July 27, 2016
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Uceris

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Uceris




Uceris Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 7/26/2016

Uceris (budesonide) rectal foam is a glucocorticosteroid indicated for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge. Common side effects of Uceris include:

  • decreased blood cortisol
  • adrenal insufficiency, and
  • nausea

The recommended dosage of Uceris is 1 metered dose administered twice daily for 2 weeks followed by 1 metered dose administered once daily for 4 weeks. Uceris may interact with CYP3A4 Inhibitors (e.g., ketoconazole, grapefruit juice). Tell your doctor all medications and supplements you use. Uceris is not recommended for use during pregnancy; it may harm a fetus. Uceris passes into breast milk. Consult your doctor before breastfeeding.

Our Uceris (budesonide) rectal foam Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Uceris FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Serious and important adverse reactions include:

  • Hypercorticism and adrenal axis suppression [see WARNINGS AND PRECAUTIONS]
  • Symptoms of steroid withdrawal in those patients transferring from systemic glucocorticosteroid therapy [see WARNINGS AND PRECAUTIONS]
  • Increased susceptibility to infection [see WARNINGS AND PRECAUTIONS]
  • Other glucocorticosteroid effects [see WARNINGS AND PRECAUTIONS]

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 these trials, 268 patients received UCERIS rectal foam 2 mg twice a day for 2 weeks followed by 2 mg once a day for 4 weeks [see Clinical Studies].

The most common adverse reactions ( ≥ 2% of the UCERIS rectal foam or Placebo group and at higher frequency in the UCERIS rectal foam group) were decreased blood cortisol, adrenal insufficiency, and nausea (Table 1). Decreased blood cortisol was defined as a morning cortisol level of < 5 mcg/dL. Adrenal insufficiency was defined as a cortisol level of < 18 mcg/dL at 30 minutes post challenge with adrenocorticotropic hormone (ACTH).

A total of 10% of UCERIS rectal foam-treated patients discontinued treatment due to an adverse reaction compared with 4% of placebo-treated patients.

Table 1: Summary of Adverse Reactions in 2 Placebo Controlled Trials* (Studies 1 and 2)

Adverse Reaction UCERIS Rectal Foam 2 mg/25 mL
N = 268
n (%)
Placebo
N = 278
n (%)
Decreased blood cortisol# 46 (17) 6 (2)
Adrenal insufficiency† 10 (4) 2 (1)
Nausea 6 (2) 2 (1)
*Experienced by ≥ 2% of the UCERIS rectal foam or Placebo group and at higher frequency in the UCERIS rectal foam group
#Decreased blood cortisol was defined as a morning cortisol level of < 5 mcg/dL
†Adrenal insufficiency was defined as a cortisol level of < 18 mcg/dL at 30 minutes post challenge with ACTH.

Of the 46 UCERIS rectal foam treated patients with decreased blood cortisol (defined as a morning cortisol level of < 5 mcg/dL) reported as an adverse event, none had adrenal insufficiency (defined as a cortisol level of < 18 mcg/dL at 30 minutes post challenge with ACTH) (see Table 2). All cases of adrenal insufficiency resolved.

Table 2 summarizes the percentages of patients reporting glucocorticoid related effects in the 2 placebo-controlled trials (Studies 1 and 2).

Table 2: Summary of Glucocorticoid Related Effects in Two Placebo-Controlled Trials (Studies 1 and 2)

Adverse Reaction UCERIS Rectal Foam 2 mg/25 mL
N = 268
n (%)
Placebo
N = 278
n (%)
Overall 60 (22) 10 (4)
Blood cortisol decreased 46 (17)* 6 (2)
Adrenal insufficiency 10 (4) 2 (1)
Insomnia 1 (0.4) 1 (0.4)
Sleep disorder 1 (0.4) 0
Acne 1 (0.4) 0
Depression 1 (0.4) 1 (0.4)
Hyperglycemia 1 (0.4) 0
* Decreases in serum cortisol levels associated with budesonide treatment were seen at Weeks 1 and 2 (twice-daily treatment) in the UCERIS rectal foam group, but gradually returned to baseline levels during the 4 weeks of once daily treatment.

No clinically significant differences were observed with respect to the overall percentages of patients with any glucocorticoid related effects between UCERIS rectal foam and placebo after 6 weeks of therapy.

For additional details on morning cortisol levels and the response to the ACTH stimulation test, see CLINICAL PHARMACOLOGY.

Post-Marketing Experience

In addition to adverse reactions reported from clinical trials for UCERIS rectal foam, the following adverse reactions have been identified during post-approval use of other oral and rectal formulations of budesonide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiac disorders: hypertension

Gastrointestinal disorders: pancreatitis

General disorders and administration site conditions: pyrexia, peripheral edema

Immune System Disorders: anaphylactic reactions

Nervous System Disorders: dizziness, benign intracranial hypertension

Psychiatric Disorders: mood swings

Skin and subcutaneous tissue disorders: pruritus, maculo-papular rash, allergic dermatitis

Read the entire FDA prescribing information for Uceris (Budesonide Extended-Release Tablets)

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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