Dextroamphetamine: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Dextroamphetamine. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| Vomiting | 22% |
| General | 14% |
| Cardiovascular system | 6% |
| Fever | 5% |
| Infection | 4% |
| Metabolic/nutritional | 4% |
| Accidental injury | 3% |
| Anorexia (loss of appetite) | 2.9% |
| Asthenia (fatigue) | 2% |
| Viral infection | 2% |
| Nervousness | 2% |
| Insomnia | 1.5% |
| Weight loss | 1.2% |
| Emotional lability | 1% |
| Depression | 0.7% |
*Highest percentage across placebo-controlled trial tables summarized in current labeling.
Labeled uses
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The efficacy of Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules in the treatment of ADHD was established on the basis of two controlled trials in children aged 6 to 12, one controlled trial in adolescents aged 13 to 17, and one controlled trial in adults who met DSM-IV® criteria for ADHD (see CLINICAL PHARMACOLOGY ), along with extrapolation from the known efficacy of ADDERALL® , the immediate-release formulation of this substance. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by anot…
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