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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 ConsumerApplies 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:
More common
Less common
Rare
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:
More common
Less common
Incidence not known
For Healthcare Professionals
Applies to amphetamine: oral suspension extended release, oral tablet, oral tablet disintegrating, oral tablet disintegrating extended release
GeneralThe 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.
CardiovascularFrequency 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.
HypersensitivityPostmarketing reports: Hypersensitivity reactions including angioedema and anaphylaxis
DermatologicPostmarketing reports: Urticaria, rash, serious skin rashes, including Stevens-Johnson Syndrome and toxic epidermal necrolysis, alopecia
PsychiatricRare (less than 0.1%): Psychotic episodes
Frequency not reported: Euphoria, dysphoria, insomnia, restlessness, irritability, depression, aggression, anger, logorrhea, dermatillomania
Nervous systemFrequency not reported: Overstimulation, dizziness, dyskinesia, tremor, headache, exacerbation of motor/phonic tics and Tourette's syndrome, paresthesia, formication
MusculoskeletalPostmarketing reports: Rhabdomyolysis
GastrointestinalCommon (1% to 10%): Upper abdominal pain
Frequency not reported: Dry mouth, unpleasant taste, diarrhea, constipation, other GI disturbances, bruxism
EndocrineFrequency not reported: Impotence, libido changes, frequent or prolonged erections
ImmunologicFrequency not reported: Urticaria
MetabolicFrequency not reported: Anorexia, weight loss
RespiratoryCommon (1% to 10%): Epistaxis, allergic rhinitis
OcularPostmarketing reports: Blurred vision, mydriasis
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/3/2022.
Source: Drugs.com Adzenys Xr-odt (www.drugs.com/mtm/adzenys-xr-odt.html).
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