Slideshows Images Quizzes

Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. See additional information.

Adzenys ER

Last reviewed on RxList: 9/24/2019
Adzenys ER Side Effects Center

Last reviewed on RxList 9/24/2019

Adzenys ER (amphetamine) extended-release oral suspension is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. Common side effects of Adzenys ER for pediatric patients include:

  • loss of appetite,
  • insomnia,
  • abdominal pain,
  • mood changes,
  • vomiting,
  • nervousness,
  • nausea,
  • fever,
  • weight loss,
  • and nervousness.

Common side effects of Adzenys ER for adult patients also include:

The starting dose of Adzenys ER for pediatric patients (ages 6 to 17 years) is 6.3 mg (5 mL) once daily in the morning. Maximum dose is 18.8 mg (15 mL) for patients 6 to 12 years, and 12.5 mg (10 mL) once daily for patients 13 to 17 years. The dose of Adzenys ER for adults is 12.5 mg (10 mL) once daily in the morning. Adzenys ER may interact with monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRI), serotonin norepinephrine reuptake inhibitors (SNRI), triptans, antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's wort, sodium bicarbonate, acetazolamide, some thiazides, quinidine, ritonavir, omeprazole, esomeprazole, pantoprazole, and cimetidine. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Adzenys ER; it may harm a fetus. Adzenys ER passes into breast milk. Large dosages of amphetamines such as Adzenys ER might interfere with milk production. Because of the potential for serious adverse reactions in nursing infants, breastfeeding is not recommended during treatment with Adzenys ER. Withdrawal symptoms may occur if you suddenly stop taking Adzenys ER.

Our Adzenys ER (amphetamine) Extended-Release Oral Suspension Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

The abbreviated term ADHD denotes the condition commonly known as: See Answer
Adzenys ER Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety of ADZENYS ER has been established from adequate and well-controlled studies of single-entity amphetamine product extended-release (MAS ER) capsules [see Clinical Studies]. The adverse reactions of MAS ER capsules in these adequate and well-controlled studies are described below.

The premarketing development program for MAS ER included exposures in a total of 1315 participants in clinical trials (635 pediatric patients, 350 adolescent patients, 248 adult patients, and 82 healthy adult subjects). Of these, 635 patients (ages 6 to 12) were evaluated in two controlled clinical studies, one open-label clinical study, and two single-dose clinical pharmacology studies (N= 40).

Adverse Reactions Leading To Discontinuation Of Treatment

The most frequent adverse reactions leading to discontinuation of MAS ER in controlled and uncontrolled, multiple-dose clinical trials of pediatric patients ages 6 to 12 years (N=595) were anorexia (loss of appetite) (2.9%), insomnia (1 5%), weight loss (1.2%), emotional lability (1%), and depression (0.7%).

In a separate placebo-controlled 4-week study in pediatric patients 13 to 17 years with ADHD, five patients (2.1%) discontinued treatment due to adverse events among MAS ER-treated patients (N=233) compared to none who received placebo (N=54). The most frequent adverse event leading to discontinuation and considered to be drug-related (i.e. leading to discontinuation in at least 1% of MAS ER-treated patients and at a rate at least twice that of placebo) was insomnia (1.3%, n=3).

In one placebo-controlled 4-week study among adults with ADHD with doses 20 mg to 60 mg, 23 patients (12.0%) discontinued treatment due to adverse events among MAS ER-treated patients (N=191) compared to one patient (1.6%) who received placebo (N=64). The most frequent adverse events leading to discontinuation and considered to be drug-related (i.e. leading to discontinuation in at least 1% of MAS ER-treated patients and at a rate at least twice that of placebo) were insomnia (5.2%, n=10), anxiety (2.1%, n=4), nervousness (1.6%, n=3), dry mouth (1.6%, n=3), anorexia (1.6%, n=3), tachycardia (1.6%, n=3), headache (1.6%, n=3), and asthenia (1.0%, n=2).

Adverse Reactions Occurring In Controlled Trials

Adverse reactions reported in a 3-week clinical trial of pediatric patients 6 to 12 years and a 4week clinical trial in pediatric patients 13 to 17 years of age and adults, respectively, treated with MAS ER or placebo are presented in the tables below.

Table 2: Adverse Reactions Reported by 2% or More of Children (6-12 years old) Receiving MAS ER with Higher Incidence than on Placebo in a 584-Patient Clinical Study

Body System Preferred Term MAS ER
(n=374)
Placebo
(n=210)
General Abdominal Pain (stomachache) 14% 10%
Fever 5% 2%
Infection 4% 2%
Accidental Injury 3% 2%
Asthenia (fatigue) 2% 0%
Digestive System Loss of Appetite 22% 2%
Vomiting 7% 4%
Nausea 5% 3%
Dyspepsia 2% 1%
Nervous System Insomnia 17% 2%
Emotional Lability 9% 2%
Nervousness 6% 2%
Dizziness 2% 0%a
Metabolic/Nutritional Weight Loss 10% 0%

Table 3: Adverse Reactions Reported by 5% or More of Adolescents (13-17 Years Old) Weighing ≤ 75kg Receiving MAS ER with Higher Incidence than Placebo in a 287 Patient Clinical Forced Weekly-Dose Titration Study*

Body System Preferred Term MAS ER
(n=233)
Placebo
(n=54)
General Abdominal Pain (stomachache) 11% 2%
Digestive System Loss of Appetite b 36% 2%
Nervous System Insomnia b 12% 4%
Metabolic/Nutritional Weight Loss b 9% 0%
* Included doses up to 40 mg
b Dose-related adverse reactions
Note: The following reactions did not meet the criterion for inclusion in Table 3 but were reported by 2% to 4% of adolescent patients receiving
MAS ER with a higher incidence than patients receiving placebo in this study: accidental injury, asthenia (fatigue), dry mouth, dyspepsia, emotional lability, nausea, somnolence, and vomiting.

Table 4: Adverse Reactions Reported by 5% or More of Adults Receiving MAS ER with Higher Incidence Than Placebo in a 255 Patient Clinical Forced Weekly-Dose Titration Study*

Body System Preferred Term MAS ER
(n=191)
Placebo
(n=64)
General Headache 26% 13%
Asthenia 6% 5%
Digestive System Dry Mouth 35% 5%
Loss of Appetite 33% 3%
Nausea 8% 3%
Diarrhea 6% 0%
Nervous System Insomnia 27% 13%
Agitation 8% 5%
Anxiety 8% 5%
Dizziness 7% 0%
Cardiovascular System Tachycardia 6% 3%
Metabolic/Nutritional Weight Loss 10% 0%
Urogenital System Urinary Tract Infection 5% 0%
* Included doses up to 60 mg.
Note: The following reactions did not meet the criterion for inclusion in Table 4 but were reported by 2% to 4% of adult patients receiving MAS ER with a higher incidence than patients receiving placebo in this study: infection, photosensitivity reaction, constipation, tooth disorder (e.g. teeth clenching, tooth infection), emotional lability, libido decreased, somnolence, speech disorder (e.g., stuttering, excessive speech), palpitation, twitching, dyspnea, sweating, dysmenorrhea, and impotence.

Adverse Reactions From Clinical Trials And Spontaneous Postmarketing Reports Of Other Amphetamine Products

The following adverse reactions are from clinical trials and spontaneous postmarketing reports of other amphetamine products in pediatric patients and adults with ADHD. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Cardiovascular: Palpitations, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.

Central Nervous System: Restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, aggression, anger, logorrhea, and paresthesia (including formication).

Eye Disorders: Vision blurred, mydriasis.

Gastrointestinal: Unpleasant taste, constipation, other gastrointestinal disturbances.

Allergic: Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis.

Serious skin rashes, including Stevens-Johnson Syndrome and toxic epidermal necrolysis have been reported.

Endocrine: Impotence, change in libido, frequent or prolonged erections.

Skin: Alopecia.

Musculoskeletal, Connective Tissue, and Bone Disorders: Rhabdomyolysis.

Psychiatric Disorders: Dermatillomania, bruxism.

Vascular Disorders: Raynaud’s phenomenon

Read the entire FDA prescribing information for Adzenys ER (Amphetamine Extended-Release Oral Suspension)

SLIDESHOW

ADHD Symptoms in Children See Slideshow
Related Resources for Adzenys ER

© Adzenys ER Patient Information is supplied by Cerner Multum, Inc. and Adzenys ER Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors

CONTINUE SCROLLING FOR RELATED SLIDESHOW