Zepbound label update revises diabetic retinopathy warning for type 2 diabetes
Zepbound's August 2026 label revision updates the diabetic retinopathy section for patients with type 2 diabetes and keeps its oral contraceptive guidance.
The prescribing information for Zepbound (tirzepatide) was revised in August 2026, and its change log lists an update to the section covering diabetic retinopathy complications in patients with type 2 diabetes [1]. The document itself carries a revision date of 8/2026 [1].
Under the heading Recent Major Changes, the label lists Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus, section 5.8 of the Warnings and Precautions, as changed in 08/2026 [1]. The current text of that section tells prescribers to monitor patients with a history of diabetic retinopathy for progression [1]. The label does not describe what wording changed within that section, and the reason for the update is not stated in the document [1].
The same table lists other recent changes: Severe Gastrointestinal Adverse Reactions (section 5.2) changed in 02/2026, Dosage and Administration (section 2.4) in 01/2026, and Never Share a ZEPBOUND KwikPen Between Patients (section 5.10) in 01/2026 [1]. It also lists Suicidal Behavior and Ideation as removed in 02/2026, meaning that warning no longer appears in the label [1].
One item that is not part of the August revision is the guidance for patients who use oral hormonal contraceptives. Section 8.3 advises females using oral contraceptives to switch to a non-oral contraceptive method, or add a barrier method, for four weeks after starting Zepbound and for four weeks after each dose escalation [1]. A separate section on drug interactions notes that Zepbound delays gastric emptying and can affect the absorption of oral medications taken at the same time [1]. The change table does not list the contraceptive guidance, and the label does not give a date for that instruction [1].
The approved uses listed in the label are long-term reduction and maintenance of excess body weight in adults with obesity, or adults with overweight who also have at least one weight-related condition, and treatment of moderate to severe obstructive sleep apnea in adults with obesity [1]. Coadministration with another tirzepatide-containing product or with any GLP-1 receptor agonist is not recommended [1].
The recommended starting dose is 2.5 mg injected under the skin once weekly for four weeks, with increases of 2.5 mg after at least four weeks until a maintenance dose is reached [1]. Maintenance doses for weight reduction are 5 mg, 10 mg, or 15 mg once weekly; for obstructive sleep apnea they are 10 mg or 15 mg once weekly. The maximum recommended dose is 15 mg once weekly [1].
The label keeps its boxed warning about thyroid C-cell tumors seen in rats, and states that it is unknown whether Zepbound causes these tumors, including medullary thyroid carcinoma, in humans [1]. Zepbound is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2 [1]. The most common adverse reactions, reported in at least 5% of patients treated with Zepbound, are nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, and gastroesophageal reflux disease [1]. Suspected adverse reactions can be reported to Eli Lilly at 1-800-545-5979 or to the FDA at 1-800-FDA-1088 or through MedWatch [1].
Why it matters for patients
For people who take Zepbound and also have type 2 diabetes, the label directs that those with a history of diabetic retinopathy be monitored for progression of the eye condition [1]. The August 2026 update is listed as a change to that section, but the document does not say whether the change was a wording clarification or reflected new data [1].
The February 2026 removal of the suicidal behavior and ideation warning is also part of the current label's history [1]. That means the warning is no longer among the listed risks in the prescribing information, though the removal itself does not explain why it was taken out [1].
The contraceptive instruction is a practical detail for patients who rely on a daily pill. The label says a non-oral method or an added barrier method is advised for four weeks after the first dose and again for four weeks after each dose increase [1]. That instruction appears alongside, rather than inside, the list of changes dated August 2026 [1].
What happens next
The current prescribing information is dated 8/2026 [1]. Prior updates in the document are dated 01/2026 and 02/2026 [1]. The label does not state whether further revisions are planned, and a timeline for any additional changes has not been reported [1]. The reason the diabetic retinopathy section was revised in August 2026 has not been disclosed [1].
Sources
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