Dextrostat Side Effects

Generic name: dextroamphetamine

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

Some side effects of Dextrostat 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 dextroamphetamine: oral capsule extended release, oral solution, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking dextroamphetamine (the active ingredient contained in Dextrostat) 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 or pounding heartbeats;

• feeling light-headed, fainting;

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

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

Less serious side effects of dextroamphetamine may include:

• headache or dizziness;

• sleep problems (insomnia);

• dry mouth or an unpleasant taste in your mouth;

• diarrhea, constipation;

• loss of appetite, weight loss; or

• loss of interest in sex, impotence, or difficulty having an orgasm.

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 dextroamphetamine: oral capsule extended release, oral solution, oral tablet

Cardiovascular

Cardiovascular side effects have included palpitations, tachycardia, and elevated blood pressure. Cardiomyopathy, myocardial infarction, and sudden death have been reported rarely.

Nervous system

Nervous system side effects have included overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and phonic tics, and Tourette's syndrome. Psychotic episodes at recommended doses have been reported rarely.

It is unclear whether CNS stimulant drugs (i.e., dextroamphetamine, methylphenidate, mixed- salts amphetamine) have a role in either the development or worsening of tic disorders such as Tourette's syndrome. According to several case reports, use of CNS stimulant medications may have precipitated or exacerbated tic disorders in some patients with ADHD. Based on these cases, in Tourette's-susceptible patients, CNS stimulants may exacerbate motor and phonic tics that do not subside following discontinuation of the offending agent. In several controlled studies involving patients with ADHD and tic disorders, in the majority of patients, tics did not increase following use of CNS stimulants. In addition, controlled studies have not found that methylphenidate worsens motor tics in Tourette's syndrome nor has it increased tics in patients without Tourette's. However, it should be noted that tics were reported in 7% of patients using the methylphenidate patch compared to 1% to those taking it orally. Additional studies are required in order to clarify this association.

Gastrointestinal

Gastrointestinal side effects have included dry mouth, unpleasant taste, diarrhea, constipation, (undesired) anorexia and weight loss, and other disturbances.

Dermatologic

Dermatologic side effects have included urticaria.

Endocrine

Endocrine side effects have included impotence and changes in libido.

Other

Amphetamines may interfere with urinary steroid determination.

Other side effects have included a significant elevation (highest in the evening) of the plasma corticosteroid levels.

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