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Budesonide (Systemic)

Medically reviewed by Drugs.com. Last updated on Jul 13, 2020.

Pronunciation

(byoo DES oh nide)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule Delayed Release Particles, Oral:

Entocort EC: 3 mg

Generic: 3 mg

Capsule Extended Release 24 Hour, Oral:

Ortikos: 6 mg, 9 mg [contains corn starch]

Tablet Extended Release 24 Hour, Oral:

Uceris: 9 mg [contains soybean lecithin]

Generic: 9 mg

Brand Names: U.S.

  • Entocort EC
  • Ortikos
  • Uceris

Pharmacologic Category

  • Corticosteroid, Systemic

Pharmacology

Budesonide, a glucocorticoid with high topical potency and limited systemic effects, depresses the activity of endogenous chemical mediators of inflammation (eg, kinins, prostaglandins). Oral budesonide formulations allow for targeted, pH-dependent budesonide release in the treatment of IBD (eg, Crohn disease, ulcerative colitis). The controlled release capsule contains enteric coated granules that dissolve at a pH ≥5.5, delivering budesonide to the ileum and ascending colon. The multimatrix enteric coated tablet dissolves at a pH ≥7, delivering budesonide to the entire colon (Abdalla 2016; Iborra 2014).

Distribution

Children ≥9 years and Adolescents ≤14 years: IV: 2.2 ± 0.4 L/kg

Adults: 2.2 to 3.9 L/kg

Metabolism

Hepatic via CYP3A4 to two metabolites: 16 alpha-hydroxyprednisolone and 6 beta-hydroxybudesonide; both are <1% as active as parent

Excretion

Urine (60%) and feces as metabolites

Time to Peak

Capsules: Children ≥9 years of age and adolescents ≤14 years of age: Median: 5 hours; Adults: 0.5 to 10 hours; Tablet (extended release): 13.3 ± 5.9 hours.

Half-Life Elimination

Children ≥9 years of age and adolescents ≤14 years of age: IV: 1.9 hours.

Adults: IV: 2 to 3.6 hours; Capsule (delayed release): 6.3 ± 1.6 hours (range: 2 to 8 hours).

Protein Binding

85% to 90%

Special Populations: Hepatic Function Impairment

Increased systemic exposure (≥2.5 fold) has been reported in moderate hepatic impairment.

Use: Labeled Indications

Crohn disease, mild to moderate (capsules): Treatment of active Crohn disease (mild to moderate) involving the ileum and/or the ascending colon in patients ≥8 years of age; maintenance of clinical remission (for up to 3 months) of Crohn disease (mild to moderate) involving the ileum and/or the ascending colon in adults

Ulcerative colitis (tablets): Induction of remission in patients with active ulcerative colitis (mild to moderate)

Off Label Uses

Eosinophilic esophagitis

Data from controlled trials and meta-analyses indicate that budesonide inhalational suspension, compounded into a viscous suspension and swallowed rather than inhaled, is effective at improving the clinicopathologic features of eosinophilic esophagitis [Chuang 2015], [Dohil 2010], [Murali 2016], [Straumann 2010].

Guidelines from the American College of Gastroenterology and consensus recommendations from the American Gastroenterological Association (AGA) Institute/North American Society of Pediatric Gastroenterology, Hepatology, and Nutrition on the management of eosinophilic esophagitis recommend oral administration of inhalational corticosteroids (eg, fluticasone, budesonide) as first-line therapy in adults and children with eosinophilic esophagitis and that the corticosteroid type and duration of therapy be individualized. They note that symptoms often recur upon discontinuation, and steroid resistance has been reported [ACG [Dellon 2013]], [AGA/NASPGHAN [Furuta 2007]], [Liacouras 2011]. AGA Institute/Joint Task Force on Allergy-Immunology Practice Parameters guidelines also recommend oral administration of inhalational corticosteroids over oral glucocorticosteroid therapy or no treatment for patients with eosinophilic esophagitis [AGA/JTF [Hirano 2020]].

Microscopic (lymphocytic and collagenous) colitis

Data from multiple small randomized, double-blind, placebo-controlled trials support the use of budesonide as an effective treatment for induction of clinical remission and histological improvement in patients with active lymphocytic colitis [Miehlke 2009], [Miehlke 2018]. Data from multiple small, randomized, double-blind, placebo-controlled trials support the use of budesonide as an effective treatment for the induction and maintenance of clinical remission, histological improvement, and quality of life improvement in patients with active collagenous colitis [Bonderup 2009], [Madisch 2005], [Miehlke 2002], [Miehlke 2008], [Miehlke 2014].

Based on the AGA Institute Guideline on the Medical Management of Microscopic Colitis, budesonide is recommended as first line therapy for the induction and maintenance of clinical remission in patients with symptomatic microscopic colitis.

Contraindications

Hypersensitivity to budesonide or any component of the formulation

Documentation of allergenic cross-reactivity for corticosteroids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Canadian labeling: Additional contraindications (not in US labeling): Active tuberculosis; systemic or local bacterial, fungal or viral infections; hypersensitivity to soya, lecithin (derived from soya oil, peanut oil), or peanut (Cortiment)

Dosing: Adult

Crohn disease, mild to moderate (active): Oral: Capsules: 9 mg once daily in the morning for up to 8 weeks; recurring episodes may be treated with a repeat 8-week course of treatment.

Maintenance of remission: Following treatment of active disease (control of symptoms with Crohn Disease Activity Index [CDAI] <150), treatment may be continued at a dosage of 6 mg once daily for up to 3 months. If symptom control is maintained for 3 months, tapering of the dosage to complete cessation is recommended. Continued dosing beyond 3 months has not been demonstrated to result in substantial benefit.

Eosinophilic esophagitis (off-label use): Oral:

Note: Individualize dose. Optimal dosing has not been established. Swallow oral budesonide viscous liquid/suspension slowly over 5 to 10 minutes (ACG [Dellon 2013]; AGA/NASPGHAN [Furuta 2007]; Contreras 2014; Dellon 2017; Dohil 2010).

Induction therapy: 2 mg/day as an oral budesonide viscous liquid/suspension; may divide into 2 doses (ACG [Dellon 2013]; Liacouras 2011; Straumann 2010). Note: Duration of induction therapy is up to 12 weeks followed by assessment of symptomatic response (eg, dysphagia). Once remission is achieved, the dose may be gradually lowered to an individualized maintenance dose (Dellon 2014; Dellon 2017).

Maintenance therapy: 0.5 to 1 mg/day; may divide into 2 doses (ACG [Dellon 2013]; Hirano 2020; Straumann 2011).

Microscopic (lymphocytic and collagenous) colitis (off-label use): Oral:

Induction: 9 mg once daily for 6 to 8 weeks (AGA [Nguyen 2016]; Miehlke 2002; Miehlke 2018). After clinical remission (<3 stools daily and no watery stools) and following at least 8 weeks of therapy, some experts suggest to gradually taper the dose to 6 mg for 2 weeks, followed by 3 mg for 2 weeks, then discontinue (Dietrich 2019).

Maintenance/relapse therapy: Note: For patients who have had a clinical relapse after cessation of induction therapy (AGA [Nguyen 2016]). 6 mg once daily, then taper to the lowest effective dose and continue for 6 to 12 months (AGA [Nguyen 2016]; Bonderup 2009; Miehlke 2008); alternatively, 3 mg/day alternating with 6 mg/day over 12 months may be used (AGA [Nguyen 2016]).

Ulcerative colitis (active): Oral: Tablet: 9 mg once daily in the morning for up to 8 weeks.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Crohn disease (mild to moderate); treatment:

Manufacturer's labeling: Children ≥8 years and Adolescents weighing >25 kg: Oral: Capsule (Entocort EC): 9 mg once daily for up to 8 weeks then 6 mg once daily for 2 weeks

Alternate dosing: Limited data available: Children ≥6 years and Adolescents: Oral: Capsule (Entocort EC): Induction: 9 mg once daily or in divided doses every 8 hours for 7 to 8 weeks, followed by a maintenance dose of 6 mg daily for 3 to 4 weeks; therapy was discontinued after a total duration of 10 to 12 weeks (Escher 2004; Levine 2003; Levine 2009). In another study of patients 10 to 19 years of age, a trend for higher remission rates using an initial dose of 12 mg daily for 4 weeks, followed by 9 mg daily for 3 weeks, followed by 6 mg daily for 3 weeks was observed (Levine 2009).

Eosinophilic esophagitis: Limited data available: Note: Requires extemporaneous preparation of oral viscous budesonide suspension using the inhalation suspension (see Extemporaneous Preparations). Although there are other dosage forms of oral budesonide, they are enteric coated and should not be used for this indication; therapeutic efficacy for eosinophilic esophagitis requires topical corticosteroid effect in the esophagus. After administration of a budesonide dose, avoid ingesting any solid or liquid food for at least 30 minutes.

Children <10 years: Oral: Viscous liquid/suspension (using inhalation suspension): Initial: 1 mg once daily or divided twice daily. (Aceves 2005; Aceves 2007; Liacouras 2011; Rubinstein 2014)

Children ≥10 years and Adolescents: Oral: Viscous liquid/suspension (using inhalation suspension): 2 mg once daily or divided twice daily (Aceves 2007; Liacouras 2011; Rubinstein 2014)

Protein-losing enteropathy (PLE) following Fontan: Limited data available: Children ≥7 years and Adolescents: Oral capsule (Entocort EC): Initial: 9 mg once daily or in divided doses every 8 hours; after clinical improvement and albumin >3 g/dL may then wean dose over several weeks to 3 mg once daily or every other day; if during the weaning process the serum albumin decreases to <2.5 g/dL, do not further reduce dose, consider dosage increase. Dosing based on several case series describing institutional experiences, the majority of pediatric patients described were ≥7 years of age (n=17) (John 2011; Schumacher 2011; Thacker 2010; Turner 2012). Reported experience in children <7 years is very limited (n=1); in one report, an initial dose of 6 mg once daily was recommended for children <4 years (Thacker 2010).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Extemporaneously Prepared

Oral viscous budesonide liquid/suspension: An oral viscous budesonide suspension may be made using nebulization suspension (eg, Pulmicort Respules) and Splenda (sucralose) packets. Mix 10 packets of Splenda (10 g sucralose) for every 1 mg of budesonide until slurry is formed. Respules/vials containing budesonide 0.5 mg/2 mL is reported most often and provides a volume of ~8 to 12 mL. Use of 2.5 mL of Neocate Nutra for every 1 mg of budesonide has also been reported. Oral viscous budesonide suspension should be prepared immediately prior to ingestion (Aceves 2007; Dohil 2010; Rubinstein 2014).

Aceves SS, Bastian JF, Newbury RO, Dohil R. Oral viscous budesonide: a potential new therapy for eosinophilic esophagitis in children. Am J Gastroenterol. 2007;102(10):2271-227917581266Dohil R, Newbury R, Fox L, Bastian J, Aceves S. Oral viscous budesonide is effective in children with eosinophilic esophagitis in a randomized, placebo-controlled trial. Gastroenterology. 2010;139(2):418-429.20457157Rubinstein E, Lee JJ, Fried A, et al. Comparison of 2 delivery vehicles for viscous budesonide to treat eosinophilic esophagitis in children. J Pediatr Gastroenterol Nutr. 2014;59(3):317-320.24821535

Administration

Oral:

Capsule, extended release: Administer in the morning without regard to meals. Swallow whole; do not crush or chew.

Capsule, delayed release: Administer in the morning without regard to meals. Swallow whole; do not crush or chew. However, if unable to swallow capsule, may be opened and granules sprinkled onto 1 tablespoonful of applesauce (applesauce should be soft enough to swallow without chewing and should not be hot); mix granules with applesauce and consume within 30 minutes of mixing; do not save the mixture for later use. Do not chew or crush granules. Follow with 8 oz of cool water.

Tablet: Swallow whole; do not crush, chew, or break. Administer in the morning without regard to meals.

Viscous liquid/suspension (off-label use): Swallow viscous liquid/suspension (oral inhalation preparation) slowly over 5 to 10 minutes immediately after preparation. Avoid ingesting any solid or liquid food, brushing teeth, or rinsing mouth for at least 30 minutes after budesonide administration (ACG [Dellon 2013]; AGA/NASPGHAN [Furuta 2007]; Contreras 2014; Dellon 2017; Dohil 2010; Rubinstein 2014). When administering twice daily, preferably take after breakfast and before bedtime (Richter 2016).

Bariatric surgery: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate.

Capsule, delayed release: Capsule may be opened and contents sprinkled onto soft food of choice. Patient should be instructed to swallow the mixture without biting down or chewing.

Tablet, extended release: Do not cut, crush, or chew. Switch to Entocort EC; capsule may be opened and contents sprinkled onto soft food of choice. Mixture should be swallowed immediately without chewing.

Dietary Considerations

Avoid grapefruit juice.

Storage

Store at 20°C to 25°C (68°C to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light and moisture.

Drug Interactions

Abametapir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination

Antacids: May decrease the bioavailability of Corticosteroids (Oral). Management: Consider separating doses by 2 or more hours. Budesonide enteric coated tablets could dissolve prematurely if given with drugs that lower gastric acid, with unknown impact on budesonide therapeutic effects. Consider therapy modification

Baricitinib: Immunosuppressants may enhance the immunosuppressive effect of Baricitinib. Management: Use of baricitinib in combination with potent immunosuppressants such as azathioprine or cyclosporine is not recommended. Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted. Consider therapy modification

BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

Bile Acid Sequestrants: May decrease the absorption of Corticosteroids (Oral). Monitor therapy

Cladribine: May enhance the immunosuppressive effect of Immunosuppressants. Avoid combination

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy

Conivaptan: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Budesonide (Systemic). Management: Avoid the concomitant use of CYP3A4 inhibitors and oral budesonide. If patients receive both budesonide and CYP3A4 inhibitors, they should be closely monitored for signs and symptoms of corticosteroid excess. Exceptions: Grapefruit Juice. Consider therapy modification

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Budesonide (Systemic). Management: Avoid the concomitant use of CYP3A4 inhibitors and oral budesonide. If patients receive both budesonide and a strong CYP3A4 inhibitor, they should be closely monitored for signs and symptoms of corticosteroid excess. Consider therapy modification

Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Management: Consider avoiding Echinacea in patients receiving therapeutic immunosuppressants. If coadministered, monitor for reduced efficacy of the immunosuppressant during concomitant use. Consider therapy modification

Erdafitinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Grapefruit Juice: May increase the serum concentration of Budesonide (Systemic). Avoid combination

Idelalisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Inebilizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy

Larotrectinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification

MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Consider therapy modification

Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination

Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Management: Avoid use of immunosuppressants (including systemic corticosteroids) prior to initiation of nivolumab. Use of immunosuppressants after administration of nivolumab (eg, for immune-related toxicity) is unlikely to affect nivolumab efficacy. Consider therapy modification

Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy

Ozanimod: Immunosuppressants may enhance the immunosuppressive effect of Ozanimod. Monitor therapy

Palbociclib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Monitor therapy

Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Management: Consider avoiding concomitant use of roflumilast and immunosuppressants as recommended by the Canadian product monograph. Inhaled or short-term corticosteroids are unlikely to be problematic. Consider therapy modification

Simeprevir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Siponimod: Immunosuppressants may enhance the immunosuppressive effect of Siponimod. Monitor therapy

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Management: Evaluate patients to see if it is medically appropriate to reduce or discontinue therapy with immunosuppressants prior to initiating sipuleucel-T therapy. Consider therapy modification

Smallpox and Monkeypox Vaccine (Live): Immunosuppressants may diminish the therapeutic effect of Smallpox and Monkeypox Vaccine (Live). Monitor therapy

Stiripentol: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy

Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Consider therapy modification

Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Adverse Reactions

>10%:

Central nervous system: Headache (15% to 21%)

Dermatologic: Acne vulgaris (15%)

Endocrine & metabolic: Decreased cortisol (foam 17%; tablets 2% to 4%), bruise (15%), moon face (11%)

Gastrointestinal: Nausea (2% to 11%)

Respiratory: Respiratory tract infection (11%)

1% to 10%:

Cardiovascular: Chest pain (<5%), edema (<5%), facial edema (<5%), flushing (<5%), hypertension (<5%), palpitations (<5%), tachycardia (<5%)

Central nervous system: Dizziness (<5% to 7%), fatigue (3% to 5%), agitation (<5%), amnesia (<5%), confusion (<5%), drowsiness (<5%), insomnia (<5%), malaise (<5%), nervousness (<5%), paresthesia (<5%), sleep disorder (<5%), vertigo (<5%)

Dermatologic: Alopecia (<5%), dermatitis (<5%), dermatological disease (<5%), diaphoresis (<5%), eczema (<5%)

Endocrine & metabolic: Hirsutism (≤5%), hypokalemia (1% to <5%), intermenstrual bleeding (<5%), menstrual disease (<5%), weight gain (<5%), adrenocortical insufficiency (foam 4%; capsules >1%), redistribution of body fat (1%)

Gastrointestinal: Diarrhea (10%), dyspepsia (6%), anal disease (<5%), enteritis (<5%), epigastric pain (<5%), exacerbation of Crohn's disease (<5%), gastrointestinal fistula (<5%), glossitis (<5%), hemorrhoids (<5%), increased appetite (<5%), intestinal obstruction (<5%), oral candidiasis (<5%), upper abdominal pain (3% to 4%), flatulence (3%), abdominal distention (2%), constipation (2%)

Genitourinary: Urinary tract infection (2% to <5%), dysuria (<5%), nocturia (<5%), urinary frequency (<5%), hematuria (≥1%), pyuria (≥1%)

Hematologic & oncologic: C-reactive protein increased (1% to <5%), leukocytosis (1% to <5%), purpura (<5%), abnormal neutrophils (≥1%), anemia (≥1%), increased erythrocyte sedimentation rate (≥1%)

Hepatic: Increased serum alkaline phosphatase (≥1%)

Hypersensitivity: Tongue edema (<5%)

Infection: Viral infection (6%), abscess (<5%)

Neuromuscular & skeletal: Ankle edema (7%), arthralgia (5%), arthritis (≤5%), hyperkinesia (<5%), muscle cramps (<5%), myalgia (<5%), tremor (<5%), weakness (<5%)

Ophthalmic: Eye disease (<5%), visual disturbance (<5%)

Otic: Otic infection (<5%)

Respiratory: Sinusitis (8%), bronchitis (<5%), dyspnea (<5%), flu-like symptoms (<5%), pharyngeal disease (<5%), rhinitis (<5%)

Miscellaneous: Fever (<5%)

<1%, postmarketing, and/or case reports: Allergic dermatitis, anaphylaxis, emotional lability, hyperglycemia, maculopapular rash, pancreatitis, peripheral edema, pruritus, pseudotumor cerebri, rectal bleeding, skin rash

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products or corticosteroids with lower systemic effect due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Adult patients receiving >20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections.

• Anaphylactoid reactions: Rare cases of anaphylactoid reactions have been observed in patients receiving corticosteroids.

• Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to killed or inactivated vaccines. Exposure to chickenpox or measles should be avoided; corticosteroids should not be used to treat ocular herpes simplex. Corticosteroids should not be used for cerebral malaria, fungal infections, viral hepatitis. Close observation is required in patients with latent tuberculosis and/or tuberculosis (TB) reactivity; restrict use in active TB (only fulminating or disseminated TB in conjunction with antituberculosis treatment). Amebiasis should be ruled out in any patient with recent travel to tropic climates or unexplained diarrhea prior to initiation of corticosteroids. Use with extreme caution in patients with Strongyloides infections; hyperinfection, dissemination and fatalities have occurred.

• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).

• Myopathy: Acute myopathy has been reported with high-dose corticosteroids, usually in patients with neuromuscular transmission disorders; may involve ocular and/or respiratory muscles; monitor creatine kinase; recovery may be delayed.

• Psychiatric disturbances: Corticosteroid use may cause psychiatric disturbances, including euphoria, insomnia, mood swings, personality changes, severe depression or psychotic manifestations. Preexisting psychiatric conditions may be exacerbated by corticosteroid use.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with heart failure and/or hypertension; use has been associated with fluid retention, electrolyte disturbances, and hypertension. Use with caution following acute myocardial infarction; corticosteroids have been associated with myocardial rupture.

• Diabetes: Use corticosteroids with caution in patients with diabetes mellitus; may alter glucose production/regulation leading to hyperglycemia.

• Gastrointestinal disease: Use with caution in patients with GI diseases (diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, ulcerative colitis, abscess or other pyogenic infection) due to perforation risk.

• Hepatic impairment: Avoid use of ER capsules in moderate to severe hepatic impairment (Child-Pugh class B and C) and delayed release capsules in severe hepatic impairment (Child-Pugh Class C). Consider reduced dosage of delayed release capsules in patients with moderate hepatic impairment (Child-Pugh Class B); monitor for hypercortisolism. Long-term use of corticosteroids in patients with hepatic impairment, including cirrhosis, has been associated with fluid retention.

• Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation of symptoms has occurred especially during initial treatment with corticosteroids.

• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, open-angle glaucoma, and cataracts have occurred with prolonged use. Consider routine eye exams in chronic users.

• Osteoporosis: Use with caution in patients with osteoporosis; high doses and/or long-term use of corticosteroids have been associated with increased bone loss and osteoporotic fractures.

• Renal impairment: Use with caution in patients with renal impairment; fluid retention may occur.

• Seizure disorders: Use corticosteroids with caution in patients with a history of seizure disorder; seizures have been reported with adrenal crisis.

• Systemic sclerosis: Use with caution in patients with systemic sclerosis; an increase in scleroderma renal crisis incidence has been observed with corticosteroid use. Monitor BP and renal function in patients with systemic sclerosis treated with corticosteroids (EULAR [Kowal-Bielecka 2017]).

• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in hyperthyroid patients and decreases in hypothyroid ones.

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.

Monitoring Parameters

Serum glucose, electrolytes; blood pressure, weight and other growth parameters, presence of infection; monitor IOP with therapy >6 weeks; bone mineral density; assess HPA axis suppression (eg, ACTH stimulation test, morning plasma cortisol test, urinary free cortisol test)

Reproductive Considerations

Fertility may be decreased in females with active inflammatory bowel disease. Corticosteroids used for the management of inflammatory bowel disease are not expected to decrease female fertility (AGA [Mahadevan 2019]).

Pregnancy Considerations

Some studies have shown an association between first trimester systemic corticosteroid use and oral clefts (Park-Wyllie 2000; Pradat 2003). Systemic corticosteroids may also influence fetal growth (decreased birth weight); however, information is conflicting (Lunghi 2010). Hypoadrenalism may occur in newborns following maternal use of corticosteroids in pregnancy (monitor).

Because systemic corticosteroids may increase the risk of gestational diabetes and other adverse pregnancy outcomes, use for maintenance therapy in pregnant women with inflammatory bowel disease is not recommended. However, corticosteroids may be used to treat disease flares in pregnant patients (AGA [Mahadevan 2019]).

Patient Education

What is this drug used for?

• It is used to treat Crohn disease and ulcerative colitis.

• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Common cold symptoms

• Heartburn

• Nausea

• Vomiting

• Diarrhea

• Constipation

• Passing gas

• Fatigue

• Joint pain

• Back pain

• Abdominal pain

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• High blood sugar like confusion, fatigue, increased thirst, increased hunger, passing a lot of urine, flushing, fast breathing, or breath that smells like fruit

• Skin changes like acne, stretch marks, slow healing, or hair growth

• Bleeding like vomiting blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding

• Infection

• Adrenal gland problems like severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss

• Moon face

• Buffalo hump

• Severe loss of strength and energy

• Irritability

• Tremors

• Fast heartbeat

• Confusion

• Sweating a lot

• Dizziness

• Passing out

• Swelling of the ankles

• Severe headache

• Bone pain

• Vision changes

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.