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HealthRX.com · Printable medication review sheet

Mounjaro label version check

Use this to confirm which version of the Mounjaro prescribing information or Medication Guide you are reading, see what FDA has changed since, and list the questions those changes raise for your pharmacist or prescriber.

Companion to “Mounjaro Label Updates 2020 to 2026: A Complete FDA Regulatory Timeline” · healthrx.com/regulatory-mounjaro/label-updates · Facts checked 2026-10-18

The label in your hands

The revision date is printed at the end of the Highlights box and at the end of the Medication Guide.

Where it came frompharmacy leaflet, DailyMed, Drugs@FDA, prescriber
Revision date printed on it
Uses listed under Indications
Highest weekly dose listed for your age group
Presentation you usesingle-dose pen, single-dose vial, multiple-dose vial, KwikPen

Changes FDA approved, with action dates

  • November 1, 2024: a warning on severe gastrointestinal adverse reactions was added.[1]
  • November 1, 2024: a warning on pulmonary aspiration during general anesthesia or deep sedation was added.[2]
  • May 28, 2025: alopecia (hair loss) was added to postmarketing reports in section 6.2.[3]
  • September 25, 2025: the lactation section (8.2) was revised.[4]
  • December 19, 2025: use was extended to children 10 years and older with type 2 diabetes.[5]
  • August 27, 2026: the 2.5 mg dose may be used for ongoing glycemic control.[6]
  • Current label: a use to reduce the risk of major cardiovascular events in adults with type 2 diabetes at high risk.[7]
  • Current label: the maximum dose is 15 mg weekly in adults and 10 mg weekly in children.[7]

If your copy predates August 2026, re-read

  • Section 1, Indications: the cardiovascular use and the age range
  • Section 2.1, Dosage: what the label now says about the 2.5 mg dose
  • Section 5, Warnings: severe stomach and bowel reactions, and anesthesia or sedation
  • Section 8.2, Lactation, if you are breastfeeding
  • The Instructions for Use for your own pen or vial type

Questions the changes raise

  1. Does the cardiovascular use on the current label apply to me?
  2. My dose has stayed at 2.5 mg. Is that now intended as my ongoing dose?
  3. I have a procedure with anesthesia or sedation coming up. Who on my care team should know I take Mounjaro?
  4. I am breastfeeding. What does the revised lactation section mean for me?
  5. My pharmacy switched me to a different pen or vial. How do I measure each dose?
Sources for the facts on this sheet
  1. U.S. Food and Drug Administration. NDA 215866/S-010, S-015 and S-022 supplement approval letter for Mounjaro (tirzepatide) injection. Accessed 2026-10-18. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215866Orig1s010, s015, s022ltr.pdf
  2. U.S. Food and Drug Administration. Mounjaro (tirzepatide) prescribing information approved with supplements S-010, S-015 and S-022. Accessed 2026-10-18. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215866s010s015s022lbl.pdf
  3. U.S. Food and Drug Administration. NDA 215866/S-031 supplement approval letter for Mounjaro (tirzepatide) injection. Accessed 2026-10-18. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215866Orig1s031ltr.pdf
  4. U.S. Food and Drug Administration. NDA 215866/S-034 supplement approval letter for Mounjaro (tirzepatide) injection. Accessed 2026-10-18. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215866Orig1s034ltr.pdf
  5. U.S. Food and Drug Administration. NDA 215866/S-039 supplement approval and fulfillment of postmarketing requirement letter for Mounjaro (tirzepatide) injection. Accessed 2026-10-18. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215866Orig1s039ltr.pdf
  6. U.S. Food and Drug Administration. NDA 215866/S-044 and S-045 supplement approval letter for Mounjaro (tirzepatide) injection. Accessed 2026-10-18. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215866Orig1s044,215866Orig1s045ltr.pdf
  7. Eli Lilly and Company, via DailyMed. Mounjaro (tirzepatide) injection, for subcutaneous use: prescribing information and Medication Guide. Effective 2026-08-27. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0

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