Budesonide ER oral tablets: Side effects, dosage, and more (original) (raw)

Budesonide ER oral tablets are a generic prescription medication. They’re FDA-approved to treat mild to moderate ulcerative colitis in adults.

Ulcerative colitis is a type of inflammatory bowel disease. It causes inflammation (swelling) of the large intestine, which includes the colon and rectum. Ulcerative colitis leads to symptoms such as abdominal (belly) pain and diarrhea.

Budesonide is used to help achieve remission in people who currently have symptoms of ulcerative colitis. (Remission is a period of time without any symptoms.) For more details about how the drug is used, see the “Budesonide ER oral tablets uses” section below.

Drug details

Budesonide ER oral tablets are a type of steroid. Specifically, they belong to a class of drugs called corticosteroids. (A drug class is a group of medications that work in a similar way.)

“ER” stands for extended release, which means the tablet releases the drug slowly, allowing your body to absorb it over time.

Budesonide ER oral tablets should be swallowed whole. The tablets come in one strength of 9 milligrams. The drug is typically taken once per day in the morning.

Note: Budesonide also comes in other forms: oral capsules, nasal spray, dry powder inhaler, rectal foam, and liquid solution that’s used with a nebulizer. This article addresses only the oral ER tablets. For information on budesonide’s other forms, talk with your doctor or pharmacist.

Brand-name version

Budesonide ER oral tablets are available as a brand-name drug called Uceris.

Note: The other forms of budesonide are available under other brand names. For information on those forms, talk with your doctor or pharmacist.

Effectiveness

For information about the effectiveness of budesonide ER oral tablets, see the “Budesonide ER oral tablets uses” section below.

Budesonide ER oral tablets are a generic drug. A generic drug is an exact copy of the active drug in a brand-name medication. Uceris is the brand-name medication that budesonide ER oral tablets are based on. A generic is considered to be as safe and effective as the original drug. Generics tend to cost less than brand-name drugs.

If you’re interested in taking Uceris instead of budesonide ER oral tablets, talk with your doctor. They can tell you if Uceris comes in strengths for your condition. If you have insurance, you’ll also need to check whether your plan will cover Uceris.

To learn more about how generics compare with brand-name drugs, see this article.

Budesonide ER oral tablets can cause mild or serious side effects. The following lists contain some of the key side effects that may occur. These lists do not include all possible side effects.

For more information about the possible side effects of budesonide ER oral tablets, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with budesonide ER oral tablets, you can do so through MedWatch.

Mild side effects

Mild side effects* of budesonide ER oral tablets 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 budesonide ER oral tablets. To learn about other mild side effects, talk with your doctor or pharmacist, or view the drug’s prescribing information.

Serious side effects

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

Serious side effects and their symptoms can include:

* For more information about this side effect, see “Side effect details” below. † Over time, a high level of cortisol in your blood can cause your body to produce less cortisol naturally. Eventually, this can lead to a decreased level of cortisol in your blood.

Side effect details

Here are some details on certain side effects this drug may cause.

Increased level of cortisol

Budesonide ER oral tablets may increase the level of cortisol in the blood. Cortisol is a hormone that’s produced naturally in your body. Corticosteroids, such as budesonide, mimic the activity of cortisol in your body.

An increased level of cortisol wasn’t reported in clinical studies of the drug. However, this is a common side effect of corticosteroids.

With an increased level of cortisol, you may have the following symptoms:

If you’re concerned about an increased level of cortisol while taking budesonide ER oral tablets, talk with your doctor. They can recommend ways to lower your risk for this side effect, such as taking budesonide for only a short time.

Infections

Budesonide ER oral tablets can prevent the immune system from working properly. This may raise your risk for infections.

The most common infection reported in clinical studies of the drug was urinary tract infection. To find out how often this side effect happened in clinical studies, see the drug’s prescribing information.

The exact symptoms you experience will depend on the type of infection you may have. But common symptoms of infection include:

Talk with your doctor about your risk for infections with budesonide ER oral tablets. And be sure to tell them if you’ve been around anyone with an infection, especially measles and chickenpox. This is because you may have a higher risk for a more serious case of these infections while taking the drug. Your doctor will watch you closely for signs of infection during your budesonide treatment.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking budesonide ER oral tablets. This side effect wasn’t reported in initial studies of the drug. But allergic reaction has been reported after budesonide ER oral tablets became available for use.

Symptoms of a mild allergic reaction can include:

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

Call your doctor right away if you have an allergic reaction to budesonide ER oral tablets, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Here are answers to some frequently asked questions about budesonide ER oral tablets.

Is budesonide used for COVID-19?

Budesonide ER oral tablets are not currently approved to treat COVID-19. But other forms of budesonide have been used off-label for this purpose. (Off-label means taking a drug for a purpose other than its FDA-approved use.)

For example, a study has shown the budesonide dry powder inhaler may be effective for treating symptoms of COVID-19.

If you have questions about taking budesonide for COVID-19, talk with your doctor.

Does budesonide treat asthma or COPD? What’s the dosage for these conditions?

No, budesonide ER oral tablets are not currently approved to treat asthma or chronic obstructive pulmonary disease (COPD).

But the following forms of budesonide are approved to treat asthma:

Doctors may prescribe the inhaled and solution forms of budesonide off-label to treat COPD. (Off-label means taking a drug for a purpose other than its FDA-approved use.)

If you have questions about taking budesonide for asthma and COPD, including the dosages for each condition, talk with your doctor.

What should I know about budesonide vs. albuterol, fluticasone, Brovana, and formoterol?

Budesonide ER oral tablets are a corticosteroid approved to treat ulcerative colitis. But other forms of budesonide are approved to treat other conditions.

For example, the following forms of budesonide are approved to treat asthma:

Like these forms of budesonide, the corticosteroid fluticasone (Flovent HFA) is used to treat asthma.

In addition, the following drugs (which belong to a group of medications called beta-agonists) may be used to treat asthma or COPD:

Albuterol is a rescue inhaler. A rescue inhaler reduces symptoms of an asthma attack, such as shortness of breath. Arformoterol and formoterol are not rescue inhalers. They’re taken to prevent an asthma attack from happening.

For more details about how budesonide compares with albuterol, fluticasone, Brovana, and formoterol, talk with your doctor or pharmacist.

Is budesonide used for microscopic colitis, lymphocytic colitis, or eosinophilic esophagitis?

Budesonide isn’t currently approved to treat microscopic colitis, lymphocytic colitis,* or eosinophilic esophagitis. However, budesonide may be used off-label for microscopic colitis or lymphocytic colitis. (Off-label means taking a drug for a purpose other than its FDA-approved use.)

A budesonide slurry may be used off-label for eosinophilic esophagitis. (For details on this form of budesonide, see “What’s a budesonide slurry?” directly below.)

If you have questions about taking budesonide for these purposes, talk with your doctor.

* Lymphocytic colitis is a type of swelling in the colon caused by a buildup of white blood cells.

What’s a budesonide slurry? Are there side effects from taking the slurry?

Budesonide slurry is a form of budesonide that’s used off-label to treat eosinophilic esophagitis. A slurry is needed because the esophagus becomes severely swollen with eosinophilic esophagitis. This makes it difficult to swallow tablets.

The slurry is made using the liquid solution form of budesonide. The liquid is mixed with a sweetener, such as sucralose. The liquid mixture is then swallowed instead of being used with a nebulizer (which is how the solution is typically used).

You should not use budesonide ER oral tablets to make a slurry. These tablets should not be crushed.

Specific side effects of budesonide slurry haven’t been reported. But side effects have been reported for other corticosteroids that are applied to the esophagus. The most common side effect of these drugs is esophageal thrush (a fungal infection on the esophagus).

If you have questions about taking a budesonide slurry, talk with your doctor.

Will I have weight gain with budesonide?

It’s possible. Weight gain wasn’t a side effect reported in clinical studies of budesonide ER oral tablets. But weight gain is a common side effect of corticosteroids. (Budesonide is a corticosteroid.)

Keep in mind that budesonide can also cause swelling in your arms and legs. And this swelling can cause weight gain.

If you’re concerned about weight gain while taking budesonide ER oral tablets, talk with your doctor. They can suggest ways to manage your weight during your treatment.

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 strength

Budesonide ER oral tablets come in one strength: 9 milligrams (mg).

“ER” stands for extended release, which means your body slowly absorbs the drug over time. This allows for the drug to be taken once per day.

Note: The other forms of budesonide are available in different strengths. For example, budesonide capsules are available in one strength of 3 mg. For more information on budesonide’s other forms, talk with your doctor or pharmacist.

Dosage for ulcerative colitis

Budesonide ER oral tablets are used help achieve remission in adults with mild to moderate ulcerative colitis. Remission is a period of time without any symptoms.

For this condition, the drug’s typical dosage is one 9 mg tablet taken once per day.

What if I miss a dose?

If you miss a dose of budesonide ER oral tablets, take your missed dose as soon as you remember. But if it’s almost time for your next dose, just skip the missed dose and take your next dose at its regular time.

You should not take an extra dose of budesonide to make up for a missed dose. Doing this can increase your risk for side effects from the drug. (For more about side effects, see the “Budesonide ER oral tablets side effects” section above.)

To help make sure you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too.

Will I need to take this drug long term? How long can you take budesonide ER oral tablets?

Budesonide isn’t typically used as a long-term treatment. The drug is generally used for up to 8 weeks. But your doctor will determine how long you’ll need to take budesonide ER oral tablets for your condition.

The Food and Drug Administration (FDA) approves prescription drugs such as budesonide ER oral tablets to treat certain conditions. Budesonide may also be used off-label for other conditions. Off-label means taking a drug for a purpose other than its FDA-approved use.

Budesonide ER oral tablets for ulcerative colitis

Budesonide ER oral tablets are FDA-approved to treat mild to moderate ulcerative colitis in adults.

Ulcerative colitis is a type of inflammatory bowel disease. The condition causes inflammation (swelling) and ulcers (sores) in the large intestine. (The large intestine includes the colon and rectum.)

With ulcerative colitis, you may have periods of flares (active symptoms) and remission (no symptoms). Budesonide is used to help achieve remission in people who are having a flare.

Symptoms of ulcerative colitis can include:

Effectiveness for ulcerative colitis

Budesonide ER oral tablets have been found to be effective for treating ulcerative colitis.

Budesonide is a recommended treatment option in the following treatment guidelines:

For details on how budesonide performed in clinical studies, see the drug’s prescribing information.

Budesonide ER oral tablets and children

Budesonide ER oral tablets are not approved for children. It is not known if the drug is safe and effective for them.

Budesonide ER oral tablets are approved to treat mild to moderate ulcerative colitis in adults.

Ulcerative colitis is a type of inflammatory bowel disease. It causes inflammation (swelling) of the large intestine, which includes the colon and rectum. Ulcerative colitis leads to symptoms such as abdominal (belly) pain and diarrhea.

Budesonide ER oral tablets are used to help achieve remission in people who currently have symptoms of ulcerative colitis. (Remission is a period of time without any symptoms.) For more details about this condition, see the “Budesonide ER oral tablets uses” section above.

What budesonide ER oral tablets do

Budesonide belongs to a group of drugs called corticosteroids. The drug works* by reducing the swelling in your large intestine. This helps ease symptoms of ulcerative colitis.

Budesonide ER oral tablets contain a special coating that prevents the tablets from breaking down in your stomach. Instead, the tablets slowly break down in your large intestine. This allows the drug to be released and absorbed directly where the swelling is located.

* The way a drug works in your body is called its “mechanism of action.”

How long do they take to work?

Budesonide ER oral tablets begin working right after you take your first dose. But it may be several days before you notice reduced symptoms.

How long do they stay in your system?

The half-life of budesonide ER oral tablets can be used to figure out how long the drug stays in your system. The half-life of a drug is the time it takes for half of its dose to leave your body.

The half-life of budesonide ER oral tablets is about 2 to 3.6 hours. This means it takes about 2 to 3.6 hours for your body to get rid of half of a dose of budesonide.

It usually takes about five half-lives for a drug to leave your system entirely. For budesonide, this means the drug will stay in your system for about 10 to 18 hours after your last dose.

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

Examples of other drugs that may be used to treat ulcerative colitis include:

As with all medications, the cost of budesonide ER oral tablets can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Keep in mind that you may be able to get a 90-day supply of budesonide ER oral tablets. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor or your insurance company.

Before approving coverage for budesonide, your insurance company may require you to get prior authorization. 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 prior authorization request and decide if the drug will be covered.

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

Financial and insurance assistance

Financial assistance to help you pay for budesonide ER oral tablets may be available.

Medicine Assistance Tool and NeedyMeds are two websites offering resources that may help decrease the price you pay for budesonide ER oral tablets. They also offer tools to help you find low-cost healthcare, as well as educational resources. To learn more, visit their sites. You can also learn more about saving money on prescriptions here.

Mail-order pharmacies

Budesonide ER oral tablets may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If recommended by your doctor, you may be able to receive a 90-day supply of budesonide ER oral tablets, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor and your insurance company. Some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

There haven’t been studies on whether budesonide ER oral tablets can cause drug dependence. (With dependence, your body gets used to a drug and needs it to feel comfortable.)

But you may have withdrawal symptoms if you suddenly stop taking corticosteroids, such as budesonide. This may happen after you’ve used corticosteroids for a long time.

Symptoms of withdrawal from corticosteroids can include:

These symptoms can last only a few days or up to several months after you stop taking the drug.

If you’re concerned about your risk for withdrawal and dependence while taking budesonide, talk with your doctor. You should not stop taking budesonide unless your doctor recommends it. They can suggest ways to lessen your risk for withdrawal symptoms when it’s time to stop the drug.

There isn’t a known interaction between budesonide ER oral tablets and alcohol.

However, alcohol may worsen symptoms of ulcerative colitis. So in general, it’s recommended that you avoid alcohol if you have this condition. And because budesonide is used to treat ulcerative colitis, it may be best to avoid alcohol while taking the drug.

If you drink alcohol, talk with your doctor about how much alcohol (if any) is safe for you to drink during your budesonide treatment.

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

Note: For more information about the potential negative effects of budesonide ER oral tablets, see the “Budesonide ER oral tablets side effects” section above.

It’s not known if budesonide ER oral tablets are safe to take while pregnant. The drug hasn’t been studied during pregnancy.

However, animal studies have shown that budesonide is harmful to offspring of females that received budesonide during pregnancy. In animal studies, budesonide caused pregnancy loss, decreased offspring weight, and problems with bone structure. But keep in mind that animal studies don’t always predict what will happen in humans.

If you’re pregnant or planning to become pregnant while taking budesonide ER oral tablets, talk with your doctor. They’ll discuss the risks and benefits of budesonide treatment with you.

It’s not known whether it’s safe to take budesonide ER oral tablets during pregnancy. 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 taking budesonide.

For more information about taking budesonide ER oral tablets during pregnancy, see the “Budesonide ER oral tablets and pregnancy” section above.

It’s not known whether it’s safe to take budesonide ER oral tablets while breastfeeding. Taking this drug while breastfeeding hasn’t been studied. But it’s possible that budesonide may pass into breast milk.

If you’re breastfeeding or planning to breastfeed, talk with your doctor before taking budesonide.

Budesonide ER oral tablets can interact with several other medications. They 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 side effects or make them more severe.

Budesonide ER oral tablets and other medications

Below is a list of medications that can interact with budesonide ER oral tablets. This list does not contain all drugs that may interact with budesonide.

Before taking budesonide, 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 take. Sharing this information can help you avoid potential interactions.

Drugs that can raise your risk for side effects from budesonide ER oral tablets include:

Drugs that may make budesonide ER oral tablets less effective include:

If you take any of the above drugs or have questions about drug interactions, talk with your doctor or pharmacist before taking budesonide. They will advise if the drugs are safe to take together.

Budesonide ER oral tablets and herbs and supplements

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

Budesonide ER oral tablets and foods

You should not eat grapefruit or drink grapefruit juice while taking budesonide ER oral tablets. Grapefruit may increase your risk for side effects from budesonide. (To learn about possible side effects, see the “Budesonide ER oral tablets side effects” section above.)

If you have questions about eating certain foods while you’re taking budesonide, talk with your doctor.

You should take budesonide ER oral tablets according to the instructions your doctor or other healthcare professional gives you.

When to take

You’ll likely take budesonide ER oral tablets once per day, in the morning.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too.

Taking Budesonide ER oral tablets with food

Budesonide ER oral tablets can be taken with or without food.

Can Budesonide ER oral tablets be crushed, split, or chewed?

You should not crush, split, or chew budesonide ER oral tablets. The tablets should be swallowed whole.

If you have trouble swallowing tablets, talk with your doctor. They may suggest a drug other than budesonide.

Do not take more budesonide ER oral tablets than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much budesonide

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 use their online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

When you get budesonide ER oral tablets from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. 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 taking expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to take it.

Storage

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

Budesonide ER oral tablets should be stored at room temperature, 68°F to 77°F (20°C to 25°C). You should keep the tablets in a tightly sealed container away from light. Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take budesonide ER oral tablets 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 about how to dispose of your medication.

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 another 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.