Wegovy label adds an acute kidney injury warning

Novo Nordisk's Wegovy (semaglutide) prescribing information now carries a warning about acute kidney injury caused by volume depletion — in plain terms, dehydration. The label's "Recent Major Changes" section dates the addition of Warnings and Precautions 5.5, "Acute Kidney Injury due to Volume Depletion," to 08/2025 ^[1].

The one-line summary in the Warnings and Precautions highlights is direct: "Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion" ^[1]. The adverse reactions most likely to cause that kind of fluid loss with a GLP-1 medicine are gastrointestinal — the same label separately warns that semaglutide use "has been associated with gastrointestinal adverse reactions, sometimes severe," and says Wegovy is not recommended in patients with severe gastroparesis ^[1].

The kidney warning reportedly follows postmarketing reports of kidney injury, including cases that required hemodialysis, in patients who became dehydrated from vomiting, nausea or diarrhea. The label excerpt available here shows the highlights line and the section number for 5.5 but not the full text of that section, so the number of reported cases, how many needed dialysis, and how many patients recovered are not known from this source ^[1].

A label that has changed repeatedly

The kidney warning is one of several revisions logged in the same Recent Major Changes block. The label records changes to Indications and Usage in 08/2025 and 12/2025, and to Dosage and Administration in 08/2025, 12/2025 and 03/2026 ^[1]. Severe Gastrointestinal Adverse Reactions (5.6) was updated in 10/2025, the Suicidal Behavior and Ideation section (5.10) was removed in 02/2026, and a new section, "Never Share WEGOVY FlexTouch Between Patients" (5.11), was added in 06/2026 ^[1]. The version of the label posted on DailyMed was updated June 18, 2026 ^[1].

Wegovy has also grown well beyond a single weekly injection. The label now covers both injection and oral tablets, with tablet strengths of 1.5 mg, 4 mg, 9 mg and 25 mg, injection strengths from 0.25 mg/0.5 mL up to 7.2 mg/0.75 mL (Wegovy HD), and a multi-dose Wegovy FlexTouch pen that delivers four 2.4 mg doses ^[1]. Approved uses include reducing the risk of major adverse cardiovascular events in adults with established cardiovascular disease plus obesity or overweight, long-term weight reduction in adults and in children 12 and older with obesity, and — for the injection — noncirrhotic MASH with moderate to advanced liver fibrosis (F2 to F3), an accelerated approval that may depend on a confirmatory trial ^[1].

The drug still carries a boxed warning about thyroid C-cell tumors seen in rodents, with the label noting it is unknown whether Wegovy causes such tumors in humans ^[1]. Other Warnings and Precautions include acute pancreatitis, acute gallbladder disease, hypoglycemia when combined with insulin or an insulin secretagogue, hypersensitivity reactions including anaphylaxis and angioedema, and diabetic retinopathy complications ^[1].

Why it matters for patients

Most people who take semaglutide know about nausea, vomiting and diarrhea. What the August 2025 change formalizes is that those symptoms can have a downstream consequence: if a person loses enough fluid, the kidneys can be injured. That moves dehydration from an inconvenience to something the label asks clinicians to watch, by checking kidney function in patients who report side effects that could deplete fluids ^[1].

Practically, this gives patients a concrete reason to report persistent vomiting or diarrhea rather than waiting it out, and it gives prescribers label-backed justification to order blood work. It may matter more for people who already have reduced kidney function or who take other medicines that affect the kidneys — though the label excerpt reviewed here does not spell out which groups are at higher risk.

What happens next

The warning is already in effect and appears in the current label posted as of June 18, 2026 ^[1]. Whether FDA or Novo Nordisk adds further detail — such as case counts or specific monitoring intervals — is not stated in this source. Patients with questions about kidney monitoring can raise them with the clinician who prescribed the medication.