Does Sertraline have a black box warning? (+5 factors)

In this article, we will discover if Sertraline is given a black box warning or not. We will further dig deep into the side effects associated with Sertraline due to which it has been given a black box warning. We will also look at the precautions to avoid these effects.

Does Sertraline have a black box warning?

Yes, Sertraline has a black box warning. The Food and Drug Administration (FDA) has issued a black box warning against Sertraline about the increased risk of suicidal thoughts and behaviours in adolescents.

Close monitoring and careful balance between the potential benefits over risks should be maintained particularly in young patients taking Sertraline in their early course of treatment to avoid suicidal effects.

Why does Sertraline have a black box warning?

Sertraline and other SSRI antidepressants are issued a black box warning by the USFDA for their suicidal effects on adolescents and young children.

Sertraline is a drug of choice for major depressive disorder (MDD), obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), and other mental health conditions.

Serotonin plays an important role in mood uplifting. While on sertraline, there is a surge of serotonin in the brain which may cause serotonin imbalance usually in young patients that leads to suicidal thoughts and behaviour.

Sertraline may develop suicidal thoughts among the younger population (up to 25 years) during the initial course of treatment. These thoughts are generated especially while starting, changing, or discontinuing the medication (1).

Sertraline is given a black box warning to emphasize the importance of careful monitoring of the dosage given to patients. The early treatment period may induce mood or behaviour changes in patients taking Sertraline (1).

Which factors can influence the black box warning of Sertraline?

There are various factors that can influence the black box warning of Sertraline. Some of them include:

  • Age
  • Dose variation
  • Individual variability
  • Frequent dosage adjustments
  • No regular monitoring
  • Serotonin imbalance

Many antidepressants fall under the category of boxed drugs due to such factors. Careful monitoring of signs and symptoms after taking boxed drugs is essential to avoid any hazardous event from happening.

However, side effects may vary individually but seeking medical help is necessary upon the emergence of adverse effects.

How to ensure the safe use of Sertraline?

To ensure the safe and effective use of Sertraline always follow the recommended schedule given by your prescriber. Sertraline may take 4-6 weeks to show its effects therefore, do not abruptly discontinue the drug if you don’t see the results immediately.

Carefully monitor your signs and symptoms of suicidal thoughts and behaviours at the beginning of treatment and at times of dosage changes. It is especially advised for young adults and children (3).

Always take Sertraline in the prescribed dosage only. It is important to counsel family members and the caregivers of the patients to look for emergent behavioural changes and immediately alert their doctor (3).

If the condition of the patient is persistently getting worse, then changing the therapeutic regimen or discontinuing Sertraline may also result in better outcomes. But this should only be done under your doctor’s supervision and guidance (3)

What other drugs come with black box warnings?

Some other drugs with black box warnings from the FDA include (4):

  • Fluoroquinolone antibiotics (Tendinitis or tendon rupture risk)
  • Rosiglitazone (Myocardial infarction risk)
  • Celecoxib (Cardiovascular or gastrointestinal risk)
  • Medroxyprogesterone (Long-term use induces decreased bone density)

Patients should be informed about the boxed warning drugs before prescribing them. They should be well aware of the possible harmful effects that the boxed medications have the potential to cause.

They should be warned about regular and careful monitoring of their symptoms and side effects after taking boxed medications.


In this article, we have discussed the black box warning associated with Sertraline. We have also discovered some other drugs with black box warnings given by the FDA. We have looked at the ways to ensure safe and effective use of Sertraline.

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Fornaro M, Anastasia A, Valchera A, Carano A, Orsolini L, Vellante F, Rapini G, Olivieri L, Di Natale S, Perna G, Martinotti G, Di Giannantonio M, De Berardis D. The FDA “Black Box” Warning on Antidepressant Suicide Risk in Young Adults: More Harm Than Benefits? Front Psychiatry. 2019 May 3;10:294. doi: 10.3389/fpsyt.2019.00294. PMID: 31130881; PMCID: PMC6510161.


ZOLOFT (sertraline hydrochloride) tablets, for oral use. ZOLOFT (sertraline hydrochloride) oral solution. Initial U.S. Approval: 1991. Reference ID: 4032692. Revised:12/2016


Delong C, Preuss CV. Box Warning. [Updated 2023 Jun 17]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from:

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