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Adderall Xr

Source: OpenFDA label data · Not medical advice · For personal tracking only

The most user-facing sections are shown first. FDA professional label details are kept below and collapsed because they can be technical, repetitive, or difficult to read out of context.

Safety Warning Highlights

No structured warning highlights available.

Reported Side Effects

28

Serious — Get Medical Help

These may signal more serious reactions and may require prompt medical attention.

Common or Likely

Frequently reflected in adverse reaction or label text.

Infection

Illness caused by bacteria, viruses, fungi, or other germs entering the body.

FDA label warnings

9

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Source label wording. This may be long, technical, or formatted for the original package label.

WARNING: ABUSE, MISUSE, and ADDICTION ADDERALL XR ® has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction

Misuse and abuse of CNS stimulants, including ADDERALL XR, can result in overdose and death [see Overdosage ( 10 )] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection

Before prescribing ADDERALL XR, assess each patient’s risk for abuse, misuse, and addiction

Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug

Throughout ADDERALL XR treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 )]

Professional label: Usage and Indications

4

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Technical label wording. It may be incomplete, repetitive, or written for clinicians.

This label section may be messy because it contains repeated wording. Use it as source-label context, not as a simplified explanation.
  • ADDERALL XR, a CNS stimulant, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older
  • Limitations of Use The use of ADDERALL XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage
  • Attention Deficit Hyperactivity Disorder ADDERALL XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older

Professional label: Dosage Details

15

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Not dosing guidance. Follow your clinician, pharmacist, or product label.

This dosage label section may be difficult to read because it contains large label paragraphs and many dosing values and repeated wording. Do not use it to decide how much medicine to take.
  • Pediatric patients (ages 6 to 17): 10 mg once daily in the morning. Maximum dose for children 6 to 12 years of age is 30 mg once daily
  • Adults: 20 mg once daily in the morning
  • Pediatric patients (ages 6 to 17) with severe renal impairment: 5 mg once daily in the morning. Maximum dose for children 6 to 12 years of age with severe renal impairment is 20 mg once daily

WARNING: ABUSE, MISUSE, and ADDICTION See full prescribing information for complete boxed warning

ADDERALL XR has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction

Misuse and abuse of CNS stimulants, including ADDERALL XR, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing ADDERALL XR, assess each patient’s risk for abuse, misuse, and addiction

Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction