Adzenys XR-ODT Side Effects

Generic name: amphetamine

Medically reviewed by Drugs.com. Last updated on Sep 10, 2023.

Note: This document provides detailed information about Adzenys XR-ODT Side Effects associated with amphetamine. Some dosage forms listed on this page may not apply specifically 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.

Important warnings This medicine can cause some serious health issues

Oral route (suspension, extended release; tablet, extended release; tablet, extended release, disintegrating)

Abuse, Misuse, and Addiction. Amphetamine has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction.

Misuse and abuse of CNS stimulants, including amphetamine, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.Before prescribing amphetamine, assess each patient’s risk for abuse, misuse, and addiction.

Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug.

Throughout lisdexamfetamine dimesylate treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

Oral route (tablet, disintegrating)

Amphetamine sulfate has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction.

Misuse and abuse of CNS stimulants, including amphetamine sulfate, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing amphetamine sulfate, assess each patient’s risk for abuse, misuse, and addiction.

Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug.

Throughout amphetamine sulfate treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

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
• agitation
• angry
• blurred vision
• change in consciousness
• chest pain or discomfort
• confusion
• dark urine
• diarrhea
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• extremely high fever or body temperature
• fainting
• fast breathing
• fast, slow, or irregular heartbeat
• headache
• inability to speak
• loss of bladder control
• loss of consciousness
• muscle cramps, spasms, jerking, pain, or stiffness
• nausea
• nervousness
• overactive reflexes
• pain or discomfort in the arms, jaw, back, or neck
• pale, clammy skin
• palpitations
• panic states
• physical attempt to injure
• poor coordination
• pounding in the ears
• restlessness
• seeing, hearing, or feeling things that are not there
• seizures
• shakiness in the legs, arms, hands, or feet
• shivering
• slurred speech
• stomach cramps
• sudden loss of consciousness
• sweating
• swelling of the feet or lower legs
• talking or acting with excitement you cannot control
• temporary blindness
• thirst
• trembling or shaking of the hands or feet
• unusual tiredness or weakness
• violent actions
• vomiting
• weakness in the arm or leg on one side of the body, sudden and severe

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

• belching
• heartburn
• indigestion
• stomach discomfort, upset, or pain

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

• Frequency not reported: Palpitations, tachycardia, elevated blood pressure, cardiomyopathy
• Postmarketing reports: Peripheral vasculopathy, myocardial infarction, sudden death, Raynaud's phenomenon^[Ref]

There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.^[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

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Further information

Adzenys XR-ODT side effects can vary depending on the individual. 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