Rybelsus is a brand-name prescription medication that’s FDA-approved to treat type 2 diabetes. The drug helps control blood sugar in adults when used with diet and exercise. Type 2 diabetes is a condition in which your blood sugar level becomes too high due to problems with a hormone called insulin.

If diet and exercise aren’t helping you manage your type 2 diabetes, Rybelsus shouldn’t be the first medication that you try. Rybelsus isn’t approved to treat type 1 diabetes or a complication of diabetes called diabetic ketoacidosis.

Also, Rybelsus hasn’t been studied in people who have had a pancreas problem known as pancreatitis. So if you have had this condition, your doctor may recommend a different diabetes medication.

Rybelsus contains one active ingredient: semaglutide. Rybelsus belongs to a group of medications called glucagon-like peptide-1 (GLP-1) receptor agonists.

Rybelsus comes as a tablet that you swallow. It’s available in three strengths: 3 mg, 7 mg, and 14 mg. You’ll take Rybelsus once a day.

FDA approval

The Food and Drug Administration (FDA) approved Rybelsus in 2017.

Effectiveness

A study has shown that Rybelsus helps lower blood sugar more than a placebo (treatment with no active drug). Researchers used blood tests to measure the level of hemoglobin A1c (HbA1c), which is a marker of blood sugar control. Target values of 7% are common for HbA1c, but this varies from person to person. Talk with your doctor about the target goal for your treatment.

In a 26-week study of adults with type 2 diabetes, those who took Rybelsus had a decrease in their HbA1c level of 1.2% to 1.4%. This was compared with a decrease of only 0.3% in people who took a placebo. At the end of the study, about 69% to 77% of people who took Rybelsus had an HbA1c level of less than 7%, compared with 31% of those who took a placebo.

Rybelsus is available only as a brand-name medication. It’s not currently available in generic form. A generic drug is an exact copy of the active drug in a brand-name medication.

Rybelsus contains one active drug: semaglutide. (As the active drug, semaglutide is the ingredient that makes Rybelsus work.) Semaglutide is also the active drug in a brand-name medication called Ozempic.

Rybelsus can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Rybelsus. These lists don’t include all possible side effects.

For more information on the possible side effects of Rybelsus, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs they have approved. If you would like to report to the FDA a side effect you’ve had with Rybelsus, you can do so through MedWatch.

Mild side effects

The most common mild side effects* of Rybelsus can include:

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Rybelsus. To learn about other mild side effects, talk with your doctor or pharmacist, or visit the Rybelsus Medication Guide.

Serious side effects

Serious side effects from Rybelsus aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • Hypoglycemia (low blood sugar) when used with a hormone called insulin. Symptoms can include:
    • sweating
    • weakness
    • confusion
  • Pancreatitis (swelling or irritation of the pancreas). Symptoms can include:
    • severe belly pain
    • vomiting
  • Complications of diabetic retinopathy (a form of eye damage due to diabetes). Symptoms can include:
    • worsened eyesight, such as blurred vision, floaters (specks in your vision that move), and trouble seeing colors
  • Sudden kidney problems. Symptoms can include:
    • urinating less
    • changes in the levels of electrolytes (minerals that are electrically charged, such as potassium and sodium)
    • nausea

Other serious side effects, explained in more detail below in “Side effect details,” include:

* Rybelsus has a boxed warning for the risk of thyroid C-cell tumors. This is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warning: Thyroid C-cell tumors” at the beginning of this article.

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on several of the side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Rybelsus. However, it’s not known how often allergic reactions occur with Rybelsus.

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing or speaking

Call your doctor right away if you have a severe allergic reaction to Rybelsus. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Weight loss

Weight loss of about 5 to 10 pounds (2 to 3 kilograms) may occur when taking Rybelsus for type 2 diabetes. Studies showed that people who took Rybelsus lost more weight than people who took liraglutide (Victoza), sitagliptin (Januvia), empagliflozin (Jardiance), or a placebo (treatment with no active drug). But exact numbers for how many people lost weight with each treatment aren’t known.

The weight loss may be a result of better blood sugar management, in addition to changes in diet and exercise. It could also be the result of digestive side effects caused by Rybelsus (see below).

If you have any concerns about weight loss while taking Rybelsus, talk with your doctor. They can review your treatment plan to help make sure you’re at a healthy weight.

Digestive side effects

The most common side effects caused by Rybelsus are digestive side effects, which occurred in more than 5% of people who took the medication. The side effects included nausea, belly pain, diarrhea, decreased appetite, vomiting, and constipation. Higher doses of Rybelsus are usually more likely to cause the effects.

Here’s how often digestive side effects occurred in studies of people who took 7-mg or 14-mg doses of Rybelsus or a placebo:

  • nausea: in 11% to 20% of people who took Rybelsus compared with 6% who took a placebo
  • belly pain: in 10% to 11% of people who took Rybelsus compared with 4% who took a placebo
  • diarrhea: in 9% to 10% of people who took Rybelsus compared with 4% who took a placebo
  • decreased appetite: in 6% to 9% of people who took Rybelsus compared with 1% who took a placebo
  • vomiting: in 6% to 8% of people who took Rybelsus compared with 3% who took a placebo
  • constipation: in 5% to 6% of people who took Rybelsus compared with 2% who took a placebo

Other less common digestive side effects such as gas, acid reflux, and burping were also reported in studies.

If you have digestive symptoms that bother you or don’t go away, tell your doctor. They may be able to recommend ways to help ease your side effects or select a different dose or medication for you.

Thyroid C-cell tumors

Semaglutide, the active drug in Rybelsus, has been shown to cause thyroid C-cell tumors* in animal studies. (Tumors are masses of cancerous tissue, and in this instance, they occur in the thyroid gland. The tumors actually start in a type of cell called a C cell.) However, it’s not known if Rybelsus causes these tumors in humans.

If you’re concerned about thyroid C-cell tumors while taking Rybelsus, talk with your doctor.

* Rybelsus has a boxed warning for the risk of thyroid C-cell tumors. This is the most serious warning from the FDA. For more information, see “FDA warning: Thyroid C-cell tumors” at the beginning of this article.

The Rybelsus dosage your doctor prescribes will depend on several factors. These include:

  • the severity of the condition you’re using Rybelsus to treat
  • other medical conditions you may have

Typically, your doctor will start you on a low dosage. Then they’ll adjust it over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Rybelsus comes as a tablet that you swallow. It’s available in the following strengths: 3 mg, 7 mg, and 14 mg.

Dosage for type 2 diabetes

For treatment of type 2 diabetes, you’ll usually take 3 mg of Rybelsus once a day for the first 30 days. After that, your doctor will likely increase your dose to 7 mg once a day. This is usually the dose that’s needed to help improve blood sugar management.

After you’ve been taking 7 mg of Rybelsus for 30 days, your doctor will decide whether they should increase the dose. If you could benefit from better blood sugar management, your doctor may increase your dose to 14 mg once a day.

What if I miss a dose?

If you miss a dose of Rybelsus, wait until the next day to take your regularly scheduled dose. Don’t double up on doses to make up for the dose you missed.

To help make sure that you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Will I need to use this drug long term?

Rybelsus is meant to be used as a long-term treatment. If you and your doctor determine that Rybelsus is safe and effective for you, you’ll likely take it long term.

In addition to taking Rybelsus, good diet and exercise habits may help improve type 2 diabetes. In some instances, the condition may improve so much that your doctor may decrease your dosage of Rybelsus or have you stop taking the drug.

The Food and Drug Administration (FDA) approves prescription drugs such as Rybelsus to treat certain conditions. Rybelsus may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Rybelsus is FDA-approved for the treatment of type 2 diabetes in adults when used with diet and exercise.

If diet and exercise aren’t helping your type 2 diabetes, Rybelsus shouldn’t be the first medication that you try. The drug isn’t for people who have type 1 diabetes or a complication of diabetes called diabetic ketoacidosis. Also, Rybelsus hasn’t been studied in people who have had a pancreas problem known as pancreatitis.

Type 2 diabetes is a condition in which your blood sugar level becomes too high due to problems with insulin. Insulin is a hormone that your pancreas makes to help control blood sugar. With type 2 diabetes, either your body doesn’t respond well to insulin or doesn’t produce enough insulin.

Type 2 diabetes is the most common form of diabetes. If type 2 diabetes goes untreated, it can lead to problems with the heart, eyes, and nerves, among other parts of the body. These complications can include high blood pressure, diabetic retinopathy, and neuropathy (nerve damage).

Effectiveness

A study has shown that Rybelsus helps lower blood sugar more than a placebo (treatment with no active drug). Researchers used blood tests to measure the level of hemoglobin A1c (HbA1c), which is a marker of blood sugar control. Target values of 7% are common for HbA1c, but this varies from person to person. Talk with your doctor about the target goal for your treatment.

In the 26-week study of adults with type 2 diabetes, those who took Rybelsus had a decrease in their HbA1c level of 1.2% to 1.4%. This was compared with a decrease of only 0.3% in people who took a placebo. At the end of the study, about 69% to 77% of people who took Rybelsus had an HbA1c level of less than 7%, compared with 31% of those who took a placebo.

In addition to the uses listed above, Rybelsus may be used off-label. Off-label drug use is when a drug that’s approved for one use is used for a different one that’s not approved. And you may wonder if Rybelsus is used for certain other conditions.

Rybelsus for type 1 diabetes (under study)

Type 1 diabetes is another form of diabetes, but it’s less common than type 2 diabetes. Type 1 diabetes causes high blood sugar levels because the body doesn’t make enough of a hormone called insulin, which helps control blood sugar.

The Food and Drug Administration (FDA) hasn’t approved Rybelsus for the treatment of type 1 diabetes. However, the drug is being studied for use with insulin and other medications for type 1 diabetes and may be prescribed off-label by doctors. Research shows that adding drugs such as Rybelsus to insulin treatment in people with type 1 diabetes may help lower hemoglobin A1c (HbA1c) levels and body weight.

If you have questions about Rybelsus or treatments for type 1 diabetes, talk with your doctor.

Rybelsus and children

Rybelsus isn’t approved for use in children. More studies are needed to show whether the medication is safe and effective for this age group.

Rybelsus is approved for the treatment of type 2 diabetes when used with diet and exercise. But if Rybelsus and diet and exercise changes aren’t enough to help you reach your blood sugar goals, your doctor may also prescribe other medications, such as metformin (Glumetza).

If you have questions about your diet and exercise plan or other medications while using Rybelsus, talk with your doctor.

There’s no known interaction between Rybelsus and alcohol.

Keep in mind that you should take Rybelsus at least 30 minutes before eating or drinking anything other than 4 ounces of water. If you don’t wait the 30 minutes, the medication may be less effective. So it’s best to avoid drinking alcohol at least 30 minutes before taking Rybelsus.

If you have questions about alcohol use during your Rybelsus treatment, talk with your doctor.

Rybelsus can interact with several other medications. It can also interact with certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

Rybelsus and other medications

Below is a list of medications that can interact with Rybelsus. This list doesn’t contain all drugs that may interact with Rybelsus.

Before taking Rybelsus, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Rybelsus and sulfonylurea drugs

You may be more likely to have hypoglycemia (low blood sugar) if you take Rybelsus and medication in a drug class called sulfonylureas. (A drug class is a group of medications that work in a similar way.) Sulfonylurea drugs help treat type 2 diabetes.

Examples of medications in the sulfonylurea drug class include:

  • glipizide (Glucotrol, Glucotrol XL)
  • glimepiride (Amaryl)
  • glyburide (DiaBeta, Glynase)

If you’re taking any of these drugs, tell your doctor before you start using Rybelsus. They’ll create a plan to monitor you for signs and symptoms of low blood sugar, which can include sweating, dizziness, and confusion. Your doctor may also want to decrease your dose of the sulfonylurea drug during your Rybelsus treatment.

Rybelsus and insulin

You may be more likely to have hypoglycemia if you take Rybelsus and any type of insulin.

Examples of insulin include:

  • insulin aspart (Novolog)
  • insulin detemir (Levemir)
  • insulin glargine (Lantus)
  • insulin human (Novolin R, Humulin R)

If you’re taking insulin, tell your doctor before you start using Rybelsus. They can create a plan to monitor your blood sugar. Also, your doctor may want to decrease your dose of insulin during your Rybelsus treatment.

Rybelsus and all other oral medications

You should take Rybelsus at least 30 minutes before taking any other oral medications. (“Oral” refers to a drug that you swallow as a tablet, capsule, or liquid.) Otherwise, Rybelsus won’t work as well to treat your condition.

Rybelsus slows down how quickly your stomach empties, and this can change the way your body absorbs other medications. Because of this, your doctor may test you more often to make sure your medication is working well.

Before you start taking Rybelsus, tell your doctor about any medications you take. They can help advise you on when to take them and Rybelsus.

Rybelsus and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Rybelsus. However, you should still check with your doctor or pharmacist before using any of these products while taking Rybelsus.

Rybelsus and foods

You should take Rybelsus at least 30 minutes before you eat or drink anything, except for water. And you shouldn’t drink more than 4 ounces of water within those 30 minutes. Taking Rybelsus with food or liquids other than water can decrease the amount of the drug that your body absorbs. So Rybelsus may not work as well to treat your condition.

If you have any questions about the timing of your Rybelsus doses and meals, talk with your doctor.

As with all medications, the cost of Rybelsus can vary.

The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Your insurance plan may require you to get prior authorization before approving coverage for Rybelsus. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the request and let you and your doctor know if your plan will cover Rybelsus.

If you’re not sure if you’ll need to get prior authorization for Rybelsus, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Rybelsus, or if you need help understanding your insurance coverage, help is available.

Novo Nordisk, the manufacturer of Rybelsus, offers a savings card and Patient Assistance Program. For more information and to find out if you’re eligible for support, call 844-NOVO4ME (844-668-6463) or visit the program website.

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Rybelsus, talk with your doctor. They can tell you about other medications that may work well for you.

Alternatives for type 2 diabetes

Examples of other drugs that may be used to treat type 2 diabetes include:

You may wonder how Rybelsus compares with other medications that are prescribed for similar uses. Here we look at how Rybelsus and Ozempic are alike and different.

Ingredients

Both Rybelsus and Ozempic contain the active ingredient semaglutide.

Uses

The Food and Drug Administration (FDA) has approved Rybelsus and Ozempic to treat type 2 diabetes. The drugs help control blood sugar in adults when used with diet and exercise. Type 2 diabetes is a condition in which your blood sugar level becomes too high due to problems with a hormone called insulin.

Rybelsus and Ozempic aren’t approved to treat type 1 diabetes or a complication of diabetes called diabetic ketoacidosis. Also, the drugs haven’t been studied in people who have had a pancreas problem known as pancreatitis. So if you have had this condition, your doctor will likely recommend a different diabetes medication.

If diet and exercise aren’t helping your type 2 diabetes, Rybelsus shouldn’t be the first medication that you try.

Ozempic is also FDA-approved to decrease the risk of major heart problems in people with type 2 diabetes and heart disease. Rybelsus isn’t approved by the FDA for this use.

Drug forms and administration

Rybelsus comes as a tablet that you swallow.

Ozempic comes as a single-use pen that you use to give yourself an injection just under your skin (subcutaneous). You’ll have the injections in your belly, thigh, or upper arm.

Dosage differences between Rybelsus and Ozempic

You’ll usually take 3 mg of Rybelsus once a day for the first 30 days. After that, your doctor will likely increase your dose to 7 mg, once a day. This is usually the dose that’s needed to help improve blood sugar management.

After you’ve been taking 7 mg of Rybelsus for 30 days, your doctor will decide whether they should increase the dose. If you could benefit from better blood sugar management, your doctor may increase your dose to 14 mg once a day.

You’ll usually start with a 0.25-mg injection of Ozempic once a week. After 4 weeks, your doctor may increase the dose to a 0.5-mg injection once a week. If you could benefit from better blood sugar management, your doctor may increase the dosage to a 1-mg injection once a week.

Switching between Rybelsus and Ozempic

Your doctor may switch you to Rybelsus from Ozempic if you prefer taking medication by mouth instead of having injections. Or they may switch you to Ozempic from Rybelsus if you prefer taking a drug once a week instead of once a day.

If you have heart disease, your doctor may recommend Ozempic over Rybelsus. Ozempic is FDA-approved to decrease the risk of major heart problems in people with type 2 diabetes and heart disease. Rybelsus isn’t approved by the FDA for this use.

If you’re taking 14 mg of Rybelsus once a day, your doctor may switch you to a 0.5-mg injection of Ozempic once a week. You can start having your Ozempic injections the day after your last dose of Rybelsus.

If you’re taking a 0.5-mg injection of Ozempic once a week, your doctor may switch you to either a 7-mg or 14-mg dose of Rybelsus once a day. You can start taking Rybelsus up to 7 days after your last injection of Ozempic.

If you’re taking 1-mg injections of Ozempic once a week, keep in mind that there’s no equal dose of Rybelsus.

Side effects and risks

Rybelsus and Ozempic both contain the active drug semaglutide. Therefore, these medications can cause very similar side effects, but some different ones as well. Below are examples of these side effects.

Mild side effects

These lists contain examples of up to 10 of the most common mild side effects that can occur with each drug, or with both Rybelsus and Ozempic (when taken individually).

  • Can occur with Rybelsus:
    • decreased appetite
  • Can occur with Ozempic:
    • reactions at the site of the injection, such as redness or discomfort
  • Can occur with both Rybelsus and Ozempic:
    • belly pain
    • weight loss

Serious side effects

This list contains examples of serious side effects that can occur with Rybelsus and Ozempic (when taken individually):

* Rybelsus and Ozempic have a boxed warning for the risk of thyroid C-cell tumors. This is the most serious warning from the FDA. For more information, see “FDA warning: Thyroid C-cell tumors” at the beginning of this article.

Effectiveness

Rybelsus and Ozempic have different FDA-approved uses, but they’re both used to treat type 2 diabetes, in combination with diet and exercise.

These drugs haven’t been directly compared in clinical studies, but studies have found both Rybelsus and Ozempic to be effective for treating type 2 diabetes when used with diet and exercise.

Costs

Rybelsus and Ozempic are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

According to estimates on GoodRx.com, Rybelsus and Ozempic generally cost about the same. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

RECALL OF METFORMIN EXTENDED RELEASE

In May 2020, the Food and Drug Administration (FDA) recommended that some makers of metformin extended release remove some of their tablets from the U.S. market. This is because an unacceptable level of a probable carcinogen (cancer-causing agent) was found in some extended-release metformin tablets. If you currently take this drug, call your healthcare provider. They will advise whether you should continue to take your medication or if you need a new prescription.

Like Ozempic (above), the drug metformin has uses similar to those of Rybelsus. Here’s a comparison of how Rybelsus and metformin are alike and different.

Ingredients

Rybelsus contains the active ingredient semaglutide. Metformin contains the active ingredient metformin. It’s a generic drug, and it’s also the active ingredient in the brand-name drug Glumetza.

Uses

The Food and Drug Administration (FDA) has approved Rybelsus and metformin to treat type 2 diabetes in adults. Metformin is also approved to be used in children ages 10 years and older. The drugs help control blood sugar in adults when used with diet and exercise. Type 2 diabetes is a condition in which your blood sugar level becomes too high due to problems with a hormone called insulin.

If diet and exercise aren’t helping your type 2 diabetes, Rybelsus shouldn’t be the first medication that you try. Rybelsus isn’t approved to treat type 1 diabetes or a complication of diabetes called diabetic ketoacidosis.

Also, Rybelsus hasn’t been studied in people who have had a pancreas problem known as pancreatitis. So if you have had this condition, your doctor will likely recommend a different diabetes medication.

Drug forms and administration

Rybelsus comes as a tablet that you swallow. You’ll usually take it once a day.

Metformin comes in three forms. One is a tablet that you swallow. You’ll typically take it once or twice a day. With higher doses, your doctor may want you to take metformin three times a day.

The second form of metformin is an extended-release tablet, which releases the drug into your body slowly over time. You’ll swallow the tablet. The third form is a liquid solution that you swallow.

Side effects and risks

Rybelsus and metformin are both used to treat type 2 diabetes. Therefore, these medications can cause some similar side effects, but some different ones as well. Below are examples of these side effects.

Mild side effects

These lists contain examples of up to 10 of the most common mild side effects that can occur with each drug, or with both Rybelsus and metformin (when taken individually).

Serious side effects

These lists contain examples of serious side effects that can occur with Rybelsus, with metformin, or with both drugs (when taken individually).

* Rybelsus has a boxed warning for the risk of thyroid C-cell tumors. This is the most serious warning from the FDA. For more information, see “FDA warning: Thyroid C-cell tumors” at the beginning of this article.

** Metformin has a boxed warning for lactic acidosis.

Effectiveness

The only condition both Rybelsus and metformin are used to treat is type 2 diabetes, in combination with diet and exercise.

These drugs haven’t been directly compared in clinical studies, but studies have found both Rybelsus and metformin to be effective for treating type 2 diabetes when used with diet and exercise.

Costs

Rybelsus is a brand-name drug. Metformin is a generic drug. Brand-name medications usually cost more than generics.

According to estimates on GoodRx.com, Rybelsus costs significantly more than metformin. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

You should take Rybelsus according to your doctor’s or healthcare provider’s instructions.

Rybelsus comes as a tablet that you swallow.

When to take

You’ll usually take Rybelsus once a day. You should take the drug at least 30 minutes before you eat or drink anything, except for water. And you shouldn’t drink more than 4 ounces of water within those 30 minutes.

Also, you should take Rybelsus at least 30 minutes before taking other medication that you swallow.

To help make sure that you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Taking Rybelsus with food

It’s important to take Rybelsus at least 30 minutes before having any food or drink (aside from up to 4 ounces of water).

Taking Rybelsus with food or liquids other than water can decrease the drug’s ability to help manage your blood sugar.

Can Rybelsus be crushed, split, or chewed?

No, you shouldn’t split, crush, or chew Rybelsus tablets. Swallow them whole with less than 4 ounces of water.

With type 2 diabetes, your blood sugar level is higher than normal. This is because of insulin (a hormone that controls blood sugar). The insulin level in your body is too low or your body doesn’t react as well to insulin as normal.

Rybelsus works to decrease blood sugar levels. The drug does this by raising the level of insulin and lowering the level of a hormone called glucagon. Rybelsus also increases the amount of time that food stays in your stomach before moving through the rest of your digestive system. This may help decrease blood sugar levels as well.

How long does it take to work?

It typically takes about 1 month for Rybelsus to work.

You’ll usually start taking 3 mg of Rybelsus a day, which helps your body get used to the medication. Keep in mind that this isn’t the dose used to treat type 2 diabetes.

After 1 month, your doctor will change your dose to 7 mg a day. This will start adjusting your blood sugar levels to reach the goal you and your doctor set. It’s possible that you may need a higher dose of Rybelsus. (For more information, see the “Rybelsus dosage” section above.)

It’s usually not recommended that you take Rybelsus during pregnancy unless your doctor believes that the benefits of treatment are greater than potential side effects.

There hasn’t been enough research in humans to show whether the drug is safe to use while pregnant. Animal studies show that Rybelsus may harm the baby, but it’s not known whether these results apply to humans.

If you’re planning a pregnancy and decide to take Rybelsus, you should wait until at least 2 months after your last dose to become pregnant. It takes that long for the drug to fully clear out of your body.

If you’re pregnant or are planning to become pregnant, tell your doctor before you start taking Rybelsus. They can review your treatment options with you.

It’s usually not recommended that you use Rybelsus during pregnancy unless your doctor believes that the benefits of treatment are greater than potential side effects.

If you do decide to take Rybelsus, you should wait until at least 2 months after your last dose of Rybelsus to become pregnant. It takes that long for the drug to fully clear out of your body.

If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Rybelsus.

You shouldn’t breastfeed while taking Rybelsus. Animal studies show that Rybelsus passes into breast milk. For this reason, you shouldn’t take the drug while breastfeeding.

If you’re breastfeeding or are planning to breastfeed, tell your doctor before taking Rybelsus. They may recommend a different drug for you.

Here are answers to some frequently asked questions about Rybelsus.

Is Rybelsus a type of insulin?

No, Rybelsus isn’t a type of insulin. Insulin is a hormone that controls blood sugar. Rybelsus is a type of drug called a glucagon-like peptide-1 (GLP-1) receptor agonist. GLP-1s such as Rybelsus help control blood sugar by increasing insulin levels and decreasing levels of a hormone called glucagon.

In some cases, your doctor may want you to take Rybelsus with insulin for even better blood sugar management.

If you have questions about Rybelsus or insulin, talk with your doctor.

Why do I need to take Rybelsus 30 minutes before I eat or drink?

Taking Rybelsus at least 30 minutes before you eat or drink helps your body absorb the drug properly. Keep in mind that you can drink a little water (no more than 4 ounces) when you take the medication. But consuming other drinks or food, or taking other medications, within 30 minutes can decrease the effectiveness of Rybelsus.

If you have any questions about the timing of your Rybelsus doses and meals, talk with your doctor.

What’s wrong with storing Rybelsus tablets in my pill box?

If you store Rybelsus tablets in a pill box or pill organizer, the drug may be exposed to moisture. This can make Rybelsus less effective in managing your blood sugar. So it’s best to keep the medication in its original packaging until you’re ready to take it.

Can I take Rybelsus for type 1 diabetes?

The Food and Drug Administration (FDA) hasn’t approved Rybelsus for the treatment of type 1 diabetes. However, the drug is being studied for use with other medications to treat type 1 diabetes. For more information, see the “Other uses for Rybelsus” section.

If you have questions about Rybelsus or treatments for type 1 diabetes, talk with your doctor.

This drug comes with several precautions.

FDA warning: Thyroid C-cell tumors

This drug has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Semaglutide, the active drug in Rybelsus, has been shown to cause thyroid C-cell tumors in animal studies. (Tumors are masses of cancerous tissue, and in this instance, they occur in the thyroid gland. The tumors actually start in a type of cell called a C cell.) However, it’s not known if Rybelsus causes these tumors in humans. The tumors include medullary thyroid carcinoma (MTC).

You shouldn’t take Rybelsus if you or someone in your family has had MTC. You also shouldn’t take the drug if you have a rare type of cancer known as multiple endocrine neoplasia syndrome type 2 (MEN 2). Your doctor will talk with you about the risk of MTC and other thyroid tumors as well as possible symptoms. These symptoms can include trouble swallowing, hoarseness that lasts, a mass in your neck, or shortness of breath.

Other precautions

Before taking Rybelsus, talk with your doctor about your health history. Rybelsus may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Diabetic retinopathy. Taking Rybelsus may increase your risk for diabetic retinopathy (a form of eye damage due to diabetes). If you have a history of diabetic retinopathy, your doctor will monitor you closely while you use Rybelsus.
  • Worsening chronic kidney failure. Taking Rybelsus may cause chronic kidney failure to worsen. Your doctor will monitor you closely during your Rybelsus treatment.
  • Pancreatitis. Rybelsus hasn’t been studied in people who have had a pancreas problem known as pancreatitis. So if you have this condition, your doctor will likely recommend a different diabetes medication.
  • Allergic reaction. If you’re allergic to Rybelsus or any of its ingredients, you shouldn’t take the drug. Ask your doctor what other treatment is a better choice for you.
  • Pregnancy. It’s usually not recommended that you take Rybelsus during pregnancy. For more information, please see the “Rybelsus and pregnancy” section above.
  • Breastfeeding. You shouldn’t breastfeed while taking Rybelsus. For more information, please see the “Rybelsus and breastfeeding” section above.

Note: For more information about the potential negative effects of Rybelsus, see the “Rybelsus side effects” section above.

Don’t use more Rybelsus than your doctor recommends.

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or visit the website. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

When you get Rybelsus from the pharmacy, the pharmacist will add an expiration date to the label on the packaging. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

You should store Rybelsus tablets at room temperature (68°F to 77°F/20°C to 25°C) in the original container. If needed, you can keep the drug between 59°F and 86°F (15°C and 30°C) for a short time. Avoid storing this medication in areas where it could get damp or wet, such as in bathrooms.

Disposal

If you no longer need to take Rybelsus and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

The following information is provided for clinicians and other healthcare professionals.

Indications

The Food and Drug Administration (FDA) has approved Rybelsus for the treatment of type 2 diabetes in combination with diet and exercise. It is not recommended as a first-line therapy for those who have not achieved blood sugar control with diet and exercise. Rybelsus is not FDA-approved for the treatment of type 1 diabetes or diabetic ketoacidosis. However, Rybelsus is being studied in conjunction with other therapies for blood sugar control in people with type 1 diabetes.

Rybelsus has not been studied in people with previous pancreatitis. For this reason, other treatments are usually recommended prior to Rybelsus in those with a history of pancreatitis.

Mechanism of action

Rybelsus is a glucagon-like peptide 1 (GLP-1) analogue and binds to the GLP-1 receptor to increase insulin secretion and decrease glucagon secretion, decreasing blood sugar levels overall. The drug also works to delay gastric emptying, which decreases postprandial blood sugar levels.

Pharmacokinetics and metabolism

Rybelsus reaches maximum blood concentrations about 1 hour after each dose. Steady-state concentrations are reached after 4 to 5 weeks of treatment. Rybelsus has an elimination half-life of 1 week, and it takes about 5 weeks for the drug to be eliminated from the circulation system.

The primary route of elimination for semaglutide is metabolism following separation of the peptide backbone and beta-oxidation of the fatty acid side chain. Rybelsus is primarily excreted via the urine and feces.

Contraindications

Rybelsus is contraindicated in those with previous hypersensitivity reactions to the drug.

It is also contraindicated in people with a personal or family history of medullary thyroid carcinoma (MTC) or in those with multiple endocrine neoplasia syndrome type 2 (MEN 2), a condition that increases the risk of developing MTC and other tumors within the endocrine system.*

In animal studies, Rybelsus has been shown to cause thyroid tumors, including a type of tumor known as MTC.* It is not known how this risk in animals applies to humans.

* Rybelsus has a boxed warning for the risk of thyroid C-cell tumors. For more information, see “FDA warning: Thyroid C-cell tumors” at the beginning of this article.

Storage

Rybelsus should be stored at room temperature (68°F to 77°F/20°C to 25°C). Variability in temperature (59°F to 86°F/15°C to 30°C) is allowed. Rybelsus should be stored in the original packaging to protect it from moisture. It should be kept in a dry place.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.