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Dexmethylphenidate / serdexmethylphenidate Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 18, 2023.

Applies to dexmethylphenidate / serdexmethylphenidate: oral capsule.

Warning

Oral route (Capsule)

Warning: Abuse, Misuse, and AddictionDexmethylphenidate / serdexmethylphenidate have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including dexmethylphenidate/serdexmethylphenidate, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing dexmethylphenidate / serdexmethylphenidate, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout amphetamine treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

Serious side effects

Along with its needed effects, dexmethylphenidate / serdexmethylphenidate may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking dexmethylphenidate / serdexmethylphenidate:

More common

Incidence not known

Get emergency help immediately if any of the following symptoms of overdose occur while taking dexmethylphenidate / serdexmethylphenidate:

Symptoms of overdose

Other side effects

Some side effects of dexmethylphenidate / serdexmethylphenidate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

For Healthcare Professionals

Applies to dexmethylphenidate / serdexmethylphenidate: oral capsule.

General

The more commonly reported adverse reactions with methylphenidate products have included decreased appetite, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight loss, anxiety, dizziness, irritability, affect lability, tachycardia, and increased blood pressure.[Ref]

Cardiovascular

Increased blood pressure, and tachycardia have been reported in 5% or greater of patients receiving a methylphenidate product for ADHD (Attention Deficit Hyperactivity Disorder) and at least twice the rate of placebo.

Methylphenidate products:

Frequency not reported: Increased blood pressure, tachycardia

Postmarketing reports: Angina pectoris, bradycardia, extrasystole, supraventricular tachycardia, ventricular extrasystole, palpitations, increased heart rate, chest pain, chest discomfort, Raynaud's phenomenon

Hypersensitivity

Frequency not reported: Bronchospasm, rash, pruritus

Methylphenidate products:

Postmarketing reports: Hypersensitivity reactions such as angioedema, anaphylactic reactions, auricular swelling, bullous conditions, exfoliative conditions, urticaria, pruritus, rashes, eruptions, exanthemas

Psychiatric

Insomnia, anxiety, affect lability, and irritability have been reported in 5% or greater of patients receiving a methylphenidate product for ADHD and at least twice the rate of placebo.

Methylphenidate products:

Postmarketing reports: Disorientation, libido changes, hallucination, hallucination auditory, hallucination visual, logorrhea, mania, restlessness, agitation

Methylphenidate Products:

Frequency not reported: Insomnia, anxiety, affect lability, irritability

Musculoskeletal

In an open label safety study with this drug, growth in pediatric patients 6 to 12 years of age was assessed and compared to age and sex matched population standards. The mean increase in weight from baseline to Month 12 was 3.4 kg among study completers. The mean change in z-score from baseline to Month 12 was -0.2, indicating a lower-than-expected increase in body weight. Most of the weight z-score decline occurred in the first 4 months of treatment. The mean increase in height from baseline to Month 12 was 4.9 cm among completers. Using the same z-score analysis for height, the mean change in z-score from baseline to Month 12 was - 0.21, indicating a lower-than-expected increase in height compared to pediatric patients of the same age and sex.

Frequency not reported: Lower than expected increases in height and weight

Methylphenidate products:

Postmarketing reports: Arthralgia, myalgia, muscle twitching, rhabdomyolysis, muscle cramps

Metabolic

Decreased appetite and weight loss have been reported in 5% or greater of patients receiving a methylphenidate product for ADHD and at least twice the rate of placebo.

Methylphenidate Products:

Frequency not reported: Decreased appetite, weight loss

Gastrointestinal

Methylphenidate Products:

Frequency not reported: Nausea, abdominal pain, dyspepsia, vomiting

Postmarketing reports: Dry mouth

Nausea, abdominal pain, dyspepsia, and vomiting have been reported in 5% or greater of patients receiving a methylphenidate product for ADHD and at least twice the rate of placebo.

Genitourinary

Methylphenidate products:

Postmarketing reports: Priapism

Nervous system

Dizziness was reported in 5% or greater of patients receiving a methylphenidate product for ADHD and at least twice the rate of placebo.

Methylphenidate Products:

Frequency not reported: Dizziness

Postmarketing reports: Convulsion, grand mal convulsion, dyskinesia, serotonin syndrome in combination with serotonergic drugs, nervousness, headache, tremor, drowsiness, vertigo

Hematologic

Methylphenidate Products:

Postmarketing reports: Pancytopenia, thrombocytopenia, thrombocytopenic purpura, platelet count decreased, white blood cell counts abnormal

Ocular

Methylphenidate products

Postmarketing reports: Diplopia, mydriasis, visual impairment, blurred vision

Hepatic

Methylphenidate products:

Postmarketing reports: Hepatocellular injury, acute hepatic failure, alkaline phosphatase increased, bilirubin increased, hepatic enzyme increased

Other

Methylphenidate products

Postmarketing reports: Hyperpyrexia

Dermatologic

Methylphenidate products:

Postmarketing reports: Alopecia, erythema, hyperhidrosis

References

1. Product Information. Azstarys (dexmethylphenidate-serdexmethylphenidate). Corium, Inc. 2021.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer