risk of seizures, especially in people who have had seizures before. If you have a history of seizures, you should talk with your healthcare provider before taking Focalin.
Focalin can cause blurred vision and other vision problems.
Focalin is considered a pregnancy Category C medication. This means that Focalin may not be safe to use during pregnancy. Talk with your healthcare provider before using Focalin during pregnancy (see Focalin and Pregnancy for more information).
It is not known if Focalin passes through breast milk. Therefore, if you are breastfeeding or plan to breastfeed, be sure to talk with your healthcare provider about this.