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MEDICATION GUIDE
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RYBELSUS® (reb-EL-sus)
(semaglutide)
tablets, for oral use
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OZEMPIC® (oh-ZEM-pick)
(semaglutide)
tablets, for oral use
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Read this Medication Guide before you start using RYBELSUS or OZEMPIC tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
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What is the most important information I should know about RYBELSUS and OZEMPIC tablets?
RYBELSUS and OZEMPIC tablets may cause serious side effects, including:
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Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, RYBELSUS and OZEMPIC tablets and other medicines that work like RYBELSUS and OZEMPIC tablets caused thyroid tumors, including thyroid cancer. It is not known if RYBELSUS and OZEMPIC tablets will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
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- Do not use RYBELSUS or OZEMPIC tablets if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
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What are RYBELSUS and OZEMPIC tablets?
RYBELSUS and OZEMPIC tablets are prescription medicines used:
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- along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes mellitus.
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- to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus who are at high risk for these events.
It is not known if RYBELSUS and OZEMPIC tablets are safe and effective for use in children.
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Do not use RYBELSUS or OZEMPIC tablets if:
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- you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
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- you have had a serious allergic reaction to semaglutide or any of the ingredients in RYBELSUS or OZEMPIC tablets. See the end of this Medication Guide for a complete list of ingredients in RYBELSUS and OZEMPIC tablets.See “What are the possible side effects of RYBELSUS and OZEMPIC tablets?” for symptoms of a serious allergic reaction.
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Before using RYBELSUS or OZEMPIC tablets, tell your healthcare provider if you have any other medical conditions, including if you:
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- have or have had problems with your pancreas or kidneys.
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- have a history of vision problems related to your diabetes.
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- are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation).
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- are pregnant or plan to become pregnant. It is not known if RYBELSUS and OZEMPIC tablets will harm your unborn baby. You should stop using RYBELSUS or OZEMPIC tablets 2 months before you plan to become pregnant. Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.
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- are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with RYBELSUS or OZEMPIC tablets.
Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. RYBELSUS and OZEMPIC tablets may affect the way some medicines work, and some medicines may affect the way RYBELSUS and OZEMPIC tablets work.
Before using RYBELSUS or OZEMPIC tablets, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking other medicines to treat diabetes, including insulin or sulfonylureas.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
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How should I take RYBELSUS or OZEMPIC tablets?
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- Take RYBELSUS or OZEMPIC tablets exactly as your healthcare provider tells you to.
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- Take 1 RYBELSUS or OZEMPIC tablet by mouth on an empty stomach in the morning with water (no more than 4 ounces). Do not take RYBELSUS or OZEMPIC tablets with any other liquids besides water.
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Do not split, crush, chew, or dissolve RYBELSUS or OZEMPIC tablets. Swallow RYBELSUS or OZEMPIC tablets whole.
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- After 30 minutes, you can eat, drink, or take other oral medicines.
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- Do not take more than 1 RYBELSUS or OZEMPIC tablet each day.
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- If you miss a dose of RYBELSUS or OZEMPIC tablets, skip the missed dose and go back to your regular schedule.
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- If you take too much RYBELSUS or OZEMPIC tablets, call your healthcare provider or Poison Help line at 1-800-222-1222, or go to the nearest hospital emergency room right away. Advice is also available online at poisonhelp.org.
Your dose of RYBELSUS or OZEMPIC tablets and other diabetes medicines may need to change because of:
change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, fever, trauma, infection, surgery or because of other medicines you take.
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What are the possible side effects of RYBELSUS and OZEMPIC tablets?
RYBELSUS and OZEMPIC tablets may cause serious side effects, including:
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See “What is the most important information I should know about RYBELSUS and OZEMPIC tablets?”
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inflammation of your pancreas(pancreatitis). Stop using RYBELSUS or OZEMPIC tablets and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.
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changes in vision. Tell your healthcare provider if you have changes in vision during treatment with RYBELSUS or OZEMPIC tablets.
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low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use RYBELSUS or OZEMPIC tablets with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include:
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- dizziness or light-headedness
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- blurred vision
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- anxiety, irritability, or mood changes
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- sweating
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- slurred speech
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- hunger
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- confusion or drowsiness
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- shakiness
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- weakness
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- headache
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- fast heartbeat
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- feeling jittery
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dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.
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severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use RYBELSUS or OZEMPIC tablets. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
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serious allergic reactions. Stop using RYBELSUS or OZEMPIC tablets and get medical help right away, if you have any symptoms of a serious allergic reaction including:
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- swelling of your face, lips, tongue or throat
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- problems breathing or swallowing
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- severe rash or itching
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- fainting or feeling dizzy
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- very rapid heartbeat
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gallbladder problems. Gallbladder problems have happened in some people who take RYBELSUS andOZEMPIC tablets. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include:
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- pain in your upper stomach (abdomen)
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- yellowing of skin or eyes (jaundice)
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- fever
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- clay-colored stools
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food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). RYBELSUS and OZEMPIC tablets may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking RYBELSUS or OZEMPIC tablets before you are scheduled to have surgery or other procedures.
The most common side effects of RYBELSUS and OZEMPIC tablets may include nausea, stomach (abdominal) pain, diarrhea, decreased appetite, vomiting and constipation. Nausea, vomiting and diarrhea are most common when you first start RYBELSUS or OZEMPIC tablets.
Talk to your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of RYBELSUS and OZEMPIC tablets.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.
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How should I store RYBELSUS and OZEMPIC tablets?
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- Store RYBELSUS or OZEMPIC tablets at room temperature between 68°F and 77°F (20°C to 25°C).
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- Store in a dry place away from moisture.
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- Store tablets in the original closed RYBELSUS or OZEMPIC bottle until you are ready to take one. Do not store in any other container.
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Keep RYBELSUS, OZEMPIC tablets and all medicines out of the reach of children.
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General information about the safe and effective use of RYBELSUS and OZEMPIC tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use RYBELSUS or OZEMPIC tablets for a condition for which it was not prescribed. Do not give RYBELSUS or OZEMPIC tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about RYBELSUS or OZEMPIC tablets that is written for health professionals.
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What are the ingredients in RYBELSUS and OZEMPIC tablets?
Active Ingredient in RYBELSUS and OZEMPIC: semaglutide
Inactive Ingredients in RYBELSUS: magnesium stearate, microcrystalline cellulose, povidone and salcaprozate sodium
Inactive ingredients in OZEMPIC: magnesium stearate and salcaprozate sodium
Marketed by: Novo Nordisk Inc., Plainsboro, NJ 08536
RYBELSUS® and OZEMPIC® are registered trademarks of Novo Nordisk A/S.
Patent Information: http://www.novonordisk-us.com/products/product-patents.html
© 2026 Novo Nordisk
For more information, go to www.RYBELSUS.com, www.OZEMPIC.com or call 1-833-GLP-PILL.
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