Ozempic side effects
In Ozempic's FDA label (revised Jun 1, 2026), the most common side effects at 1 mg were nausea (20.3% vs 6.1% on placebo), vomiting (9.2% vs 2.3%) and diarrhea (8.8% vs 1.9%).
Source: FDA label on DailyMed (Novo Nordisk Pharmaceutical Industries, LP), revised , version 20. Read every day: a new FDA version updates this page by itself.
How often Ozempic side effects happened
Table 1. Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of OZEMPIC-Treated Patients with Type 2 Diabetes Mellitus
| Side effect | Ozempic 1 mg | Placebo |
|---|---|---|
| Nausea | 20.3% | 6.1% |
| Vomiting | 9.2% | 2.3% |
| Diarrhea | 8.8% | 1.9% |
| Abdominal pain | 5.7% | 4.6% |
| Constipation | 3.1% | 1.5% |
People in the trial reporting each side effect, as FDA prints it. The placebo column is the rate among people given no medication, which is why a side effect can be common on both.
Boxed warning
- In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether OZEMPIC causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions (5.1), Nonclinical Toxicology (13.1)].
- OZEMPIC is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications (4)]. Counsel patients regarding the potential risk for MTC with the use of OZEMPIC 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 OZEMPIC [see Contraindications (4), Warnings and Precautions (5.1)].
Source: Ozempic prescribing information (FDA label on DailyMed), revised 2026-06-01
What the label warns about
Section 5 of the label, word for word.
Risk of Thyroid C-Cell Tumors
In mice and rats, semaglutide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure at clinically relevant plasma exposures [see Nonclinical Toxicology (13.1)] . It is unknown whether OZEMPIC causes thyroid C-cell tumors, including MTC, in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.
Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans.
OZEMPIC 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 OZEMPIC 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 OZEMPIC. 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 value 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.
Source: Ozempic prescribing information (FDA label on DailyMed), revised 2026-06-01
Acute Pancreatitis
Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including OZEMPIC [see Adverse Reactions (6)].
After initiation of OZEMPIC, observe patients carefully for signs and symptoms of acute pancreatitis, which may include persistent or severe abdominal pain (sometimes radiating to the back), and which may or may not be accompanied by nausea or vomiting. If pancreatitis is suspected, discontinue OZEMPIC and initiate appropriate management.
Source: Ozempic prescribing information (FDA label on DailyMed), revised 2026-06-01
Diabetic Retinopathy Complications
In a 2-year trial involving patients with type 2 diabetes and high cardiovascular risk, more events of diabetic retinopathy complications occurred in patients treated with OZEMPIC (3.0%) compared to placebo (1.8%). The absolute risk increase for diabetic retinopathy complications was larger among patients with a history of diabetic retinopathy at baseline (OZEMPIC 8.2%, placebo 5.2%) than among patients without a known history of diabetic retinopathy (OZEMPIC 0.7%, placebo 0.4%).
Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. The effect of long-term glycemic control with semaglutide on diabetic retinopathy complications has not been studied. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.
Source: Ozempic prescribing information (FDA label on DailyMed), revised 2026-06-01
Never Share an OZEMPIC Pen Between Patients
OZEMPIC pens must never be shared between patients, even if the needle is changed. Pen-sharing poses a risk for transmission of blood-borne pathogens.
Source: Ozempic prescribing information (FDA label on DailyMed), revised 2026-06-01
Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin
Patients receiving OZEMPIC in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia [see Adverse Reactions (6.1), Drug Interactions (7)].
The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
Source: Ozempic prescribing information (FDA label on DailyMed), revised 2026-06-01
Acute Kidney Injury Due to Volume Depletion
There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with semaglutide. The majority of the reported events occurred in patients who experienced gastrointestinal reactions leading to dehydration such as nausea, vomiting, or diarrhea [see Adverse Reactions (6.1)]. Monitor renal function in patients reporting adverse reactions to OZEMPIC that could lead to volume depletion, especially during dosage initiation and escalation of OZEMPIC.
Source: Ozempic prescribing information (FDA label on DailyMed), revised 2026-06-01
Severe Gastrointestinal Adverse Reactions
Use of OZEMPIC has been associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions ( 6 )] . In OZEMPIC clinical trials, severe gastrointestinal adverse reactions were reported more frequently among patients receiving OZEMPIC (0.5 mg 0.4%, 1 mg 0.8%) than placebo (0%). Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists.
OZEMPIC is not recommended in patients with severe gastroparesis.
Source: Ozempic prescribing information (FDA label on DailyMed), revised 2026-06-01
Hypersensitivity Reactions
Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported in patients treated with OZEMPIC. If hypersensitivity reactions occur, discontinue use of OZEMPIC; treat promptly per standard of care, and monitor until signs and symptoms resolve. Do not use in patients with a previous hypersensitivity to OZEMPIC [see Contraindications (4), Adverse Reactions (6.2)] .
Anaphylaxis and angioedema have been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to anaphylaxis with OZEMPIC.
Source: Ozempic prescribing information (FDA label on DailyMed), revised 2026-06-01
Acute Gallbladder Disease
Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In placebo-controlled trials, cholelithiasis was reported in 1.5% and 0.4% of patients-treated with OZEMPIC 0.5 mg and 1 mg, respectively. Cholelithiasis was not reported in placebo-treated patients. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.
Source: Ozempic prescribing information (FDA label on DailyMed), revised 2026-06-01
Pulmonary Aspiration During General Anesthesia or Deep Sedation
OZEMPIC delays gastric emptying [see Clinical Pharmacology (12.2)] . There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations.
Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking OZEMPIC, including whether modifying preoperative fasting recommendations or temporarily discontinuing OZEMPIC could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking OZEMPIC.
Source: Ozempic prescribing information (FDA label on DailyMed), revised 2026-06-01
Who should not take Ozempic
OZEMPIC 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 )] .
Source: Ozempic prescribing information (FDA label on DailyMed), revised 2026-06-01
Ozempic, pregnancy and breastfeeding
Pregnancy
Risk Summary
There are limited data with semaglutide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy (see Clinical Considerations ). Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy. OZEMPIC should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
In pregnant rats administered semaglutide during organogenesis, embryofetal mortality, structural abnormalities and alterations to growth occurred at maternal clinical exposure based on AUC. In rabbits and cynomolgus monkeys administered semaglutide during organogenesis, early pregnancy losses or structural abnormalities were observed at clinical exposure (rabbit) and ≥2-fold the MRHD (monkey). These findings coincided with a marked maternal body weight loss in both animal species (see Data ).
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a peri-conceptional HbA 1c >7 and has been reported to be as high as 20 to 25% in women with a peri-conceptional HbA 1c >10. The estimated background risk of miscarriage for the indicated population is unknown.
Clinical Considerations
Disease-Associated Maternal and/or Embryo/fetal Risk
Hypoglycemia and hyperglycemia occur more frequently during pregnancy in patients with pre-gestational diabetes. Poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, pre- eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.
Data
Animal Data
In a combined fertility and embryofetal development study in rats, subcutaneous doses of 0.01, 0.03 and 0.09 mg/kg/day (0.06-, 0.2-, and 0.6-fold the MRHD) were administered to males for 4 weeks prior to and throughout mating and to females for 2 weeks prior to mating, and throughout organogenesis to Gestation Day 17. In parental animals, pharmacologically mediated reductions in body weight gain and food consumption were observed at all dose levels. In the offspring, reduced growth and fetuses with visceral (heart blood vessels) and skeletal (cranial bones, vertebra, ribs) abnormalities were observed at the human exposure.
In an embryofetal development study in pregnant rabbits, subcutaneous doses of 0.0010, 0.0025 or 0.0075 mg/kg/day (0.02-, 0.2-, and 1.2-fold the MRHD) were administered throughout organogenesis from Gestation Day 6 to 19. Pharmacologically mediated reductions in maternal body weight gain and food consumption were observed at all dose levels. Early pregnancy losses and increased incidences of minor visceral (kidney, liver) and skeletal (sternebra) fetal abnormalities were observed at ≥0.0025 mg/kg/day, at clinically relevant exposures.
In an embryofetal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015, 0.075, and 0.15 mg/kg twice weekly (0.5-, 3-, and 8-fold the MRHD) were administered throughout organogenesis, from Gestation Day 16 to 50. Pharmacologically mediated, marked initial maternal body weight loss and reductions in body weight gain and food consumption coincided with the occurrence of sporadic abnormalities (vertebra, sternebra, ribs) at ≥0.075 mg/kg twice weekly (≥3X human exposure).
In a pre- and postnatal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015, 0.075, and 0.15 mg/kg twice weekly (0.3-, 2-, and 4-fold the MRHD) were administered from Gestation Day 16 to 140. Pharmacologically mediated marked initial maternal body weight loss and reductions in body weight gain and food consumption coincided with an increase in early pregnancy losses and led to delivery of slightly smaller offspring at ≥0.075 mg/kg twice weekly (≥2X human exposure).
Source: Ozempic prescribing information (FDA label on DailyMed), revised 2026-06-01
Breastfeeding
Risk Summary
There are no data on the presence of semaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. Semaglutide was present in the milk of lactating rats, however, due to species-specific differences in lactation physiology, the clinical relevance of these data are not clear (see Data ). The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for OZEMPIC and any potential adverse effects on the breastfed infant from OZEMPIC or from the underlying maternal condition.
Data
In lactating rats, semaglutide was detected in milk at levels 3- to 12-fold lower than in maternal plasma.
Source: Ozempic prescribing information (FDA label on DailyMed), revised 2026-06-01
What Ozempic interacts with
Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin
OZEMPIC stimulates insulin release in the presence of elevated blood glucose concentrations. Patients receiving OZEMPIC in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia.
When initiating OZEMPIC, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia [see Warnings and Precautions (5.5), Adverse Reactions (6)] .
Oral Medications
OZEMPIC causes a delay of gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications. In clinical pharmacology trials, semaglutide did not affect the absorption of orally administered medications to any clinically relevant degree [see Clinical Pharmacology (12.3)] . Nonetheless, caution should be exercised when oral medications are concomitantly administered with OZEMPIC.
Source: Ozempic prescribing information (FDA label on DailyMed), revised 2026-06-01
All side-effect tables and trial data in the label
Everything the label reports under adverse reactions, in its own order.
The 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)]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Pool of Placebo-Controlled Trials
The data in Table 1 are derived from 2 placebo-controlled trials (1 monotherapy trial and 1 trial in combination with basal insulin) in patients with type 2 diabetes [see Clinical Studies (14)] . These data reflect exposure of 521 patients to OZEMPIC and a mean duration of exposure to OZEMPIC of 32.9 weeks. Across the treatment arms, the mean age of patients was 56 years, 3.4% were 75 years or older and 55% were male. In these trials 71% were White, 7% were Black or African American, and 19% were Asian; 21% identified as Hispanic or Latino ethnicity. At baseline, patients had type 2 diabetes for an average of 8.8 years and had a mean HbA 1c of 8.2%. At baseline, 8.9% of the population reported retinopathy. Baseline estimated renal function was normal (eGFR ≥90 mL/min/1.73m 2 ) in 57.2%, mildly impaired (eGFR 60 to 90 mL/min/1.73m 2 ) in 35.9% and moderately impaired (eGFR 30 to 60 mL/min/1.73m 2 ) in 6.9% of patients.
Pool of Placebo- and Active-Controlled Trials
The occurrence of adverse reactions was also evaluated in a larger pool of patients with type 2 diabetes
participating in 7 placebo- and active-controlled glycemic control trials [see Clinical Studies (14)] including two trials in Japanese patients evaluating the use of OZEMPIC as monotherapy and add-on therapy to oral medications or insulin. In this pool, a total of 3150 patients with type 2 diabetes were treated with OZEMPIC for a mean duration of 44.9 weeks. Across the treatment arms, the mean age of patients was 57 years, 3.2% were 75 years or older and 57% were male. In these trials, 60% were White, 6% were Black or African American, and 31% were Asian; 16% identified as Hispanic or Latino ethnicity. At baseline, patients had type 2 diabetes for an average of 8.2 years and had a mean HbA 1c of 8.2%. At baseline, 7.8% of the population reported retinopathy. Baseline estimated renal function was normal (eGFR ≥90 mL/min/1.73m 2 ) in 63.1%, mildly impaired (eGFR 60 to 90 mL/min/1.73m 2 ) in 34.3%, and moderately impaired (eGFR 30 to 60 mL/min/1.73m 2 ) in 2.5% of the patients.
Common Adverse Reactions
Table 1 shows common adverse reactions, excluding hypoglycemia, associated with the use of OZEMPIC in the pool of placebo-controlled trials. These adverse reactions occurred more commonly on OZEMPIC than on placebo and occurred in at least 5% of patients treated with OZEMPIC.
Table 1. Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of OZEMPIC-Treated Patients with Type 2 Diabetes Mellitus
| Adverse Reaction | Placebo (N=262) % | OZEMPIC 0.5 mg (N=260) % | OZEMPIC 1 mg (N=261) % |
|---|---|---|---|
| Nausea | 6.1 | 15.8 | 20.3 |
| Vomiting | 2.3 | 5 | 9.2 |
| Diarrhea | 1.9 | 8.5 | 8.8 |
| Abdominal pain | 4.6 | 7.3 | 5.7 |
| Constipation | 1.5 | 5 | 3.1 |
In the pool of placebo- and active-controlled trials and in the 2-year cardiovascular outcomes trial, the types and frequency of common adverse reactions, excluding hypoglycemia, were similar to those listed in Table 1 .
In a clinical trial with 959 patients treated with OZEMPIC 1 mg or OZEMPIC 2 mg as add-on to metformin with or without sulfonylurea treatment for 40 weeks, no new safety signals were identified.
In the FLOW trial [see Clinical Studies (14.3)] in patients with type 2 diabetes mellitus and chronic kidney disease, safety data collection was limited to serious adverse events and selected predefined categories of adverse events regardless of seriousness. There were no new serious or severe adverse reactions identified in this trial.
Gastrointestinal Adverse Reactions
In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients receiving OZEMPIC than placebo (placebo 15.3%, OZEMPIC 0.5 mg 32.7%, OZEMPIC 1 mg 36.4%). The majority of reports of nausea, vomiting, and/or diarrhea occurred during dose escalation. More patients receiving OZEMPIC 0.5 mg (3.1%) and OZEMPIC 1 mg (3.8%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.4%).
In the trial with OZEMPIC 1 mg and 2 mg, gastrointestinal adverse reactions occurred more frequently among patients receiving OZEMPIC 2 mg (34%) vs OZEMPIC 1 mg (30.8%).
- In addition to the reactions in Table 1 , the following gastrointestinal adverse reactions with a frequency of <5% were associated with OZEMPIC (frequencies listed, respectively, as: placebo; 0.5 mg; 1 mg): dyspepsia (1.9%, 3.5%, 2.7%), eructation (0%, 2.7%, 1.1%), flatulence (0.8%, 0.4%, 1.5%), gastroesophageal reflux disease (0%, 1.9%, 1.5%), and gastritis (0.8%, 0.8%, 0.4%).
Other Adverse Reactions
Hypoglycemia
Table 2 summarizes the incidence of events related to hypoglycemia by various definitions in the placebo-controlled trials.
Table 2. Hypoglycemia Adverse Reactions in Placebo-Controlled Trials in Patients with Type 2 Diabetes Mellitus
| Placebo | OZEMPIC 0.5 mg | OZEMPIC 1 mg | |
| Monotherapy | Monotherapy | Monotherapy | Monotherapy |
| (30 weeks) | N=129 | N=127 | N=130 |
| Severe | 0% | 0% | 0% |
| Documented symptomatic (≤70 mg/dL glucose threshold) | 0% | 1.6% | 3.8% |
| Severe or Blood Glucose Confirmed Symptomatic (≤56 mg/dL glucose threshold) | 1.6% | 0% | 0% |
| Add-on to Basal Insulin with or without Metformin | Add-on to Basal Insulin with or without Metformin | Add-on to Basal Insulin with or without Metformin | Add-on to Basal Insulin with or without Metformin |
| (30 weeks) | N=132 | N=132 | N=131 |
| Severe | 0% | 0% | 1.5% |
| Documented symptomatic (≤70 mg/dL glucose threshold) | 15.2% | 16.7% | 29.8% |
| Severe or Blood Glucose Confirmed Symptomatic (≤56 mg/dL glucose threshold) | 5.3% | 8.3% | 10.7% |
| “Severe” hypoglycemia adverse reactions are episodes requiring the assistance of another person. | “Severe” hypoglycemia adverse reactions are episodes requiring the assistance of another person. | “Severe” hypoglycemia adverse reactions are episodes requiring the assistance of another person. | “Severe” hypoglycemia adverse reactions are episodes requiring the assistance of another person. |
Hypoglycemia was more frequent when OZEMPIC was used in combination with a sulfonylurea [see Warnings and Precautions (5.5), Clinical Studies (14)]. Severe hypoglycemia occurred in 0.8% and 1.2% of patients when OZEMPIC 0.5 mg and 1 mg, respectively, was coadministered with a sulfonylurea.
Documented symptomatic hypoglycemia occurred in 17.3% and 24.4% of patients when OZEMPIC 0.5 mg and 1 mg, respectively, was coadministered with a sulfonylurea. Severe or blood glucose confirmed symptomatic hypoglycemia occurred in 6.5% and 10.4% of patients when OZEMPIC 0.5 mg and 1 mg, respectively, was coadministered with a sulfonylurea.
Injection Site Reactions
In placebo-controlled trials, injection site reactions (e.g., injection-site discomfort, erythema) were reported in 0.2% of OZEMPIC-treated patients.
Increases in Amylase and Lipase
In placebo-controlled trials, patients exposed to OZEMPIC had a mean increase from baseline in amylase of 13% and lipase of 22%. These changes were not observed in placebo-treated patients.
Acute Pancreatitis
In glycemic control trials, acute pancreatitis was confirmed by adjudication in 7 OZEMPIC-treated patients (0.3 cases per 100 patient years) versus 3 in comparator-treated patients (0.2 cases per 100 patient years).
Cholelithiasis
In placebo-controlled trials, cholelithiasis was reported in 1.5% and 0.4% of patients-treated with OZEMPIC 0.5 mg and 1 mg, respectively. Cholelithiasis was not reported in placebo-treated patients.
Increases in Heart Rate
In placebo-controlled trials, OZEMPIC 0.5 mg and 1 mg resulted in a mean increase in heart rate of 2 to 3 beats per minute. There was a mean decrease in heart rate of 0.3 beats per minute in placebo-treated patients.
Fatigue, Dysgeusia and Dizziness
Other adverse reactions with a frequency of >0.4% were associated with OZEMPIC include fatigue, dysgeusia and dizziness.
Postmarketing Experience
The following adverse reactions have been reported during post-approval use of semaglutide, the active ingredient of OZEMPIC. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal : acute pancreatitis and necrotizing pancreatitis, sometimes resulting in death; ileus, intestinal obstruction, severe constipation including fecal impaction
Hypersensitivity : anaphylaxis, angioedema, rash, urticaria
Hepatobiliary : cholecystitis, cholecystectomy
Neurologic : dysesthesia, headache
Pulmonary : Pulmonary aspiration has occurred in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation.
Renal : acute kidney injury
Skin and Subcutaneous Tissue : alopecia
Source: Ozempic prescribing information (FDA label on DailyMed), revised 2026-06-01
What changed for Semaglutide
- RecallRecall: SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage…
- RecallRecall: SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage…
- RecallRecall: SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees…
- FDAFDA approved a labeling supplement for Ozempic
- RecallRecall: SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial
- RecallRecall: SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial
Written from each source's own record as it changes. Every change on GLPcompare
What people have reported to FDA about Ozempic
70,863 reports name Ozempic, 35,203 of them marked serious, in FDA's file of Oct 28, 2026. Anyone can file a report and a report names every medicine the person took, so these counts cannot show that Ozempic caused a problem or how often it happens. For how often, use the trial rates above.
Symptoms reported most
- Nausea10,184
- Vomiting6,681
- Diarrhea6,331
- Decreased appetite4,689
- Constipation4,639
- Weight decreased4,432
- Slowed stomach emptying4,025
- Blood glucose increased3,102
- Fatigue2,967
- Upper abdominal pain2,960
- Headache2,937
- Weight increased2,695
Pen, dose and use problems reported most
- Off label use7,491
- Product use in unapproved indication3,555
- Wrong technique in product usage process3,008
- Inappropriate schedule of product administration2,443
- Drug ineffective1,657
- Product dose omission issue1,436
- Product use issue1,081
- Incorrect dose administered901
Counted through openFDA from FDA's Adverse Event Reporting System. One report can list several problems.
Ozempic side effects: common questions
What are the most common side effects of Ozempic?
In Ozempic's FDA label (revised Jun 1, 2026), the most common side effects at 1 mg were nausea (20.3% vs 6.1% on placebo), vomiting (9.2% vs 2.3%) and diarrhea (8.8% vs 1.9%). These come from FDA's table of placebo-controlled trials (Table 1. Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of OZEMPIC-Treated Patients with Type 2 Diabetes Mellitus).
Does Ozempic cause constipation?
In its FDA label, 3.1% of people taking Ozempic at 1 mg reported constipation, against 1.5% on placebo.
Does Ozempic cause hair loss?
Its FDA label lists alopecia among side effects reported after approval, without a rate: reports like these come from people using it in practice, so they cannot say how often it happens or prove the medicine caused it.
What serious side effects does the Ozempic label warn about?
Its Warnings and Precautions section covers Risk of Thyroid C-Cell Tumors; Acute Pancreatitis; Diabetic Retinopathy Complications; Never Share an OZEMPIC Pen Between Patients; Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin; Acute Kidney Injury Due to Volume Depletion; Severe Gastrointestinal Adverse Reactions; Hypersensitivity Reactions; Acute Gallbladder Disease; and Pulmonary Aspiration During General Anesthesia or Deep Sedation.
Does Ozempic have a boxed warning?
Yes. In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether OZEMPIC causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions (5.1), Nonclinical Toxicology (13.1)]....
Can you take Ozempic while pregnant?
There are limited data with semaglutide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.
Can you take Ozempic while breastfeeding?
There are no data on the presence of semaglutide in human milk, the effects on the breastfed infant, or the effects on milk production.
Should you stop Ozempic before surgery?
Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking OZEMPIC, including whether modifying preoperative fasting recommendations or temporarily discontinuing OZEMPIC could reduce the incidence of retained gastric contents.
Does Ozempic cause withdrawal symptoms?
The warnings and side effect sections of its FDA label do not list any. What trials do show after people stop a GLP-1 is weight coming back. What happens when you stop a GLP-1
Who should not take Ozempic?
OZEMPIC is contraindicated in patients with: A personal or family history of MTC or in patients with MEN 2. 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.
How many side effect reports has FDA received about Ozempic?
FDA's adverse event system holds 70,863 reports that name Ozempic, 35,203 of them marked serious. The most reported symptoms are nausea, vomiting, diarrhea. Anyone can file a report and a report names every medicine the person took, so these cannot show that Ozempic caused a problem or how often it happens. The trial rates in its label do that.
Trial rates describe groups, not what one person will feel. Talk to your clinician before starting, stopping or changing a medicine. Label revised Jun 1, 2026.