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Aptensio XR

Last reviewed on RxList: 1/19/2021
Aptensio XR Side Effects Center

What Is Aptensio XR?

Aptensio XR (methylphenidate hydrochloride extended-release) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

What Are Side Effects of Aptensio XR?

Common side effects of Aptensio XR include:

Dosage for Aptensio XR

The recommended starting dose of Aptensio XR for patients 6 years and above is 10 mg once daily with or without food in the morning. Dosage may be increased weekly in increments of 10 mg per day. Daily dosage above 60 mg is not recommended.

What Drugs, Substances, or Supplements Interact with Aptensio XR?

Aptensio XR may interact with monoamine oxidase inhibitors (MAOIs). Tell your doctor all medications and supplements you use.

Aptensio XR During Pregnancy and Breastfeeding

During pregnancy, Aptensio XR should be used only if prescribed. Premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. Aptensio XR passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking Aptensio XR.

Additional Information

Our Aptensio XR (methylphenidate hydrochloride extended-release) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


The abbreviated term ADHD denotes the condition commonly known as: See Answer
Aptensio XR Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • signs of heart problems--chest pain, trouble breathing, feeling like you might pass out;
  • signs of psychosis--hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
  • signs of circulation problems--numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; or
  • penis erection that is painful or lasts 4 hours or longer (rare).

Methylphenidate can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

  • excessive sweating;
  • mood changes, feeling nervous or irritable, sleep problems (insomnia);
  • fast heart rate, pounding heartbeats or fluttering in your chest, increased blood pressure;
  • loss of appetite, weight loss;
  • dry mouth, nausea, stomach pain; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Aptensio XR (Methylphenidate Hydrochloride Extended-release Capsules )


ADHD Symptoms in Children See Slideshow
Aptensio XR Professional Information


The following are discussed in more detail in other sections of the labeling:

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical Trials Experience With Other Methylphenidate Products In Children, Adolescents, And Adults With ADHD

Commonly reported (≥2% of the methylphenidate group and at least twice the rate of the placebo group) adverse reactions from placebo-controlled trials of methylphenidate products include: decreased appetite, decreased weight, nausea, abdominal pain, dyspepsia, dry mouth, vomiting, insomnia, anxiety, nervousness, restlessness, affect lability, agitation, irritability, dizziness, vertigo, tremor, blurred vision, increased blood pressure, increased heart rate, tachycardia, palpitations, hyperhidrosis, and pyrexia.

Clinical Trials Experience With APTENSIO XR In Pediatric Patients With ADHD

The safety data in this section is based on data from two one-week controlled clinical studies of APTENSIO XR in pediatric patients with ADHD, one in children ages 6 to 12 years (RP-BP-EF001, hereafter “Study 1”), and one in children and adolescents ages 6 to 17 years (RP-BP-EF002, hereafter “Study 2”).

Two APTENSIO XR clinical studies evaluated a total of 256 patients with ADHD. Two hundred and forty-three (243) patients participated in the double-blind phase of these two clinical studies.

Study 1 was a randomized, double-blind, single center, placebo-controlled, flexible-dose, cross-over study to evaluate the time of onset, duration of efficacy, tolerability and safety of APTENSIO XR 15 mg, 20 mg, 30 mg, or 40 mg administered for one week in 26 pediatric patients aged 6 to 12 years who met DSM-IV criteria for ADHD [see Clinical Studies].

Most Common Adverse Reactions (incidence of ≥ 5% and at a rate at least twice placebo): abdominal pain, pyrexia and headache.

Adverse Reactions Leading to Discontinuation: No subjects discontinued due to adverse reactions during the double-blind phase of this study.

Study 2 was a randomized, double-blind, multicenter, placebo-controlled, parallel group, fixed-dose study of 10 mg, 15 mg, 20 mg, and 40 mg of APTENSIO XR administered for one week in 221 pediatric patients (6 to 17 years of age) who met DSM-IV criteria for ADHD [see Clinical Studies].

Most Common Adverse Reactions (incidence of ≥ 5% and at a rate of at least twice placebo): abdominal pain, decreased appetite, headache and insomnia.

Adverse Reactions Leading to Discontinuation: Two patients (4.4%) in the APTENSIO XR 40 mg group discontinued due to insomnia, nausea and rapid heart rate, respectively during the double-blind phase of the study.

Table 1: Common Adverse Reactions Occurring in ≥ 2% of Pediatric Patients (6 to 17 years of age) with ADHD Taking APTENSIO XR and at a Rate Greater than Placebo (Study 2)

System Organ Class
Adverse Reaction
Aptensio XR
(n= 183)
Nervous System Disorders
Headache 10.9% 8.5%
Insomnia 9.8% 2.1%
Dizziness 2.2% 2.1%
Gastrointestinal Disorders
Abdominal pain upper 8.2% 0%
Nausea 3.8% 2.1%
Vomiting 3.8% 0%
Metabolism and Nutritional
Decreased Appetite 4.9% 0%

Post-Marketing Experience

The following adverse reactions have been identified during post approval use of methylphenidate products. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions are as follows:

Blood and Lymphatic System Disorders: Pancytopenia, Thrombocytopenia, Thrombocytopenic purpura

Cardiac Disorders: Angina pectoris, Bradycardia, Extrasystole, Supraventricular tachycardia, Ventricular extrasystole

Eye Disorders: Diplopia, Mydriasis, Visual impairment

General Disorders: Chest pain, Chest discomfort, Hyperpyrexia

Immune System Disorders: Hypersensitivity reactions such as Angioedema, Anaphylactic reactions, Auricular swelling, Bullous conditions, Exfoliative conditions, Urticarias, Pruritus NEC, Rashes, Eruptions, and Exanthemas NEC

Investigations: Alkaline phosphatase increased, Bilirubin increased, Hepatic enzyme increased, Platelet count decreased, White blood cell count abnormal, severe hepatic injury

Musculoskeletal, Connective Tissue and Bone Disorders: Arthralgia, Myalgia, Muscle twitching, Rhabdomyolysis

Nervous System: Convulsion, Grand mal convulsion, Dyskinesia, serotonin syndrome in combination with serotonergic drugs

Psychiatric Disorders: Disorientation, Libido changes

Skin and Subcutaneous Tissue Disorders: Alopecia, Erythema

Read the entire FDA prescribing information for Aptensio XR (Methylphenidate Hydrochloride Extended-release Capsules )

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