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HealthRX.com · Printable medication review sheet

Rybelsus label history check: what changed since you started

Note when you started and which tablet is on your bottle, then tick off the FDA label changes made since. Take the questions to your prescriber or pharmacist at your next visit.

Companion to “Rybelsus Release Date: FDA Approval History and Label Changes” · healthrx.com/regulatory-rybelsus/fda-approval-history · Facts checked 2026-10-19

Your tablets

Name printed on the bottleRybelsus or Ozempic tablets
Tablet strength
Month and year you started oral semaglutide
Revision date at the end of your Medication Guide

FDA label changes to check against your start date

  • June 10, 2022: information on acute gallbladder disease added.[1]
  • January 12, 2023: the statement that Rybelsus is not recommended as first-line therapy was removed.[2]
  • November 1, 2024: information on the risk of pulmonary aspiration during procedures under general anesthesia or deep sedation added.[3]
  • December 9, 2024: formulation R2 added, with its own dosage and instructions for switching between R1 and R2.[4]
  • October 17, 2025: indication added to reduce major adverse cardiovascular events in adults with type 2 diabetes at high risk for them.[5]
  • January 30, 2026: formulation R2 renamed Ozempic (semaglutide) tablets.[6]

At each refill

  • The product name on the bottle is the one your prescriber named
  • The tablet strength matches your current step
  • If the name or strength changed, you asked the pharmacist why before taking it
  • You kept the newest Medication Guide and noted its revision date

For your prescriber or pharmacist

  1. Does the October 2025 cardiovascular indication apply to me, and does it change why I take this medicine?
  2. Am I on formulation R1 or R2, and what happens to my dose if my pharmacy switches products?
  3. Have the gallbladder, pancreatitis or kidney warnings changed what you check at my visits?
  4. If I need a procedure with sedation or anesthesia, what should the team know about my tablets?

Refills and label versions

DateName on bottleStrengthMedication Guide revision dateNotes
Sources for the facts on this sheet
  1. U.S. Food and Drug Administration. NDA 213051/S-011 supplement approval letter for Rybelsus (semaglutide) tablets. Accessed 2026-10-19. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213051Orig1s011ltr.pdf
  2. U.S. Food and Drug Administration. NDA 213051/S-012 supplement approval letter for Rybelsus (semaglutide) tablets. Accessed 2026-10-19. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213051Orig1s012ltr.pdf
  3. U.S. Food and Drug Administration. NDA 213051/S-023 supplement approval letter for Rybelsus (semaglutide) tablets. Accessed 2026-10-19. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213051Orig1s023ltr.pdf
  4. U.S. Food and Drug Administration. NDA 213051/S-020 and S-021 supplement approval letter for Rybelsus (semaglutide) tablets. Accessed 2026-10-19. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213051Orig1s020,213051Orig1s021ltr.pdf
  5. U.S. Food and Drug Administration. NDA 213051/S-024, S-028 and S-029 supplement approval letter for Rybelsus (semaglutide) tablets. Accessed 2026-10-19. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213051Orig1s024,s028,s029ltr.pdf
  6. U.S. Food and Drug Administration. NDA 213051/S-030 supplement approval letter for Ozempic (semaglutide) tablets and Rybelsus (semaglutide) tablets. Accessed 2026-10-19. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/213051Orig1s030ltr.pdf

This sheet records information for a conversation with your prescriber or pharmacist. It does not replace their instructions or the medication's prescribing information.