Budesonide

Budesonide is a prescription medication used for the treatment of Crohn’s disease, ulcerative colitis, and primary immunoglobulin A-type nephropathy.

• Budesonide is available under the following different brand names: Entocort EC, Uceris, Ortikos, Tarpeyo

Adult and pediatric dosage

Capsule, delayed-release

• 3mg (Entocort EC)
• 4mg (Tarpeyo)
• 6mg (Ortikos)
• 9mg (Ortikos)

Tablet, extended-release

• 9mg (Uceris)

Ulcerative Colitis

Adult dosage

• 9 mg orally every morning for up to 8 weeks

Crohn’s disease

Adult dosage

Induction

• 9 mg orally every morning for up to 8 weeks; for recurring episodes of active disease, 8-week courses may be repeated

Maintenance

• 6 mg  orally every morning for up to 3 months
• If symptom control is maintained at 3 months, tapering to complete cessation may be attempted (recommended)

Pediatric dosage

• Children below 8 years: Safety and efficacy not established
• Children above 8 years and weighing above 25 kg: 9 mg orally every morning for up to 8 weeks, followed by 6 mg every morning for 2 weeks

Primary Immunoglobulin A Nephropathy

Tarpeyo only

Adult dosage

• 16 mg orally every day
• Therapy duration: 9 Months
• When discontinuing, reduce to 8 mg orally every day  for the last 2 weeks of therapy

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Budesonide include:

• headache,
• abdominal pain,
• respiratory infection,
• gas,
• nausea,
• vomiting,
• back pain,
• tiredness,
• indigestion,
• pain, and
• dizziness.

Serious side effects of Budesonide include:

• acne
• bruise easily
• rounding of the face (moon face)
• ankle swelling
• thicker or more hair on the body and face
• a fatty pad or hump between the shoulders (buffalo hump)
• pink or purple stretch marks on the skin of the abdomen, thighs, breasts, and arms
• tiredness, 
• weakness, 
• nausea and vomiting,
• low blood pressure,
• worsening of allergy,
• fever,
• chills,
• pain,
• feeling tired, and
• aches.

Rare side effects of Budesonide include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Budesonide has severe interactions with the following drugs:
  • lopinavir
  • mifepristone
  • ribociclib
• Budesonide has serious interactions with at least 76 other drugs.
• Budesonide has moderate interactions with at least 228 other drugs.
• Budesonide has minor interactions with at least 105 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Documented hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Budesonide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Budesonide?”

Cautions

• When used chronically, systemic effects (eg, hypercorticism, adrenal suppression) may occur; glucocorticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress; if patients are subject to surgery or other stress situations, supplement with a systemic glucocorticosteroid
• Caution in patients who are transferred from glucocorticosteroid treatment with higher systemic effects to those with lower systemic effects (e.g., budesonide); monitor for symptoms of steroid withdrawal, including those of acute adrenal suppression or benign intracranial hypertension
• Drugs that suppress the immune system, including budesonide, may increase the risk for infection; patients who have not had certain infections (e.g., chickenpox, measles) can have more serious infections, including fatalities
• Reduced liver function affects the elimination of glucocorticosteroids; increased systemic availability of oral budesonide demonstrated with liver cirrhosis; consider discontinuing use in patients with moderate-to-severe liver disease
• Caution with hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with other conditions where glucocorticosteroids may have unwanted effects
• Drug interaction overview
  • Substrate of CYP3A4
  • CYP3A4 inhibitors or inducers
  • Coadministration with potent CYP3A4 inhibitors may increase systemic exposure; oral ketoconazole (inhibits CYP3A4 in liver and intestine) caused an 8-fold increase of the systemic exposure to oral budesonide
  • If treatment with CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin) is indicated, consider discontinuing budesonide
  • Extensive intake of grapefruit juice (inhibits CYP3A4 activity predominantly in the intestine) increase oral budesonide systemic exposure ~2-fold; avoid coadministration
  • Conversely, CYP3A4 inducers may decrease budesonide systemic exposure
  • Drugs that inhibit gastric acid secretion
  • Uceris: Dissolution of the tablet coating is pH-dependent; release properties and uptake of the compound may be altered when used after treatment with gastric acid-reducing agents (e.g., PPIs, H2-blockers, antacids)

Pregnancy and Lactation

• Available data from published case series, epidemiological studies, and reviews with oral budesonide use in pregnant females have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
• Clinical considerations
  • Studies showed an association of adverse pregnancy outcomes in women with Crohn's disease, including preterm birth and low birth weight infants, during periods of increased disease activity (including increased stool frequency and abdominal pain)
  • IgA nephropathy in pregnancy is associated with adverse maternal outcomes, including increased rates of cesarean section, pregnancy-induced hypertension, pre-eclampsia, and preterm delivery, and adverse fetal/neonatal outcomes, including stillbirth and low birth weight
  • Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy; carefully observe infants for signs of hypoadrenalism (eg, poor feeding, irritability, weakness, vomiting), and managed accordingly
• Lactation
  • Breastfeeding is not expected to result in significant exposure of the infant
  • No lactation studies have been conducted; no information is available on effects on infants or effects on milk production
  • One published study reports that budesonide is present in human milk following maternal inhalation of budesonide
  • Routine monitoring of linear growth in infants is recommended with chronic use of budesonide in nursing mother