Medical Editor: John P. Cunha, DO, FACOEP
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,
- abdominal pain,
- mood changes,
- weight loss,
- and nervousness.
Common side effects of Adzenys ER for adult patients also include:
- dry mouth,
- fast heart rate,
- weakness or lack of energy,
- and urinary tract infections (UTIs).
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.
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Drug Dependence [see BOX WARNING, WARNINGS AND PRECAUTIONS and Drug Abuse And Dependence]
- Hypersensitivity to amphetamine, or other components of ADZENYS ER [see CONTRAINDICATIONS]
- Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see CONTRAINDICATIONS and DRUG INTERACTIONS]
- Serious Cardiovascular Reactions [see WARNINGS AND PRECAUTIONS]
- Blood Pressure and Heart Rate Increases [see WARNINGS AND PRECAUTIONS]
- Psychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Long-Term Suppression of Growth [see WARNINGS AND PRECAUTIONS]
- Peripheral Vasculopathy, including Raynaud's phenomenon [see WARNINGS AND PRECAUTIONS]
- Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]
- Potential for Intestinal Necrosis [see WARNINGS AND PRECAUTIONS]
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
|General||Abdominal Pain (stomachache)||14%||10%|
|Digestive System||Loss of Appetite||22%||2%|
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
|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
|Digestive System||Dry Mouth||35%||5%|
|Loss of Appetite||33%||3%|
|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.
Eye Disorders: Vision blurred, mydriasis.
Gastrointestinal: Unpleasant taste, constipation, other gastrointestinal disturbances.
Endocrine: Impotence, change in libido, frequent or prolonged erections.
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)