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Asacol (Mesalamine) - Summary



Asacol (mesalamine) is thought to be the major therapeutically active part of the sulfasalazine molecule in the treatment of ulcerative colitis.

Asacol tablets are indicated for the treatment of mildly to moderately active ulcerative colitis and for the maintenance of remission of ulcerative colitis.

See all Asacol indications & dosage >>


Published Studies Related to Asacol (Mesalamine)

Randomised clinical trial: evaluation of the efficacy of mesalazine (mesalamine) suppositories in patients with ulcerative colitis and active rectal inflammation -- a placebo-controlled study. [2013]
categorised by the extent of lesions... CONCLUSIONS: The effectiveness of mesalazine suppositories in all types of UC

Budesonide 9 mg is at least as effective as mesalamine 4.5 g in patients with mildly to moderately active Crohn's disease. [2011.02]
BACKGROUND & AIMS: Comparative data on budesonide vs mesalamine for the treatment of mild-to-moderately active Crohn's disease (CD) are sparse. We assessed the efficacy and safety of each therapy in patients with mildly to moderately active CD... CONCLUSIONS: Budesonide (9 mg/day) was numerically, but not statistically, more effective than Eudragit-L-coated mesalamine (4.5 g/day) in patients with mildly to moderately active CD. Budesonide (9 mg/day), administered once daily, was as effective as the standard (3 times daily) regimen. Copyright (c) 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.

A multicenter, randomized study to evaluate the efficacy and safety of mesalamine suppositories 1 g at bedtime and 500 mg Twice daily in patients with active mild-to-moderate ulcerative proctitis. [2011.02]
BACKGROUND: Ulcerative proctitis (UP) is a prevalent condition associated with increased morbidity and mortality. Topical mesalamine (5-aminosalicylic acid [5-ASA]) inhibits inflammatory processes in UP... CONCLUSIONS: Mesalamine 500-mg BID and 1-g QHS suppositories are safe and effective for patients with UP. Most patients reported significant improvement within 3 weeks and UP remission and reduced disease extension after 6 weeks of treatment. Validity of QHS administration was confirmed.

Clinical trial: a novel high-dose 1 g mesalamine suppository (Salofalk) once daily is as efficacious as a 500-mg suppository thrice daily in active ulcerative proctitis. [2010.11]
BACKGROUND: Mesalamine suppositories are first-line therapy in active ulcerative proctitis; the standard regime still recommends multiple doses per day. The primary objective of this study was to show the noninferiority of once-daily administration of a novel 1 g mesalamine suppository versus thrice-daily administration of the 0.5 g mesalamine suppository... CONCLUSIONS: In active ulcerative proctitis the once-daily administration of a 1 g mesalamine suppository is as effective and safe, yet considerably more convenient, than the standard thrice-daily administration of a 0.5 g mesalamine suppository.

Clinical trial: once-daily mesalamine granules for maintenance of remission of ulcerative colitis - a 6-month placebo-controlled trial. [2010.10]
BACKGROUND: Ulcerative colitis (UC) is a chronic relapsing and remitting idiopathic inflammatory bowel disorder. AIM: To evaluate once-daily mesalamine (mesalazine) granules (MG) for maintenance of remission of UC... CONCLUSIONS: Once-daily mesalamine (mesalazine) was effective in maintaining remission of UC for 6 months. (c) 2010 Salix Pharmaceuticals.

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Clinical Trials Related to Asacol (Mesalamine)

Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis [Completed]
The purpose of this study is to determine the safety and pharmacokinetics of MMX mesalamine following administration in children and adolescents with ulcerative colitis.

Pharmacokinetics of Asacol 2.4 g/Day and Lialda 2.4 g/Day in Healthy Volunteers [Completed]
This study evaluated pharmacokinetics of 5-ASA and N-Ac-5-ASA associated with each of 3 regimens of oral mesalamine 2. 4 g/day (Lialda 2. 4 g/day 2 x 1. 2 g every 24 hours, Asacol® 6 x 400 mg every 24 hours, or Asacol 2 x 400 mg every 8 hours). Primary endpoints were 5-ASA area under the plasma concentration versus time curve from zero to 24 hours (AUC24) and total 5-ASA percent of dose excreted (A'e [%]) over the 24-hour period on Day 7.

The Colitis Once Daily Asacol Study [Completed]

Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis [Terminated]

The purpose of this study is to determine whether low dose Asacol® (27 mg/kg - 71 mg/kg) and

high dose Asacol® (53 mg/kg - 118 mg/kg) are safe and effective when dosed as 400 mg

delayed-release tablets given twice daily for 26 weeks to children and adolescents for the maintenance of remission of ulcerative colitis.

The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study [Recruiting]
The purpose of this study is to evaluate the effects of long acting mesalamine (Lialda) in patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will evaluate gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma cytokines before and after treatment with Lialda.

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Reports of Suspected Asacol (Mesalamine) Side Effects

Drug Hypersensitivity (6)Colitis Ulcerative (4)Pyrexia (4)Chest Pain (3)Dizziness (3)Diarrhoea (3)Neutropenia (3)Headache (2)Lower Respiratory Tract Infection (2)Myalgia (2)more >>


Based on a total of 5 ratings/reviews, Asacol has an overall score of 5.20. The effectiveness score is 6.40 and the side effect score is 7.20. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Asacol review by 33 year old female patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   ulcerative colitis
Dosage & duration:   400mg taken 3 times a day for the period of 1yr
Other conditions:   none
Other drugs taken:   none
Reported Results
Benefits:   The treatment benefits included a decrease an abdominal pain, a decrease in diahrea and blood in the stool. There were also benefits in overall comfort when dealing with day to day activities. The decrease in abdominal pain and frequent diahrea allows me to perform my daily activities.
Side effects:   The main side effects was nausea at first but disappeared over time. Headaches occurred frequently at first and have decreased but I still experience them occationally. They usually disappear with tyenol. Other than that the only other issues I experienced was slight symptoms that were not completely taken care of with the medication.
Comments:   My treatment consists of taking 3 pills 3 times a day. Routine colonoscopys are necessary. I also take a multivitamin twice a day. I watch my diet. I drink a minimum amount of milk, eat a minimum amount of fried and unhealthy food, drink more water and fruits and vegetables.


Asacol review by 25 year old male patient

Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   Moderate Side Effects
Treatment Info
Condition / reason:   Ulcerative Colitis
Dosage & duration:   100mg taken 3 times a day for the period of 6 months
Other conditions:   N/A
Other drugs taken:   N/A
Reported Results
Benefits:   Flare-ups were less frequent as well and the duration of time they lasted was less. I noticed that it didn't help with the amount of bowl movements I was having but it did help stop the internal bleeding.
Side effects:   Nausea, cramping, abdominal pain were just some of the bigger side effects. Sometimes the stomach pain was so painful it was worse then an actual flare-up.
Comments:   I stopped taking Asacol because of the intense stomach pain it caused me as well as the nausea. I found that while taking Asacol, my falre-ups did decrease but the side effects outweighed the benefits.


Asacol review by care giver of 15 year old male patient

Overall rating:  
Effectiveness:   Ineffective
Side effects:   Extremely Severe Side Effects
Treatment Info
Condition / reason:   Ulcerative Colitis
Dosage & duration:   800 mg taken bid for the period of 2 weeks
Other conditions:   None
Other drugs taken:   None
Reported Results
Benefits:   There were no benefits as he had to stop taking it
Side effects:   Brownish colored urine, nausea and vomiting, stomache ache
Comments:   Patient was to take 800 mg twice daily to treat ulcerative colitis but was found to be intolerant to Asacol and was discontinued. The side effects began about 7-10 days after starting the Asacol. The nausea and vomiting was not immediately associated with Asacol but was attributed to possibly having the flu. It was only until his urine became a brownish purple color that we thought it must be the Asacol and immediately stopped it. Symptoms went away when stopped.

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Page last updated: 2014-11-30

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