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.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure the medicine is working properly. Blood and blood pressure tests may be needed to check for unwanted effects. Your doctor may occasionally stop treatment to check symptoms of ADHD.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI), including isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]), within the past 14 days.

If you have been using this medicine for a long time and you think you may have become mentally or physically dependent on it, check with your doctor right away. Some signs of dependence may be:

• A strong desire or need to continue using the medicine.
• A need to increase the dose to receive the same effects.
• Withdrawal effects after stopping the medicine including agitation, generalized slowing of mental and physical activity, increased appetite, trouble sleeping, unable to sleep, unpleasant dreams, unusual tiredness or weakness, or unusually deep sleep or long duration of sleep.

This medicine may cause serious heart or blood vessel problems. This may be more likely to occur in patients who have a family history of heart disease. Check with your doctor right away if you have chest pain, fast or uneven heartbeat, trouble breathing, or fainting while using this medicine.

Tell your doctor right away if you or your family notice any unusual changes in behavior, including an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behavior. Also tell your doctor if you or your child see, hear, or feel things that are not there, or have any unusual thoughts, especially if they are new or getting worse quickly.

Symptoms of an overdose include: agitation, 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, fast, pounding, or irregular heartbeat or pulse, headache, inability to speak, loss of bladder control, muscle cramps, pains, or stiffness, muscle spasm or jerking of all extremities, 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, 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, trouble breathing, twitching, unusual tiredness or weakness, violent actions, vomiting, weakness in the arm or leg on one side of the body, sudden and severe. Call your doctor right away if you notice these symptoms.

This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child's height and weight.

This medicine may cause some people to feel a false sense of well-being or to become dizzy, lightheaded, or less alert than they are normally. It may also cause blurred vision or other vision problems. Do not drive or do anything else that could be dangerous until you or your child know how this medicine affects you.

This medicine may cause Raynaud's phenomenon, which is a problem with blood circulation in the fingers or toes. Tell your doctor if you or your child have tingling or pain, a cold feeling, paleness, or skin color changes in the fingers or toes, especially when exposed to cold temperatures. Call your doctor right away if you have unexplained sores or ulcers on your fingers or toes.

Check with your doctor right away if you or your child have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Avoid drinking alcohol while using this medicine.

Use with medications that increase stomach or urine alkalinity, including sodium bicarbonate, acetazolamide, and some thiazide diuretics (water pill) should be avoided. .

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, herbal (eg, St. John's wort) or vitamin supplements, and medicine for appetite control, asthma, colds, cough, hayfever, or sinus problems.

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:

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:

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 adverse events

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]

See also:

Frequently asked questions

• Is Adzenys XR-ODT the same as Adderall XR?
• Adderall vs Vyvanse - What's the difference between them?
• How is Adzenys ER different to other brands of amphetamine?
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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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer