Amphetamine / dextroamphetamine Side Effects

Some side effects of amphetamine / dextroamphetamine 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 amphetamine / dextroamphetamine: oral capsule extended release, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking amphetamine / dextroamphetamine: 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;

• pain or burning when you urinate;

• talking more than usual, feelings of extreme happiness or sadness;

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

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

Less serious side effects of amphetamine / dextroamphetamine may include:

• headache, weakness, dizziness, blurred vision;

• feeling restless, irritable, or agitated,

• sleep problems (insomnia);

• dry mouth or an unpleasant taste in your mouth;

• diarrhea, constipation, stomach pain, nausea, vomiting;

• fever;

• hair loss, 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 amphetamine / dextroamphetamine: oral capsule extended release, oral tablet

Gastrointestinal

Gastrointestinal side effects have included dry mouth (35%), loss of appetite (33%), nausea (8%), diarrhea (6%), unpleasant taste, constipation, (undesired) anorexia, weight loss, and other disturbances.

Nervous system

Nervous system side effects have included insomnia (27%), agitation (8%), anxiety (8%), dizziness (7%), depression, seizures, stroke, overstimulation, restlessness, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and phonic tics, and Tourette's syndrome. Additional reports have included irritability, aggression, anger, logorrhea, dermatillomania and paresthesia (including formication).

It is unclear whether CNS stimulant drugs (i.e., dextroamphetamine, methylphenidate, amphetamine-dextroamphetamine) 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.

Metabolic

Metabolic side effects including weight loss (11%) have been reported.

Cardiovascular

Cardiovascular side effects have included tachycardia (6%), palpitations, elevated blood pressure, sudden death, and myocardial infarction. There are isolated reports of cardiomyopathy associated with chronic amphetamine use.

Genitourinary

Genitourinary side effects including urinary tract infection (5%), dysmenorrhea, and impotence have been reported.

Other

Other side effects have included a significant elevation (highest in the evening) of the plasma corticosteroid levels. Amphetamines may interfere with urinary steroid determination. Headache (26%), asthenia (6%), somnolence, infection, tooth disorder, speech disorder, and twitching have also been reported.

Dermatologic

Dermatologic side effects have included urticaria, photosensitivity reaction, and sweating. Additional reports have included alopecia.

Endocrine

Endocrine side effects have included impotence and changes in libido.

Psychiatric

Psychiatric side effects including emotional lability and psychotic episodes have been reported rarely at recommended doses.

Respiratory

Respiratory side effects including dyspnea have been reported.

Hypersensitivity

Hypersensitivity side effects have included urticaria rash, angioedema and anaphylaxis, Stevens-Johnson Syndrome and toxic epidermal necrolysis.

Ocular

Ocular side effects have included blurred vision and mydriasis.

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