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Generic Name
Semaglutide
Brand Names
Ozempic, Wegovy, Rybelsus
FDA approval date: September 20, 2019
Classification: GLP-1 Receptor Agonist
Form: Injection, Tablet
What is Ozempic (Semaglutide)?
OZEMPIC 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 in adults with type 2 diabetes mellitus and established cardiovascular disease.
Approved To Treat
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Related Clinical Trials
Open-label, Randomised, 4 Parallel-group, Phase I Clinical Trial to Investigate BI 456906 Occupancy of Glucagon Receptors in Liver and Glucagon-like Peptide 1 Receptors in Pancreas in Comparison With Semaglutide After Administration of Radiolabeled Tracer in Male and Female Subjects With Obesity Using PET and MRI
Summary: This study is open to adults with obesity. People with a body mass index (BMI) in the range from 30 to 40 kg/m2 and a body weight of 70 to 150 kg can participate in the study. The purpose of this study is to find out whether treatment with a medicine called BI 456906 changes the occupancy of receptors in the liver and in the pancreas. These receptors are involved in appetite and weight regulation....
Glycemic and Weight Loss Effects of GLP-1R Agonist Therapy in Subjects With Spinal Cord Injury and Type 2 Diabetes
Summary: It is not known whether a new diabetes drug, semaglutide, is an effective treatment for type 2 diabetes for persons with spinal cord injury (SCI), a population at higher risk for this condition. Therefore, this study looks at the effect of semaglutide on glucose levels in the body and other information about type 2 diabetes and obesity.
A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study to Evaluate the Efficacy and Safety of CS060380 Tablets in Patients With Metabolic Dysfunction-associated Steatohepatitis (MASH) and Obesity.
Summary: this study is looking at a new investigational medicine called CS060380, when used together with semaglutide, in adults who have both metabolic dysfunction-associated steatohepatitis (MASH) and obesity. MASH is a condition where too much fat builds up in the liver, leading to inflammation and damage. Obesity is a major risk factor for this condition. This is a Phase II clinical trial, which means ...
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Brand Information
OZEMPIC (oral semaglutide)
WARNING: RISK OF THYROID C-CELL TUMORS
- In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether RYBELSUS and OZEMPIC tablets cause 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
- RYBELSUS and OZEMPIC tablets are contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
1INDICATIONS AND USAGE
RYBELSUS and OZEMPIC tablets are 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 (CV) events (CV death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events.
2DOSAGE FORMS AND STRENGTHS
RYBELSUS (semaglutide) tablets are available as:
- 3 mg: white to light yellow, oval shaped debossed with “3” on one side and “novo” on the other side.
- 7 mg: white to light yellow, oval shaped debossed with “7” on one side and “novo” on the other side.
- 14 mg: white to light yellow, oval shaped debossed with “14” on one side and “novo” on the other side.
OZEMPIC (semaglutide) tablets are available as:
- 1.5 mg: white to light yellow, round shaped debossed with “1.5” on one side and “novo” on the other side.
- 4 mg: white to light yellow, round shaped debossed with “4” on one side and “novo” on the other side.
- 9 mg: white to light yellow, round shaped debossed with “9” on one side and “novo” on the other side.
3CONTRAINDICATIONS
RYBELSUS and OZEMPIC tablets are contraindicated in patients with:
- A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- A prior serious hypersensitivity reaction to semaglutide or to any of the excipients in RYBELSUS or OZEMPIC tablets. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with semaglutide tablets
4ADVERSE REACTIONS
The following serious adverse reactions are described below or elsewhere in the prescribing information:
- Risk of Thyroid C-cell Tumors
- Acute Pancreatitis
- Diabetic Retinopathy Complications
- 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
- Pulmonary Aspiration During General Anesthesia or Deep Sedation
4.1Clinical 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.
The safety of OZEMPIC tablets (1.5 mg, 4 mg and 9 mg strengths)
Pool of Placebo-Controlled Trials
The data in
Pool of Placebo- and Active-Controlled Trials
The occurrence of adverse reactions was also evaluated in a larger pool of adult patients with type 2 diabetes mellitus participating in 9 placebo- and active-controlled trials
Common Adverse Reactions
Table 2 shows common adverse reactions, excluding hypoglycemia, associated with the use of semaglutide tablets in adult patients with type 2 diabetes mellitus in the pool of placebo-controlled trials. These adverse reactions occurred more commonly on semaglutide tablets than on placebo and occurred in at least 5% of patients treated with semaglutide tablets.
Table 2. Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of Semaglutide Tablets-Treated Patients with Type 2 Diabetes Mellitus
In the pool of placebo- and active-controlled trials, the types and frequency of common adverse reactions, excluding hypoglycemia, were similar to those listed in
In a 4-year CV outcomes trial (Trial 7), 4,825 patients were randomized to semaglutide tablets for a median follow-up of 49.6 months and 4,825 patients were randomized to placebo for a median follow-up of 49.4 months
Additional information from this trial is included in subsequent sections below, when relevant.
Gastrointestinal Adverse Reactions
In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients who received semaglutide tablets than placebo: semaglutide tablets 14 mg once daily (41%), semaglutide tablets 7 mg once daily (32%) and placebo (21%), including severe reactions (semaglutide tablets 14 mg 2.0%, semaglutide tablets 7 mg 0.6%, placebo 0.3%). The majority of reports of nausea, vomiting and/or diarrhea occurred during dose escalation. A greater percentage of patients who received semaglutide tablets 14 mg once daily (8%) and semaglutide tablets 7 mg once daily (4%) discontinued treatment due to gastrointestinal adverse reactions than patients who received placebo (1%).
In addition to the reactions in
Other Adverse Reactions
Pancreatitis: In the pool of placebo- and active-controlled trials with semaglutide tablets, pancreatitis was reported as a serious adverse event in 6 semaglutide tablets -treated patients (0.1 events per 100 patient years) versus 1 in comparator-treated patients (<0.1 events per 100 patient years).
Diabetic Retinopathy Complications: In the pool of placebo- and active-controlled trials with semaglutide tablets, patients reported diabetic retinopathy related adverse reactions during the trial (4.2% with semaglutide tablets and 3.8% with comparator).
Hypoglycemia: Table 3 summarizes the incidence of hypoglycemia by various definitions in the placebo-controlled trials.
Table 3. Hypoglycemia Adverse Reactions in Placebo-Controlled Trials in Patients with Type 2 Diabetes Mellitus
* “Severe” hypoglycemia adverse reactions are episodes requiring the assistance of another person.
Hypoglycemia was more frequent when semaglutide tablets were used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin.
Increases in Amylase and Lipase: In placebo-controlled trials, patients exposed to semaglutide tablets 7 mg and 14 mg tablets had a mean increase from baseline in amylase of 10% and 13%, respectively and lipase of 30% and 34%, respectively. These changes were not observed in placebo-treated patients.
Cholelithiasis: In placebo-controlled trials to improve glycemic control, cholelithiasis was reported in 1% of patients treated with semaglutide tablets 7 mg.
In a 4-year CV outcomes trial (Trial 7), cholelithiasis was reported in 1.1% of patients treated with semaglutide 14 mg tablets and in 0.9% of placebo-treated patients. In Trial 7, cholecystitis was reported in 1.1% of patients treated with semaglutide14 mg tablets and in 0.7% of placebo-treated patients.
Increases in Heart Rate: In placebo-controlled trials, semaglutide tablets 7 mg and 14 mg tablets resulted in a mean increase in heart rate of 1 to 3 beats per minute. There was no change in heart rate in placebo-treated patients.
4.2Postmarketing Experience
The following adverse reactions have been reported during post-approval use of semaglutide, the active ingredient in RYBELSUS and OZEMPIC tablets. 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, cholelithiasis requiring cholecystectomy
- Nervous system disorders: dizziness, dysesthesia, dysgeusia, 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
5OVERDOSAGE
In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of semaglutide of approximately 1 week.
6DESCRIPTION
RYBELSUS and OZEMPIC tablets, for oral use, contain semaglutide, a GLP-1 receptor agonist. The peptide backbone is produced by yeast fermentation. The main protraction mechanism of semaglutide is albumin binding, facilitated by modification of position 26 lysine with a hydrophilic spacer and a C18 fatty di-acid. Furthermore, semaglutide is modified in position 8 to provide stabilization against degradation by the enzyme dipeptidyl-peptidase 4 (DPP-4). A minor modification was made in position 34 to ensure the attachment of only one fatty di-acid. The molecular formula is C
Structural formula:
Semaglutide is a white to almost white hygroscopic powder.
RYBELSUS tablets contain 3 mg, 7 mg or 14 mg of semaglutide and the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and salcaprozate sodium (SNAC).
OZEMPIC tablets contain 1.5 mg, 4 mg or 9 mg of semaglutide and the following inactive ingredients: magnesium stearate and SNAC.
7HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
RYBELSUS strengths are available as follows:
OZEMPIC tablet strengths are available as follows:
Storage and Handling
Store RYBELSUS and OZEMPIC tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store and dispense in the original bottle.
Store tablets in the original bottle until use to protect tablets from moisture. Store product in a dry place away from moisture.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Risk of Thyroid C-cell Tumors
Inform patients that semaglutide causes thyroid C-cell tumors in rodents and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia or dyspnea) to their physician
Acute Pancreatitis
Inform patients of the potential risk for acute pancreatitis and its symptoms: severe abdominal pain that may radiate to the back, and which may or may not be accompanied by nausea or vomiting. Instruct patients to discontinue RYBELSUS or OZEMPIC tablets promptly and contact their physician if pancreatitis is suspected
Diabetic Retinopathy Complications
Inform patients to contact their physician if changes in vision are experienced during treatment with RYBELSUS or OZEMPIC tablets
Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin
Inform patients that the risk of hypoglycemia is increased when RYBELSUS or OZEMPIC tablets are used with an insulin secretagogue (such as a sulfonylurea) or insulin. Educate patients on the signs and symptoms of hypoglycemia
Acute Kidney Injury Due to Volume Depletion
Inform patients of the potential risk of acute kidney injury due to dehydration associated with gastrointestinal adverse reactions. Advise patients to take precautions to avoid fluid depletion. Inform patients of the signs and symptoms of acute kidney injury and instruct them to promptly report any of these signs or symptoms or persistent (or extended) nausea, vomiting, and diarrhea to their healthcare provider
Severe Gastrointestinal Adverse Reactions
Inform patients of the potential risk of severe gastrointestinal adverse reactions. Instruct patients to contact their healthcare provider if they have severe or persistent gastrointestinal symptoms
Hypersensitivity Reactions
Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of semaglutide tablets. Advise patients on the symptoms of hypersensitivity reactions and instruct them to stop taking RYBELSUS or OZEMPIC tablets and seek medical advice promptly if such symptoms occur
Acute Gallbladder Disease
Inform patients of the potential risk for cholelithiasis or cholecystitis. Instruct patients to contact their physician if cholelithiasis or cholecystitis is suspected for appropriate clinical follow-up
Pulmonary Aspiration During General Anesthesia or Deep Sedation:
Inform patients that RYBELSUS or OZEMPIC tablets may cause their stomach to empty more slowly which may lead to complications with anesthesia or deep sedation during planned surgeries or procedures. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking RYBELSUS or OZEMPIC tablets
Pregnancy
Advise a pregnant woman of the potential risk to a fetus. Advise women to inform their healthcare provider if they are pregnant or intend to become pregnant
Lactation
RYBELSUS and OZEMPIC tablets pass into breast milk, and it is not known how it affects your baby. Advise females not to breastfeed during treatment with RYBELSUS or OZEMPIC tablets
Females and Males of Reproductive Potential
Discontinue RYBELSUS or OZEMPIC tablets at least 2 months before a planned pregnancy due to the long washout period for semaglutide
Marketed by:
Novo Nordisk Inc.
Plainsboro, NJ 08536
For additional information about RYBELSUS and OZEMPIC tablets contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
1-833-457-7455
RYBELSUS
Patent Information: http://www.novonordisk-us.com/products/product-patents.html
© 2026 Novo Nordisk
9Medication Guide
- This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 1/2026
10PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – OZEMPIC 1.5 mg tablets
- NDC 0169-1715-30List 171530
- OZEMPIC
(semaglutide) Tablets
1.5 mg
Rx only
DISPENSE WITH MEDICATION GUIDE
Note to Pharmacist: Individual strengths of semaglutide are not substitutable on a mg-to-mg basis
New Formulation of semaglutide
30 tablets
11PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – OZEMPIC 4 mg tablets
- NDC 0169-1704-30List 170430
- OZEMPIC
(semaglutide) Tablets
4 mg
Rx only
DISPENSE WITH MEDICATION GUIDE
Note to Pharmacist: Individual strengths of semaglutide are not substitutable on a mg-to-mg basis
New Formulation of semaglutide
30 tablets
12PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – OZEMPIC 9 mg tablets
- NDC 0169-1709-30List 170930
- OZEMPIC
(semaglutide) Tablets
9 mg
Rx only
DISPENSE WITH MEDICATION GUIDE
Note to Pharmacist: Individual strengths of semaglutide are not substitutable on a mg-to-mg basis
New Formulation of semaglutide
30 tablets
13PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – RYBELSUS 3 mg bottle
- NDC 0169
- RYBELSUS
(semaglutide) Tablets
3 mg
Once daily
Oral use only
Rx only
DISPENSE WITH MEDICATION GUIDE
30 tablets
14PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – RYBELSUS 7 mg bottle
- NDC 0169
- RYBELSUS
(semaglutide) Tablets
7 mg
Once daily
Oral use only
Rx only
DISPENSE WITH MEDICATION GUIDE
30 tablets
15PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – RYBELSUS 14 mg bottle
- NDC 0169
- RYBELSUS
(semaglutide) Tablets
14 mg
Once daily
Oral use only
Rx only
DISPENSE WITH MEDICATION GUIDE
30 tablets
16PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – RYBELSUS 3 mg blister
- NDC 0169
- RYBELSUS
(semaglutide) Tablets
3 mg
Once daily
Each tablet contains 3 mg semaglutide
Oral use only
Rx only
Dispense the Enclosed Medication Guide to Each Patient
30 tablets
3 blister packs. Each pack contains 10 tablets.
Open Here
17PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – RYBELSUS 7 mg blister
- NDC 0169
- RYBELSUS
(semaglutide) Tablets
7 mg
Once daily
Each tablet contains 7 mg semaglutide
Oral use only
Rx only
Dispense the Enclosed Medication Guide to Each Patient
30 tablets
3 blister packs. Each pack contains 10 tablets.
Open Here
18PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – RYBELSUS 14 mg blister
- NDC 0169
- RYBELSUS
(semaglutide) Tablets
14 mg
Once daily
Each tablet contains 14 mg semaglutide
Oral use only
Rx only
Dispense the Enclosed Medication Guide to Each Patient
30 tablets
3 blister packs. Each pack contains 10 tablets.
Open Here
19PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – R2 1.5 mg bottle
- NDC 0169-
- RYBELSUS
(semaglutide) Tablets
1.5 mg
Rx only
DISPENSE WITH MEDICATION GUIDE
Note to Pharmacist: Individual strengths of Rybelsus are not substitutable on a mg-to-mg basis
New Formulation (Formulation R2)
30 tablets
20PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – R2 4 mg bottle
- NDC 0169-
- RYBELSUS
(semaglutide) Tablets
4 mg
Rx only
DISPENSE WITH MEDICATION GUIDE
Note to Pharmacist: Individual strengths of Rybelsus are not substitutable on a mg-to-mg basis
New Formulation (Formulation R2)
30 tablets
21PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – R2 9 mg bottle
- NDC 0169-
- RYBELSUS
(semaglutide) Tablets
9 mg
Rx only
DISPENSE WITH MEDICATION GUIDE
Note to Pharmacist: Individual strengths of Rybelsus are not substitutable on a mg-to-mg basis
New Formulation (Formulation R2)
30 tablets
