Ozempic Side Effects: What the FDA Label Lists
[Side effects · Ozempic]

Ozempic side effects

semaglutide · once-weekly injection · Label checked

Short answer: In the label's placebo-controlled trials, the most common side effect of Ozempic was nausea: 15.8% on 0.5 mg and 20.3% on 1 mg, against 6.1% on placebo. Vomiting, diarrhea, stomach pain and constipation followed. Most nausea, vomiting and diarrhea happened while the dose was being raised. The label carries a boxed warning about thyroid C-cell tumors seen in rodents.

What Ozempic is approved for: The label says Ozempic is approved, along with diet and exercise, to improve blood sugar control in adults with type 2 diabetes. It is also approved to lower the risk of major heart events in adults with type 2 diabetes and known heart disease, and to lower the risk of kidney decline, kidney failure and death from heart causes in adults with type 2 diabetes and chronic kidney disease.

Source
OZEMPIC (semaglutide) injection, for subcutaneous use, prescribing information and Medication Guide. Novo Nordisk. DailyMed, version published June 10, 2026. DailyMed setid adec4fd2-6858-4c99-91d4-531f5f2a2d79

Does Ozempic have a boxed warning?

Boxed warning

WARNING: RISK OF THYROID C-CELL TUMORS

In rodents, semaglutide caused thyroid C-cell tumors, and it is not known whether Ozempic causes these tumors, including medullary thyroid carcinoma (MTC), in people. Ozempic must not be used by people with a personal or family history of MTC or with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). The label lists a lump in the neck, trouble swallowing, shortness of breath and lasting hoarseness as possible thyroid tumor symptoms.

What are the most common Ozempic side effects?

These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Ozempic.

Table 1. Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of OZEMPIC-Treated Patients with Type 2 Diabetes Mellitus [Section 6.1]
Adverse reactionPlacebo (N=262) %Ozempic 0.5 mg (N=260) %Ozempic 1 mg (N=261) %
Nausea6.115.820.3
Vomiting2.359.2
Diarrhea1.98.58.8
Abdominal pain4.67.35.7
Constipation1.553.1

Pooled from 2 placebo-controlled trials in adults with type 2 diabetes (one with Ozempic alone, one added to basal insulin): 521 patients took Ozempic for a mean of 32.9 weeks. Low blood sugar is not included in this table.

Table 2. Hypoglycemia Adverse Reactions in Placebo-Controlled Trials in Patients with Type 2 Diabetes Mellitus [Section 6.1]
Trial and definitionPlaceboOzempic 0.5 mgOzempic 1 mg
Monotherapy: Severe†0%0%0%
Monotherapy: Documented symptomatic (≤70 mg/dL glucose threshold)0%1.6%3.8%
Monotherapy: Severe† or Blood Glucose Confirmed Symptomatic (≤56 mg/dL glucose threshold)1.6%0%0%
Add-on to Basal Insulin: Severe†0%0%1.5%
Add-on to Basal Insulin: Documented symptomatic (≤70 mg/dL glucose threshold)15.2%16.7%29.8%
Add-on to Basal Insulin: Severe† or Blood Glucose Confirmed Symptomatic (≤56 mg/dL glucose threshold)5.3%8.3%10.7%

Two 30-week trials: Ozempic used alone (N=129 placebo, 127 on 0.5 mg, 130 on 1 mg) and Ozempic added to basal insulin with or without metformin (N=132, 132, 131). "Severe" means an episode that needed another person's help.

Other numbers in the Adverse Reactions section

  • Section 6.1

    Stomach and gut side effects overall: 15.3% on placebo, 32.7% on 0.5 mg and 36.4% on 1 mg. In a separate trial, they were reported in 34% on 2 mg and 30.8% on 1 mg.

  • Section 6.1

    Stopping treatment because of stomach and gut side effects: 3.1% on 0.5 mg and 3.8% on 1 mg, against 0.4% on placebo.

  • Section 6.1

    Injection site reactions (such as discomfort or redness) were reported in 0.2% of people on Ozempic in placebo-controlled trials.

  • Section 6.1

    With a sulfonylurea, severe low blood sugar occurred in 0.8% on 0.5 mg and 1.2% on 1 mg, and documented symptomatic low blood sugar in 17.3% and 24.4%.

  • Section 6.1

    Heart rate rose by a mean of 2 to 3 beats per minute on 0.5 mg and 1 mg. Amylase rose by a mean of 13% and lipase by 22% from baseline.

What serious risks does the Ozempic label warn about?

The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.

  • Section 5.1

    Risk of thyroid C-cell tumors. Semaglutide caused thyroid C-cell tumors in mice and rats; whether this happens in people is unknown. People with a personal or family history of MTC or with MEN 2 must not use Ozempic.

  • Section 5.2

    Acute pancreatitis. Inflammation of the pancreas, including fatal cases, has been seen with GLP-1 drugs including Ozempic. The label says to stop Ozempic if pancreatitis is suspected.

  • Section 5.3

    Diabetic retinopathy complications. In a 2-year trial, eye complications from diabetes occurred in 3.0% on Ozempic and 1.8% on placebo. The rise was larger in people who already had diabetic retinopathy (8.2% vs 5.2%).

  • Section 5.4

    Never share a pen. Ozempic pens must never be shared between people, even if the needle is changed, because of the risk of passing on blood-borne infections.

  • Section 5.5

    Low blood sugar with insulin or sulfonylureas. Using Ozempic with insulin or a sulfonylurea may raise the risk of low blood sugar, including severe episodes. The label says a lower dose of those medicines may reduce this risk.

  • Section 5.6

    Kidney injury from fluid loss. Acute kidney injury, sometimes needing dialysis, has been reported, mostly in people who became dehydrated from nausea, vomiting or diarrhea. The label says to monitor kidney function in these people, especially when starting or raising the dose.

  • Section 5.7

    Severe stomach and gut side effects. Severe stomach and gut side effects were reported in 0.4% on 0.5 mg and 0.8% on 1 mg, against 0% on placebo. Ozempic is not recommended in people with severe gastroparesis.

  • Section 5.8

    Allergic reactions. Serious allergic reactions such as anaphylaxis and angioedema have been reported. The label says to stop Ozempic if they occur.

  • Section 5.9

    Gallbladder disease. Gallstones were reported in 1.5% on 0.5 mg and 0.4% on 1 mg in placebo-controlled trials, and in no one on placebo.

  • Section 5.10

    Food or liquid in the lungs during anesthesia. Ozempic slows stomach emptying. Rare reports describe food entering the lungs during procedures with general anesthesia or deep sedation. The label says to tell your providers you take Ozempic before any planned procedure.

When does the label say to call your doctor?

From the Medication Guide that comes with Ozempic:

  • A lump or swelling in the neck, hoarseness, trouble swallowing or shortness of breath: tell your healthcare provider (possible thyroid tumor symptoms).
  • Severe stomach pain that will not go away, with or without vomiting, sometimes felt through to the back: stop using Ozempic and call your healthcare provider right away.
  • Changes in vision during treatment: tell your healthcare provider.
  • Signs of low blood sugar such as dizziness, sweating, confusion, shakiness, fast heartbeat or hunger, especially with a sulfonylurea or insulin: the guide lists these as warning signs.
  • Nausea, vomiting or diarrhea that does not go away: tell your healthcare provider right away, because fluid loss can cause kidney problems.
  • Stomach problems that are severe or will not go away: tell your healthcare provider.
  • Swelling of the face, lips, tongue or throat, trouble breathing or swallowing, severe rash or itching, fainting or a very rapid heartbeat: stop using Ozempic and get medical help right away.
  • Pain in the upper stomach, fever, yellowing of the skin or eyes, or clay-colored stools: tell your healthcare provider right away (possible gallbladder problems).
  • A planned surgery or procedure with anesthesia or deep sedation: tell all your healthcare providers you take Ozempic beforehand.

How do I keep track of side effects in Dose Track?

Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.

This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.

Side effects for similar medicines

Frequently asked questions

What is the most common side effect of Ozempic?+
Nausea. In the label's placebo-controlled trials it was reported by 15.8% of people on 0.5 mg and 20.3% on 1 mg, compared with 6.1% on placebo. The label says most reports of nausea, vomiting and diarrhea happened while the dose was being increased.
How many people stopped Ozempic because of side effects?+
The label reports that 3.1% of people on 0.5 mg and 3.8% on 1 mg stopped treatment because of stomach and gut side effects, compared with 0.4% on placebo. It does not give a single figure for all side effects combined in that section.
Does Ozempic cause low blood sugar?+
Used alone, severe low blood sugar was 0% in all groups. Added to basal insulin, severe low blood sugar was 1.5% on 1 mg. The label says the risk is higher with insulin or a sulfonylurea; with a sulfonylurea, severe episodes occurred in 0.8% on 0.5 mg and 1.2% on 1 mg.
Are injection site reactions common with Ozempic?+
No. The label reports injection site reactions, such as discomfort or redness, in 0.2% of people on Ozempic in placebo-controlled trials. The label says to use a different injection site each week when injecting in the same body area.
What side effects were reported after Ozempic went on the market?+
The label lists postmarketing reports including pancreatitis (sometimes fatal), bowel blockage, severe constipation, anaphylaxis, angioedema, rash, hives, gallbladder inflammation, headache, abnormal skin sensations, acute kidney injury, hair loss, and food entering the lungs during anesthesia. Their frequency cannot be reliably estimated.