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The most serious adverse reactions seen in Asacol HD clinical trials or with other products that contain mesalamine or are metabolized to mesalamine were:
- Renal impairment, including renal failure (rare) [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.
Asacol HD has been evaluated in 896 patients with ulcerative colitis in controlled studies. Three six-week, active-controlled studies were conducted comparing Asacol HD 4.8 grams/day with Asacol (mesalamine) 2.4 grams/day in patients with mildly to moderately active ulcerative colitis. In these studies, 727 patients were dosed with the Asacol HD tablet and 732 patients were dosed with the Asacol 400 mg tablet. (One Asacol HD 800 mg tablet cannot be substituted for two Asacol 400 mg tablets [see CLINICAL PHARMACOLOGY].)
The most common reactions reported in the Asacol HD group were headache (4.7 percent), nausea (2.8 percent), nasopharyngitis (2.5 percent), abdominal pain (2.3 percent), exacerbation of ulcerative colitis (2.3 percent), diarrhea (1.7 percent), and dyspepsia (1.7 percent); Table 1 enumerates adverse reactions that occurred in the three studies. The most common reactions in patients with moderately active ulcerative colitis (602 patients dosed with Asacol HD and 618 patients dosed with the Asacol 400 mg) were the same as all treated patients.
Discontinuations due to adverse reactions occurred in 3.9 percent of patients in the Asacol HD group and in 4.2 percent of patients in the Asacol 400 mg tablet comparator group. The most common cause for discontinuation was gastrointestinal symptoms associated with ulcerative colitis.
Severe adverse reactions occurred in 7.6 percent of patients in the Asacol HD group and in 7.6 percent of patients in the Asacol 400 mg tablet comparator group. Most of these reactions were gastrointestinal symptoms related to ulcerative colitis. Serious adverse reactions occurred in 0.8 percent of patients in the Asacol HD group and in 1.8 percent of patients in the Asacol 400 mg tablet comparator group. The majority involved the gastrointestinal system.
Table 1: Adverse Reactions
Occurring in 1 Percent or More of All Treated Patients (Three studies combined)
|Adverse Reaction||Asacol* 2.4 g/day( 400 mg Tablet)
(N = 732)
|Asacol HD* 4.8 g/day (800 mg Tablet)
(N = 727)
|Headache||4.9 %||4.7 %|
|Nausea||2.9 %||2.8 %|
|Nasopharyngitis||1.4 %||2.5 %|
|Abdominal pain||2.3 %||2.3 %|
|Ulcerative Colitis||2.7 %||2.3 %|
|Diarrhea||1.9 %||1.7 %|
|Dyspepsia||0.8 %||1.7 %|
|Vomiting||1.6 %||1.4 %|
|Flatulence||0.7 %||1.2 %|
|Influenza||1.2 %||1.0 %|
|Pyrexia||1.2 %||0.7 %|
|Cough||1.4 %||0.3 %|
|N = number of patients within
specified treatment group
Percent = percentage of patients in category and treatment group
*One Asacol HD 800 mg tablet cannot be substituted for two Asacol 400 mg tablets [see CLINICAL PHARMACOLOGY].
In addition to the adverse reactions reported above in clinical trials involving the Asacol HD tablet, the adverse events listed below have been reported in controlled clinical trials, open label studies, literature reports, or foreign and domestic marketing experience with Asacol 400 mg tablets or other products that contain mesalamine or are metabolized to mesalamine. 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.
Gastrointestinal: Dry mouth, stomatitis, oral ulcers, anorexia, increased appetite, eructation, pancreatitis, cholecystitis, gastritis, gastroenteritis, gastrointestinal bleeding, perforated peptic ulcer (rare), constipation, hemorrhoids, rectal hemorrhage, bloody diarrhea, tenesmus, stool abnormality.
Hepatic: There have been rare reports of hepatotoxicity, including jaundice, cholestatic jaundice, hepatitis, and possible hepatocellular damage including liver necrosis and liver failure. Some of these cases were fatal. Asymptomatic elevations of liver enzymes which usually resolve during continued use or with discontinuation of the drug have also been reported. One case of Kawasaki-like syndrome, that included changes in liver enzymes, was also reported [see WARNINGS AND PRECAUTIONS].
Neurological/Psychiatric: Anxiety, depression, somnolence, insomnia, nervousness, confusion, emotional lability, dizziness, vertigo, tremor, paresthesia, hyperesthesia, peripheral neuropathy (rare), Guillain-Barré syndrome (rare), and transverse myelitis (rare).
Renal/Urogenital: Renal failure (rare), interstitial nephritis, minimal change nephropathy [see WARNINGS AND PRECAUTIONS], dysuria, urinary frequency and urgency, hematuria, epididymitis, decreased libido, dysmenorrhea, menorrhagia.
Read the Asacol HD (mesalamine delayed-release tablets, oral) Side Effects Center for a complete guide to possible side effects
No formal drug interaction studies have been performed using Asacol HD 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.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/25/2016
Additional Asacol HD 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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