Adzenys Xr-odt

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.

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

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

• Blurred vision
• confusion
• diarrhea
• dizziness
• fast, irregular, pounding, or racing heartbeat or pulse
• headache
• overactive reflexes
• pounding in the ears
• restlessness
• shakiness in the legs, arms, hands, or feet
• shivering
• slow or fast heartbeat
• sweating
• talking or acting with excitement you cannot control
• 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)

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

Symptoms of overdose

• Dark urine
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• muscle cramps, spasms, pain, or stiffness
• nausea
• seizures
• stomach cramps
• sweating
• unusual tiredness or weakness
• vomiting

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
• sore throat
• stomach ache
• voice changes
• weight loss

Less common

• Belching
• dizziness
• heartburn
• indigestion
• stomach discomfort, upset, or pain

Incidence not known

• Decreased interest in sexual intercourse
• difficulty having a bowel movement
• hives or welts, itching, or skin rash
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• redness of the skin
• unpleasant taste

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

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.

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.

Postmarketing reports: Hypersensitivity reactions including angioedema and anaphylaxis

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

Rare (less than 0.1%): Psychotic episodes

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

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

Postmarketing reports: Rhabdomyolysis

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

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

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

Frequency not reported: Urticaria

Frequency not reported: Anorexia, weight loss

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

Postmarketing reports: Blurred vision, mydriasis