Medical Editor: John P. Cunha, DO, FACOEP
What Is Evekeo ODT?
What Are Side Effects of Evekeo ODT?
Common side effects of Evekeo ODT include:
- decreased appetite,
- abdominal pain, and
- mood changes
Dosage for Evekeo ODT
The starting dose of Evekeo ODT is 5 mg once or twice daily. If necessary, administer an additional dose of Evekeo ODT after 4 to 6 hours.
What Drugs, Substances, or Supplements Interact with Evekeo ODT?
Evekeo ODT may interact with monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRI), serotonin norepinephrine reuptake inhibitors (SNRI), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's wort, sodium bicarbonate, proton pump inhibitors, acetazolamide, some thiazides, guanethidine, reserpine, glutamic acid HCl, ascorbic acid, ammonium chloride, sodium acid phosphate, methenamine salts, quinidine, and ritonavir. Tell your doctor all medications and supplements you use.
Evekeo ODT During Pregnancy or Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Evekeo ODT; it may harm a fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Evekeo ODT during pregnancy. Because of the potential for serious adverse reactions in nursing infants, breastfeeding is not recommended while using Evekeo ODT. Withdrawal symptoms may occur if you suddenly stop taking Evekeo ODT.
Our Evekeo ODT (amphetamine sulfate) Orally Disintegrating Tablets, CII 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:
- Abuse and Dependence [see BOXED WARNING, WARNINGS AND PRECAUTIONS, and Drug Abuse And Dependence]
- Hypersensitivity to amphetamine, or other components of EVEKEO ODT [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]
- Seizures [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]
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.
Study 1 was conducted with EVEKEO tablets (i.e., not the ODT formulation) in children ages 6 to 12 years who met Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria for ADHD. This study began with an 8-week, open-label, dose-optimization phase followed by a 2-week double-blind, placebo-controlled, randomized, crossover phase. Adverse reactions reported in > 5% of patients (N=105; doses of 10 to 40 mg/day) during the open-label phase included: decreased appetite (28%), infections (22%), abdominal pain (15%), irritability (14%), headache (13%), nausea (6%), vomiting (6%), affect lability (includes mood swings; 9%), tachycardia (9%), insomnia (10%), fatigue (10%),and dry mouth (6%). During the open-label phase, six patients discontinued due to adverse reactions: irritability (n=3), affect lability (n=1), initial insomnia (n=1), and rash (n=1).
Table 1 lists the adverse reactions reported during the double-blind, cross-over phase. No patient discontinued the study for an adverse reaction during the double-blind crossover phase. Because of the trial design (an initial 8-week, open-label, active treatment phase), the adverse reaction rates described in the double-blind phase are lower than expected in clinical practice.
Table 1: Adverse Reactions Reported in ≥ 2%, and
> Placebo, of EVEKEO -Treated Pediatric Patients (6 to 12 Years) During the
Double-Blind Cross-Over Weeks.a
|System Organ Class
|Subjects with at least one adverse event||22%||14%|
|Metabolism and Nutrition Disorders|
|Injury, poisoning and procedural complications|
|aDrug exposures and placebo exposures from
cross-over were combined for analysis.
b Includes mood swings.
The following adverse reactions have been associated during post approval use of amphetamines. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.
Central Nervous System
Psychotic episodes at recommended doses, overstimulation, irritability, restlessness, dizziness, insomnia, euphoria, mood swings, aggression, anger, logorrhea, dermatillomania, dyskinesia, dysphoria, tremor, fatigue, headache, exacerbation of motor and phonic tics and Tourette's syndrome
Dry mouth, unpleasant taste, constipation, nausea, other gastrointestinal disturbances, anorexia, and weight loss.
Urticaria, rash, hypersensitivity reactions, including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson Syndrome and toxic epidermal necrolysis have been reported.
Impotence, changes in libido, and frequent or prolonged erections.
Read the entire FDA prescribing information for Evekeo ODT (Aphetamine Sulfate Orally Disintegrating Tablets)