Lisdexamfetamine Side Effects

Some side effects of lisdexamfetamine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to lisdexamfetamine: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking lisdexamfetamine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

• fast, pounding, or uneven heartbeats;

• decreased blood pressure (feeling light-headed, fainting);

• tremor, restlessness, hallucinations, unusual behavior, or motor tics (muscle twitches); or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, seizure).

Less serious side effects of lisdexamfetamine may include:

• loss of appetite, weight loss;

• sleep problems (insomnia);

• nausea, vomiting, stomach pain;

• feeling irritable;

• mild skin rash; or

• dry mouth or an unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to lisdexamfetamine: oral capsule

General

All side effects listed, unless otherwise noted, were reported in pediatric patients.

Other

Other side effects have included decreased appetite (39%), headache, and pyrexia (2%).

Gastrointestinal

Gastrointestinal side effects have included upper abdominal pain (12%), dry mouth (5%), nausea (6%), and vomiting (9%). Gastrointestinal side effects associated with amphetamine or lisdexamfetamine have included dryness of mouth, unpleasant taste, diarrhea, and constipation.

Metabolic

Metabolic side effects have included weight loss.

Nervous system

Nervous system side effects have included insomnia (19%), dizziness (5%), initial insomnia (4%), and somnolence (2%). Nervous system side effects associated with the use of recommended doses of amphetamine or lisdexamfetamine have included dyskinesia and seizures. Postmarketing reports have included psychotic episodes, mania, hallucination, and aggression.

Psychiatric

Psychiatric side effects have included irritability (10%), affect lability (3%), and tic (2%). Psychiatric side effects associated with the use of recommended doses of amphetamine or lisdexamfetamine have included overstimulation, restlessness, euphoria, dysphoria, depression, tremor, and exacerbation of motor and phonic tics and Tourette syndrome. Postmarketing reports have included dermatillomania.

Dermatologic

Dermatological side effects have included rash (3%). Dermatological side effects associated with amphetamine or lisdexamfetamine have included serious skin rashes, Stevens Johnson Syndrome, and toxic epidermal necrolysis.

Cardiovascular

Cardiovascular side effects associated with amphetamine or lisdexamfetamine have included palpitations, tachycardia, increased blood pressure, sudden death, stroke, and myocardial infarction. Cardiomyopathy has been associated with chronic amphetamine use.

Hypersensitivity

Hypersensitivity reactions associated with amphetamine or lisdexamfetamine have included urticaria, angioedema, anaphylaxis, Stevens Johnson Syndrome, and toxic epidermal necrolysis.

Genitourinary

Genitourinary side effects associated with amphetamine or lisdexamfetamine have included decreased libido (less than 2%), erectile dysfunction (less than 2%), impotence, and changes in libido.

Ocular

Ocular side effects including blurred vision have been reported.

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