uceris
Uceris (Budesonide) is a corticosteroid used to treat Perennial Allergic Rhinitis, Inflammatory Bowel Diseases.
Budesonide · by Salix
Key facts
- Active ingredient
- Budesonide
- Drug class
- Corticosteroid
- Form
- Tablet, extended release, Spray/Inhaler, Topical
- Strength
- Budesonide 2MG/ACTUATION
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Salix
- Half-life
- about 2 to 3.6 hours (terminal elimination half-life, measured after intravenous dosing) (how long it stays in your system)
- What the pharmacy pays
- ~$0.75 per ml — not your price
- FDA application
- NDA205613
What is Uceris?
From the FDA label:UCERIS rectal foam contains budesonide, a non-halogenated synthetic glucocorticoid, as the active ingredient. It is a mixture of the 2 epimers (22R and 22S) differing in the position of an acetal chain. Both epimers are active glucocorticoids applied in a mixture of approximately 1:1. Budesonide is designated chemically as (RS)-11β, 16α, 17,21 tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. The empirical formula of budesonide is C 25 H 34 O 6 and its molecular weight is 430.5. Its structural formula is: UCERIS rectal foam contains 2 mg budesonide per metered dose. Inactive ingredients: cetyl alcohol, citric acid monohydrate, edetate disodium, emulsifying wax, polyoxyl (10) stearyl ether, propylene glycol, and purified water. Propellant: n-butane, isobutane, and propane. formula
How to use
Uceris is sold in more than one form (Tablet, extended release, Spray/Inhaler and Topical), and each is dosed differently. The instructions below come from the FDA label for application NDA205613 — follow the label that came with the product you were actually prescribed.
The recommended dosage is 1 metered dose administered twice daily for 2 weeks followed by 1 metered dose administered once daily for 4 weeks. ( 2.1 ) • For rectal administration only. ( 2.2 ) • Warm the canister in the hands while shaking it vigorously for 10 to 15 seconds prior to use. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage regimen is 1 metered dose administered rectally twice daily for 2 weeks followed by 1 metered dose administered rectally once daily for 4 weeks. 2.2 Administration Instructions Advise patients: • UCERIS rectal foam is only to be applied rectally. It is not for oral use. • Before using UCERIS rectal foam, use the bathroom to empty your bowels. • Each applicator is coated with a lubricant. If additional lubrication is needed, petrolatum or petroleum jelly can also be used. • Warm the canister in the hands while shaking it vigorously for 10 to 15 seconds prior to use. • UCERIS rectal foam can be used in a standing, lying or sitting position (e.g., while using the toilet). • Apply UCERIS rectal foam in the morning and the evening for the first 2 weeks of treatment; then once daily in the evening for the next 4 weeks. When applied in the evening, use immediately prior to bedtime. Try not to empty your bowels again until the next morning. • Avoid concomitant use of CYP3A4 inhibitors (e.g., ketoconazole, grapefruit juice) during treatment with…
Side effects
Serious and important adverse reactions include: • Hypercorticism and adrenal axis suppression [see Warnings and Precautions ( 5.1 )] • Symptoms of steroid withdrawal in those patients transferring from systemic glucocorticosteroid therapy [see Warnings and Precautions ( 5.2 )] • Increased susceptibility to infection [see Warnings and Precautions ( 5.3 )] • Other glucocorticosteroid effects [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (≥ 2%) are decreased blood cortisol, adrenal insufficiency, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to UCERIS rectal foam in 332 patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge. The median duration of exposure was 42 days. This included 14 patients exposed for at least 6 months. UCERIS rectal foam was studied primarily in 2 placebo-controlled, 6-week trials in patients with active disease (Study 1 and Study 2). In…
Warnings
Important safety information
Hypercorticism and adrenal suppression: Follow general warnings concerning glucocorticosteroids. ( 5.1 ) • Impaired Adrenal Function in Patients Transferred from Other Glucocorticoids: Taper slowly from glucocorticosteroids with high systemic effects; monitor for withdrawal symptoms and unmasking of allergies (rhinitis, eczema). ( 5.2 ) • Increased Risk of Infection, including serious and fatal chicken pox and measles: Monitor patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex. ( 5.3 ) • Other Glucocorticosteroid Effects: Monitor patients with other conditions where glucocorticoids may have unwanted effects. ( 5.4 ) • Flammable Contents: The contents of UCERIS rectal foam are flammable. Instruct the patient to avoid fire, flame and smoking during and immediately following administration. ( 5.5 ) 5.1 Hypercorticism and Adrenal Axis Suppression When glucocorticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Glucocorticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to surgery or other stress situations, supplementation with a systemic glucocorticosteroid is recommended. Since UCERIS rectal foam contains a glucocorticosteroid, general warnings concerning glucocorticoids should be followed [see Clinical Pharmacology ( 12.2 )]. Reduced liver function affects the elimination of glucocorticosteroids, and increased systemic availability of oral budesonide has been demonstrated in patients with liver cirrhosis [see Use in Specific Populations ( 8.6 )] . 5.2 Impaired Adrenal Suppression in Patients Transferred from Other Glucocorticoids Monitor patients who are transferred from glucocorticosteroid treatment with higher systemic effects to glucocorticosteroids with lower systemic effects, such as UCERIS rectal foam, since symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal suppression or benign intracranial hypertension, may develop. Adrenocortical function monitoring may be required in these patients and the dose of glucocorticosteroid treatment with high systemic effects should be reduced cautiously. Replacement of systemic glucocorticosteroids with UCERIS rectal foam may unmask allergies (e.g., rhinitis and eczema), which were previously controlled by the systemic drug. 5.3 Increased Risk of Infection Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible patients or patients on immunosuppressant doses of glucocorticosteroids. In patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of glucocorticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior glucocorticosteroid treatment to the risk is also not known. If exposed, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated (see prescribing information for VZIG and IG). If chicken pox develops, treatment with antiviral agents may be considered. Glucocorticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex. 5.4 Other Glucocorticosteroid Effects Monitor patients with hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where glucocorticosteroids may have unwanted effects. 5.5 Flammable Contents The contents of UCERIS rectal foam include n-butane, isobutane and propane as propellants which are flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following administration. Patients should temporarily discontinue use of UCERIS rectal foam before initiation of bowel preparation for colonoscopy and consult their healthcare provider before resuming therapy.
Who should not take Uceris
UCERIS rectal foam is contraindicated in patients with a history of a known hypersensitivity to budesonide or any of the ingredients of UCERIS rectal foam. Reactions have included anaphylaxis [see Adverse Reactions ( 6.2 )] . Known hypersensitivity to budesonide or any of the ingredients in UCERIS rectal foam. ( 4 )
Overdose — what happens if you take too much
Acute overdosage with UCERIS rectal foam is unlikely. However, UCERIS rectal foam is absorbed systemically and chronic overdosage may result in signs/symptoms of hypercorticism [see Warnings and Precautions ( 5.1 )] .
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
CYP3A4 Inhibitors (e.g., ketoconazole, grapefruit juice): May cause increased systemic corticosteroid effects; avoid concomitant use. ( 7.1 ) 7.1 CYP3A4 Inhibitors The active ingredient of UCERIS rectal foam, budesonide, is metabolized by CYP3A4. Inhibitors of CYP3A4 activity (such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine and grapefruit juice) can increase systemic budesonide concentrations. Avoid concomitant use of CYP3A4 inhibitors with UCERIS rectal foam [see Clinical Pharmacology ( 12.3 )] .
How long does Budesonide stay in your body?
The elimination half-life of budesonide is about 2 to 3.6 hours (terminal elimination half-life, measured after intravenous dosing) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The label reports the true (terminal) plasma elimination half-life from IV dosing as 2 to 3.6 hours, the same in healthy adults and Crohn's disease patients. The APPARENT half-life after ORAL dosing is longer — mean 6.3 ± 1.6 hours (range 2 to 8 hours) after a single 9 mg dose in healthy fasted subjects — because absorption is slower than elimination (flip-flop kinetics), not because the drug lingers; use the ~2–3.6 h IV figure as the elimination half-life. Budesonide is NOT a prodrug and has NO longer-lasting active metabolite: its two major CYP3A4 metabolites (6β-hydroxy budesonide and 16α-hydroxy prednisolone) have negligible corticosteroid activity (<1/100 of the parent). Liver impairment: budesonide is a high-hepatic-clearance drug, so systemic exposure rises with impaired liver function — patients with moderate impairment (Child-Pugh B) had a 3.5-fold higher AUC than those with normal liver function, and the label says to avoid use in severe impairment (Child-Pugh C). Kidney impairment: the label gives no PK half-life change (budesonide is cleared hepatically, not renally). Older adults: the label states studies did not include enough patients aged 65+ to characterize any difference. This is an elimination half-life, not a drug-test detection window and not dosing guidance.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Budesonide (oral) FDA label, §12.3 Pharmacokinetics — DailyMed.
Drug class
How this class works, per Corticosteroids - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Uceris ranks — best-rated corticosteroid for:
Dosage forms
Tablet, extended release, Spray/Inhaler and Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Uceris treat?
- Uceris (Budesonide) may be used to treat perennial allergic rhinitis, inflammatory bowel diseases, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Uceris work?
- Uceris is a corticosteroid. Corticosteroids mimic the body's natural stress hormone cortisol: they enter cells and bind a glucocorticoid receptor that switches off genes for inflammatory chemicals, calming swelling, redness, and an overactive immune response.
- How much does Uceris cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.75 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Pred Forte — about $0.60 on the same basis.
- Is there a coupon or discount for Uceris?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Uceris. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Uceris?
- Uceris is marketed by Salix. You can see Salix's full profile, rating, and other products on pharmaranks.
- Is Uceris a brand-name or generic drug?
- Uceris is a brand-name product with the active ingredient Budesonide.
- Is Uceris available over the counter?
- No. Uceris is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Uceris come in?
- Uceris is currently marketed as tablet, extended release, spray/inhaler and topical, per the FDA's National Drug Code Directory.
- What class of drug is Uceris?
- Uceris is classified as corticosteroid, per the FDA's Established Pharmacologic Class.
- Is Uceris FDA-registered?
- Uceris is on record with the U.S. FDA under application number NDA205613. You can verify this on its official FDA label.
- Is Uceris safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Uceris. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Uceris?
- Uceris's side effects are taken directly from its FDA label. From the label: Serious and important adverse reactions include: • Hypercorticism and adrenal axis suppression [see Warnings and Precautions ( 5.1 )] • Symptoms of steroid withdrawal in those patients transferring from systemic glucocorticosteroid therapy [see Warnings and Precautions ( 5.2 )] • Increased susceptib… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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