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

Applies to amphetamine: oral suspension extended release, oral tablet, oral tablet disintegrating, oral tablet extended release disintegrating.

Serious side effects of Evekeo

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Shakiness.
• Change in eyesight.
• Seizures.
• Trouble controlling body movements.
• Change in color of hands or feet from pale to blue or red.
• Numbness, pain, tingling, or cold feeling of the hands or feet.
• Any sores or wounds on the fingers or toes.
• Muscle pain or weakness, dark urine, or trouble passing urine.
• Not able to get or keep an erection.
• Change in sex interest.
• For males, erections (hard penis) that happen often or that last a long time.
• Heart attacks, strokes, and sudden deaths have happened in adults taking this drug. Sudden deaths have also happened in children with some heart problems or heart defects. Call your doctor right away if you have a fast, slow, or abnormal heartbeat; weakness on 1 side of the body; trouble speaking or thinking; change in balance; drooping on 1 side of the face; change in eyesight; chest pain or pressure; shortness of breath; or severe dizziness or passing out.

Other side effects of Evekeo

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling dizzy, tired, or weak.
• Dry mouth.
• Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry.
• Trouble sleeping.
• Headache.
• Weight loss.
• Bad taste in your mouth.
• Feeling nervous and excitable.
• Restlessness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

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 Evekeo) 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 Evekeo) 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]