Adalimumab (HADLIMA) Label Adds Boxed Warning for Serious Infections

The label for Adalimumab, specifically the product HADLIMA, underwent a significant revision on 2026-05-14 with the addition of a Boxed Warning. This update alerts healthcare providers and patients to an increased risk of serious infections and malignancy associated with the use of adalimumab products, risks that may lead to hospitalization or even death.

Background

HADLIMA is an adalimumab product, a type of biologic medication. The inclusion of a Boxed Warning, also known as a black box warning, represents the strongest warning that the U.S. Food and Drug Administration (FDA) requires for prescription drug labels. It is used to highlight known serious or potentially life-threatening risks associated with a drug. This type of warning is crucial for ensuring that prescribers and patients are fully aware of the most severe potential adverse effects before treatment initiation.

What this means

The newly added Boxed Warning on the HADLIMA label emphasizes that patients receiving treatment with adalimumab products, including HADLIMA, are at an elevated risk for developing serious infections. These infections can be severe enough to require hospitalization and, in some cases, may prove fatal. Furthermore, the warning also addresses the potential for malignancy. For clinicians, this means a heightened necessity for patient screening for latent infections, careful monitoring throughout the treatment course, and comprehensive counseling on the signs and symptoms of serious infections and malignancy. Patients should be advised to seek immediate medical attention if they experience symptoms such as fever, persistent cough, or unusual bruising or bleeding, which could indicate a serious adverse event.

Source

This information regarding the label revision was sourced from the FDA, detailing an update to the product label for HADLIMA. The revision, which includes the new Boxed Warning, became effective on 2026-05-14. Further details are publicly available on the dailymed.nlm.nih.gov website, an official source for drug product information.