FDA Black Box Warning Labels on ADHD Medications

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ADHD Medications and the FDA

After much debate the following medications carry the "black box warnings" on the labels of the bottles. These are the strongest warnings that the FDA requires, a step away from pulling the medications.

  • Adderall Tablets (mixed salts of a single entity amphetamine product)
  • Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules
  • Concerta (methylphenidate hydrochloride) Extended-Release Tablets
  • Daytrana (methylphenidate) Transdermal System
  • Desoxyn (methamphetamine hydrochloride) Tablets Label (will be updated soon)
  • Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets
  • Focalin (dexmethylphenidate hydrochloride) Tablets
  • Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules
  • Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules
  • Methylin (methylphenidate hydrochloride) Oral Solution
  • Methylin (methylphenidate hydrochloride) Chewable Tablets
  • Ritalin (methylphenidate hydrochloride) Tablets
  • Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets
  • Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
  • Strattera (atomoxetine hydrochloride) Capsules


Warnings for Amphetamine, Dextroamphetamine, Lisdexamfetamine dismesylate, Methamphetamine, Mixed Salts of a Single Entity Amphetamine Products :Adderall, Adderall XR, Desoxyn, and Dexedrine (SR)

  • High abuse/diversion potential: Amphetamines have a high potential for abuse. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly.
  • Drug dependence: Administration of amphetmaines for prolonged periods of time may lead to drug dependence and must be avoided.
  • Serious Adverse Events: Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events


Warnings for Dexmethylphenidate, and Methylphenidate Medications :Ritalin, Ritalin LA, Ritalin SR, Concerta, Daytrana, Desoxyn, Focalin, Metadate, Methylin

All Dexmethylphenidate, Methylphenidate Products

  • Chronic abusive use can lead to a marked tolerance and psychological dependence with varying degree of abnormal behavior
  • Frank psychotic episodes can occur, especially with parenteral abuse.
  • Methylphenidate Products: Concerta, Metadate, Ritalin, Daytrana
    Dexmethylphenidate Products: Focalin

    • Should be given cautiously to patients with a history of drug dependence or alcoholism.
    • Careful supervision required during drug withdrawal from abusive use since severe depression may occur.
    • Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

    Methylphenidate Products: Methylin Products

    • Should be given cautiously to emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because such patients may increase dosage on their own initiative.
    • Careful supervision required during drug withdrawal, since severe depression as well as the effects of chronic over-activity can be unmasked.
    • Long term follow-up may be required because of the patient's basic personality disturbances.


    Strattera Atomoxetine

    Strattera Suicidal Ideation in Children and Adults

  • Atomoxetine increased the risk of suicidal ideation in short-term studies in children or adolescents with attention-deficit/hyperactivity disorder (ADHD).
  • Anyone considering the use of atomoxetine in a child or adolescent must balance this risk with the clinical need.
  • Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior.
  • Families and caregivers should be advised of the need for close observation and communication with the prescriber.
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