Label Changes for:
ADDERALL XR (dextroamphetamine mixed salts of a single-entity amphetamine product) Capsules
Changes have been made to the ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- paresthesia (including formication)
Adverse Reactions with the Use of Amphetamine, Adderall XR, or Adderall
- Central Nervous System-Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, tics, aggression, anger, logorrhea, dermatillomania.
- Eye Disorders-Vision blurred, mydriasis
- Gastrointestinal - Unpleasant taste, constipation, other gastrointestinal disturbances.
- Skin- Alopecia.
- Proton Pump Inhibitors (PPIs) PPIs act on proton pumps by blocking acid production, thereby reducing gastric acidity. When ADDERALL XR (20 mg single-dose) was administered concomitantly with the proton pump inhibitor, omeprazole (40 mg once daily for 14 days), the median Tmax of d-amphetamine was decreased by 1.25 hours (from 4 to 2.75 hours), and the median Tmax of l-amphetamine was decreased by 2.5 hours (from 5.5 to 3 hours), compared to ADDERALL XR administered alone. The AUC and Cmax of each moiety were unaffected. Therefore, co-administration of ADDERALL XR and proton pump inhibitors should be monitored for changes in clinical effect.