DELZICOL® is DBP-free, which classifies it as Pregnancy Category B.1
The safety and efficacy of DELZICOL has been established based on adequate and well-controlled studies of mesalamine delayed-release tablets.
Adverse reactions reported in a 6-week placebo-controlled trial1*
Most frequent adverse reactions reported in a study for the treatment of mild to moderate UC in adults. At least 2% in the mesalamine delayed-release tablets group and at a rate greater than placebo
Most frequent adverse reactions reported in a study for the treatment of mild to moderate UC in children 5 years of age and older in at least 5% of patients in the low dosage or high dosage group.
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Adverse reactions in a 6-month placebo controlled trial1
In a 6-month placebo-controlled maintenance trial, the following additional adverse reactions occurred in
patients using mesalamine delayed-release 400 mg tablets at 1.6 g/day at a frequency of ≥2%:
abdominal enlargement, gastroenteritis, gastrointestinal hemorrhage, infection, joint disorder, migraine, nervousness,
paresthesia, rectal disorder, rectal hemorrhage, stool abnormalities, tenesmus, urinary frequency, vasodilation, and
- DELZICOL® [Package Insert]. Irvine, CA: Allergan USA, Inc.; 2016.
- IMS National Prescription Data: 1992-March 2014 (estimate derived from information used under license from IMS Health, Inc., which expressly reserves all rights, including rights of copying, distribution, and republication).
- Sninsky CA, Cort DH, Shanahan F, et al. Oral mesalamine (Asacol) for mildly to moderately active ulcerative colitis. Ann Intern Med. 1991;115:350-355.
- Data on file. Rockaway, NJ: Allergan USA, Inc.
- The Mesalamine Study Group. An oral preparation of mesalamine as long-term maintenance therapy for ulcerative colitis: a randomized, placebo-controlled trial. Ann Intern Med. 1996;124:204-211.
IMPORTANT SAFETY INFORMATION
- Patients with known or suspected hypersensitivity to salicylates or aminosalicylates
or to any of the ingredients of DELZICOL.
Warnings and Precautions
Mesalamine-Induced Acute Intolerance Syndrome
- Renal impairment, including minimal change nephropathy, acute and chronic
interstitial nephritis, and renal failure, has been reported with products such as
DELZICOL that contain or are converted to mesalamine. Evaluate renal function
prior to initiation of DELZICOL and periodically while on therapy. Evaluate the risks
and benefits of using DELZICOL in patients with known renal dysfunction, a
history of renal disease, or who are taking concomitant nephrotoxic drugs.
- Mesalamine treatment has been associated with an acute intolerance syndrome that
may be difficult to distinguish from an exacerbation of UC. Symptoms include
cramping, abdominal pain, bloody diarrhea, and sometimes fever, headache, and rash.
Observe patients closely for worsening of these symptoms while on treatment. If
acute intolerance syndrome is suspected, promptly discontinue treatment with
- Use caution when treating patients who are hypersensitive to sulfasalazine as they
may have a similar reaction to DELZICOL.
- Mesalamine-induced hypersensitivity reactions may present as internal organ
involvement, including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis,
and hematologic abnormalities. Evaluate patients immediately if signs or
symptoms of a hypersensitivity reaction are present. Discontinue DELZICOL if an
alternative etiology for the signs or symptoms cannot be established.
- Hepatic failure has been reported in patients with pre-existing liver disease who have
been administered mesalamine. Evaluate the risks and benefits of using DELZICOL
in patients with known liver impairment.
- The most common adverse reactions (incidence ≥ 5%) in adults were eructation,
abdominal pain, constipation, dizziness, rhinitis, back pain, and rash.
- The most common adverse reactions (incidence ≥ 5%) in pediatric patients (5 to
17 years old) were nasopharyngitis, headache, abdominal pain, dizziness,
sinusitis, rash, cough, diarrhea, fatigue, pyrexia, and increased lipase.
- The risk of nephrotoxicity may be increased with the concurrent use of mesalamine
and known nephrotoxic agents, including NSAIDs. Monitor patients taking
nephrotoxic drugs for changes in renal function and mesalamine-related adverse
- The risk for blood disorders may be increased with the concurrent use of
mesalamine and azathioprine or 6-mercaptopurine. If concomitant use of
DELZICOL and azathioprine or 6-mercaptopurine cannot be avoided, monitor
blood tests, including complete blood cell counts and platelet counts.
- A higher incidence of blood dyscrasias (agranulocytosis, neutropenia, pancytopenia)
has been reported in subjects receiving mesalamine who are 65 years or older
compared to younger patients. Monitor complete blood cell counts and platelet
counts in elderly patients during treatment with DELZICOL.
DELZICOL is indicated for the treatment of mildly to moderately active ulcerative
colitis (UC) in patients 5 years of age and older and for the maintenance of remission of
UC in adults.
Full Prescribing Information
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