Ozempic Side Effects and Safety: What the FDA Record Shows

Ozempic 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 Ozempic: 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 Ozempic Is Prescribed For, and Where Ozempic Side Effects Come From

According to the FDA label, is indicated: as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease. […]

Two separate official sources describe ozempic 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: Warnings and Precautions, Severe Gastrointestinal Adverse Reactions ( 5.7 ) ………………10/2025 A recent revision usually means new safety information was added.

The FDA Boxed Warning on Ozempic

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 Ozempic Side Effects

The label’s warnings and precautions section describes risks the FDA requires prescribers to weigh. For Ozempic it covers: Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including OZEMPIC. Discontinue if pancreatitis is suspected. ( 5.2 ) Diabetic Retinopathy Complications: Has been reported in a clinical trial.

Patients with a history of diabetic retinopathy should be monitored. ( 5.3 ) Never share an OZEMPIC pen between patients , even if the needle is changed. ( 5.4 ) Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia.

Reducing dose of insulin secretagogue or insulin may be necessary. ( 5.5 ) Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. ( 5.6 ) Severe Gastrointestinal Adverse Reactions : Use has been associated with gastrointestinal adverse reactions, sometimes severe. OZEMPIC is not recommended in patients with severe gastroparesis. ( 5.7 ) Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. […]

These are the risks the FDA has judged significant enough to state formally, and they sit apart from the routine ozempic 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.

Ozempic 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 )] Acute Pancreatitis [see Warnings and Precautions ( 5.2) ] Diabetic Retinopathy Complications [see Warnings and Precautions ( 5.3 )] Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin [see Warnings and Precautions ( 5.5 )] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.6 )] Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.7 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.8 )] Acute Gallbladder Disease [see Warnings and Precautions ( 5.9 )] Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.10 )] The most common adverse reactions reported in ≥5% of patients treated with OZEMPIC are: […]

Trial data is the most reliable source for how common ozempic 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 Ozempic Side Effects in the FDA Database

Who the Label Says Should Take Extra Care

Contraindications. The label states that Ozempic 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 )] . A serious hypersensitivity reaction to semaglutide or to any of the excipients in OZEMPIC. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with OZEMPIC [see Warnings and Precautions ( 5.8 )] . Personal or family history of MTC or in patients with MEN 2. […]

Interactions with other medicines. ral Medications : OZEMPIC delays gastric emptying. May impact absorption of concomitantly administered oral medications. Use with caution. ( 7.2 ) 7.1 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin OZEMPIC stimulates insulin release in the presence of elevated blood glucose concentrations. […]

Older adults. 8.5 Geriatric Use In the pool of placebo- and active-controlled glycemic control trials, 744 (23.6%) OZEMPIC-treated patients were 65 years of age and over and 102 OZEMPIC-treated patients (3.2%) patients were 75 years of age and over. In SUSTAIN 6, the cardiovascular outcome trial, 788 (48%) OZEMPIC-treated patients were 65 years of age and over and 157 OZEMPIC-treated patients (9.6%) patients were 75 years of age and over. […]

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.

Ozempic Recall History

The FDA enforcement database records 1 recall entries involving Ozempic products (1 Class II). A recall almost always concerns specific manufactured batches rather than the medicine itself, and different manufacturers of the same generic drug have separate recall records.

The FDA classifies recalls by how serious the potential consequence is. Class I means a reasonable probability of serious harm or death; Class II means temporary or reversible harm is possible; Class III means the product breaks a regulation but is unlikely to cause harm.

If a batch you have was recalled, the pharmacy that dispensed it is the fastest way to find out and to get a replacement. Do not simply stop taking a prescribed medicine because a recall notice exists — the recall may not affect your batch, and stopping can carry its own risk.

Is There Litigation Involving Ozempic?

Lawsuits involving Ozempic have been filed in the United States. A lawsuit is an allegation: it means claimants assert that a manufacturer failed to warn adequately or that a product was defective. It is not a finding that the medicine caused any particular person’s illness, and courts have not necessarily reached any conclusion.

Whether any individual claim has merit depends on medical records, timing and the law in that person’s state. Our case pages track the current status of the litigation itself.

Read the current case status and filing information →

Litigation Timeline

If You Are Worried About Ozempic Side Effects

Concern about ozempic 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 ozempic 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 ozempic side effects?

In FDA reports, the most frequently mentioned are nausea, vomiting, diarrhoea. 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 Ozempic been recalled?

There are 1 recall records for Ozempic products, the most recent dated 2021-06-02. Recalls generally affect specific manufactured batches rather than the medicine as a whole. Your pharmacy can tell you whether a batch you have was affected.

Does Ozempic 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 ozempic 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 ozempic 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 Ozempic 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 Ozempic 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.