Are psychiatric medications safe for children? There is no single answer, because safety depends on the medicine, the diagnosis, the child and how closely treatment is watched. When a medication is prescribed after a careful evaluation and monitored, it can be an appropriate part of care. Every medication also has risks, and some carry serious FDA warnings that parents should know about before starting.
Part of our guide: A Parent’s Guide to Child and Teen Mental Health
The American Academy of Child and Adolescent Psychiatry (AACAP) says parents should be told about known risks and FDA warnings before a child starts, and whether the use is on-label or off-label. AACAP also says medication may reduce or eliminate troubling symptoms and improve daily functioning when prescribed appropriately and taken as directed. This article helps you ask the right questions. Decisions belong with you, your child and the prescriber.
If your child talks about suicide or self-harm, or you think they are in danger, call or text 988 (988 Suicide & Crisis Lifeline), call 911, or go to the nearest ER.
What is the FDA boxed warning on antidepressants?
A boxed warning is the prominent warning at the top of a drug's prescribing information. Antidepressant labels carry one on suicidal thoughts and behaviors. The current Prozac (fluoxetine) label, as one example, states that antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents and young adults in short-term studies. It tells clinicians to monitor closely for worsening and for new suicidal thoughts and behaviors in patients of all ages who start an antidepressant.
What do the numbers say?
The label reports pooled results from short-term placebo-controlled trials. In patients under 18, there were about 14 more cases of suicidal thoughts or behavior per 1,000 treated compared with placebo. For ages 18 to 24, there were about 5 more per 1,000. The pediatric pool covered 24 short-term trials of 9 antidepressants in over 4,400 patients. No suicides occurred in any of the pediatric trials. The label says it is unknown whether the risk extends to longer-term use beyond several months.
What should parents do with this?
- Know when to watch most closely. The label emphasizes the first few months of treatment and any time the dose changes, up or down.
- Know what to report. It lists anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, restlessness, and hypomania or mania, along with any suicidal thoughts or worsening mood. Families should report such symptoms to the prescriber immediately, and the label says monitoring should include daily observation by families and caregivers.
- Get a plan before starting. Ask who to call, how often your child will be seen in the early weeks, and what would trigger a change.
- Do not stop on your own. The label says a gradual dose reduction is recommended rather than abrupt stopping whenever possible. If you are worried, call the prescriber right away, and use 988, 911 or an ER if it is an emergency.
The warning is a reason for careful monitoring and an informed conversation. Your prescriber can go over how it applies to your child, including the risks of an untreated condition.
What does on-label and off-label mean for children?
On-label means the FDA has approved the medicine for that condition and age group. Off-label means a prescriber is using an approved drug in another way. Approvals are specific. For example, the fluoxetine label lists major depressive disorder for ages 8 to 18 and obsessive-compulsive disorder for ages 7 to 17, and says fluoxetine is not approved for use in children under 7.
The FDA explains that once a drug is approved, health care providers generally may prescribe it for an unapproved use when they judge it medically appropriate. It also cautions that the FDA has not determined the drug is safe and effective for that use. Off-label prescribing is legal and is sometimes the reasonable option. You are entitled to ask why it is being recommended and what evidence supports it in children.
Are other medications covered by warnings too?
Yes. Each drug has its own label, so ask about the exact medicine being proposed. Three common examples:
| Group | What sources say | Ask the prescriber |
|---|---|---|
| Antidepressants | Boxed warning on suicidal thoughts and behaviors in children, adolescents and young adults | What is the early monitoring schedule? What symptoms should we call about? |
| Some non-stimulant ADHD medicines | The atomoxetine label has a boxed warning that it increased the risk of suicidal ideation in pediatric patients 6 and older in short-term studies, with close monitoring especially in the first months and at dose changes. The viloxazine label has a boxed warning on suicidal thoughts and behaviors. | Does this medicine carry that warning? What is the monitoring schedule, and what should we call about? |
| Stimulants for ADHD | The FDA announced in 2023 that it was requiring a boxed warning update to describe risks of misuse, abuse, addiction and overdose across the class. It advises storing them securely and never sharing them. NIMH says stimulants are safe when taken under a provider's supervision and used as directed, and that misuse or dependence is unlikely when used as prescribed. | How should we store it? How will we check growth, sleep, appetite and heart-related concerns? |
For anything not listed here, ask the prescriber and read the medication guide from the pharmacy.
Will medication change my child's personality?
This worry comes up often. NIMH says some children may report feeling slightly different or unlike their usual selves on stimulants. If your child seems flat, not themselves, or noticeably different in a way that worries you, tell the prescriber. That is useful information and may lead to a change in the plan. Your child's own view counts here too, and AACAP says children and adolescents should be included in appropriate parts of the discussion, using words they understand.
Does medication replace therapy?
AACAP says psychiatric medication should not be used alone and should be one part of a broader treatment plan. Whether to begin with therapy, medication or both depends on the diagnosis and how severe things are. The article on therapy vs medication for children and teens covers that choice in more depth.
What should happen before a prescription?
According to AACAP, a child and adolescent psychiatrist makes a thorough diagnostic evaluation. Depending on the case, this may include a physical exam, parent and teacher reports, psychological testing, lab tests or an EKG. AACAP also says ongoing medical assessment and close contact with the treating clinician are recommended, and it advises: do not stop or change a medication without speaking to your child's doctor.
The article on what happens at a child psychiatric evaluation describes how a first visit may go.
Questions to bring to the appointment
This list is adapted from AACAP's Questions to Ask:
- What is the medication called, and is it known by other names?
- What is known about how it has helped other children with a similar condition?
- Is this use FDA-approved for my child's age and condition? Are there FDA warnings?
- How will it help, and when should we expect it to start working?
- Which side effects are common, and which mean we should call right away?
- Is it addictive, or can it be misused?
- Are any lab or heart tests needed before or during treatment?
- How often will progress be checked, and by whom?
- Are there other medications, foods or activities to avoid?
- What do we do if a dose is missed, our child gets sick, or a problem develops?
- How long might our child take it, and how will the decision to stop be made?
- Does the school nurse need to know?
Who decides, and does my teen get a say?
In most cases, a parent or guardian consents to medication for a minor. New York Office of Mental Health guidance for its licensed outpatient programs says that where psychotropic medication is recommended in an outpatient setting, the consent of the minor's legal guardian is required. Hospital rules for older teens are different. Rules vary by setting, and this is general information, not legal advice. See minors and consent in New York.
Even with parental consent, a teen who feels heard is more likely to stick with a plan and tell you about side effects. The article on medication management for teens and young adults says more about that stage.
If you would like to talk through whether medication is worth considering, the child and adolescent psychiatry and therapy page and the medication management page explain how care works here. Costs are covered on the fees and insurance page.
FAQs
Do antidepressants cause suicide in teens?
The FDA-approved labeling says antidepressants increased the risk of suicidal thoughts and behavior in young people in short-term studies, and that no suicides occurred in the pediatric trials. This is why close monitoring is required. Ask the prescriber how it applies to your child.
Can my child stop whenever they feel better?
Talk to the prescriber first. NIMH says stopping too soon may cause unpleasant or harmful side effects, and a provider can reduce the dose slowly when it is time.
Will medication stunt my child's development?
That depends on the specific medicine, so ask the prescriber what is known about it in children and what will be tracked over time, such as growth, sleep and appetite.
What if my child refuses to take it?
Tell the prescriber rather than forcing it or quietly stopping. Refusal often has a reason, like side effects or stigma, that can be discussed and sometimes addressed.
