Yes. 91 FDA-approved labels for Carbamazepine carry a boxed warning, and its subject is serious dermatologic reactions and hla-b*1502 allele serious and sometimes fatal dermatologic reactions. 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 Carbamazepine warning opens on one specific label, identified underneath it. Of the 25 Carbamazepine labels sampled, 3 carried materially different wordings and this was the most common, used by 17 of them.
WARNINGS SERIOUS DERMATOLOGIC REACTIONS AND HLA-B*1502 ALLELE SERIOUS AND SOMETIMES FATAL DERMATOLOGIC REACTIONS, INCLUDING TOXIC EPIDERMAL NECROLYSIS (TEN) AND STEVENS-JOHNSON SYNDROME (SJS), HAVE BEEN REPORTED DURING TREATMENT WITH CARBAMAZEPINE. THESE REACTIONS ARE ESTIMATED TO OCCUR IN 1 TO 6 PER 10,000 NEW USERS IN COUNTRIES WITH MAINLY CAUCASIAN POPULATIONS, BUT THE RISK IN SOME ASIAN COUNTRIES IS ESTIMATED TO BE ABOUT 10 TIMES HIGHER. STUDIES IN PATIENTS OF CHINESE ANCESTRY HAVE FOUND A STRONG ASSOCIATION BETWEEN THE RISK OF DEVELOPING SJS/TEN AND THE PRESENCE OF HLA-B*1502, AN INHERITED ALLELIC VARIANT OF THE HLA-B GENE.
CARBAMAZEPINE, A-S Medication Solutions, label version effective 18 February 2025. Opening of the warning; 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 Carbamazepine labels sampled for this page, 3 carried materially different wordings of the same warning, and the version quoted above was used by 17 of them.
The hazard does not change between those 3 versions. Only the sentences do, which is why a refill from a different manufacturer can carry warning text that reads differently without anything about Carbamazepine or its risks having changed.
Carbamazepine is dispensed under 91 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 Carbamazepine have a black box warning?
Yes. 91 FDA-approved labels for Carbamazepine carry a boxed warning, and its subject is serious dermatologic reactions and hla-b*1502 allele serious and sometimes fatal dermatologic reactions. 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 Carbamazepine 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 18 February 2025, the warning concerns serious dermatologic reactions and hla-b*1502 allele serious and sometimes fatal dermatologic reactions. The full text is linked so the exact version can be read rather than summarised.
Does the Carbamazepine boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of serious dermatologic reactions and hla-b*1502 allele serious and sometimes fatal dermatologic reactions to be communicated prominently so prescribers weigh it explicitly. Carbamazepine remains FDA-approved and is dispensed under 91 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 Carbamazepine labels sampled here, 3 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 Carbamazepine because of this warning?
This page does not answer that and cannot. The warning about serious dermatologic reactions and hla-b*1502 allele serious and sometimes fatal dermatologic reactions is written for a prescriber deciding whether Carbamazepine 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 Carbamazepine label, linked below by its DailyMed set identifier so the exact version can be opened rather than taken on trust. The figure of 91 labels, and the count of 3 distinct wordings among 25 sampled, were computed from the openFDA labelling API on 30 August 2026.
- CARBAMAZEPINE prescribing information, A-S Medication Solutions, effective 18 February 2025.
- 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.