From the Guidelines
Concerta (Methylphenidate) can cause several side effects, including appetite loss, abdominal pain, headaches, and sleep disturbance, as well as more serious but less common effects like hallucinations, growth suppression, and increased heart rate and blood pressure. When considering the side effects of Concerta, it is essential to weigh the benefits of treatment against the potential risks, prioritizing morbidity, mortality, and quality of life as outcomes. According to the clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents 1, the most common short-term adverse effects of stimulants like Concerta are appetite loss, abdominal pain, headaches, and sleep disturbance. Some key points to consider include:
- The Multimodal Treatment of Attention Deficit Hyperactivity Disorder (MTA) study results identified stimulants as having a more persistent effect on decreasing growth velocity compared to most previous studies, with diminished growth in the range of 1 to 2 cm from predicted adult height 1.
- Stimulant medications, on average, increase patient heart rate (HR) and blood pressure (BP) to a mild and clinically insignificant degree, but can be linked to more substantial increases in HR and BP in a subset of individuals (5%–15%) 1.
- Although concerns have been raised about sudden cardiac death among children and adolescents using stimulant medications, it is an extremely rare occurrence, and stimulant medications have not been shown to increase the risk of sudden death beyond that observed in children who are not receiving stimulants 1.
- Clinicians are encouraged to monitor vital signs in patients receiving stimulant treatment and obtain the child or adolescent’s history of specific cardiac symptoms, as well as the family history of sudden death, cardiovascular symptoms, Wolff-Parkinson-White syndrome, hypertrophic cardiomyopathy, and long QT syndrome before initiating therapy with stimulant medications 1.
From the FDA Drug Label
Methylphenidate Hydrochloride Oral Solution may cause serious side effects, including:
- Painful and prolonged erections (priapism)
- Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon)
- Slowing of growth (height and weight) in children
- Eye problems (increased pressure in the eye and glaucoma)
- New or worsening tics or worsening Tourette’s syndrome The most common side effects of Methylphenidate Hydrochloride Oral Solution include:
- Increased heart rate
- Headache
- Anxiety
- Weight loss
- Dry mouth
- Stomach pain
- Irregular heart beat (palpitations)
- Trouble sleeping
- Sweating
- Decreased appetite
- Nausea
The side effects of Concerta (Methylphenidate) include serious side effects such as:
- Priapism: painful and prolonged erections
- Peripheral vasculopathy: circulation problems in fingers and toes
- Slowing of growth: in children
- Eye problems: increased pressure in the eye and glaucoma
- Tics or Tourette’s syndrome: new or worsening And common side effects such as:
- Increased heart rate
- Headache
- Anxiety
- Weight loss
- Dry mouth
- Stomach pain
- Irregular heart beat
- Trouble sleeping
- Sweating
- Decreased appetite
- Nausea 2
From the Research
Side Effects of Concerta (Methylphenidate)
- The most common side effects of methylphenidate include irritability, appetite reduction, palpitations, and headache 3
- Methylphenidate is safe in healthy children and has shown to have no cardiac side effects in these patients 4
- Other potential side effects of methylphenidate may include increased heart rate and blood pressure, insomnia, anxiety, and nausea
Combination Therapy with Atomoxetine
- Combination therapy with methylphenidate and atomoxetine may enhance the effectiveness of monotherapy, but may also increase the risk of side effects such as irritability, appetite reduction, and palpitations 3, 5
- The effectiveness of combining stimulants such as methylphenidate with atomoxetine is still being investigated, and more research is needed to fully understand the benefits and risks of this combination therapy 5
Neural Mechanisms and Therapeutic Effects
- Methylphenidate and atomoxetine have distinct pharmacological mechanisms and may have different effects on brain activation and neural mechanisms 6
- Methylphenidate may increase activations in the inferior frontal gyrus, which correlates with decreased severity of impulsivity, while atomoxetine may decrease activations in the dorsal anterior cingulate cortex and dorsolateral prefrontal cortex, which correlates with improvement in focused attention 6