U.S. Food and Drug Administration (FDA) Requires Updated Boxed Warnings on Prescription Stimulants (2023)

Table of Contents

1. What the U.S. Food and Drug Administration Did
2. Which Medicines Are Covered
3. Why the U.S. Food and Drug Administration Acted
4. How the Boxed Warning Changed
5. The Other Label Sections That Changed
6. What the U.S. Food and Drug Administration’s Review of the Research Found
7. Harms, Routes of Use and Counterfeit Pills
8. The Advice the U.S. Food and Drug Administration Addressed to Patients and Prescribers
9. Overdose Signs the U.S. Food and Drug Administration Lists
10. What the Action Does Not Do
11. Dates and Legal Status as of 18 October 2026
12. How It Fits Other U.S. Food and Drug Administration Actions
13. Primary Documents
14. Key Research Papers
15. Connections
16. Featured Videos

1. What the U.S. Food and Drug Administration Did

The action was announced as a U.S. Food and Drug Administration Drug Safety Communication, the kind of public notice the agency uses to tell patients and health professionals about a safety issue with a medicine and what it is doing about it. Its title is “U.S. Food and Drug Administration updating warnings to improve safe use of prescription stimulants used to treat attention-deficit/hyperactivity disorder and other conditions,” with the subtitle “Serious risks with misuse, abuse, addiction, and sharing these drugs.” It is dated 11 May 2023.

In the communication’s words: “We are requiring the Boxed Warning, U.S. Food and Drug Administration’s most prominent warning, to be updated and we are adding other information to the prescribing information for all prescription stimulants.” The prescribing information is the detailed label written for health professionals, and the U.S. Food and Drug Administration calls the Boxed Warning within it the agency’s “most prominent warning.” The U.S. Food and Drug Administration said the updated Boxed Warning “will describe the risks of misuse, abuse, addiction, and overdose consistently across all medicines in the class” and “will advise heath care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.”

The U.S. Food and Drug Administration also required matching information in other parts of the prescribing information — the Warnings and Precautions, Drug Abuse and Dependence, Overdosage and Patient Counseling sections — and updates to the patient Medication Guides, the leaflets handed out with a filled prescription that, in the U.S. Food and Drug Administration’s description, explain “the side effects, what the medicine is used for, how to take and store it properly, and other things to watch out for.”

The communication was published with an attached table, “Key Prescription Stimulant Label Updates,” that sets the former label wording beside the new wording (section 4 and section 5).

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2. Which Medicines Are Covered

The requirement applies to “all prescription stimulants,” the whole class rather than a single product. The U.S. Food and Drug Administration lists three conditions these medicines treat:

• Attention-deficit/hyperactivity disorder, where, the U.S. Food and Drug Administration says, stimulants “may help decrease impulsivity and hyperactivity, and increase attention”;
• Binge-eating disorder, where they “help reduce the number of excessive overeating episodes” (see the site’s Eating Disorders page);
• Narcolepsy, which the U.S. Food and Drug Administration describes as “uncontrollable episodes of deep sleep,” where they “help promote wakefulness” (see Narcolepsy).

As examples of common prescription stimulants the communication names amphetamine/dextroamphetamine, methylphenidate and dextroamphetamine (it also gives brand names, which are not repeated here). Its fact list adds that there are two main categories — immediate-release stimulants, “usually taken two or three times a day,” and extended-release stimulants, “taken once a day” — and that they come as tablets, capsules and liquids. The common side effects it lists are loss of appetite, trouble sleeping, headache, stomachache, irritability, fast heart rate and high blood pressure.

The U.S. Food and Drug Administration’s own summary of the benefit side is that prescription stimulants “can be an important treatment option for disorders for which they are indicated.”

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3. Why the U.S. Food and Drug Administration Acted

The communication gives three reasons:

• Labels were out of date and inconsistent. “The current prescribing information for some prescription stimulants does not provide up to date warnings about the harms of misuse and abuse, and particularly that most individuals who misuse prescription stimulants get their drugs from other family members or peers.”
• Pressure to share. “Individuals who are prescribed stimulants are often faced with requests to share their medication.” In its information for health professionals the U.S. Food and Drug Administration adds that “As many as half of youth with valid prescriptions for these medicines are approached by peers and other individuals in the person’s peer group to sell or give away their medicine.”
• Harm to the people who receive shared pills. “Sharing these medicines with others can lead to development of substance use disorder and addiction in those with whom these drugs are shared.”

The U.S. Food and Drug Administration also states that risk is not limited to people who take someone else’s medicine: “even when prescribed to treat an indicated disorder, their use can lead to misuse or abuse.” It explains that misuse and abuse, “also called nonmedical use, can include taking your own medicine differently than prescribed or using someone else’s medicine,” and that misuse and abuse “can result in overdose and death,” a risk “increased with higher doses or unapproved methods of taking the medicine such as snorting or injecting.”

The attached label table states the aims of the update in one line: the changes “will align labels with recent labeling language, address diversion and stigmatization, and incorporate recent safety changes.” Diversion, in the new label’s words, is a drug being “diverted for non-medical use into illicit channels or distribution.”

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4. How the Boxed Warning Changed

The U.S. Food and Drug Administration’s table compares the former and new Boxed Warning, using “DRUG-X” as a stand-in for each product’s name. It notes that the former wording varied across the class.

• Heading. Former: “POTENTIAL for ABUSE AND DEPENDENCE.” New: “WARNING: ABUSE, MISUSE, AND ADDICTION.”
• Former core text. Central nervous system (CNS) stimulants “have high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.”
• New core text. The drug “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 central nervous system stimulants … can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.”
• New instructions to prescribers. Before prescribing, “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 … treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.”

Three things are new in the box: the word “misuse” alongside “abuse,” an explicit statement that overdose and death can result, and the naming of snorting and injection as higher-risk routes. The word “dependence” in the old heading is replaced by “addiction.”

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5. The Other Label Sections That Changed

The table lists the more significant changes in four other sections of the prescribing information:

• Warnings and Precautions. The heading changes from “Potential for Abuse and Dependence” to “Abuse, Misuse, and Addiction.” The new text adds that the drug “can be diverted for non-medical use into illicit channels or distribution,” and that prescribers are to advise patients to store it “in a safe place, preferably locked,” and “instruct patients to not give DRUG-X to anyone else.”
• Drug Abuse and Dependence. The new text separates two terms the U.S. Food and Drug Administration defines. Abuse is “the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect.” Misuse is “the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed.” The section keeps descriptions of physical dependence and tolerance, and lists withdrawal signs after stopping abruptly or lowering the dose after prolonged use: dysphoric mood, depression, fatigue, vivid unpleasant dreams, sleeping too little or too much, increased appetite, and slowed movement or agitation.
• Overdosage. Reorganized under “Clinical Effects of Overdose” and “Overdose Management.” The new text describes cardiovascular effects (fast irregular heart rhythms, high or low blood pressure; vasospasm, heart attack or aortic dissection that “may precipitate sudden cardiac death”; and Takotsubo cardiomyopathy), nervous-system effects (agitation, confusion, hallucinations; serotonin syndrome, seizures, strokes and coma), and “Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis.” It points clinicians to the Poison Help line (1-800-222-1222) or a medical toxicologist.
• Patient Counseling Information. A new “Abuse, Misuse, and Addiction” paragraph on educating patients and families about the risks, “which can lead to overdose and death,” and about locked storage, not giving the drug to others, and disposal of unused drug.

The table adds that “Other minor updates were incorporated within this action but are not listed below and will be available once the label updates for each product are approved by U.S. Food and Drug Administration.” It closes with a note on language: the term abuse “is not intended to imply moral judgment,” and the U.S. Food and Drug Administration “is committed to reducing stigma, expanding therapeutic options, and ensuring access to evidence-based treatment for individuals with substance use disorders.”

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6. What the U.S. Food and Drug Administration’s Review of the Research Found

The U.S. Food and Drug Administration reviewed the medical literature published from January 2006 to May 2020 on nonmedical use of prescription stimulants and the harms linked to it. Its findings, as the communication reports them:

• Where the pills come from. Friends or family members were the most common source for nonmedical use, with estimates “generally ranging from 56 percent to 80 percent, usually provided for free.” A person’s own prescription accounted for about 10 to 20 percent; drug dealers or strangers for 4 to 7 percent; the internet for 1 to 2 percent.
• Why people use them. “In general, people use these medicines nonmedically thinking they will enhance work or academic performance, and less commonly for recreational or social reasons.”
• Trend. Nonmedical use “has remained relatively stable over the past two decades, despite the increasing number of prescription stimulants dispensed.” The U.S. Food and Drug Administration’s analysis of dispensing data found prescriptions for Schedule II stimulants (a federal controlled-substance category) almost doubled in ten years, from about 12.5 million in the first quarter of 2011 to 20 million in the first quarter of 2022.
• Who is most affected. Past-year nonmedical use was highest among young adults aged 18 to 25 (4.1 to 7.5 percent), college students (4.3 percent), and adolescents and young adults diagnosed with attention-deficit/hyperactivity disorder (14 to 32 percent). It “often begins in early adulthood.”
• How often. About 50 to 75 percent of people who use stimulants nonmedically report doing so once a month or less, “although some college students reported doing so more frequently.”
• Substance use disorder. People who use prescription stimulants nonmedically “may have a higher risk of developing a substance use disorder than those who do not.” Use of other substances in the past year is common among them; alcohol, marijuana, cocaine and opioids are the ones named. The U.S. Food and Drug Administration adds that “college students who nonmedically use prescription stimulants may not perceive polysubstance use as a risky behavior.”

The communication’s reference list draws on national surveys and published studies; several of them are listed under Key Research Papers below.

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7. Harms, Routes of Use and Counterfeit Pills

The U.S. Food and Drug Administration’s background summary reports how harms differ by the way a stimulant is taken. In U.S. poison center cases from 2001 to 2018 that documented nonmedical use of a Schedule II prescription stimulant and a related medical outcome:

• about 70 percent of cases mentioning injection had a moderate or major effect;
• about 65 percent of nasal or inhalation cases did;
• about 56 percent of oral cases did.

The poison centers’ definitions, quoted by the U.S. Food and Drug Administration, describe a moderate effect as more pronounced, prolonged or systemic than minor symptoms, usually needing some treatment but not life-threatening; a major effect is one that was “life-threatening or resulted in significant residual disability or disfigurement.” The U.S. Food and Drug Administration notes that the risk of overdose and death rises “when a pill is manipulated (e.g., crushed or made into a liquid form) and snorted or injected.”

On deaths and the illicit market the communication states that “Deaths involving stimulants continue to increase and often involve multiple substances, such as opioids,” that deaths involving illicit stimulants or opioids outnumber deaths involving prescription stimulants, and that people trying to obtain stimulants illegally face greater risks “because of the increasing presence of illicit sellers offering falsified prescription stimulant products that contain harmful substances such as methamphetamine or fentanyl.” The site’s Addiction and Substance Use Disorders page covers the wider medical picture.

The U.S. Food and Drug Administration also lists effects of nonmedical use on students: “anxiety, nervousness, loss of appetite, and sleep deprivation—all of which can interfere with studying and performance on exams.”

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8. The Advice the U.S. Food and Drug Administration Addressed to Patients and Prescribers

The communication contains two advice lists. They are the U.S. Food and Drug Administration’s own advice, summarized here as the agency wrote it.

To health care professionals, the U.S. Food and Drug Administration’s advice is to assess each patient’s risk of misuse, abuse and addiction before prescribing; counsel patients not to share their stimulant; educate patients and families on the risks, on storage and on disposal of unused medicine; and throughout treatment monitor for signs of nonmedical use, addiction and diversion, which, it says, “may be evidenced by more frequent renewal requests than warranted by the prescribed dosage.” It also asks prescribers to keep careful records of quantity, frequency and renewal requests “as required by state and federal laws,” and to tell patients that taking a stimulant other than as prescribed, or with alcohol or other controlled substances, “could increase the risk of overdose and death.”

To patients and caregivers, the U.S. Food and Drug Administration’s advice is to take the medicine exactly as prescribed, not in larger doses or more often; never to give it to anyone else; to store it “out of sight and reach of children and in a location not accessible by others, including visitors to the home”; and to dispose of unused or expired stimulants promptly or through a drug take-back site or program. The agency states that using these controlled substances without a prescription, or using someone else’s, “is dangerous and is against the law,” and warns against buying them from dealers or illegal online sellers and against combining them with alcohol or with controlled substances such as opioids that were not prescribed. It suggests talking to a health care professional if stimulant use has caused problems “with your health, relationships, responsibilities, or the law,” and reading the Medication Guide that comes with each filled prescription.

The U.S. Food and Drug Administration also says it “cannot determine how likely it is that someone will experience these side effects,” because people respond differently depending on their health, other diseases and medicines, genetics and other factors. Decisions about any medicine belong with the prescribing clinician.

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9. Overdose Signs the U.S. Food and Drug Administration Lists

The U.S. Food and Drug Administration’s patient information states that stimulant overdose “can lead to a heart attack, stroke, or seizures,” and that emergency care (an emergency room or 911) is the U.S. Food and Drug Administration’s stated response to serious symptoms. The symptoms it lists are:

• fast heart rate, fast breathing and increased blood pressure;
• dilated pupils;
• restlessness, tremors, overactive reflexes and loss of coordination;
• muscle pain, stomach cramps, nausea and vomiting;
• aggressive behavior, panic, confusion and hallucinations.

The professional label’s fuller description of overdose is summarized in section 5.

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10. What the Action Does Not Do

• It does not restrict prescribing or supply. The action changes labeling: the Boxed Warning, other sections of the prescribing information and the Medication Guides. The U.S. Food and Drug Administration describes stimulants as something that “can be an important treatment option for disorders for which they are indicated.”
• It is not a finding that nonmedical use is rising. The U.S. Food and Drug Administration’s review found nonmedical use “relatively stable over the past two decades,” even as dispensing increased.
• It does not single out one medicine. The purpose is consistency, so that the same warnings appear “across the entire class.”
• It does not say how likely harm is for an individual. The U.S. Food and Drug Administration states that it cannot determine that probability for any one person.

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11. Dates and Legal Status as of 18 October 2026

• Announced: 11 May 2023, U.S. Food and Drug Administration Drug Safety Communication, with the attached table of label changes.
• Implementation: the U.S. Food and Drug Administration’s table says the full changes “will be available once the label updates for each product are approved by U.S. Food and Drug Administration.” The date on which the updated labels were approved could not be confirmed from a U.S. Food and Drug Administration document available for this page, so it is not given here.

Status as of 18 October 2026: a required, class-wide labeling change announced in May 2023. The U.S. Food and Drug Administration’s communication remains posted on fda.gov, with the page marked “Content current as of” 3 April 2026. A check of the Federal Register through 18 October 2026 found no U.S. Food and Drug Administration document that withdraws, stays or reverses this requirement. No Federal Register rule was found for it; the requirement was announced through a Drug Safety Communication.

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12. How It Fits Other U.S. Food and Drug Administration Actions

The 2023 communication is the U.S. Food and Drug Administration’s class-wide update on misuse, abuse and sharing. A later and separate stimulant labeling action, announced in June 2025, concerns weight loss and other side effects in children younger than 6 taking extended-release stimulants; it is reported on its own page, U.S. Food and Drug Administration Label Change for Extended-Release attention-deficit/hyperactivity disorder Stimulants Under Age 6 (2025). It is a different safety question, not a continuation of the 2023 requirement.

Later in 2023 the U.S. Food and Drug Administration also published a draft guidance for drug developers, “Stimulant Use Disorders: Developing Drugs for Treatment” (88 FR 69205, 5 October 2023, Docket No. FDA-2023-D-1848), which, according to its Federal Register notice, gives the agency’s current recommendations on clinical trials for medicines to treat moderate to severe cocaine use disorder, methamphetamine use disorder or prescription stimulant use disorder. A docket is the public file that holds a document and the comments on it; comments on that draft were requested by 4 December 2023.

The same year the U.S. Food and Drug Administration took several steps on opioids and overdose, each on its own page: over-the-counter naloxone nasal spray, new safety labeling for opioid pain medicines and import restrictions on xylazine. All 2023 actions are listed on the U.S. Food and Drug Administration Actions of 2023 hub.

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13. Primary Documents

1. U.S. Food and Drug Administration (2023). U.S. Food and Drug Administration updating warnings to improve safe use of prescription stimulants used to treat attention-deficit/hyperactivity disorder and other conditions. U.S. Food and Drug Administration Drug Safety Communication, 11 May 2023 — fda.gov Drug Safety Communication
2. U.S. Food and Drug Administration (2023). Key Prescription Stimulant Label Updates (table of former and new label wording, attached to the Drug Safety Communication of 11 May 2023) — fda.gov PDF
3. U.S. Food and Drug Administration (2023). Drug Safety Communication of 11 May 2023, printable version — fda.gov PDF
4. Food and Drug Administration, U.S. Department of Health and Human Services (HHS) (2023). Stimulant Use Disorders: Developing Drugs for Treatment; Draft Guidance for Industry; Availability. Federal Register 88:69205, 5 October 2023. Docket No. FDA-2023-D-1848 — FR Doc. 2023-22189

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Key Research Papers

1. Compton WM, Han B, Blanco C, Johnson K, Jones CM (2018). Prevalence and correlates of prescription stimulant use, misuse, use disorders, and motivations for misuse among adults in the United States. American Journal of Psychiatry 175(8):741-755 — PubMed PMID: 29656665
2. Han B, Jones CM, Blanco C, Compton WM (2017). National trends in and correlates of nonmedical use of prescription stimulants, nonmedical use frequency, and use disorders. Journal of Clinical Psychiatry 78(9):e1250-e1258 — PubMed PMID: 29045771
3. Chen LY, Crum RM, Strain EC, Alexander GC, Kaufmann C, Mojtabai R (2016). Prescriptions, nonmedical use, and emergency department visits involving prescription stimulants. Journal of Clinical Psychiatry 77(3):e297-e304 — PubMed PMID: 26890573
4. Chen LY, Strain EC, Crum RM, Storr CL, Mojtabai R (2014). Sources of nonmedically used prescription stimulants: differences in onset, recency and severity of misuse in a population-based study. Drug and Alcohol Dependence 145:106-112 — PubMed PMID: 25454408
5. McCabe SE, Teter CJ, Boyd CJ, Wilens TE, Schepis TS (2018). Sources of prescription medication misuse among young adults in the United States: the role of educational status. Journal of Clinical Psychiatry 79(2):17m11958 — PubMed PMID: 29570970
6. Arria AM, Caldeira KM, O’Grady KE, Vincent KB, Johnson EP, Wish ED (2008). Nonmedical use of prescription stimulants among college students: associations with attention-deficit-hyperactivity disorder and polydrug use. Pharmacotherapy 28(2):156-169 — PubMed PMID: 18225963
7. Hoots B, Vivolo-Kantor A, Seth P (2020). The rise in non-fatal and fatal overdoses involving stimulants with and without opioids in the United States. Addiction 115(5):946-958 — PubMed PMID: 31912625

All seven papers appear in the reference list of the U.S. Food and Drug Administration’s 11 May 2023 Drug Safety Communication. The first two are national-survey analyses of stimulant use and misuse among U.S. adults; the 2016 paper compares prescriptions, nonmedical use and emergency visits; the 2014 and 2018 papers examine where nonmedically used stimulants come from; the 2008 paper studies college students, attention-deficit/hyperactivity disorder and use of several substances; the 2020 paper reports trends in overdoses involving stimulants with and without opioids.

PubMed Topic Searches

1. PubMed: nonmedical use of prescription stimulants
2. PubMed: stimulant diversion and ADHD
3. PubMed: prescription stimulant overdose

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Connections

• U.S. Food and Drug Administration Actions of 2023
• U.S. Food and Drug Administration and Regulation
• Attention-Deficit/Hyperactivity Disorder
• Narcolepsy
• Eating Disorders
• Addiction and Substance Use Disorders
• Opioid Overdose
• Attention-Deficit/Hyperactivity Disorder Stimulants Under Age 6 (2025)
• Opioid Pain Medicine Label Updates (2023)
• Over-the-Counter Naloxone (2023)
• Xylazine Import Restriction (2023)

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