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Clinical Trials

Adderall (mixed salts of a single-entity amphetamine)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Supplemental NDA Approved February 1996

Specific Treatments:

Attention Deficit/Hyperactivity Disorder (ADHD)

General Information

Adderall has been indicated for use in children three years of age and older with ADHD as an integral part of a total treatment program which typically includes psychological, educational, and social measures.

Adderall may improve attention span, decrease distractibility, and increase the ability to follow directions and finish tasks. The therapy may also improve the subject's ability to think before acting (decrease impulsivity), decrease hyperactivity and improve legibility of handwriting. In addition, aggression may decrease in youngsters with ADHD.

Adderall is available in 10 mg and 20 mg double-scored tablets.

Side Effects

Adderall is generally well tolerated with few adverse reactions reported. The most frequently reported adverse reactions include anorexia, insomnia, stomach pain, headache, irritability, and weight loss. As with most psychostimulants indicated for ADHD, the possibility of growth suppression and the potential for precipitating motor tics and Tourette Syndrome exists with Adderall treatment, and in rare cases exacerbations of psychosis have been reported. Since psychostimulants have a high potential for abuse, Adderall should only be prescribed as part of an overall treatment program for ADHD with close physician supervision.

Additional Information

Adderall had previously been approved and marketed by another company under the name of Obetrol, indicated for exogenous obesity and ADHD. Richwood acquired the company, including the formulation and manufacturing rights to Obetrol, and renamed the product Adderall in 1994.

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