What are the common side effects of budesonide tablets, capsules, and granules? Learn about the serious side effects to watch out for and how to manage them effectively.

Common Side Effects of Budesonide

Budesonide, a widely used medication, can cause various side effects, although not everyone experiences them. The common side effects of budesonide happen in more than 1 in 100 people and include:

Stomach Pain or Indigestion

To help cope with this, it may be helpful to stick to plain foods. If the pain is severe or does not go away, it’s best to talk to your doctor, as they may be able to prescribe an extra medicine to protect your stomach.

Headaches

Ensuring you rest and drink plenty of fluids, while limiting alcohol consumption, can be beneficial. You can also ask your pharmacist to recommend a painkiller. If the headaches last longer than a week or are severe, it’s advisable to speak with your doctor.

Muscle Pains

If you experience unusual muscle ache that is not from exercise or physical work, it’s a good idea to talk to your doctor or pharmacist.

Skin Reactions

Skin reactions such as a rash, acne, or wounds that do not heal should be discussed with your doctor or pharmacist.

Oral Thrush

Pain, discomfort, or white spots in the mouth or food pipe (thrush) can be a sign of an infection. Talk to your pharmacist or doctor, as they may prescribe something to treat the infection.

Serious Side Effects of Budesonide

It’s important to be aware of the serious side effects that may require immediate medical attention. If you experience any of the following, contact your doctor or call 111 straight away:

Signs of Infection

Symptoms like a high temperature, sore throat, ear or sinus pain, a change in mucus color, or a wound that won’t heal can be signs of an infection.

Cushing’s Syndrome

Weight gain in the upper back or tummy, a puffy, rounded face, severe headaches, and slow wound healing may indicate Cushing’s syndrome.

Adrenal Gland Problems

Feeling or being sick, dizziness, muscle weakness, mood changes, loss of appetite, and weight loss can be signs of adrenal gland problems.

Eye Problems

Changes in your eyesight, such as blurred vision or a cloudy lens in the eye, can be signs of increased pressure in your eyes (glaucoma) or a cataract.

Potassium Level Changes

Muscle pain or weakness, muscle cramps, or changes in your heart rate can be signs of low potassium levels.

Pancreas Problems

Severe stomach pain, severe back pain, feeling or being sick, or diarrhea can be signs of pancreas problems.

Mood Changes and Mental Health

You may notice mood changes and mental health problems while taking budesonide. Talk to your doctor or contact 111 if you experience:

• Feeling depressed
• Feeling high or having mood swings
• Feeling anxious, having problems sleeping, difficulty in thinking, or being confused and losing your memory
• Feeling, seeing, or hearing things that do not exist (hallucinations)
• Having strange and frightening thoughts, changing how you act, or having feelings of being alone

The higher the dose, the more intense the mood changes can be. If you experience any of these, it’s important to seek medical attention.

Serious Allergic Reaction

It’s possible to have a serious allergic reaction to budesonide (anaphylaxis). Call 999 or go to A&E immediately if you experience:

• A skin rash that may include itchy, red, swollen, blistered, or peeling skin
• Wheezing
• Tightness in the chest or throat
• Trouble breathing or talking
• Your mouth, face, lips, tongue, or throat start swelling

This could be a serious allergic reaction and may require immediate treatment in the hospital.

Long-Term Side Effects in Children and Teenagers

Taking budesonide at higher doses for a long time can slow down the normal growth of children and teenagers. Their doctor will monitor their height and weight carefully to spot any slowing down of their growth and make adjustments to the treatment if necessary.

Managing Side Effects

If the advice on how to cope with the common side effects does not help and a side effect is still bothering you or does not go away, it’s best to speak to a doctor or pharmacist. They can provide further guidance on managing the side effects and ensure your treatment is as effective and safe as possible.

Side effects of budesonide tablets, capsules and granules

Like all medicines, budesonide can cause side effects, although not everyone gets them.

Common side effects

Different brands of budesonide have different common side effects, so it’s best to check the leaflet in your medicine packet.

These common side effects of budesonide happen in more than 1 in 100 people. There are things you can do to help cope with them:

Stomach pain or indigestion

It may help to stick to plain food. If the pain is severe or does not go away, tell your doctor. They may be able to prescribe an extra medicine to protect your stomach.

Headaches

Make sure you rest and drink plenty of fluids. Try not to drink too much alcohol. Ask your pharmacist to recommend a painkiller. Talk to your doctor if the headaches last longer than a week or are severe.

Muscle pains

If you get unusual muscle ache that is not from exercise or physical work, talk to your doctor or pharmacist.

Skin reactions such as a rash, acne, or wounds that do not heal

Talk to your doctor or pharmacist.

Pain, discomfort or white spots in the mouth or food pipe (thrush)

This can happen with the tablets that dissolve on your tongue. These are signs of an infection (oral thrush or thrush in the food pipe). Talk to your pharmacist or doctor. They may give you something to treat the infection.

Speak to a doctor or pharmacist if the advice on how to cope does not help and a side effect is still bothering you or does not go away.

Serious side effects

Tell a doctor or contact 111 straight away if you get:

• a high temperature, a very sore throat, ear or sinus pain, a cough, coughing up more mucus (phlegm) or a change in colour of your mucus, pain when you pee, mouth sores or a wound that will not heal – these can be signs of an infection
• weight gain in your upper back or tummy, a puffy, rounded face (moon face), very bad headaches and slow wound healing – these can be signs of Cushing’s syndrome
• feeling or being sick (nausea or vomiting), very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, loss of appetite and weight loss – these can be signs of adrenal gland problems
• changes in your eyesight, such as blurred vision or a cloudy lens in the eye – these can be signs of increased pressure in your eyes (glaucoma) or a cataract
• muscle pain or weakness, muscle cramps, or changes in your heart rate – these can be signs of low potassium levels
• severe stomach pain, severe back pain, feeling or being sick or diarrhoea – these can be signs of pancreas problems

Go to 111. nhs.uk or call 111.

Immediate action required: Call 999 or go to A&E now if:

• you have black poo, black or dark brown vomit or you’re vomiting blood

Find your nearest A&E

Mood changes

You may notice mood changes and mental health problems while taking budesonide.

Talk to your doctor or contact 111 if you have any mood changes including:

• feeling depressed
• feeling high, or moods that go up and down
• feeling anxious, having problems sleeping, difficulty in thinking, or being confused and losing your memory
• feeling, seeing or hearing things that do not exist (hallucinations)
• having strange and frightening thoughts, changing how you act, or having feelings of being alone

The higher the dose, the more intense the mood changes can be.

Go to 111.nhs.uk or call 111.

Immediate action required: Call 999 or go to A&E if:

Serious allergic reaction

It’s possible to have a serious allergic reaction to budesonide (anaphylaxis).

Immediate action required: Call 999 or go to A&E now if:

• you get a skin rash that may include itchy, red, swollen, blistered or peeling skin
• you’re wheezing
• you get tightness in the chest or throat
• you have trouble breathing or talking
• your mouth, face, lips, tongue or throat start swelling

You could be having a serious allergic reaction and may need immediate treatment in hospital.

Long-term side effects

Children and teenagers

Taking budesonide at higher doses for a long time can slow down the normal growth of children and teenagers.

Your child’s doctor will monitor their height and weight carefully for as long as they’re taking this medicine. This will help them spot any slowing down of your child’s growth and change their treatment if needed.

Even if your child’s growth slows down, it does not seem to have much effect on their eventual adult height.

Talk to your doctor if you’re worried. They will be able to explain the benefits and risks of giving your child budesonide.

Other long-term side effects

Most people will not need to take budesonide for a long time.

If you do need to take it for a long time, side effects are less likely than with some other steroid medicines, because budesonide works mainly in your gut, liver or food pipe and does not reach the rest of your body.

But there’s still a chance of long-term side effects if you take budesonide for a long time. These could include changes in your mood, problems with your adrenal glands, eyesight problems, weak bones (osteoporosis) and Cushing’s syndrome.

Other side effects

These are not all the side effects of budesonide tablets, capsules and granules. For a full list see the leaflet inside your medicines packet.

Information:

You can report any suspected side effect using the Yellow Card safety scheme.

Visit Yellow Card for further information.

Page last reviewed: 14 June 2022

Next review due: 14 June 2025

Budesonide: MedlinePlus Drug Information

pronounced as (bue des’ oh nide)

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Budesonide (Entocort EC) is used to treat Crohn’s disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever). Budesonide (Tarpeyo) is used to decrease protein in the urine in patients with primary immunoglobulin A nephropathy (kidney disease that occurs in some people when too much immunoglobin A builds up in the kidney, causing inflammation). Budesonide is in a class of medications called corticosteroids. It works by decreasing inflammation (swelling) in the digestive tract of people who have Crohn’s disease or in the kidney of people with nephropathy.

Budesonide comes as a capsule to take by mouth. It is usually taken once a day in the morning. Take budesonide at around the same time every day. Budesonide (Tarpeyo) should be taken at least one hour before a meal. Your doctor will tell you how long to take budesonide. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take budesonide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not split, chew, or crush them. If you are unable to swallow the budesonide (Entocort EC) capsules whole, the capsules may be opened and sprinkled on a tablespoonful of apple sauce, mixed well and swallowed whole with no chewing within 30 minutes of mixing. The applesauce mixture should be followed by a full glass of water.

Budesonide may help control your symptoms, but it will not cure your condition. Your doctor will watch you carefully to see how well budesonide works for you. If your symptoms are controlled, your doctor may decrease your dose of budesonide. After your symptoms have been controlled for 3 months, your doctor may slowly decrease your dose and then stop treating you with this medication. It is important to tell your doctor how you are feeling during your treatment.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking budesonide,

• tell your doctor and pharmacist if you are allergic to budesonide, or any other medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: cyclosporine, erythromycin, ketoconazole, indinavir, itraconazole, ritonavir, and saquinavir. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with budesonide, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor if you or anyone in your family has had diabetes (high blood sugar) or glaucoma, or if you have tuberculosis, high blood pressure, osteoporosis (a condition in which the bones become thin and weak and break easily), stomach ulcer, cataracts, or liver disease.
• tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant, or are breast-feeding. If you become pregnant while taking budesonide, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking budesonide.
• tell your doctor if you have never had chicken pox or measles and you have not been vaccinated against these infections. Stay away from people who are sick, especially people who have chicken pox or measles. If you are exposed to one of these infections or if you develop symptoms of one of these infections, call your doctor right away. You may need treatment to protect you from these infections.

Do not eat grapefruit or drink grapefruit juice while taking this medication.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Budesonide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• dizziness
• runny nose, sneezing, coughing
• nausea
• indigestion
• abdominal pain
• dry, itchy skin
• gas
• vomiting
• fatigue
• back pain
• pain
• muscle cramps

Some side effects can be serious.

If you experience any of these symptoms, call your doctor immediately:

• itching
• skin rash
• fever
• swelling of face and neck
• difficulty breathing
• severe headache
• changes in vision
• acne
• bruising
• swelling of the legs or arms
• fatty pad or hump between your shoulders
• pink or purple stretch marks on the skin of your stomach, thighs, breasts or arms

Budesonide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication or if your symptoms get worse.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.