What are the side effects of Concerta (methylphenidate)?

Concerta Side Effects

Concerta (methylphenidate) commonly causes appetite suppression, insomnia, increased heart rate, headache, and anxiety, with most side effects being dose-dependent and reversible upon discontinuation. 1

Common Side Effects

The most frequently reported side effects of methylphenidate include:

• Appetite and weight changes: Decreased appetite and weight loss are among the most common effects, requiring monitoring of growth parameters in children 1
• Sleep disturbances: Insomnia is very common, particularly when doses are taken late in the day; scheduling the last dose before 6 PM may help minimize this effect 2, 3
• Cardiovascular effects: Increased heart rate, palpitations, and elevated blood pressure occur frequently 1
• Gastrointestinal symptoms: Stomach pain, nausea, dry mouth, and vomiting are commonly reported 2, 1
• Neuropsychiatric effects: Headache, anxiety, agitation, jitteriness, and sweating are frequent 2, 1

Serious Adverse Effects

While less common, several serious side effects require immediate medical attention:

• Priapism: Painful and prolonged erections can occur in males taking methylphenidate and require emergency medical care 1
• Cardiovascular complications: Rare but serious effects include hypertension, arrhythmias, palpitations, and in extreme cases, myocardial infarction or sudden cardiac death, particularly in patients with underlying cardiac disease 2, 1
• Peripheral vasculopathy: Circulation problems in fingers and toes (including Raynaud's phenomenon) may manifest as numbness, color changes (pale to blue to red), pain, or unexplained wounds 1
• Psychiatric symptoms: Confusion, psychosis, hallucinations, mania, agitation, and suicidal ideation have been reported, though these are rare 2, 4, 5
• Movement disorders: Involuntary motor tics involving the face, tongue, and oral muscles can occur, presenting as tongue movements, lip smacking, or clicking sounds; these are typically reversible with discontinuation 6

Growth and Development Concerns

• Growth suppression: Long-term use may slow growth in height and weight in children, necessitating regular monitoring during treatment 1
• Treatment interruption: Children not growing or gaining weight as expected may need temporary discontinuation of therapy 1

Neurological and Sensory Effects

• Tic disorders: New or worsening tics or Tourette's syndrome may develop during treatment 1
• Eye problems: Increased intraocular pressure and glaucoma can occur; vision changes, eye pain, swelling, or redness require immediate evaluation 1
• Tremor and headache: These neurological symptoms are reported as rare side effects 2

Psychiatric and Mood Effects

• Depression: While uncommon, depressive symptoms can emerge or worsen with methylphenidate, particularly after dose increases 4
• Rebound effects: When methylphenidate wears off (due to its 2-hour half-life), patients may experience a "crash" manifesting as increased fatigue, dysphoric mood, or irritability 3

Contraindications and High-Risk Situations

Methylphenidate should be avoided in patients with:

• Uncontrolled hypertension 2, 3
• Underlying coronary artery disease 2, 3
• Tachyarrhythmias 2, 3
• Current use of monoamine oxidase inhibitors (MAOIs) 1

Abuse and Dependence Potential

• Schedule II controlled substance: Methylphenidate has high potential for abuse and misuse, which can lead to substance use disorder 1
• Overdose risk: Misuse through unapproved routes (snorting, injection) or excessive doses can result in life-threatening complications including hyperthermia, rhabdomyolysis, seizures, and death 1, 7
• Physical dependence: Abrupt discontinuation after prolonged use may cause withdrawal symptoms including dysphoric mood, depression, fatigue, vivid dreams, and increased appetite 1

Special Population Considerations

In pregnancy and breastfeeding:

• Overall, methylphenidate does not appear to be associated with major congenital malformations 2
• Possible small increased risks for cardiac malformations (OR 1.59), preterm birth (aOR 1.3), and preeclampsia (aRR 1.29), though evidence is inconsistent 2
• Breastfeeding infants should be monitored for agitation, insomnia, anorexia, and reduced weight gain 1

Clinical Management of Side Effects

• Dose adjustment: Starting with lower doses and titrating slowly can minimize side effects 3
• Timing optimization: Administering doses early in the day (last dose before 6 PM) helps prevent insomnia 3, 1
• Extended-release formulations: These provide more consistent drug levels and may reduce rebound effects compared to immediate-release preparations 3, 8
• Reversibility: Most side effects are reversible with dose reduction or discontinuation 2, 6