Yes. 137 FDA-approved labels for Sertraline carry a boxed warning, and its subject is suicidal thoughts and behaviors. A boxed warning is the most serious warning the FDA requires on a prescription label. It is applied to the drug and to the situations in which it is used, not to any particular person taking it.
What the warning says
Below is how the Sertraline warning opens on one specific label, identified underneath it. Of the 25 Sertraline labels sampled, 10 carried materially different wordings and this was the most common, used by 10 of them.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [See Warnings and Precautions (5.1) ] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients ( 5.1 ) Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 )
SERTRALINE HYDROCHLORIDE, Aurobindo Pharma Limited, label version effective 21 March 2024. read the full label on DailyMed.Why the wording differs between manufacturers
There is no single official text of a boxed warning. The FDA sets what a warning must cover, and each manufacturer writes its own label within that. Of the 25 Sertraline labels sampled for this page, 10 carried materially different wordings of the same warning, and the version quoted above was used by 10 of them.
The hazard does not change between those 10 versions. Only the sentences do, which is why a refill from a different manufacturer can carry warning text that reads differently without anything about Sertraline or its risks having changed.
Sertraline is dispensed under 137 current FDA labels despite this warning, which is the point worth holding onto: a boxed warning is a disclosure requirement, not a verdict. What a boxed warning does and does not mean sets out the distinction.
Common questions
Does Sertraline have a black box warning?
Yes. 137 FDA-approved labels for Sertraline carry a boxed warning, and its subject is suicidal thoughts and behaviors. A boxed warning is the strongest warning the FDA requires on a prescription label, and it is applied to the drug, not to any individual taking it.
What does the Sertraline boxed warning say?
The wording is set by each manufacturer within FDA requirements, so it varies. In the version quoted on this page, taken from a label effective 21 March 2024, the warning concerns suicidal thoughts and behaviors. The full text is linked so the exact version can be read rather than summarised.
Does the Sertraline boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of suicidal thoughts and behaviors to be communicated prominently so prescribers weigh it explicitly. Sertraline remains FDA-approved and is dispensed under 137 current labels. A boxed warning is a disclosure requirement, not a judgement that a drug should not be used.
Why do different pharmacies show different warning text for the same drug?
Because each manufacturer writes its own label within the FDA's requirements. Of 25 Sertraline labels sampled here, 10 carried materially different wordings of the same warning. The hazard described is the same; the sentences are not. This is a common source of confusion when a prescription is refilled with a different manufacturer's product.
Should I stop taking Sertraline because of this warning?
This page does not answer that and cannot. The warning about suicidal thoughts and behaviors is written for a prescriber deciding whether Sertraline suits a particular patient, and stopping a prescribed medicine carries its own risks that this page knows nothing about. Raise it with the prescriber or a pharmacist, who can see the whole picture.
Where this page's information comes from
The quotation above is from one Sertraline label, linked below by its DailyMed set identifier so the exact version can be opened rather than taken on trust. The figure of 137 labels, and the count of 10 distinct wordings among 25 sampled, were computed from the openFDA labelling API on 30 August 2026.
- SERTRALINE HYDROCHLORIDE prescribing information, Aurobindo Pharma Limited, effective 21 March 2024.
- openFDA drug labelling API, the source of the label counts and variant counts on this page.
Labels are revised over time. The version linked above is the one this page was written against, and a newer revision may differ. Counts reflect the labels present in openFDA on the retrieval date.