Azstarys Side Effects

Generic name: dexmethylphenidate / serdexmethylphenidate

Medically reviewed by Philip Thornton, DipPharm. Last updated on Nov 17, 2024.

Note: This document provides detailed information about Azstarys Side Effects associated with dexmethylphenidate / serdexmethylphenidate. Some dosage forms listed on this page may not apply specifically to the brand name Azstarys.

Applies to dexmethylphenidate / serdexmethylphenidate: oral capsule.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Do not take serdexmethylphenidate and dexmethylphenidate combination with or within 14 days of taking a drug with monoamine oxidase (MAO) inhibitor activity (eg, isocarboxazid [Marplan®], phenelzine [Nardil®], procarbazine [Matulane®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). If you do, you may develop extremely high blood pressure.

If you have been using this medicine for a long time and you think you may have become mentally or physically dependent on it, check with your doctor right away. Some signs of dependence may include:

• A strong desire or need to continue using the medicine.
• A need to increase the dose to receive the same effects.
• Withdrawal effects after stopping the medicine, such as irritability, anxiety, unusual tiredness or weakness, nightmares, trouble sleeping or oversleeping, increased appetite, agitation, or slowing of mental and physical activity.

You or your child will also need to have your blood pressure and heart rate measured before starting this medicine and while you are using it. If you notice any change in your blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

This medicine may cause serious heart or blood vessel problems. This may be more likely to occur in patients who have a family history of heart disease. Check with your doctor right away if you have chest pain, trouble breathing, or fainting while using this medicine.

Tell your doctor right away if you or your family notice any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behavior. Also tell your doctor if you or your child see, hear, or feel things that are not there, or have any unusual thoughts, especially if they are new or getting worse quickly.

If you or your child experience a prolonged or painful erection of the penis, check with your doctor right away.

Symptoms of overdose include: agitation, blurred vision, change in consciousness, chest pain or discomfort, confusion, dark urine, diarrhea, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, fast, pounding, or irregular heartbeat or pulse, fever, headache, inability to speak, loss of consciousness, muscle cramps, spasms, pain, or stiffness, nausea, nervousness, overactive reflexes, pain or discomfort in the arms, jaw, back, or neck, pale, clammy skin, palpitations, pounding in the ears, seeing, hearing, or feeling things that are not there, seizures, shivering, slow or fast heartbeat, slurred speech, sweating, talking or acting with excitement you cannot control, temporary blindness, thirst, trembling or shaking, trouble breathing, unusual tiredness or weakness, vomiting, or weakness in the arm or leg on one side of the body, sudden and severe. Call your doctor right away if you notice these symptoms.

This medicine may cause Raynaud's phenomenon, which is a problem with blood circulation in the fingers or toes. Tell your doctor if you have tingling or pain, a cold feeling, paleness, or skin color changes in the fingers or toes, especially when exposed to cold temperatures. Call your doctor right away if you have unexplained sores or ulcers on your fingers or toes.

This medicine may cause slow growth and weight loss. If your child is using this medicine, the doctor will need to keep track of your child's height and weight.

Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine on the day you have your surgery.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, and especially those for appetite control, asthma, colds, cough, hay fever, allergies, or sinus problems.

Serious side effects of Azstarys

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:

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

Symptoms of overdose

• agitation
• blurred vision
• change in consciousness
• chest pain or discomfort
• confusion
• dark urine
• diarrhea
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• extremely high fever or body temperature
• fast, slow, or irregular heartbeat
• fever
• headache
• inability to speak
• loss of consciousness
• muscle cramps, spasms, pain, or stiffness
• nausea
• nervousness
• overactive reflexes
• pain or discomfort in the arms, jaw, back, or neck
• pale, clammy skin
• palpitations
• pounding in the ears
• seeing, hearing, or feeling things that are not there
• seizures
• shivering
• slurred speech
• sweating
• talking or acting with excitement you cannot control
• temporary blindness
• thirst
• trembling or shaking of the hands or feet
• trouble breathing
• unusual tiredness or weakness
• vomiting
• weakness in the arm or leg on one side of the body, sudden and severe

Other side effects of Azstarys

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:

For healthcare professionals

Applies to dexmethylphenidate / serdexmethylphenidate: oral capsule.

General adverse events

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

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

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.

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

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

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.

Musculoskeletal

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

Methylphenidate products:

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

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.

Metabolic

Methylphenidate Products:

• Frequency not reported: Decreased appetite, weight loss

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.

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

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

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

Hematologic

Methylphenidate Products:

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

Ocular

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

Methylphenidate products

Hepatic

Methylphenidate products:

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

Other

• Postmarketing reports: Hyperpyrexia

Methylphenidate products

Dermatologic

Methylphenidate products:

• Postmarketing reports: Alopecia, erythema, hyperhidrosis

See also:

Frequently asked questions

• Azstarys vs Adderall, what is the difference?

Further information

Azstarys side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer