Learn why antidepressants have warnings about suicidal thinking in children and teens, what to do before your child starts taking an antidepressant, and the warning signs of a potential problem.By Mayo Clinic Staff
Antidepressant drugs are often an effective way to treat depression and anxiety in children and teenagers. However, antidepressant use in children and teens must be monitored carefully, as rarely there can be severe side effects.
Antidepressants carry a U.S. Food and Drug Administration (FDA) black box warning about a risk of increased suicidal thinking and behavior in some individuals under the age of 25.
Although at first you may find the suicide warning alarming, it's important to get the facts. Find out what the warning means and ask about all treatment options. This will help you make an informed decision about your child's health and weigh the benefits and risks of treatment options with your child's doctor.
The FDA reported that an extensive analysis of clinical trials showed that antidepressants may cause or worsen suicidal thinking or behavior in a small number of children and teens. The analysis showed that some children and teens taking antidepressants had a small increase in suicidal thoughts, compared with those taking a sugar pill (placebo).
None of the children in any of the studies actually took their own life. Still, the FDA considered the findings concerning enough to issue a public health advisory and require manufacturers to label antidepressants with strong warnings about the link to suicidal thinking and behavior in children, teenagers and young adults under 25.
However, not all mental health researchers believe these warnings are necessary. Newer research indicates that the benefits of antidepressants may be greater than the risk of suicide. And some research indicates that suicide rates in children decrease when they take antidepressants.
Although the FDA analysis examined only nine antidepressants, the FDA extended the warning to all prescription antidepressants. This black box warning is the strongest safety warning that the FDA can issue about a prescription drug. The warning is printed in bold type framed in a black border at the top of the paper inserts that come with antidepressants.
Because of the risk of suicide from depression, it's difficult to establish a clear causal relationship between antidepressant use and suicide. There could be a variety of potential reasons for an increased risk. In some children, antidepressants may also trigger anxiety, agitation, hostility, restlessness or impulsive behavior. These effects may indicate that the child's depression is getting worse or that the child is starting to develop suicidal thoughts.
The warning about a possible link between antidepressants and suicidal thoughts does not mean that antidepressants should not be used in children. Nor is the warning meant to frighten people away from antidepressants. However, the warning should be taken as a caution to carefully weigh the pros and cons of using antidepressants in children and teenagers against the real risk of suicide as a result of untreated depression.
For many children and teens, antidepressants are an effective way to treat depression, anxiety, obsessive-compulsive disorder or other mental health conditions. If these conditions aren't treated effectively, your child may not be able to lead a satisfying, fulfilled life or do everyday activities.
It's important that your child have a thorough evaluation before starting to take an antidepressant. A mental health evaluation by a psychiatrist — or a pediatrician or family physician who is experienced in the treatment of child and adolescent mood disorders — should include:
- A detailed review of any potential risk factors your child may have that increase the risk of self-harm
- An assessment of whether your child may have another mental illness, such as attention-deficit/hyperactivity disorder, substance misuse, bipolar disorder, or an anxiety disorder or an eating disorder
- An evaluation of whether there's a family history of mental illnesses or suicide
Talk with your doctor about treatment options, treatment goals and the expected results of any recommended treatment.
The FDA has approved certain antidepressants for use in children and teenagers for different types of diagnoses. Antidepressants come with a medication guide that advises parents and caregivers about risks and precautions. Be sure to carefully read the medication guide and package insert, and discuss any questions with the prescribing physician and your pharmacist.
FDA-approved antidepressants for children and teenagers
||Age (in years)
|*Many of these drugs are also available in generic form. Recommended initial dose and maximum dose vary by age.
||10 and older
||Obsessive-compulsive disorder (OCD)
|Duloxetine (Cymbalta, Drizalma Sprinkle)
||7 and older
||Generalized anxiety disorder
||12 and older
||Major depressive disorder
||8 and older
||Major depressive disorder
|7 and older
||8 and older
||10 and older
|Olanzapine and fluoxetine, combination drug (Symbyax)
||10 and older
||6 and older
Antidepressants can also be used for other conditions. The antidepressant imipramine is approved by the FDA to treat daytime or nighttime involuntary urination (childhood enuresis) in children 6 years of age and older.
Physicians may use their medical judgment to prescribe other antidepressants for children for what's called off-label use. This is a clinically common practice for many types of medications for both children and adults.
The FDA advises that doctors prescribe the smallest quantity of pills possible to help reduce the risk of deliberate or accidental overdose. Locking up all pills in the home is one measure families can take to reduce the risk of suicide. Careful monitoring by parents, caregivers and health care professionals is important for any child or teenager taking an antidepressant for depression or any other condition.
The highest risk of suicidal thinking and behavior occurs:
- During the first few months of treatment with an antidepressant
- When the dosage is increased or decreased
Parents and caregivers should closely observe the child on a daily basis during these transition periods and watch for worrisome changes for the whole time the child takes antidepressants.
The FDA also recommends that your child receive close monitoring by a health care professional during the first few months of treatment, and ongoing monitoring throughout treatment. Frequency of contact with doctors or mental health professionals depends on your child's needs. Make sure you stick to your child's recommended appointment schedule.
Sometimes the signs and symptoms of suicidal thoughts or self-harm are difficult to see, and your child may not directly tell you about such thoughts. Here are some signs that your child's condition may be worsening or that he or she may be at risk of self-harm:
- Talk of suicide or dying
- Suicide attempts
- Agitation or restlessness
- New or worsening anxiety or panic attacks
- Increasing sadness or worsening of depression symptoms
- Extreme increase in talking, energy or activity
- Aggression, violence or hostility
- Trouble sleeping or worsening insomnia
- Spending more time alone
Contact your child's health care professional right away if any of these signs occur, if they get worse, or if you, your child, a teacher or other caregiver has concerns.
Make sure your child doesn't stop antidepressant treatment without the guidance of the prescribing doctor. Suddenly stopping an antidepressant may cause flu-like symptoms, an increase in anxiety and other side effects referred to as discontinuation syndrome. Stopping too suddenly may also result in the return of depression symptoms.
Most children who take antidepressants for depression will improve with medication. However, combining medication with talk therapy (psychotherapy) is likely to be even more effective. Many types of psychotherapy may be helpful, but cognitive behavioral therapy and interpersonal therapy have been scientifically studied and shown to be effective for treating depression.
- Cognitive behavioral therapy. In cognitive behavioral therapy, a mental health professional can help your child improve coping skills, communication and problem-solving skills. Your child can also learn how to become aware of harmful ideas and behaviors, replace them with positive approaches, and manage emotions.
- Interpersonal therapy. With a focus on relationships, this therapy may help your teenager adapt to changes in current relationships and develop new ones.
For some children and teenagers with mild symptoms, talk therapy alone may be beneficial.
March 19, 2022
- Dwyer JB, et al. Antidepressants for pediatric patients. Current Psychiatry. 2019;8:26F.
- Suicidality in children and adolescents being treated with antidepressant medications. U.S. Food and Drug Administration. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/suicidality-children-and-adolescents-being-treated-antidepressant-medications. Accessed May 12, 2021.
- Antidepressants — Pediatric dosing chart. Centers for Medicare and Medicaid Services. https://www.cms.gov/Medicare-Medicaid-Coordination/Fraud-Prevention/Medicaid-Integrity-Program/Education/Resource-Library/antidepressants-pediatric-dosing-chart. Accessed May 12, 2021.
- Depression: Parents' medication guide. American Academy of Child and Adolescent Psychiatry. https://www.aacap.org/aacap/custom/googlesearch.aspx?q=parent%20guide&cx=005963334930150341854:fhyugbr2cou. Accessed May 12, 2021.
- Boaden K, et al. Antidepressants in children and adolescents: Meta-review of efficacy, tolerability and suicidality in acute treatment. Frontiers in Psychiatry. 2020; doi:10.3389/fpsyt.2020.00717.
- Teen depression. National Institute of Mental Health. https://www.nimh.nih.gov/health/publications/teen-depression/. Accessed May 15, 2021.
- Spielmans GI, et al. Duty to warn: Antidepressant black box suicidality warning is empirically justified. Frontiers in Psychiatry. 2020; doi:10.3389/fpsyt.2020.00018.
- Kaminski JA, et al. Antidepressants and suicidality: A re-analysis of the re-analysis. Journal of Affective Disorders. 2020; doi:10.1016/j.jad.2020.01.107.
- Hussain H, et al. Recent developments in the treatment of major depressive disorder in children and adolescents. Evidence-Based Mental Health. 2018; doi:10.1136/eb-2018-102937.
- Gabriel M, et al. Antidepressant discontinuation syndrome. CMAJ. 2017; doi:10.1503/cmaj.160991.
- Revisions to product labeling. U.S. Food and Drug Administration. https://www.fda.gov/media/77404/download. Accessed May 15, 2021.
- Anafranil (prescribing information). Patheon Inc.; 2019. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4074b555-7635-41a9-809d-fae3b3610059. Accessed May 15, 2021.
- Cymbalta (prescribing information). Eli Lilly and Company; 2020. http://uspl.lilly.com/cymbalta/cymbalta.html. Accessed May 15, 2021.
- Drizalma Sprinkle (prescribing information). Sun Pharmaceutical Industries Limited; 2019. https://drizalmasprinkle.com/. Accessed May 15, 2021.
- Fluvoxamine maleate (prescribing information). Actavis Pharma Inc.; 2017. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8bbd7e39-b9ab-4716-9522-aa8c4b92210e&audience=consumer. Accessed May 15, 2021.
- Lexapro (prescribing information). Allergan Inc.; 2020. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13bb8267-1cab-43e5-acae-55a4d957630a&audience=consumer. Accessed May 15, 2021.
- Prozac (prescribing information). Eli Lilly and Company; 2020. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c88f33ed-6dfb-4c5e-bc01-d8e36dd97299&audience=consumer. Accessed May 15, 2021.
- Symbyax (prescribing information). Eli Lilly and Company; 2021. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6b28c424-0b7e-4b75-b090-f116b113554e. Accessed May 15, 2021.
- Imipramine (prescribing information). Sandoz Inc.; 2019. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7d52c40c-bbcb-4698-9879-d40136301d31&audience=consumer. Accessed July 7, 2021.
- Zoloft (prescribing information). Pfizer Inc.; 2018. https://www.pfizer.com/products/product-detail/zoloft. Accessed May 15, 2021.
- Krieger CA (expert opinion). Mayo Clinic. May 28, 2021.
- Vande Voort JL (expert opinion). Mayo Clinic. June 29, 2021.
- Latuda (prescribing information). Sunovion Pharmaceuticals Inc.; 2019. https://www.latuda.com/. Accessed June 29, 2021.