From the FDA Drug Label
• Increased blood pressure and heart rate Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with dexmethylphenidate hydrochloride extended-release capsules
Dexmethylphenidate hydrochloride extended-release capsules may increase blood pressure and heart rate in pediatric patients. It is recommended that healthcare providers regularly monitor blood pressure and heart rate during treatment with dexmethylphenidate hydrochloride extended-release capsules 1.
From the Research
Focalin (Dexmethylphenidate) and Hypertension in Pediatric Patients
- There is limited direct evidence on the effects of Focalin (dexmethylphenidate) on hypertension in pediatric patients.
- A study on methylphenidate, a related medication, found that short-term treatment of ADHD in children with methylphenidate does not have a meaningful relationship with hypertension 2.
- However, the same study noted an increase in blood pressure within a non-pathological range, suggesting that longer follow-ups may reveal an association 2.
- Another study on adults with ADHD found that medications used to treat ADHD, including stimulants like methylphenidate, were associated with minor but statistically significant changes in heart rate and blood pressure 3.
- A pharmacovigilance analysis of adverse event reports found that methylphenidate, which is related to dexmethylphenidate, was associated with hypertension in children aged 13-18 years 4.
- There is no direct evidence on the effects of Focalin (dexmethylphenidate) on hypertension in pediatric patients, but the available evidence suggests that it may be associated with increases in blood pressure, particularly with long-term use 2, 4.
Mechanism of Action and Safety Profile
- Dexmethylphenidate, the active ingredient in Focalin, acts by inhibiting the reuptake of norepinephrine and dopamine 5.
- The safety profile of dexmethylphenidate is similar to that of methylphenidate, with a low risk of abuse or misuse 6.
- However, the pharmacovigilance analysis found that methylphenidate, which is related to dexmethylphenidate, was associated with significant safety signals, including hypertension, myocardial infarction, and suicidal ideation 4.
Clinical Use and Monitoring
- Focalin (dexmethylphenidate) is indicated for the treatment of attention-deficit hyperactivity disorder (ADHD) in patients aged 6 years and older 5, 6.
- The medication should be used with caution in patients with a history of hypertension or other cardiovascular conditions 3, 4.
- Regular monitoring of blood pressure and heart rate is recommended for patients taking Focalin (dexmethylphenidate), particularly with long-term use 2, 3.