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Adzenys ER Side Effects

Generic name: amphetamine

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

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

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)

Abuse, Misuse, and AddictionAmphetamine 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 ER

Along with its needed effects, amphetamine (the active ingredient contained in Adzenys ER) 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

Other side effects of Adzenys ER

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, oral tablet extended release.

General

The most commonly reported side effects with amphetamine (the active ingredient contained in Adzenys ER) 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 ER) 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.