FDA Label Change for Extended-Release ADHD Stimulants Under Age 6 (2025)

Table of Contents

1. 1. What the FDA Did
2. 2. Extended-Release, Off-Label and “Limitation of Use” Explained
3. 3. What the Labeling Change Requires
4. 4. What the FDA’s Data Review Found
5. 5. Where the Data Came From: Required Pediatric Studies
6. 6. The Background the Communication Gives on ADHD and Stimulants
7. 7. What the FDA Told Parents and Clinicians
8. 8. What the Action Does Not Do
9. 9. Dates and Status (as of 11 October 2026)
10. 10. How It Fits Other FDA Actions
11. 11. Reporting Side Effects to the FDA
12. 12. Primary Documents
13. Key Research Papers
14. Connections

1. What the FDA Did

The action was announced as an FDA Drug Safety Communication, a type of public notice the agency uses to tell patients and health professionals about a safety issue with a medicine and what the agency is doing about it. Its title is “FDA requires expanded labeling about weight loss risk in patients younger than 6 years taking extended-release stimulants for ADHD,” with the subtitle “Action Will Harmonize Labeling Across Extended-Release Stimulant Drug Class.”

The communication itself (PDF) is dated 30 June 2025. The FDA’s MedWatch listing of the same communication, headed “Extended-Release Stimulants for ADHD: FDA Drug Safety Communication,” carries a posting date of 1 July 2025. The audience it names is patients, health care professionals, pharmacy and pediatrics.

In the FDA’s words, the agency “is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD) – including certain formulations of amphetamine and methylphenidate – to warn about the risk of weight loss and other adverse reactions (side effects) in patients younger than 6 years taking these medications.”

This was not a Federal Register rulemaking: there is no proposed rule, no docket and no public comment period attached to it. It is a labeling requirement applied to approved products, announced through the FDA’s drug-safety channel.

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2. Extended-Release, Off-Label and “Limitation of Use” Explained

• Stimulant (for ADHD). The FDA describes these medicines as increasing the activity of the brain chemical messengers dopamine and norepinephrine in brain areas linked with attention, executive function and impulse control. The two drug families named in the communication are amphetamine and methylphenidate.
• Extended-release. A formulation designed to release the drug slowly so that it lasts through the day. The FDA notes that extended-release stimulants come as tablets, capsules, skin patches and liquid suspensions, and that most are designed to be taken once a day.
• Immediate-release. A formulation that releases the drug quickly and does not stay in the body as long. The FDA notes that some immediate-release stimulants are approved for children younger than 6 years.
• Off-label use. Prescribing an approved medicine for a use, dose or age group that is not in its FDA-approved labeling. The communication states that extended-release stimulants “are not approved for children younger than 6 years,” but that health care professionals can prescribe them off label.
• Prescribing information (labeling). The official document that accompanies a prescription drug, written for health professionals and approved by the FDA. It lists what the drug is approved for, how it is dosed, and its warnings.
• Limitation of Use. A statement in the prescribing information that marks the boundary of an approved use — here, a statement about how the drug behaves and what side effects were seen in children under 6.
• Plasma exposure. How much of a drug reaches the bloodstream over time. The FDA explains it as “higher levels of the drug in their bodies.”

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3. What the Labeling Change Requires

The FDA states: “We are requiring a Limitation of Use section in the prescribing information of all extended-release stimulants that includes a statement about the higher plasma exposures and higher rates of adverse reactions in children younger than 6 years.”

The requirement works in two ways, depending on what each product’s label already says:

• Manufacturers of extended-release stimulants whose labeling has no Limitation of Use section “will be required to add one about this risk.”
• Manufacturers whose labeling already has a Limitation of Use section “will be required to revise the labeling to ensure consistent messaging across the drug class.”

That second point is what the subtitle’s word “harmonize” refers to: one consistent statement across all extended-release amphetamine and methylphenidate products, rather than a statement on some products and not on others. The communication adds: “In the meantime, we want to bring public attention to this risk.”

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4. What the FDA’s Data Review Found

The FDA reports that it “assessed data from clinical trials of extended-release formulations of amphetamine and methylphenidate for ADHD treatment.” Its Data Summary lists four findings from the available clinical-trial data in children aged 4 to younger than 6 years:

1. Drug exposures were generally higher than in older children given the same dose.
2. Higher drug exposures were linked to a greater risk of adverse reactions.
3. Clinically significant weight loss — defined as at least a 10% decrease in the child’s weight percentile on the Centers for Disease Control and Prevention (CDC) growth charts — was observed in both short- and long-term studies with extended-release stimulants.
4. The findings were consistent for both amphetamine- and methylphenidate-containing products.

A weight percentile places a child’s weight against other children of the same age and sex; a 10-point drop means the child has fallen noticeably relative to peers.

The FDA then reasons from the two drug families to the whole class: because the safety profiles of amphetamine and methylphenidate are “generally similar” and their effects are “strongly linked” to how much drug is in the body, the agency writes that “it is reasonable to expect” that the results apply to all extended-release amphetamine and methylphenidate formulations, “and that there is an unfavorable benefit-risk profile for children younger than 6 years taking these medications for ADHD.” In the main text of the communication the FDA puts it this way: “the benefits of extended-release stimulants may not outweigh the risks of these products in patients younger than 6 years with ADHD.”

The communication also lists the effects of weight loss that concern the agency in young children: it “may contribute to nutritional deficiencies, impaired growth, lower energy levels, and other adverse effects.”

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5. Where the Data Came From: Required Pediatric Studies

The Pediatric Research Equity Act (PREA) is a federal law that lets the FDA require drug makers to study their products in children. When the FDA attaches such a study as a condition after approval, it is called a postmarketing requirement.

The FDA’s Data Summary states that, through PREA postmarketing requirements, the agency “required drug sponsors to evaluate pharmacokinetics (PK), efficacy, and safety of extended-release stimulants in children 4 to 5 years of age.” Pharmacokinetics means how the body absorbs, distributes and clears a drug.

According to the same summary, the FDA had determined that extended-release stimulants are “generally safe and effective for older age groups,” and before this action the labeling of 4 extended-release stimulants already included a Limitation of Use statement saying that younger children had higher exposures at the same dose than older children and higher rates of adverse reactions, including weight loss. The 2025 review was carried out “to understand the application of the existing Limitation of Use to all extended-release formulations of amphetamine and methylphenidate.” The agency evaluated differences in drug levels and in exposure-response relationships across pediatric age groups, and the short- and long-term effects on weight in children aged 4 to younger than 6.

The FDA documents do not name the 4 products whose labels already carried the statement, and do not give the number of trials or children reviewed.

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6. The Background the Communication Gives on ADHD and Stimulants

The FDA describes ADHD as “a common childhood disorder that affects the ability to pay attention, follow directions, and complete tasks,” adding that it can continue into adulthood. Citing CDC data, the communication gives an estimate of 7 million U.S. children aged 3 to 17 years (11.4%) ever diagnosed with ADHD, with boys (15%) more likely to be diagnosed than girls (8%).

The FDA describes extended-release stimulants as prescription drugs “primarily used to treat ADHD as first-line (initial) therapy” and lists their common side effects as loss of appetite, weight loss and insomnia.

On the difference between the two kinds of formulation, the communication notes that immediate-release stimulants “do not remain in the body for as long,” so “it may be possible to adjust the timing and frequency of dosing to reduce the negative impacts on appetite and sleep.” It also states that “behavior therapy can also be an effective way to treat ADHD.”

The communication’s two cited references are the CDC Growth Charts (data extracted September 2024) and the CDC’s Data and Statistics on ADHD (data extracted November 2024).

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7. What the FDA Told Parents and Clinicians

The communication contains the FDA’s own recommendations, reported here as the agency’s statements. They are not advice from this site; decisions about a child’s medicine belong with the family and the child’s clinician.

The FDA’s statements to parents and guardians

• If parents or guardians notice weight loss in a child taking an extended-release stimulant for ADHD, the FDA’s advice is to contact the pediatrician or other health care professional to discuss whether the benefits of continued treatment outweigh the risks.
• The FDA notes that parents and guardians can ask about alternative ADHD treatments, and that some immediate-release stimulants are approved for children under 6.
• The FDA advises following the health care professional’s guidance on the most appropriate course for the child, “which may involve changing or stopping the medication.”

The FDA’s statements to health care professionals

• The FDA states that extended-release stimulants are not indicated for ADHD in children under 6 because they carry a greater risk of weight loss and other adverse reactions than in older children on the same dose of the same medicine.
• For a child under 6 who is on an extended-release stimulant and experiencing weight loss or other adverse events, the FDA’s text says to “consider stopping the medication and/or switching to an alternative treatment (e.g., immediate-release stimulant).”
• The FDA asks clinicians to monitor the child’s growth and development and to intervene to limit weight loss, and notes that they may prescribe other ADHD medicines or give information about behavioral therapies.

On individual risk, the FDA writes that people respond differently to medicines and that “we cannot determine the likelihood of someone experiencing weight loss or other side effects from taking the medication.”

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8. What the Action Does Not Do

• It does not withdraw any medicine. No extended-release stimulant was removed from the market; the action changes labeling.
• It does not ban off-label prescribing. The communication itself states that health care professionals can prescribe these medicines off label for children under 6.
• It does not change immediate-release stimulant labels. The requirement covers extended-release stimulants only; the FDA notes that some immediate-release stimulants are approved for children under 6.
• It does not change the approved uses in older children, teenagers or adults. The FDA’s Data Summary describes the extended-release products as generally safe and effective for older age groups.
• It is not a rule. No Federal Register rulemaking, docket or comment period is attached.
• It does not give an individual risk estimate. The FDA states that it cannot determine the likelihood of a given child experiencing weight loss or other side effects.

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9. Dates and Status (as of 11 October 2026)

• 30 June 2025 — date printed on the Drug Safety Communication (PDF) and on its page under the FDA’s Drug Safety Communications listing.
• 1 July 2025 — the communication posted to the FDA’s MedWatch safety information page.
• 3 April 2026 — the “content current as of” date shown on the FDA’s Drug Safety Communication web page when it was fetched for this page.

Status as of 11 October 2026: the FDA has announced the requirement, and it was not issued as a proposal for public comment. The FDA documents used for this page do not report the date on which each individual product’s labeling was updated, and no later FDA follow-up action on this issue was located.

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10. How It Fits Other FDA Actions

According to the FDA’s Data Summary, this action builds on an earlier, product-by-product step: the pediatric studies required under PREA had already led to a Limitation of Use statement on the labeling of 4 extended-release stimulants. The 2025 action took that existing statement and extended it to the whole class of extended-release amphetamine and methylphenidate products, so that every label carries consistent wording.

It was one of several class-wide drug labeling actions the FDA announced in 2025. Others covered on this site are the opioid labeling changes on long-term use, the acetaminophen pregnancy labeling change and the menopausal hormone therapy labeling change request. Another 2025 action aimed at young children was the FDA’s step on ingestible fluoride for children. All of the year’s actions are listed on the FDA Actions of 2025 hub.

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11. Reporting Side Effects to the FDA

The communication asks patients and health care professionals to report side effects involving extended-release stimulants or other medicines to MedWatch, the FDA’s safety information and adverse-event reporting program. The FDA states that these reports help it track safety issues with medicines. The FDA lists three routes: an online form, a downloadable form returned by mail or by fax to 1-800-FDA-0178, and a telephone request for a form at 1-800-332-1088.

For more information, the communication gives the FDA contact number 855-543-DRUG (3784), option 4, and the address druginfo@fda.hhs.gov.

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12. Primary Documents

1. U.S. Food and Drug Administration (2025). FDA requires expanded labeling about weight loss risk in patients younger than 6 years taking extended-release stimulants for ADHD — Action Will Harmonize Labeling Across Extended-Release Stimulant Drug Class. FDA Drug Safety Communication, 30 June 2025 (web page content current as of 3 April 2026) — fda.gov Drug Safety Communication (PDF, 262 KB)
2. U.S. Food and Drug Administration (2025). Extended-Release Stimulants for ADHD: FDA Drug Safety Communication — FDA Requires Expanded Labeling about Weight Loss Risk in Patients Younger than 6 Years. MedWatch Medical Product Safety Information, posted 1 July 2025 — fda.gov MedWatch posting

No Federal Register document or public docket is associated with this action.

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Key Research Papers

1. Greenhill L, Kollins S, Abikoff H, McCracken J, Riddle M, Swanson J, et al. (2006). Efficacy and safety of immediate-release methylphenidate treatment for preschoolers with ADHD. Journal of the American Academy of Child and Adolescent Psychiatry 45(11):1284-1293 — PubMed PMID: 17023867
2. Wigal T, Greenhill L, Chuang S, McGough J, Vitiello B, Skrobala A, et al. (2006). Safety and tolerability of methylphenidate in preschool children with ADHD. Journal of the American Academy of Child and Adolescent Psychiatry 45(11):1294-1303 — PubMed PMID: 17028508
3. Swanson J, Greenhill L, Wigal T, Kollins S, Stehli A, Davies M, et al. (2006). Stimulant-related reductions of growth rates in the PATS. Journal of the American Academy of Child and Adolescent Psychiatry 45(11):1304-1313 — PubMed PMID: 17023868
4. Wolraich ML, Hagan JF Jr, Allan C, Chan E, Davison D, Earls M, et al. (2019). Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Pediatrics 144(4):e20192528 — PubMed PMID: 31570648
5. Marraffino A, Sikes CR, Laage T, Volosov A, Hart A, Engelking D (2020). An Open-Label, Multicenter, Single-Dose Pharmacokinetic Study of a Novel Amphetamine Extended-Release Orally Disintegrating Tablet in Preschool-Aged Children. Journal of Child and Adolescent Psychopharmacology 30(1):15-20 — PubMed PMID: 31295008
6. Childress AC, Findling RL, Wu J, Kollins SH, Wang Y, Martin P, Robertson B (2020). Lisdexamfetamine Dimesylate for Preschool Children with Attention-Deficit/Hyperactivity Disorder. Journal of Child and Adolescent Psychopharmacology 30(3):128-136 — PubMed PMID: 32233956
7. Childress AC, Lloyd E, Jacobsen L, Gunawardhana L, Johnson SA Jr, Findling RL (2022). Efficacy and Safety of Lisdexamfetamine in Preschool Children With Attention-Deficit/Hyperactivity Disorder. Journal of the American Academy of Child and Adolescent Psychiatry 61(12):1423-1434 — PubMed PMID: 35577034

The first three papers report the Preschoolers with ADHD Treatment Study (PATS) of immediate-release methylphenidate; the fourth is the American Academy of Pediatrics clinical practice guideline on ADHD in children and adolescents; the last three are studies of extended-release or long-acting stimulants in preschool-aged children. None of these papers is cited in the FDA communication, which does not list the trials it reviewed.

PubMed Topic Searches

1. PubMed: preschool ADHD, stimulants and weight
2. PubMed: extended-release methylphenidate pharmacokinetics in preschool children
3. PubMed: amphetamine safety in preschool children with ADHD
4. PubMed: stimulants and growth in children

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Connections

• FDA Actions of 2025
• FDA and Regulation
• ADHD (Attention-Deficit/Hyperactivity Disorder)
• ADHD: History and Discovery
• Psychiatry
• Opioid Long-Term Use Label Changes (2025)
• Acetaminophen Pregnancy Label Change (2025)
• Hormone Therapy Labeling Change Request (2025)
• Ingestible Fluoride for Children (2025)
• Leucovorin and Cerebral Folate Deficiency (2025)

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