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The most serious adverse reactions seen in Delzicol clinical trials or with other products that contain or are metabolized to mesalamine are:
- Renal impairment, including renal failure [see WARNINGS AND PRECAUTIONS]
- Acute exacerbation of colitis [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
- Hepatic failure [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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data presented in Sections 6.1 and 6.2 are from clinical trials conducted with mesalamine delayed-release tablets. Delzicol is bioequivalent to these mesalamine delayed-release tablets.
In total, mesalamine delayed-release tablets have been evaluated in 3685 inflammatory bowel disease patients (73 percent of patients with ulcerative colitis) in controlled and open-label trials. Adverse events presented in the following sections may occur regardless of length of therapy and similar events have been reported in short- and long-term studies and in the postmarketing setting.
Treatment of Ulcerative Colitis
Clinical studies supporting mesalamine delayed-release tablets use for the treatment of mildly to moderately active ulcerative colitis included two 6-week, placebo-controlled, randomized, double-blind studies in patients with mildly to moderately active ulcerative colitis. Clinical studies supporting the use of mesalamine delayed-release tablets in the maintenance of remission of ulcerative colitis included a 6month, randomized, double-blind, placebo-controlled, multi-center study and four active-controlled maintenance trials comparing mesalamine delayed-release with sulfasalazine. Mesalamine delayed-release tablets have been evaluated in 427 patients with ulcerative colitis in these controlled studies.
Treatment of Mildly to Moderately Active Ulcerative Colitis
In two 6-week placebo-controlled clinical studies (Studies 1 and 2) involving 245 patients, 155 of whom were randomized to mesalamine delayed-release tablets [see Clinical Studies], five (3.2 percent) of the patients using mesalamine delayed-release tablets discontinued therapy because of adverse reactions as compared to two (2.2 percent) of the placebo patients. The average age of patients in Study 1 was 42 years and 48 percent of patients were male. The average age of patients in Study 2 was 42 years and 59 percent of patients were male. Adverse reactions leading to withdrawal from mesalamine delayed-release tablets included (each in one patient): diarrhea and colitis flare; dizziness, nausea, joint pain, and headache; rash, lethargy and constipation; dry mouth, malaise, lower back discomfort, mild disorientation, mild indigestion and cramping; headache, nausea, aching, vomiting, muscle cramps, a stuffy head, plugged ears, and fever.
Adverse reactions in patients treated with mesalamine delayed-release tablets occurring at a frequency of 2 percent or greater in 6-week, double-blind, placebo-controlled trials (Studies 1 and 2) are listed in Table 1 below.
Table 1 : Adverse Reactions Reported in Two
Six-Week Placebo-Controlled Trials (Studies 1 and 2) Experienced by at Least 2
Percent of patients in the mesalamine delayed-release tablets Group and at a
Rate Greater than Placebo
|Event||Percent of Patients with Adverse Reactions|
|mesalamine delayed-release tablets
(n = 152)
(n = 87)
Of these adverse reactions, only rash showed a consistently higher frequency with increasing mesalamine delayed-release tablets dose in these studies.
Maintenance of Remission of Ulcerative Colitis
In a 6-month placebo-controlled maintenance trial involving 264 patients (Study 3) 177 of whom were randomized to mesalamine delayed-release tablets, six (3.4 percent) of the patients using mesalamine delayed-release tablets discontinued therapy because of adverse reactions, as compared to four (4.6 percent) of patients using placebo [see Clinical Studies]. The average age of patients in Study 3 was 42 years and 55 percent of patients were male. Adverse reactions leading to study withdrawal in patients using mesalamine delayed-release tablets included (each in one patient): anxiety; headache; pruritus; decreased libido; rheumatoid arthritis; and stomatitis and asthenia.
In addition to reactions listed in Table 1, the following adverse reactions occurred in patients using mesalamine delayed-release tablets at a frequency of 2 percent or greater in Study 3: abdominal enlargement, gastroenteritis, gastrointestinal hemorrhage, infection, joint disorder, migraine, nervousness, paresthesia, rectal disorder, rectal hemorrhage, stool abnormalities, tenesmus, urinary frequency, vasodilation, and vision abnormalities.
In 3342 patients in uncontrolled clinical studies, the following adverse reactions occurred at a frequency of 5 percent or greater and appeared to increase in frequency with increasing dose: asthenia, fever, flu syndrome, pain, abdominal pain, back pain, flatulence, gastrointestinal bleeding, arthralgia, and rhinitis.
In addition to the adverse reactions reported above in clinical trials involving mesalamine delayed-release tablets, the adverse reactions listed below have been identified during post-approval use of mesalamine delayed-release tablets and other mesalamine-containing products. 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.
Special Senses: Eye pain, taste perversion, blurred vision, tinnitus.
Elevated AST (SGOT) or ALT (SGPT), elevated alkaline phosphatase, elevated GGT, elevated LDH, elevated bilirubin, elevated serum creatinine and BUN.
Read the Delzicol (mesalamine delayed-release capsules) Side Effects Center for a complete guide to possible side effects
No formal drug interaction studies have been performed using Delzicol with other drugs. However, the following interactions between mesalamine medications and other drugs have been reported.
Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs
The concurrent use of mesalamine with known nephrotoxic agents, including nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of renal reactions.
Azathioprine or 6-mercaptopurine
The concurrent use of mesalamine with azathioprine or 6-mercaptopurine may increase the risk for blood disorders.
Last reviewed on RxList: 2/19/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Delzicol Information
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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