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Does Mounjaro have a black box warning?

Dr. Mick Singh Health-X

Reviewed by Mick Singh, MD

Does Mounjaro have a black box warning?

If you are wondering: Does Mounjaro have a black box warning? Yes it does. GLP-1s (including Mounjaro) are contraindicated in individuals with a history of medullary thyroid carcinoma, a family history of such, or in patients with multiple endocrine neoplasia syndrome type 2. Do not take them if you have ever had thyroid cancer. In studies with rodents, GLP-1s caused thyroid tumors, including thyroid cancer; it is not known if they will cause thyroid tumors or cancer in humans. Please notify your doctor ASAP if you develop trouble swallowing, hoarseness, a lump or swelling in your neck, or shortness of breath. 

What are the side effects of Mounjaro?

Mounjaro has the potential to lead to certain side effects, which include:

  • Nausea
  • Vomiting
  • Diarrhea
  • Bloating
  • Gas
  • Other gastrointestinal (GI) related problems

It’s important to note that many of these side effects are temporary and tend to subside within the initial few weeks of use. However, if these effects are notably severe or persist beyond this period, it is recommended to promptly inform your doctor.

Warnings about using Mounjaro

Avoid alcohol while taking this medication. If you’re taking diabetes medications, please discuss this with your prescribing doctor before starting Mounjaro, as your diabetes medications may need to be adjusted as you lose weight.

Females of reproductive potential should use adequate contraception while taking this medication. It is advised to use a non-oral contraceptive method (instead of oral contraceptive) or, if using oral contraception- add a barrier method of contraception 4 weeks after initiation and 4 weeks after dose escalation. 

Do not take this medication if pregnant, trying to get pregnant or breastfeeding. If you plan to become pregnant, this medication needs to be stopped at least 2 months before trying. This medication may cause fetal harm.

Notify your doctor if you have kidney, liver, or pancreas problems.

Stop using Mounjaro and call your healthcare provider immediately if you have severe stomach or abdomen pain that will not go away, with or without vomiting.

Stop using Mounjaro and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.

Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue Mounjaro if suspected and promptly seek medical advice.

Mounjaro drug interactions

Generally, there are no safety issues when taking Mounjaro along with the majority of other drugs. It’s crucial to remember that Mounjaro can have an impact on the digestive system, which could perhaps change how your body consumes oral drugs. Your doctor might need to change the dosages of the other medications you’re taking as a result. Based on their observations of how your body takes these medications, they would make these modifications.

Extra care and monitoring are required if you take insulin or any other medications that affect your insulin levels. Combining Mounjaro with such drugs may increase your risk of experiencing low blood sugar. Due to the combined effect of Mounjaro and other drugs that affect blood sugar levels, this danger may become more obvious.

In short: Does Mounjaro have a black box warning?

Does Mounjaro have a black box warning? Yes it does. GLP-1s, which include Mounjaro, should not be used by individuals with a history of medullary thyroid carcinoma, a family history of this condition, or patients with multiple endocrine neoplasia syndrome type 2. If you have a history of thyroid cancer, it is advised not to take them.

At Health-X, our team of board-certified physicians offer access to cutting-edge prescription weight loss medication (GLP-1) including Mounjaro. Schedule a virtual consultation to learn more:

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Mounjaro FDA Label Referenced from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215866s000lbl.pdf

FDA approves Lilly's Mounjaro™ (tirzepatide) injection, the first and only GIP and GLP-1 receptor agonist for the treatment of adults with type 2 diabetes https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-mounjarotm-tirzepatide-injection-first-and

Disclaimer: If you have any medical questions or concerns, please talk to your healthcare provider. The content within the Health-X Knowledge Base is supported by peer-reviewed research and data sourced from reputable medical societies and governmental entities. It is essential to note, however, that these resources do not replace the need for personalized medical guidance, diagnosis, or treatment from a qualified medical professional.

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Prior to his current position at Health-X, Dr. Singh gained invaluable experience as an Attending Physician at Mercy Healthcare for ten years. After that, he embarked on a 7-year journey as Owner and Medical Director of Elysium SurgiSpa, where he gained a deeper understanding of patient care and satisfaction. Additionally, Dr. Singh served with distinction in the United States Air Force, attaining the rank of captain. This experience has imparted in him a sense of discipline, commitment, and dedication to excellence. Dr. Singh’s exceptional pedigree and extensive skill set place him at the vanguard of health delivery models, ensuring that Health-X remains an industry leader. Health-X continues to revolutionize healthcare under his direction, positively impacting innumerable lives with each step forward.


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