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Quillivant XR

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Quillivant XR

Quillivant XR

Quillivant XR Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Quillivant XR (methylphenidate hydrochloride) is a central nervous system (CNS) stimulant and is available in generic form. Quillivant XR is used to treat Attention Deficit Hyperactivity Disorder (ADHD). Quillivant XR has a high potential for abuse and dependence. Common side effects from the use of Quillivant XR may include decreased appetite, insomnia, nausea, vomiting, upset stomach, abdominal pain, weight loss, anxiety, dizziness, irritability, increased heart rate, and increased blood pressure.

For patients 6 years of age and above, the recommended starting dose of Quillivant XR is 20 mg given orally once daily in the morning with or without food. The dosage may be increased weekly in increments of 10 mg to 20 mg per day. A daily dosage above 60 mg is not recommended. Quillivant XR may interact with monoamine oxidase inhibitors (MAOIs). The effects of Quillivant XR have not been studied in pregnant women. Undesirable pregnancy outcomes such as premature delivery and low birth weight have been seen in mothers dependent on stimulant products such as amphetamines. Nursing mothers should discontinue Quillivant XR or discontinue nursing.

Our Quillivant XR (methylphenidate hydrochloride) 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.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Quillivant XR FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials 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: 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 QUILLIVANT XR in Children and Adolescents with ADHD

There is limited experience with QUILLIVANT XR in controlled trials. Based on this limited experience, the adverse reaction profile of QUILLIVANT XR appears similar to other methylphenidate extended-release products. The most common ( ≥ 2% in the QUILLIVANT XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 45 ADHD patients (ages 6-12 years) were affect lability, excoriation, initial insomnia, tic, decreased appetite, vomiting, motion sickness, eye pain, and rash.

Table 2: Common Adverse Reactions occurring in ≥ 2% of subjects on QUILLIVANT XR and greater than placebo during the controlled cross-over phase

Adverse reaction QUILLIVANT XR
N= 45
Placebo
N= 45
Affect lability 9% 2%
Excoriation 4% 0
Initial Insomnia 2% 0
Tic 2% 0
Decreased appetite 2% 0
Vomiting 2% 0
Motion sickness 2% 0
Eye pain 2% 0
Rash 2% 0

Postmarketing 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

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

Nervous System Disorders: Convulsion, Grand mal convulsion, Dyskinesia

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

Urogenital System: Priapism

Skin and Subcutaneous Tissue Disorders: Alopecia, Erythema

Vascular Disorders: Raynaud's phenomenon

Read the entire FDA prescribing information for Quillivant XR (Methylphenidate Hydrochloride Extended Release Oral Suspension, CII ) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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