ADDERALL XR Important Safety Information

• Tell your doctor about any heart conditions, including structural abnormalities, that you, your child, or a family member, may have. Inform your doctor immediately if you or your child develop symptoms that suggest heart problems, such as chest pain or fainting.


• ADDERALL XR should not be taken by patients who have:
1. advanced disease of the blood vessels (arteriosclerosis)
2. symptomatic heart disease
3. moderate to severe high blood pressure
4. overactive thyroid gland (hyperthyroidism)
5. known allergy or unusual reactions to drugs called sympathomimetic amines (for example, pseudoephedrine)
6. seizures
7. glaucoma
8. a history of problems with alcohol or drugs
9. agitated states
10. taken a monoamine oxidase inhibitor (MAOI) within the last 14 days


• Tell your doctor before using ADDERALL XR if you or your child:
1. are being treated for or have symptoms of depression (sadness, worthlessness, or hopelessness) or bipolar disorder
2. have abnormal thought or visions, hear abnormal sounds, or have been diagnosed with psychosis
3. have had seizures or abnormal EEGs
4. have or have had high blood pressure
5. exhibit aggressive behavior or hostility

Tell your doctor immediately if any of these conditions or symptoms develop while using Adderall XR.

• Abuse of amphetamines may lead to dependence. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events. These events have also been reported rarely with amphetamine use.
• ADDERALL XR was generally well tolerated in clinical studies. The most common side effects in studies included: children—decreased appetite, difficulty falling asleep, stomachache, and emotional lability; adolescents—loss of appetite, difficulty falling asleep, stomachache, and weight loss; adults—dry mouth, loss of appetite, difficulty falling asleep, headache, and weight loss. Aggression, new abnormal thoughts/behaviors, mania, growth suppression, worsening of motion or verbal tics and Tourette's syndrome have been associated with use of drugs of this type. Tell your doctor if you or your child have blurred vision while taking ADDERALL XR.