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 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 ZEPBOUND causes thyroid C-cell tumors, including MTC, in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined.

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ZEPBOUND 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 ZEPBOUND 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 ZEPBOUND. 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: Acute Gallbladder Disease Treatment with ZEPBOUND and

GLP-1 receptor agonists is associated with an increased occurrence of acute gallbladder disease. In a pool of two ZEPBOUND clinical trials for weight reduction (Studies 1 and 2), cholelithiasis was reported in 1.1% of ZEPBOUND-treated patients and 1% of placebo-treated patients, cholecystitis was reported in 0.7% of ZEPBOUND-treated patients and 0.2% of placebo-treated patients, and cholecystectomy was reported in 0.2% of ZEPBOUND-treated patients and no placebo-treated patients. Acute gallbladder events were associated with weight reduction. Similar rates of cholelithiasis were reported in ZEPBOUND clinical trials for weight reduction and in ZEPBOUND trials for OSA. If cholecystitis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated.

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), severe gastrointestinal adverse reactions use of (Section 5.2), acute kidney injury due to volume depletion (Section 5.3), acute gallbladder disease treatment with zepbound and (Section 5.4), acute pancreatitis (Section 5.5), hypersensitivity reactions (Section 5.6), hypoglycemia (Section 5.7), diabetic retinopathy complications in patients with type 2 diabetes mellitus (Section 5.8), pulmonary aspiration during general anesthesia or deep sedation (Section 5.9), never share a zepbound 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

ZEPBOUND ® is indicated in combination with a reduced-calorie diet and increased physical activity: to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. ZEPBOUND is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated in combination with a reduced-calorie diet and increased physical activity: to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.

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( 1 ) to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. ( 1 ) Limitations of Use: Coadministration with other tirzepatide-containing products or with any GLP-1 receptor agonist is not recommended. ( 1 ) Limitations of Use ZEPBOUND contains tirzepatide. Coadministration with other tirzepatide-containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.

Frequently Asked Questions

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.