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The most serious adverse reactions seen in Asacol clinical trials or with other products that contain mesalamine or are metabolized to mesalamine are:
- Renal impairment, including renal failure [see WARNINGS AND PRECAUTIONS]
- Acute intolerance syndrome [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.
In total, Asacol tablets have been evaluated in 2,690 patients with ulcerative colitis in controlled and open-label trials. Adverse reactions presented in the following sections may occur regardless of length of therapy and similar reactions have been reported in short-and long-term studies and in the postmarketing setting.
Clinical studies supporting Asacol use for the treatment of mildly to moderately active ulcerative colitis included two 6-week, placebo-controlled, randomized, double-blind studies in adults with mildly to moderately active ulcerative colitis (Studies 1 and 2), and one 6-week, randomized, double-blind, study of 2 dose levels in children with mildly to moderately active ulcerative colitis. Clinical studies supporting the use of Asacol tablets in the maintenance of remission of ulcerative colitis included a 6-month, randomized, double-blind, placebo-controlled, multi-center study and four active-controlled maintenance trials comparing Asacol tablets with sulfasalazine. Asacol has been evaluated in 427 adults and 82 children with ulcerative colitis in these controlled studies.
Treatment of Mildly to Moderately Active Ulcerative Colitis in Adults
In two 6-week placebo-controlled clinical studies (Studies 1 and 2) involving 245 patients, 155 of whom were randomized to Asacol [see Clinical Studies], 3.2 percent of the Asacol-treated patients discontinued therapy because of adverse reactions as compared to 2.2 percent of the placebo-treated 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 Asacol 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 Asacol occurring at a frequency of at least 2 percent and at a rate greater than placebo in 6-week, double-blind, placebo-controlled trials (Studies 1 and 2) are listed in Table 2 below.
Table 2: Adverse Reactions Reported in Two Pooled
Six-Week, Placebo-Controlled Trials (Studies 1 and 2) Experienced by at Least 2
percent of Patients in the Asacol Group and at a Rate Greater than Placebo
|Adverse Reaction||% of Patients with Adverse Reactions|
(n = 152)
(n = 87)
Treatment of Mildly to Moderately Active Ulcerative Colitis in Pediatric Patients 5 to 17 Years Old
A randomized, double-blind, 6-week study of 2 dose levels of Asacol (Study 3) was conducted in 82 pediatric patients 5 to 17 years of age with mildly to moderately active ulcerative colitis. All patients were divided by body weight category (17 to less than 33 kg, 33 to less than 54 kg, and 54 to 90 kg) and randomly assigned to receive a low dose (1.2, 2.0, and 2.4 g/day for the respective body weight category) or a high dose (2.0, 3.6, and 4.8 g/day).
Duration of exposure to mesalamine among the 82 patients in the study ranged from 12 to 50 days (mean of 40 days in each dose group). The majority (88 percent) of patients in each group were treated for more than 5 weeks. Table 3 provides a summary of the specific reported adverse reactions (ARs).
Table 3: Adverse Reactions Reported in One Six-Week
Trial (Study 3) Experienced by at Least 5% of Patients in the Low Dose Group or
High Dose Group
|Adverse Reaction||% of Patients with Adverse Reactions|
|Low Dose = Asacol 1.2 – 2.4 g/day; High Dose = Asacol 2.0 – 4.8 g/day. Dosage was dependent on body weight. Adverse Reactions reported at the 1-week telephone follow-up visit are included.|
Twelve percent of the patients in the low dose group and 5 percent of the patients in the high dose group had serious adverse reactions (ARs). Ulcerative colitis was reported as a serious AR in one subject in each group. Other serious ARs consisted of sinusitis, abdominal pain, decreased body mass index, adenovirus infection, bloody diarrhea, sclerosing cholangitis, and pancreatitis in one subject each in the low dose group and anemia and syncope in one subject each in the high dose group.
Seven patients were withdrawn from the study because of ARs: 5 (12 percent) in the low dose group (ulcerative colitis, adenovirus infection, sclerosing cholangitis, pancreatitis) and 2 (5 percent) in the high dose group (increased amylase and increased lipase, upper abdominal pain).
In general, the nature and severity of reactions in the pediatric population was similar to those reported in adult populations of patients with ulcerative colitis.
Maintenance of Remission of Ulcerative Colitis in Adults
In a 6-month placebo-controlled maintenance trial involving 264 patients (Study 4) 177 of whom were randomized to Asacol, six (3.4 percent) of the patients using Asacol 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 4 was 42 years and 55 percent of patients were male. Adverse reactions leading to study withdrawal in patients using Asacol included (each in one patient): anxiety; headache; pruritus; decreased libido; rheumatoid arthritis; and stomatitis and asthenia.
In addition to reactions listed in Table 2, the following adverse reactions occurred in patients using Asacol at a frequency of 2 percent or greater in Study 4: 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 Asacol, the adverse reactions listed below have been identified during post-approval use of Asacol and other mesalaminecontaining 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.
Read the Asacol (mesalamine delayed-release tablets) Side Effects Center for a complete guide to possible side effects
No formal drug interaction studies have been performed using Asacol with other drugs. However, the following interactions between mesalamine-containing products and other drugs have been reported.
Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs
Azathioprine Or 6-mercaptopurine
The concurrent use of mesalamine with azathioprine or 6-mercaptopurine may increase the risk for blood disorders.
Read the Asacol Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 6/8/2015
Additional Asacol 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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