Yes. 18 FDA-approved labels for Liraglutide carry a boxed warning, and its subject is risk of thyroid c-cell tumors. 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 Liraglutide warning opens on one specific label, identified underneath it. Of the 18 Liraglutide labels sampled, 11 carried materially different wordings, and this was the most common, used by 4 of them.
WARNING: RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether liraglutide injection causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ) and Nonclinical Toxicology ( 13.1 )] . Liraglutide injection is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
LIRAGLUTIDE, Biocon Pharma Inc., label version effective 16 October 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 18 Liraglutide labels sampled for this page, 11 carried materially different wordings of the same warning, and the version quoted above was used by 4 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 Liraglutide or its risks having changed.
Liraglutide is dispensed under 18 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 Liraglutide have a black box warning?
Yes. 18 FDA-approved labels for Liraglutide carry a boxed warning, and its subject is risk of thyroid c-cell tumors. 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 Liraglutide 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 16 October 2025, the warning concerns risk of thyroid c-cell tumors. The full text is linked so the exact version can be read rather than summarised.
Does the Liraglutide boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of risk of thyroid c-cell tumors to be communicated prominently so prescribers weigh it explicitly. Liraglutide remains FDA-approved and is dispensed under 18 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 18 Liraglutide 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 Liraglutide because of this warning?
This page does not answer that and cannot. The warning about risk of thyroid c-cell tumors is written for a prescriber deciding whether Liraglutide 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 Liraglutide label, linked below by its DailyMed set identifier so the exact version can be opened rather than taken on trust. The figure of 18 labels, and the count of 11 distinct wordings among 18 sampled, were computed from the openFDA labelling API on 30 August 2026.
- LIRAGLUTIDE prescribing information, Biocon Pharma Inc., effective 16 October 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.