Budesonide Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 10, 2024.

Applies to budesonide: inhalation powder, inhalation suspension.

Other dosage forms:

• oral capsule delayed release, oral capsule extended release, oral tablet extended release
• rectal foam

Serious side effects of budesonide

Along with its needed effects, budesonide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking budesonide:

Other side effects of budesonide

Some side effects of budesonide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Precautions

It is very important that your doctor check you or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects caused by this medicine.

You or your child should not use this medicine if your asthma attack has already started. Your doctor will prescribe another medicine (e.g., a short-acting inhaler) for you to use in case of an acute asthma attack. Call your doctor if you have any questions about this.

If your or your child's symptoms do not improve within one to two weeks, or if they become worse, check with your doctor.

This medicine may weaken your immune system. Avoid being around people who are sick or who have infections such as chickenpox or measles. Tell your doctor right away if you think you or your child have been exposed to chickenpox or measles.

If you or your child develop a skin rash, hives, or any type of allergic reaction (including anaphylaxis) to this medicine, stop using the medicine and check with your doctor as soon as possible.

This medicine may also increase your risk of having infections or sores in your mouth or throat. Check with your doctor right away if you or your child have any signs of a throat infection.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, talk to your doctor.

This medicine may cause children to grow more slowly than normal. This would cause a child to not gain weight or get taller. Talk with your child's doctor if you think this is a problem or if you have any concerns.

This medicine may increase your risk of having an adrenal gland that is less active than normal. The adrenal gland makes steroids for your body. This is more likely for people who use steroids for a long time or use high doses. Check with your doctor right away if you or your child have more than one of the following symptoms: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. Rarely, menstrual cycle changes, acne, pimples, or weight gain (fat deposits) around the face, neck, and trunk may occur while using this medicine.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

Make sure any doctor or dentist knows that you or your child are using this medicine. You might need to stop using this medicine several days before having surgery.

Your doctor may want you or your child to carry a medical identification card that says this medicine is being used. You or your child may need additional medicine during an emergency, a severe asthma attack, an illness, or unusual stress.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

For healthcare professionals

Applies to budesonide: compounding powder, inhalation powder, inhalation suspension, oral capsule extended release, oral delayed release capsule, oral suspension, oral tablet extended release, rectal foam.

General adverse events

The most commonly reported adverse events with inhaled use have included nasopharyngitis, nasal congestion pharyngitis, rhinitis, and oral candidiasis. Headache, nausea, abdominal pain, and fatigue have been commonly reported with oral and rectal use. Due to the nature of its administration (inhalation, gastro-protective oral formulations, and rectal enema), it is less likely to cause systemic adverse effects associated with the use of corticosteroids.^[Ref]

Respiratory

• Very common (10% or more): Respiratory infection (up to 13%)
• Common (1% to 10%): Nasopharyngitis, nasal congestion, pharyngitis, allergic rhinitis, viral upper respiratory tract infection, epistaxis, cough, dysphonia, hoarseness
• Frequency not reported: Bronchitis, dyspnea, pharynx disorder, pneumonia
• Postmarketing reports: Throat irritation, sinusitis^[Ref]

Endocrine

• Common (1% to 10%): Decreased blood cortisol, moon face
• Uncommon (0.1% to 1%): Hirsutism, Cushingoid syndrome
• Frequency not reported: Intermenstrual bleeding, menstrual disorder, HPA axis suppression, deaths due to adrenal insufficiency
• Postmarketing reports: Hypocorticism^[Ref]

Immunologic

• Common (1% to 10%): Oral candidiasis
• Frequency not reported: Immunosuppression, abscess, bronchospasm in patients with severe milk protein hypersensitivity^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (up to 13%); abdominal pain (21%)
• Common (1% to 10%): Viral gastroenteritis, gastrointestinal mucosal candidiasis, upper abdominal pain, flatulence, abdominal distension, constipation, dyspepsia, vomiting, diarrhea, sore/irritated throat, dry mouth, bad taste, rectal disorder, rectal hemorrhage, ulcerative colitis, burning in the rectum or pain
• Frequency not reported: Anus disorder, enteritis, epigastric pain, gastrointestinal fistula, glossitis, hemorrhoids, intestinal obstruction, tongue edema, tooth disorder
• Postmarketing reports: Pancreatitis^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 28%)
• Common (1% to 10%): Dizziness
• Uncommon (0.1% to 1%): Disturbance of smell
• Very rare (less than 0.01%): Pseudotumor cerebri (including papilledema)
• Frequency not reported: Hyperkinesia, paresthesia, tremor, somnolence
• Postmarketing reports: Benign intracranial hypertension^[Ref]

Psychiatric

• Common (1% to 10%): Mood changes, sleep changes, insomnia,
• Frequency not reported: Amnesia
• Postmarketing reports: Psychosis, depression, aggressive reactions, irritability, nervousness, restlessness, anxiety, mood swings^[Ref]

Hypersensitivity

• Frequency not reported: Hypersensitivity reactions including anaphylaxis, rash, contact dermatitis, urticaria, angioedema, bronchospasm
• Postmarketing reports: Cough, wheezing, bronchospasm^[Ref]

Musculoskeletal

• Very common (10% or more): Muscle spasms (12%)
• Common (1% to 10%): Arthralgia, back pain
• Very rare (less than 0.01%): Osteoporosis, aseptic necrosis of bone (femur and head of the humerus)
• Frequency not reported: Bone mineral density reductions, arthritis, myalgia, growth suppression^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (12%), peripheral edema (17%)
• Common (1% to 10%): Fluid retention, palpitation

Uncommon (0.1% to 1%):

• Frequency not reported: Tachycardia, chest pain, flushing^[Ref]

Metabolic

• Frequency not reported: Weight gain, increased appetite, hypokalemia^[Ref]

Hematologic

• Common (1% to 10%): Leukocytosis
• Uncommon (0.1% to 1%): Anemia
• Rare (0.01% to 0.1%): Eosinophilic conditions, Churg-Strauss^[Ref]

Ocular

• Common (1% to 10%): Conjunctivitis
• Frequency not reported: Eye abnormality, abnormal vision
• Postmarketing reports: Glaucoma, cataracts, increased intraocular pressure^[Ref]

Genitourinary

• Common (1% to 10%): Urinary tract infection, moniliasis
• Frequency not reported: Dysuria, micturition frequency, nocturia^[Ref]

Dermatologic

• Very common (10% or more): Acne (11%)
• Common (1% to 10%): Rash, contact dermatitis, eczema, pustular rash, pruritus, purpura
• Very rare (less than 0.01%): Allergic exanthema, red striae, petechiae, ecchymosis, delayed wound healing
• Frequency not reported: Face edema, alopecia, dermatitis, eczema, skin disorder, increased sweating, purpura
• Postmarketing reports: Skin bruising^[Ref]

Hepatic

• Uncommon (0.1% to 1%): Increase in liver enzymes^[Ref]

Other

• Common (1% to 10%): Otitis media, fatigue, earache
• Frequency not reported: Asthenia, malaise, fever, flu-like disorder, vertigo^[Ref]

See also:

Frequently asked questions

• Can asthma inhalers cause a sore throat?

Further information

Budesonide side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer