Humira package insert and where to find the current FDA label

Humira package insert

The current Humira package insert is the FDA-approved label for adalimumab, supplement S-425, approved December 23, 2025 and marked "Revised: 12/2025". You can download this FDA package insert as a PDF from Drugs@FDA under BLA 125057, or read the AbbVie Inc. version on DailyMed. As of October 2, 2026, Drugs@FDA lists no 2026 labeling supplement for Humira.

Where to get the FDA package insert

Two official places hold slightly different things. Drugs@FDA has the FDA-approved labeling. Humira sits under BLA 125057, AbbVie Inc., first approved 12/31/2002. Open the latest label PDF (S-425 today) when you need the approved text.

DailyMed, run by NLM, shows the "in use" labeling that the company submitted. Its own disclaimer says the in-use labeling "may not be identical to the most recent FDA-approved labeling available at Drugs@FDA" and that "NLM does not review any SPL content prior to publication." For Humira today, both sources say Revised 12/2025. DailyMed also gives you a direct PDF, an XML download and the Medication Guide in HTML.

DailyMed carries three Humira SPLs: AbbVie Inc., Cordavis Limited and A-S Medication Solutions, a repackager whose label dates from May 17, 2024. Use the AbbVie one unless you have a reason not to. To search label text across many products, FDA runs FDALabel, a full-text search tool over manufacturer SPLs.

What the FDA prescribing information contains

US prescribing labels follow the PLR format in 21 CFR 201.56: Highlights of Prescribing Information, then the Contents, then the Full Prescribing Information. 21 CFR 201.57 sets what goes in each part, including the revision date in Highlights. In the Full Prescribing Information for Humira, the key parts are these:

• Boxed warning: "WARNING: SERIOUS INFECTIONS AND MALIGNANCY". It covers serious infections that can lead to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens. Stop Humira if a serious infection or sepsis develops. Test for latent TB before use, treat it if positive, and monitor for active TB during treatment even if the first test was negative. Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with TNF blockers, including Humira. It also notes post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL) in adolescents and young adults with inflammatory bowel disease.
• Recent Major Changes: Autoimmunity (5.9), 7/2025.
• Indications (section 1): rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and non-infectious intermediate, posterior and panuveitis. Age limits differ by indication.
• Dosage forms (section 3): the Humira Pen in 80 mg/0.8 mL, 40 mg/0.8 mL and 40 mg/0.4 mL, and prefilled glass syringes in those strengths plus 20 mg/0.2 mL and 10 mg/0.1 mL.

S-425 itself was a small change. Its approval letter removed discontinued presentations: the 40 mg/0.8 mL institutional vial and the 10 mg/0.2 mL and 20 mg/0.4 mL syringes. Older PDFs such as S-424 (July 2025) still list them, so don't cite those.

Medication Guide and Instructions for Use

Humira's patient labeling is a Medication Guide plus Instructions for Use, one per device presentation, all Revised 12/2025, not a patient package insert. Medication Guides fall under 21 CFR Part 208, which requires them for products with a serious and significant public health concern and requires FDA approval before distribution. You'll find both on the DailyMed page.

Humira biosimilars have their own labels

FDA's biosimilar list names 10 Humira biosimilars. Amjevita (September 2016) was the first on that list and Simlandi (February 2024) the latest. Each has its own label and revision date. A DailyMed search for "adalimumab" returns 35 SPLs, including unbranded ones like adalimumab-adaz.

In the August 2026 Purple Book file, eight are interchangeable: Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Simlandi and Yuflyma. Idacio and Yusimry are biosimilar only. Check the Purple Book again before you rely on this.

Common mistakes

• Reading DailyMed's publish date as the label date. The AbbVie SPL shows version 2154, published February 6, 2026, but the label revision is the "Revised: 12/2025" at the end of Highlights.
• Quoting a biosimilar or repackager label as Humira's.
• Using Drugs@FDA's "Products on BLA" table for strengths. It lists only some presentations. Section 3 of the label is the reliable list.
• Citing the label without its revision. To cite this package insert, name AbbVie, Humira, Revised 12/2025 and the URL you opened.

You can also ask RegAffairs AI about the Humira label and get an answer with citations.