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Adzenys XR-ODT Side Effects

Generic name: amphetamine

Medically reviewed by Drugs.com. Last updated on Nov 22, 2022.

Note: This document contains side effect information about amphetamine. Some dosage forms listed on this page may not apply to the brand name Adzenys XR-ODT.

Applies to amphetamine: oral suspension extended release, oral tablet, oral tablet disintegrating, oral tablet extended release chewable, oral tablet extended release disintegrating.

Warning

Oral route (Suspension, Extended Release; Tablet, 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, Disintegrating)

CNS stimulants, including amphetamine sulfate orally disintegrating tablets, 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.

Serious side effects of Adzenys XR-ODT

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

  • Agitation
  • anxiety
  • bladder pain
  • bloody or cloudy urine
  • crying
  • delusions of persecution, mistrust, suspiciousness, or combativeness
  • difficult, burning, or painful urination
  • false or unusual sense of well-being
  • feeling of unreality
  • frequent urge to urinate
  • lower back or side pain
  • mental depression
  • nervousness
  • quick to react or overreact emotionally
  • rapidly changing moods
  • sense of detachment from self or body

Less common

  • Chills
  • cough
  • fever
  • hoarseness

Rare

  • Seeing, hearing, or feeling things that are not there
  • severe mental changes

Incidence not known

  • Blistering, peeling, loosening of the skin
  • blurred vision
  • chest pain or discomfort
  • confusion
  • dark urine
  • diarrhea
  • difficulty breathing
  • dizziness
  • fainting
  • fast, irregular, pounding, or racing heartbeat or pulse
  • headache
  • hives, itching, skin rash
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • mood swings
  • muscle cramps, pain, stiffness, or spasms
  • nausea
  • overactive reflexes
  • pain or discomfort in the arms, jaw, back, or neck
  • paleness or cold feeling in the fingertips and toes
  • pounding in the ears
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • restlessness
  • shakiness in the legs, arms, hands, or feet
  • shivering
  • slow or fast heartbeat
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • sweating
  • swelling of the feet or lower legs
  • talking or acting with excitement you cannot control
  • tingling or pain in the fingers or toes when exposed to cold temperatures
  • trouble sleeping
  • twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
  • uncontrolled vocal outbursts or tics (uncontrolled repeated body movements)
  • unusual tiredness or weakness
  • vomiting

Get emergency help immediately if any of the following symptoms of overdose occur while taking amphetamine:

Symptoms of overdose

  • Aggressive
  • angry
  • confusion
  • dark urine
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • fast breathing
  • fast, slow, or irregular heartbeat
  • loss of consciousness
  • muscle cramps, spasms, pain, or stiffness
  • nausea
  • restlessness
  • seeing, hearing, or feeling things that are not there
  • seizures
  • stomach cramps
  • sweating
  • tremor
  • unusual tiredness or weakness
  • vomiting

Other side effects of Adzenys XR-ODT

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

  • Dry mouth
  • loss of appetite
  • stomach ache
  • voice changes
  • weight loss

Less common

Incidence not known

  • Constipation
  • decreased interest in sexual intercourse
  • difficulty having a bowel movement
  • inability to have or keep an erection
  • loss in sexual ability, desire, drive, or performance
  • redness of the skin
  • thinning or loss of hair
  • unpleasant taste

For Healthcare Professionals

Applies to amphetamine: oral suspension extended release, oral tablet, oral tablet disintegrating, oral tablet disintegrating extended release, oral tablet extended release.

General

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.[Ref]

Cardiovascular

There have been isolated reports of cardiomyopathy associated with chronic amphetamine (the active ingredient contained in Adzenys XR-ODT) use.[Ref]

Frequency not reported: Palpitations, tachycardia, elevated blood pressure, cardiomyopathy

Postmarketing reports: Peripheral vasculopathy, myocardial infarction, sudden death, Raynaud's phenomenon[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions including angioedema and anaphylaxis

Dermatologic

Postmarketing reports: Urticaria, rash, serious skin rashes, including Stevens-Johnson Syndrome and toxic epidermal necrolysis, alopecia

Psychiatric

Rare (less than 0.1%): Psychotic episodes

Frequency not reported: Euphoria, dysphoria, insomnia, restlessness, irritability, depression, aggression, anger, logorrhea, dermatillomania[Ref]

Nervous system

Frequency not reported: Overstimulation, dizziness, dyskinesia, tremor, headache, exacerbation of motor/phonic tics and Tourette's syndrome, paresthesia, formication[Ref]

Musculoskeletal

Postmarketing reports: Rhabdomyolysis[Ref]

Gastrointestinal

Common (1% to 10%): Upper abdominal pain

Frequency not reported: Dry mouth, unpleasant taste, diarrhea, constipation, other GI disturbances, bruxism[Ref]

Endocrine

Frequency not reported: Impotence, libido changes, frequent or prolonged erections[Ref]

Immunologic

Frequency not reported: Urticaria[Ref]

Metabolic

Frequency not reported: Anorexia, weight loss[Ref]

Respiratory

Common (1% to 10%): Epistaxis, allergic rhinitis[Ref]

Ocular

Postmarketing reports: Blurred vision, mydriasis[Ref]

Frequently asked questions

References

1. "Product Information. Adzenys ER (amphetamine)." Neos Therepeautics, Inc (2019):

2. "Product Information. Adzenys XR-ODT (amphetamine)." Neos Therepeautics, Inc (2019):

3. "Product Information. Evekeo ODT (amphetamine)." Arbor Pharmaceuticals (2021):

4. "Product Information. Evekeo (amphetamine)." Arbor Pharmaceuticals (2015):

5. "Product Information. Dyanavel XR (amphetamine)." Tris Pharma Inc (2015):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer