Yes. 102 FDA-approved labels for Lamotrigine carry a boxed warning, and its subject is serious skin rashes. 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 Lamotrigine warning opens on one specific label, identified underneath it. Of the 25 Lamotrigine labels sampled, 11 carried materially different wordings and this was the most common, used by 12 of them.
WARNING: SERIOUS SKIN RASHES Lamotrigine can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.3% to 0.8% in pediatric patients (aged 2 to 17 years) and 0.08% to 0.3% in adults receiving lamotrigine. One rash-related death was reported in a prospectively followed cohort of 1,983 pediatric patients (aged 2 to 16 years) with epilepsy taking lamotrigine as adjunctive therapy.
LAMOTRIGINE, Par Health USA, LLC, label version effective 22 April 2026. 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 Lamotrigine labels sampled for this page, 11 carried materially different wordings of the same warning, and the version quoted above was used by 12 of them.
The hazard does not change between those 11 versions. Only the sentences do, which is why a refill from a different manufacturer can carry warning text that reads differently without anything about Lamotrigine or its risks having changed.
Lamotrigine is dispensed under 102 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 Lamotrigine have a black box warning?
Yes. 102 FDA-approved labels for Lamotrigine carry a boxed warning, and its subject is serious skin rashes. 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 Lamotrigine 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 22 April 2026, the warning concerns serious skin rashes. The full text is linked so the exact version can be read rather than summarised.
Does the Lamotrigine boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of serious skin rashes to be communicated prominently so prescribers weigh it explicitly. Lamotrigine remains FDA-approved and is dispensed under 102 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 Lamotrigine labels sampled here, 11 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 Lamotrigine because of this warning?
This page does not answer that and cannot. The warning about serious skin rashes is written for a prescriber deciding whether Lamotrigine 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 Lamotrigine label, linked below by its DailyMed set identifier so the exact version can be opened rather than taken on trust. The figure of 102 labels, and the count of 11 distinct wordings among 25 sampled, were computed from the openFDA labelling API on 30 August 2026.
- LAMOTRIGINE prescribing information, Par Health USA, LLC, effective 22 April 2026.
- 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.