What an FDA Boxed Warning Means for Psychiatric Medicines
Short answer
A boxed warning, often called a black box warning, is FDA's most prominent warning on a prescription drug label. It flags a serious risk, often one that can lead to death or serious injury, that you and your prescriber should weigh and watch for. It does not mean a medicine is banned or wrong for you. Several psychiatric medicine groups carry one. If yours does, do not stop it on your own; talk with your prescriber.
In crisis or thinking about suicide? Call or text 988 now (in New York City it reaches NYC 988). If you are in immediate danger, call 911.
This guide is not enough if
- You or someone else is thinking about suicide. Call or text 988 now, or call 911 if there is immediate danger.
- You have already stopped a medicine suddenly and feel unwell. Call your prescriber; call 911 for a seizure or trouble breathing.
- You want to know your personal risk. A label describes risks in general; your prescriber can apply them to you.
- You are deciding whether to stop or switch a medicine. Make that plan with your prescriber.
What the box is
You read your new medicine's label and saw a heavy black border with the word WARNING in capital letters. That can be alarming. Here is what it means, and what it does not.
Federal labeling rules say FDA may require certain serious warnings, particularly ones that may lead to death or serious injury, to be shown in a box. The box needs an uppercase heading with the word "WARNING," a brief explanation of the risk, and a pointer to the detailed section of the label. FDA describes the boxed warning as its most prominent warning. It ordinarily rests on clinical data.
You will find it at the start of the prescribing information, before the uses and dosing, with the line "See full prescribing information for complete boxed warning." Some boxes apply to a whole class of drugs. FDA required the benzodiazepine and stimulant warnings to read the same way on every product in each class, so switching within a class usually does not change the box. Some medicines carry more than one: the quetiapine label carries both the dementia warning for antipsychotics and the suicidal thoughts warning for antidepressants.
What it does not mean
A boxed warning is not a ban. The medicine is still FDA-approved, and FDA's safety communications ask prescribers to weigh benefits against risks for each person. For benzodiazepines, for example, FDA calls them an important treatment option for the conditions they are approved for, while asking prescribers to assess each patient's risk. The box tells prescribers and patients to weigh the risk, monitor for it and act quickly if signs appear.
Warnings also change over time. FDA updated the boxed warning for all benzodiazepines in 2020 and for all prescription stimulants in 2023. FDA can also remove a boxed warning, as it did for a diabetes medicine in 2020.
Most important: a boxed warning is not a reason to stop a medicine suddenly. NIMH says people should not stop a prescribed medicine, even if they feel better, without help from a health care provider. For some medicines, stopping abruptly carries its own risks. FDA says stopping a benzodiazepine abruptly or lowering the dose too quickly can cause withdrawal reactions, including seizures.
The main boxed warnings in psychiatry
If you or someone you care for is thinking about suicide, call or text 988 now, or call 911 if there is immediate danger. Then read on.
These are the boxed warnings on medicine groups used most often in psychiatry, as FDA labels state them:
- Antidepressants: suicidal thoughts and behaviors. Labels say antidepressants increased the risk of suicidal thoughts and behaviors in children, teens and young adults in short-term studies. NIMH describes this group as people under 25. Labels tell prescribers to monitor all patients for worsening and suicidal thoughts, especially in the first months and after dose changes. Our article on SSRIs and SNRIs covers this class in depth.
- ADHD stimulants: abuse, misuse and addiction. In 2023, FDA required this warning to read the same way across all prescription stimulants, adding that misuse can lead to overdose and death and that patients should never share their medicine. See our guide to the first weeks on ADHD medication.
- Benzodiazepines: opioids, misuse, dependence and withdrawal. The box warns that combining benzodiazepines with opioids may cause profound sedation, slowed breathing, coma and death, and covers abuse, misuse, addiction, physical dependence and withdrawal reactions. Our article on benzodiazepines, their uses, risks and dependence explains each part.
- Antipsychotics: older adults with dementia. Labels warn that older adults with dementia-related psychosis treated with antipsychotics have an increased risk of death, and that these medicines are not approved for dementia-related psychosis.
- Atomoxetine (a non-stimulant for ADHD): suicidal thoughts and behaviors in children and teens 6 and older.
- Clozapine: boxed warnings that include severe neutropenia, a dangerous drop in a type of white blood cell.
| Medicine group | What the boxed warning covers | What to watch for and do |
|---|---|---|
| Antidepressants | Increased suicidal thoughts and behaviors in children, teens and young adults in short-term studies | Watch for new or worse suicidal thoughts or unusual behavior changes, especially early and after dose changes; call or text 988 for urgent thoughts |
| ADHD stimulants | Abuse, misuse and addiction; misuse can cause overdose and death | Store securely, never share, take only as prescribed |
| Benzodiazepines | Risks with opioids; abuse, misuse and addiction; dependence and withdrawal | Tell every prescriber you take one; do not stop or cut back suddenly |
| Antipsychotics | Increased risk of death in older adults with dementia-related psychosis | Families of older adults with dementia should discuss this before starting |
| Atomoxetine | Suicidal thoughts and behaviors in children and teens 6 and older | Close observation in the first months and after dose changes |
| Clozapine | Includes severe neutropenia (low white blood cell count) | Keep up with blood tests as prescribed; report fever, chills or signs of infection |
Where to read it: the label and the Medication Guide
Many medicines with a boxed warning also come with a Medication Guide. FDA describes it as patient labeling that is part of the FDA-approved label, required when FDA decides it could help prevent serious side effects or when the risks could affect whether you choose to take the medicine. It must be given to you on paper when the medicine is dispensed, unless you ask for it electronically.
For some medicines, such as benzodiazepines, FDA advises reading it every time you get a prescription, because it may contain new information. Full labels are also free on DailyMed, the National Library of Medicine's label site. If you notice a side effect, tell your prescriber; you can also report it to FDA through MedWatch.
Questions to bring to your prescriber
A boxed warning is a good reason for a real conversation. Questions like these can help, and our guide to questions to ask before starting psychiatric medication has more:
- Why do you think this medicine is right for me, given the warning?
- What signs should I, or my family, watch for, and when should we call?
- How will we monitor for this risk: visits, check-ins or lab tests?
- What are the alternatives, including therapy, and how do their risks compare?
- If we decide to stop it later, how would we do that safely?
When this guide is not enough
A label describes risk across many people. It cannot tell you your own risk, which depends on your history, other medicines and how closely you are followed. That judgment belongs to a prescriber who knows you.
For a child or teen taking an antidepressant, labels ask family members and caregivers to watch for changes in behavior and tell the prescriber. For how treatment decisions work with teens, see minors and consent in New York.
If you are worried about a warning on a medicine you already take, keep taking it as prescribed and contact your prescriber soon. If you would like a prescriber to review your medicines, see medication management.
Frequently asked questions
Does a black box warning mean a medicine is dangerous?
It means the medicine has a serious risk that FDA wants prescribers and patients to weigh and watch for. It does not mean the medicine is banned or wrong for everyone; these medicines remain FDA-approved. FDA asks prescribers to weigh benefits against risks for each patient and to monitor for warning signs. Your prescriber can explain how the warning applies to you and what to watch for.
Should I stop my medication if it has a boxed warning?
No, not on your own. NIMH says not to stop a prescribed medicine without help from a health care provider, and for some medicines, such as benzodiazepines, FDA warns that stopping abruptly can cause serious withdrawal reactions. If a warning worries you, keep taking the medicine as prescribed and call your prescriber to talk it through.
Why do antidepressants have a black box warning for young people?
In pooled short-term studies, the sertraline label reports about 14 more people per 1,000 under 18, and 5 more per 1,000 ages 18 to 24, had suicidal thoughts or behaviors on an antidepressant than on placebo. Adults 25 and older showed no increase. Labels tell prescribers to monitor everyone taking an antidepressant, especially early and after dose changes, and ask families to watch for changes. If someone has urgent thoughts of suicide, call or text 988.
Where can I read the boxed warning for my medicine?
It appears at the start of the prescribing information, and the key points are repeated in the Medication Guide that comes with many prescriptions. You can also look up the full label on DailyMed, the National Library of Medicine's free label database. Your pharmacist can print the Medication Guide for you and answer questions.
Can FDA remove a boxed warning?
Yes. FDA can add, update or remove a boxed warning as new information comes in. It removed one from a diabetes medicine in 2020. In 2025, FDA ended the special safety program (REMS) for clozapine, but its boxed warning about severe neutropenia remains, and FDA still recommends blood count monitoring as the label describes.
Next: compare your options
A question list for the medication conversation, with why each question matters and where the answer is written down.
Sources
- eCFR: 21 CFR 201.57, labeling requirements including the boxed warning
- FDA Drug Safety Communication (Sept. 23, 2020): Boxed Warning updated for benzodiazepines
- FDA Drug Safety Communication (May 11, 2023): updated warnings for prescription stimulants
- DailyMed: Zoloft (sertraline) label, boxed warning on suicidal thoughts and behaviors
- DailyMed: Seroquel (quetiapine) label, boxed warnings
- FDA: Medication Guides
- NIMH: Mental Health Medications
- FDA Drug Safety Communication (Aug. 27, 2025): clozapine REMS removed
Recent changes
- August 27, 2025: FDA announced it had removed the REMS program for clozapine (effective June 13, 2025). The boxed warning about severe neutropenia remains on all clozapine products, along with a new Medication Guide, and FDA recommends continued blood count monitoring. FDA Drug Safety Communication: FDA removes REMS program for the antipsychotic drug clozapine
Reviewed by Dr. Beata Lewis, MD, Founder and Clinical Director, board-certified in adult psychiatry, child and adolescent psychiatry, and integrative medicine on November 8, 2026. Facts checked against the sources above on November 8, 2026. This guide is general education, not medical advice, a diagnosis or a treatment plan, and reading it does not make you a patient of Mind Body Seven. For advice about your situation, talk with a licensed clinician.