Tirzepatide Side Effects and Safety: What the FDA Record Shows

Tirzepatide Side Effects are documented on the FDA prescribing label, and reported separately by patients and doctors to the FDA’s adverse event system. This page sets out what the official record actually says about Tirzepatide: what it is approved to treat, what the label warns about, its recall history, and what the reported side effects are — along with what those figures do and do not mean.

What Tirzepatide Is Prescribed For, and Where Tirzepatide Side Effects Come From

According to the FDA label, ® 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. […]

Two separate official sources describe tirzepatide side effects. The prescribing label records what was observed in clinical trials, where the drug was compared against a control group. The FDA’s adverse event database records what patients and clinicians have reported since approval, which is a much larger but far less controlled picture. Both appear below, and they answer different questions.

The FDA has revised this label recently. The label’s own record of recent major changes reads: Dosage and Administration ( 2.4 ) 01/2026 Warnings and Precautions Severe Gastrointestinal Adverse Reactions ( 5.2 ) 02/2026 Suicidal Behavior and Ideation (Removed) 02/2026 Never Share a ZEPBOUND KwikPen Between Patients ( 5.10 ) 01/2026 A recent revision usually means new safety information was added.

The FDA Boxed Warning on Tirzepatide

A boxed warning is the most serious warning the FDA requires on a prescription label. It does not mean the medicine should not be used. It means there is a specific risk serious enough that the FDA requires it to appear at the very top of the prescribing information, so that prescribers weigh it deliberately for each patient.

Prescribers see this warning every time they consult the label. If it concerns you, it is a reasonable thing to raise at your next appointment and ask how it applies to your own situation.

Warnings Beyond the Common Tirzepatide Side Effects

The label’s warnings and precautions section describes risks the FDA requires prescribers to weigh. For Tirzepatide it covers: evere Gastrointestinal Adverse Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. ZEPBOUND is not recommended in patients with severe gastroparesis. ( 5.2 ) Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. ( 5.3 ) Acute Gallbladder Disease: Has been reported in clinical trials. If cholecystitis is suspected, gallbladder studies and clinical follow-up are indicated.

( 5.4 ) Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, or ZEPBOUND. Discontinue if pancreatitis is suspected. ( 5.5 ) Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported postmarketing with tirzepatide. If suspected, advise patients to promptly seek medical attention and discontinue ZEPBOUND. ( 5.6 ) Hypoglycemia: Concomitant use with insulin or an insulin secretagogue may increase the risk of hypoglycemia, including severe hypoglycemia. […]

These are the risks the FDA has judged significant enough to state formally, and they sit apart from the routine tirzepatide side effects most people ask about. They apply to different patients to very different degrees, which is why the same medicine can be routine for one person and unsuitable for another.

Tirzepatide Side Effects Listed on the FDA Label

The label’s adverse reactions section records what was observed in clinical trials: he following serious adverse reactions are described below or elsewhere in the prescribing information: Risk of Thyroid C-cell Tumors [see Warnings and Precautions ( 5.1 )] Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.2 )] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.3 )] Acute Gallbladder Disease [see Warnings and Precautions ( 5.4 )] Acute Pancreatitis [see Warnings and Precautions ( 5.5 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.6 )] Hypoglycemia [see Warnings and Precautions ( 5.7 )] Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus [see Warnings and Precautions ( 5.8 )] Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.9 )] The most common adverse reactions, reported in ≥5% of patients treated with ZEPBOUND are: nausea, diarr […]

Trial data is the most reliable source for how common tirzepatide side effects are, because the people taking the drug were compared against people who were not. A symptom that appeared just as often in the control group is not caused by the medicine.

Reported Tirzepatide Side Effects in the FDA Database

Who the Label Says Should Take Extra Care

Contraindications. The label states that Tirzepatide should not be used in certain situations: is contraindicated in patients with: A personal or family history of MTC or in patients with MEN 2 [see Warnings and Precautions ( 5.1 )] . Known serious hypersensitivity to tirzepatide or any of the excipients in ZEPBOUND. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with tirzepatide [see Warnings and Precautions ( 5.6 ) and Adverse Reactions ( 6.2 )] . […]

Interactions with other medicines. delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. ( 7.2 ) 7.1 Concomitant Use with Insulin or an Insulin Secretagogue (e.g., Sulfonylurea) ZEPBOUND lowers blood glucose. When initiating ZEPBOUND, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (e.g., sulfonylureas) to reduce the risk of hypoglycemia [see Warnings and Precautions ( 5.7 )] . […]

Older adults. 8.5 Geriatric Use In a pool of two fixed dose ZEPBOUND clinical studies for weight reduction (Study 1 and Study 2), 226 (9%) ZEPBOUND-treated patients were 65 years of age or older, and 13 (0.5%) ZEPBOUND-treated patients were 75 years of age or older at baseline. No overall differences in safety or effectiveness of ZEPBOUND have been observed between patients 65 years of age and older and younger adult patients. […]

Your pharmacist can check your full medicine list against this in a couple of minutes, including anything bought over the counter, and that check is free.

Tirzepatide Recall History

The FDA’s enforcement database shows no recall records for Tirzepatide products in the period covered by the current data. That is a statement about recalls of the product, not about the medicine’s safety profile, which is a separate question addressed by the label and the warnings on it.

Recalls are usually about a manufacturing or packaging problem affecting particular batches, not about the medicine itself. You can check for current recalls any time on the FDA recalls page.

Is Tirzepatide the Subject of Litigation?

As of the date on this page, we are not tracking consolidated federal litigation over Tirzepatide. Safety questions have been raised about this medicine, and questions being raised is not the same thing as a case being filed or proven.

We monitor federal court filings and FDA safety communications, and this page is updated when the record changes. Our active case pages list the drug and device litigation currently underway.

Litigation Timeline

If You Are Worried About Tirzepatide Side Effects

Concern about tirzepatide side effects is a good reason to have a conversation, and not a reason to act alone. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first. Stopping some medicines abruptly carries risks of its own, and your prescriber can tell you whether that applies to yours.

Write down what you have noticed and when it started before the appointment. Not everything that happens while taking a medicine is one of its tirzepatide side effects, and a specific account — what changed, when, and how often — is what lets a clinician tell the difference.

You can also report a side effect directly to the FDA through MedWatch. Reports from patients are part of how safety signals are detected, and filing one takes a few minutes.

Frequently Asked Questions

What are the most commonly reported tirzepatide side effects?

In FDA reports, the most frequently mentioned are nausea, injection site pain, extra dose administered. The label’s own adverse reactions section, drawn from clinical trials, is the better guide to how common a side effect actually is, because reports to the FDA are not collected in a way that supports rates.

Has Tirzepatide been recalled?

The FDA enforcement database shows no recall records for Tirzepatide products in the current data. Check the FDA recalls page for anything more recent.

Does Tirzepatide have a boxed warning?

Yes. The boxed warning is reproduced above. It is the most serious warning the FDA requires, and it exists so that prescribers weigh a specific risk for each patient rather than overlooking it.

Do the FDA report numbers tell me how common these tirzepatide side effects are?

No. Reports are unverified, anyone can file one, and the total mostly reflects how many people take the medicine and how much attention it is getting. A high count is not evidence of danger, and a low one is not evidence of safety. Clinical trial data on the label is the source that supports rates.

Where can I check tirzepatide side effects for the exact product I have?

DailyMed holds the current FDA label for every marketed product, searchable by the name on your packaging. Different manufacturers and formulations of the same medicine can have slightly different labels, so checking the one you actually have is worth the two minutes.

Official Sources

• DailyMed (National Library of Medicine) — the current FDA prescribing label for every product
• FDA Adverse Event Reporting System dashboard — the public report data summarised above
• FDA recalls and safety alerts — current recall notices
• FDA MedWatch — how to report a side effect yourself

Related Guides

• All Drug Safety Profiles
• Drug Safety Explainers
• Product Recalls
• Active Case Pages

Medical and legal disclaimer. This page summarises publicly available FDA data about Tirzepatide and is general information, not medical advice, and not legal advice. It is not a substitute for the judgement of a clinician who knows your medical history. Nothing here states that Tirzepatide caused any illness or injury in any individual. Adverse event reports are unverified and do not establish causation.

FDA labels are revised regularly; confirm current information on DailyMed or with your pharmacist. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first.