Tirzepatide Side Effects: Common, Serious & FDA Warnings

Common Side Effects of Tirzepatide

The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for tirzepatide. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.

Serious Outcomes and FDA Warnings

FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.

From the FDA-approved label, Section 5.1: Risk of Thyroid C-Cell

Tumors In both sexes of rats, tirzepatide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) in a 2-year study at clinically relevant plasma exposures [see Nonclinical Toxicology ( 13.1 )] . It is unknown whether MOUNJARO causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined.

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MOUNJARO is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of MOUNJARO and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with MOUNJARO. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.

From the FDA-approved label, Section 5.4: Hypersensitivity Reactions

Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported in patients treated with MOUNJARO. If hypersensitivity reactions occur, discontinue use of MOUNJARO; treat promptly per standard of care, and monitor until signs and symptoms resolve. Do not use in patients with a previous serious hypersensitivity reaction to tirzepatide or any of the excipients in MOUNJARO [see Contraindications ( 4 ), Adverse Reactions ( 6.2 )] . Anaphylaxis and angioedema have been reported with GLP-1 receptor agonists. Use caution in patients with a history of angioedema or anaphylaxis with a GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to these reactions with MOUNJARO.

Tirzepatide Recalls

FDA enforcement actions matched to tirzepatide via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →).

No recalls are on record for this drug in the FDA enforcement database.

Tirzepatide Shortages

FDA-listed shortages of tirzepatide products. Strength and dosage-form level detail.

Is Tirzepatide Safe?

Tirzepatide is FDA-approved. The label's Warnings and Precautions section covers risk of thyroid c-cell (Section 5.1), acute pancreatitis (Section 5.2), hypoglycemia with concomitant use of insulin secretagogues or insulin patients receiving (Section 5.3), hypersensitivity reactions (Section 5.4), acute kidney injury due to volume depletion (Section 5.5), severe gastrointestinal adverse reactions use of (Section 5.6), diabetic retinopathy complications in patients with a history of (Section 5.7), acute gallbladder disease (Section 5.8), pulmonary aspiration during general anesthesia or deep sedation (Section 5.9), never share a mounjaro kwikpen between patients never share (Section 5.10).

As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.

FDA-Approved Indications

Tirzepatide is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.

• Obesity & weight

MOUNJARO ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. MOUNJARO ® is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. ( 1 )

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Data Sources & Methodology

How each section of this page is sourced, and how often the data is refreshed.

What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.