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Note: This document contains side effect information about amphetamine. Some of the dosage forms listed on this page may not apply to the brand name Adzenys XR-ODT.For the Consumer
Applies to amphetamine: oral suspension extended release, oral tablet, oral tablet extended release disintegrating
Oral route (Suspension, Extended Release; Tablet, Extended Release, Disintegrating)
CNS stimulants, including amphetamine extended-release oral formulations, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.
Oral route (Tablet)
Abuse potential is high with the use of amphetamines. Using amphetamines for a prolonged period of time may lead to drug dependence and must be avoided. Pay particular attention to the possibility of patients obtaining amphetamines for distribution to others or for nontherapeutic use. Prescribe and dispense amphetamines sparingly. Sudden death and serious cardiovascular adverse events may occur with misuse of amphetamines.
Along with its needed effects, amphetamine (the active ingredient contained in Adzenys XR-ODT) 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 amphetamine:
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking amphetamine:
Symptoms of overdose
Some side effects of amphetamine 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:
Incidence not known
For Healthcare Professionals
Applies to amphetamine: oral suspension extended release, oral tablet, oral tablet disintegrating, oral tablet disintegrating extended releaseGeneral
The most commonly reported side effects with amphetamine (the active ingredient contained in Adzenys XR-ODT) products include dry mouth, anorexia, weight loss, abdominal pain, nausea, insomnia, restlessness, emotional lability, dizziness, and tachycardia.Cardiovascular
Frequency not reported: Palpitations, tachycardia, elevated blood pressure, cardiomyopathy
Postmarketing reports: Peripheral vasculopathy, myocardial infarction, sudden death, Raynaud's phenomenon
There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.Hypersensitivity
Postmarketing reports: Hypersensitivity reactions including angioedema and anaphylaxisDermatologic
Postmarketing reports: Urticaria, rash, serious skin rashes, including Stevens-Johnson Syndrome and toxic epidermal necrolysis, alopeciaPsychiatric
Rare (less than 0.1%): Psychotic episodes
Frequency not reported: Euphoria, dysphoria, insomnia, restlessness, irritability, depression, aggression, anger, logorrhea, dermatillomaniaNervous system
Frequency not reported: Overstimulation, dizziness, dyskinesia, tremor, headache, exacerbation of motor/phonic tics and Tourette's syndrome, paresthesia, formicationMusculoskeletal
Postmarketing reports: RhabdomyolysisGastrointestinal
Common (1% to 10%): Upper abdominal pain
Frequency not reported: Dry mouth, unpleasant taste, diarrhea, constipation, other GI disturbances, bruxismEndocrine
Frequency not reported: Impotence, libido changes, frequent or prolonged erectionsImmunologic
Frequency not reported: UrticariaMetabolic
Frequency not reported: Anorexia, weight lossRespiratory
Common (1% to 10%): Epistaxis, allergic rhinitisOcular
Postmarketing reports: Blurred vision, mydriasis
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