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Jornay PM

Last reviewed on RxList: 6/3/2019
Jornay PM Side Effects Center

Last reviewed on RxList 6/3/2019

Jornay PM (methylphenidate hydrochloride) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. Common side effects of Jornay PM include:

The recommended starting dose of Jornay PM for patients 6 years and above is 20 mg daily in the evening. Jornay PM may interact with monoamine oxidase inhibitors (MAOIs). Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Jornay PM; it is unknown how it would affect a fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Jornay PM during pregnancy. Jornay PM passes into breast milk. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking Jornay PM.

Our Jornay PM (methylphenidate hydrochloride) Extended-Release Capsules, for Oral Use 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.

SLIDESHOW

ADHD Symptoms in Children See Slideshow
Jornay PM Consumer Information

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 Jornay PM (Methylphenidate Hydrochloride Extended-release Capsules )

QUESTION

The abbreviated term ADHD denotes the condition commonly known as: See Answer
Jornay PM Professional Information

SIDE EFFECTS

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

  • Drug Dependence [see BOX WARNING, WARNINGS AND PRECAUTIONS, and Drug Abuse And Dependence]
  • Hypersensitivity to methylphenidate or other components of the JORNAY PM [see CONTRAINDICATIONS]
  • Hypertensive crisis when used concomitantly with monoamine oxidase inhibitors [see CONTRAINDICATIONS and DRUG INTERACTIONS]
  • Serious Cardiovascular Reactions [see WARNINGS AND PRECAUTIONS]
  • Blood Pressure and Heart Rate Increases [see WARNINGS AND PRECAUTIONS]
  • Psychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Priapism [see WARNINGS AND PRECAUTIONS]
  • Peripheral Vasculopathy, including Raynaud’s Phenomenon [see WARNINGS AND PRECAUTIONS]
  • Long-term Suppression of Growth [see WARNINGS AND PRECAUTIONS]

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 with 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: appetite decreased, weight decreased, nausea, abdominal pain, dyspepsia, dry mouth, vomiting, insomnia, anxiety, nervousness, restlessness, affect lability, agitation, irritability, dizziness, vertigo, tremor, blurred vision, blood pressure increased, heart rate increased, tachycardia, palpitations, hyperhidrosis, and pyrexia.

Clinical Trials Experience With JORNAY PM In Pediatric Patients (6 To 12 Years) With ADHD

The safety of JORNAY PM was evaluated in 280 patients (6 to 12 years of age) who participated in two controlled clinical studies of patients with ADHD [see Clinical Studies].

Study 1, conducted in pediatric patients 6 to 12 years of age, was comprised of a 6-week open-label dose-optimization phase in which all patients received JORNAY PM (n=125; mean dose 50 mg), followed by a 1week, double-blind controlled phase in which patients were randomized to continue JORNAY PM (n=65) or switch to placebo (n=54). During the open-label JORNAY PM treatment phase, adverse reactions reported in > 5% of patients included: any insomnia (41%), decreased appetite (27%), affect lability (22%), headache (19%), upper respiratory tract infection (17%), upper abdominal pain (9%), nausea or vomiting (9%), increased diastolic blood pressure (8%), tachycardia (7%), and irritability (6%). Three patients discontinued treatment because of adverse reactions of affect lability, panic attacks, and agitation and aggression. Because of the trial design (6-week open-label active treatment phase followed by a 1-week, randomized, double-blind, placebo-controlled withdrawal), the adverse reaction rates described in the double-blind phase are lower than expected in clinical practice. No difference occurred in the incidence of adverse reactions between JORNAY PM and placebo during the 1-week, double-blind, placebo-controlled treatment phase.

Study 2 was a 3-week, placebo-controlled study of JORNAY PM (n=81; mean dose 52mg) in pediatric patients 6 to 12 years.

Most Common Adverse Reactions (incidence of ≥5% and at a rate at least twice placebo): any insomnia, decreased appetite, headache, vomiting, nausea, psychomotor hyperactivity, and affect lability or mood swings.

One patient in the JORNAY PM group discontinued from the study due to mood swings.

Table 1 provides the incidence of adverse reactions reported in Study 2 (incidence of 2% or more and at least twice placebo) among pediatric patients 6 to 12 years in a 3-week clinical trial.

Table 1: Adverse Reactions Occurring in ≥2% of JORNAY PM-treated Pediatric Patients and Greater than Placebo in a 3-Week ADHD Study (Study 2)

Body Organ System Adverse Reaction JORNAY PM
(N=81)
Placebo
(N=80)
Psychiatric disorders Any insomnia 33% 9%
  Initial insomnia 14% 5%
  Middle insomnia 11% 4%
  Terminal insomnia 11% 1%
  Insomnia, not specified 4% 1%
Affect lability/ Mood swings 6% 1%
Metabolism and nutrition disorders Decreased appetite 19% 4%
Nervous system disorders Headache 10% 5%
Psychomotor hyperactivity 5% 1%
Cardiovascular Blood pressure diastolic increased 7% 4%
Gastrointestinal disorders Vomiting 9% 0%
Nausea 6% 0%
Infections and infestations Nasopharyngitis 3% 1%
Pharyngitis streptococcal 3% 0%
Injury, poisoning and procedural complications Contusion 3% 0%
Musculoskeletal and connective tissue disorders Back pain 3% 0%
Skin and subcutaneous tissue disorders Rash 2% 0%

Postmarketing Experience

The following adverse reactions have been identified during postapproval 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, Rashes, Eruptions, and Exanthemas

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 Disorders: Convulsion, Grand mal convulsion, Dyskinesia, Serotonin syndrome in combination with serotonergic drugs

Psychiatric Disorders: Disorientation, Hallucination, Hallucination auditory, Hallucination visual, Libido changes, Mania

Urogential System: Priapism

Skin and Subcutaneous Tissue Disorders: Alopecia, Erythema

Vascular Disorders: Raynaud’s phenomenon

Read the entire FDA prescribing information for Jornay PM (Methylphenidate Hydrochloride Extended-release Capsules )

Related Resources for Jornay PM

© Jornay PM Patient Information is supplied by Cerner Multum, Inc. and Jornay PM Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

SLIDESHOW

ADHD Symptoms in Children See Slideshow

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