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Revisions

What the FDA changed in these labels

An approved label is not a fixed document. The FDA reissues it, and when that happens the old wording simply stops existing: there is no notice, no changelog and no feed to subscribe to. This page is the record we keep for the labels behind this catalogue.

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  1. Ozempic injection

    label of 22 November 202330 July 2026recorded here 11 August 2026

    Approved uses

    • Removed. Has not been studied in patients with a history of pancreatitis. Consider another antidiabetic therapy.
    • Removed. Not for treatment of type 1 diabetes mellitus.
    • Added. to reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease.

    1 entry reworded without a change of meaning.

    Warnings and precautions

    • Removed. Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
    • Removed. Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.
    • Removed. Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated. Risk of Thyroid C-Cell Tumors In mice and rats, semaglutide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure at clinically relevant plasma exposures.
    • Added. Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including OZEMPIC. Discontinue if pancreatitis is suspected.
    • Added. Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion.
    • Added. Severe Gastrointestinal Adverse Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. OZEMPIC is not recommended in patients with severe gastroparesis.
    • Added. Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated.

    Forms and strengths

    • Removed. Single-patient-use pen that delivers 0.25 mg or 0.5 mg per injection Injection: 4 mg/3 mL (1.34 mg/mL) available in:
    • Removed. Single-patient-use pen that delivers 1 mg per injection Injection: 8 mg/3 mL (2.68 mg/mL) available in:
    • Removed. Single-patient-use pen that delivers 2 mg per injection
    • Added. Injection: 2 mg/3 mL (0.68 mg/mL) for 4 doses of 0.25 mg and 2 doses of 0.5 mg or 4 doses of 0.5 mg, 4 mg/3 mL (1.34 mg/mL) for 4 doses of 1 mg, and 8 mg/3 mL (2.68 mg/mL) for 4 doses of 2 mg in...
    • Added. Injection: 0.25 mg, 0.5 mg or 1 mg per 0.5 mL in a single-dose prefilled syringe

    Dosage and administration

    • Added. To reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death, increase the dosage to 1 mg once weekly after at least 4 weeks on the 0.5 mg dosage.

How this is tracked

Every label in the catalogue is stored with its set identifier, version and effective date, and that store is kept under version control. When a label is re-imported and the regulator has issued a new revision, the two versions sit side by side and can be compared line by line.

Only a change of revision counts here. Improvements to our own parsing do not move the effective date and never appear on this page, because they are our changes, not the FDA's.

Rewording is separated from substance. Between revisions the FDA moves commas and rephrases sentences without changing what they mean; those are counted but not quoted, so that an added indication is not buried under punctuation.

What this record does not cover

It begins when the catalogue does, in July 2026, and it covers only the 18 labels this site is built from, not every medication approved in the United States.

It also records when a revision reached us, not the day the FDA published it. Those are usually close but not identical, and the effective date of the document is the authoritative one.

For the full text of any label, follow the link to DailyMed from the medication page. This site quotes sections; it does not reproduce documents.