ADDERALL XR FDA MedWatch Voluntary U.S. Reports Summary
These tables and charts are created from 1,013 U.S. reports for ADDERALL XR (AMPHETAMINE ASPARTATE\AMPHETAMINE SULFATE\DEXTROAMPHETAMINE SACCHARATE\DEXTROAMPHETAMINE SULFATE) voluntarily reported by individuals directly to the FDA via the MedWatch Reporting System from 2004 through July 30, 2026. Events listed on this page represent serious and often rare adverse events
reported to the FDA, and often do not represent typical side effects for the medication. Find common side effects on the most recent
official drug label.
For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS ADDERALL XR Report.
Top Adverse Events Reported with ADDERALL XR (from U.S. FDA Medwatch Reports)
Side Effect # of FDA Reports 1 DRUG INEFFECTIVE 244 2 PRODUCT SUBSTITUTION ISSUE 203 3 HEADACHE 110 4 NAUSEA 67 5 FATIGUE 60 6 ANXIETY 58 7 DISTURBANCE IN ATTENTION 57 8 TREATMENT FAILURE 55 9 DEPRESSION 53 10 PRODUCT QUALITY ISSUE 51 11 IRRITABILITY 43 12 FEELING ABNORMAL 41 13 INSOMNIA 40 14 DROWSINESS 38 15 DIZZINESS 36 16 DECREASED APPETITE 32 17 PALPITATIONS 29 18 MIGRAINE 27 19 SUICIDAL IDEATION 27 20 VOMITING 27 21 ABDOMINAL PAIN UPPER 25 22 ADVERSE DRUG REACTION 25 23 AGGRESSION 25 24 CONDITION AGGRAVATED 24 25 SHORTNESS OF BREATH 24
ADDERALL XR Total Medwatch Safety Reports by Patient Sex
| Male | Female | Unknown | Total |
|---|---|---|---|
| 279 | 522 | 212 | 1,013 |
| Medwatch Reporter Type | Count |
| Consumer | 559 |
| Physician | 55 |
| Pharmacist | 78 |
| Other Health Professional | 117 |
| Top Indications | |
| Attention deficit hyperactivity disorder | |
| Product used for unknown indication | |
| Narcolepsy | |
| Depression | |
| Autonomic nervous system imbalance | |
Type of Outcome Reported
Serious: 501
Not Serious: 512
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.
Suspected Role
Primary Suspect: 1012
Concomitant Drugs: 572
Note: A single MedWatch report can list more than one drug. This summary includes ADDERALL XR identified as the suspect drug or as a concomitantly taken drug.
FDA Safety-Related Labeling Changes
ADDERALL XR (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE) Rx Drug:
FDA Safety-related Labeling Changes
weight loss reported in children under age 6; not recommended for use by patients under 6; may interfere with DaTscan, used to detect dopamine levels in brain.
Have experience (good or bad) with ADDERALL XR? Rate ADDERALL XR at Ask a Patient.
For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.
NOTES
This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.
After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"
The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.
Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."
FDA uses the "MedDRA" classification system to describe reported adverse
reactions. MedDRA is a standardized medical terminology that facilitates
sharing of regulatory information internationally. In some cases, "patient
friendly" terms for the layman designated by MedDRA have been substituted
for medical jargon. Please
contact us
with questions about this report.