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Generic Name: methylphenidate
Note: This page contains side effects data for the generic drug methylphenidate. It is possible that some of the dosage forms included below may not apply to the brand name Quillivant XR.
Applies to methylphenidate: oral capsule extended release, oral powder for suspension extended release, oral solution, oral tablet, oral tablet chewable, oral tablet extended release, oral tablet extended release chewable
Other dosage forms:
As well as its needed effects, methylphenidate (the active ingredient contained in Quillivant XR) may cause unwanted side effects that require medical attention.
If any of the following side effects occur while taking methylphenidate, check with your doctor immediately:More common:
Some methylphenidate side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:More common:
Applies to methylphenidate: oral capsule extended release, oral powder for reconstitution extended release, oral solution, oral tablet, oral tablet chewable, oral tablet chewable extended release, oral tablet extended release, transdermal film extended release
Nervous system side effects have frequently included tic. Convulsions and migraine have also been reported. Dizziness, drowsiness, dyskinesia, and Tourette's syndrome have been reported rarely. Neuroleptic malignant syndrome (NMS) and reversible ischemic neurological deficit have been reported very rarely.[Ref]
Most reported cases of neuroleptic malignant syndrome (NMS) involved patients who were treated concomitantly with other drugs associated with NMS.
Nervousness and insomnia may be controllable by reducing the dosage and omitting the drug in the afternoon or evening.
It is unclear whether CNS stimulant drugs (i.e., dextroamphetamine, methylphenidate, amphetamine-dextroamphetamine) have a role in either the development or worsening of tic disorders such as Tourette's syndrome. According to several case reports, use of CNS stimulant medications may have precipitated or exacerbated tic disorders in some patients with ADHD. Based on these cases, in Tourette's-susceptible patients, CNS stimulants may exacerbate motor and phonic tics that do not subside following discontinuation of the offending agent. In several controlled studies involving patients with ADHD and tic disorders, in the majority of patients, tics did not increase following use of CNS stimulants. In addition, controlled studies have not found that methylphenidate worsens motor tics in Tourette's syndrome nor has it increased tics in patients without Tourette's. However, it should be noted that tics were reported in 7% of patients using the methylphenidate patch compared to 1% to those taking it orally. Additional studies are required in order to clarify this association.[Ref]
Gastrointestinal side effects have included nausea, vomiting, and abdominal pain. Nausea and vomiting appears to occur more frequently with the transdermal patch compared with oral administration. Postmarketing side effects include bruxism.[Ref]
Cardiovascular side effects have rarely included changes in blood pressure and pulse rate, cerebral arteritis, occlusion, angina, arrhythmia, palpitations, bradycardia, extrasystoles, ventricular extrasystoles, supraventricular tachycardia, Raynaud's phenomenon, and tachycardia. A case of cardiac arrest has also been reported. Additionally, cerebrovascular vasculitis, cerebral hemorrhages, and cerebrovascular accidents have been reported.[Ref]
Other side effects have rarely included headache, peripheral coldness, and auricular swelling. A withdrawal syndrome has been reported with the abrupt discontinuation of methylphenidate (the active ingredient contained in Quillivant XR) [Ref]
Hepatic side effects have rarely included abnormal liver function ranging from transaminase elevation to hepatic coma; however, causality has not been established. Increased blood alkaline phosphatase, increased blood bilirubin, and increased hepatic enzymes have also been reported.[Ref]
Hematologic side effects have rarely included leukopenia, anemia, pancytopenia, thrombocytopenic purpura, and thrombocytopenia; however, causality has not been established.[Ref]
Psychiatric side effects have frequently included emotional lability and insomnia. Hallucination, mania, obsessive-compulsive disorder, and nervousness have also been reported. Emotional lability and insomnia appear to occur more frequently with the transdermal patch compared with oral administration. In patients wearing the transdermal patch for 12 hrs a day, the incidence of insomnia was 30%. Transient depressed mood and aggressive behavior have been reported rarely; however, causality has not been determined. Postmarketing side effects include logorrhea.[Ref]
Dermatologic side effects have included bullous conditions, exfoliative conditions, urticarias, pruritus, rashes, eruptions, erythema, and exanthemas. Scalp hair loss has been reported rarely; however, causality has not been determined.[Ref]
Methylphenidate topical patch is a dermal irritant. The resulting erythema does not typically cause an interference or discontinuation of treatment. However, further evaluation should be sought, if erythema, edema, and/or papules do not resolve or significantly reduce within 24 hours of patch removal. Consideration should be given to sensitization if erythema is accompanied by edema, papules, vesicles, or other evidence of more intense local reactions. Diagnosis of allergic contact dermatitis should include appropriate diagnostic testing.[Ref]
Ocular side effects have included visual disturbances, mydriasis, difficulties with accommodation, diplopia, and blurring of vision.[Ref]
Respiratory side effects associated with methylphenidate (the active ingredient contained in Quillivant XR) topical patch have frequently included nasopharyngitis and nasal congestion.[Ref]
Metabolic side effects have included anorexia, decreased appetite, and weight loss (primarily with prolonged therapy). Anorexia, decreased appetite, and weigh loss appears to occur more frequently with the transdermal patch compared with oral administration. In patients wearing the transdermal patch for 12 hrs a day, the incidence of anorexia was 46%.[Ref]
Local side effects associated with the topical patch have included application site reactions such as bleeding, bruising, burn, burning, dermatitis, discharge, discoloration, discomfort, dryness, eczema, edema, erosion, erythema, excoriation, exfoliation, fissure, hyperpigmentation, hypopigmentation, induration, infection, inflammation, irritation, pain, papules, paresthesia, pruritus, rash, scab, swelling, ulcer, urticaria, vesicles, and warmth.
One subject has been reported to have experienced erythema and edema at methylphenidate (the active ingredient contained in Quillivant XR) transdermal system application sites with concurrent urticarial lesions on the abdomen and legs resulting in treatment discontinuation. This subject was not transitioned to oral methylphenidate.
Hypersensitivity side effects including generalized erythematous and urticarial rashes, allergic contact dermatitis, angioedema, and anaphylaxis have been reported.
Musculoskeletal side effects including arthralgia, myalgia, and muscle twitching have been reported.
Genitourinary side effects have included in rare instances prolonged and painful erections known as priapism.
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5. Greenhill LL, Pliszka S, Dulcan MK, et al. "Practice parameter for the use of stimulant medications in the treatment of children, adolescents, and adults." J Am Acad Child Adolesc Psychiatry 41(2 Suppl) (2002): 26S-49S
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It is possible that some side effects of Quillivant XR may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
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