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What is Colazal (balsalazide disodium)?
Colazal (balsalazide disodium) is an oral anti-inflammatory drug used to treat ulcerative colitis. It is a form of mesalamine (5-aminosalicyclic acid) that is activated by colonic bacteria when it reaches the colon. Ulcerative colitis and other inflammatory diseases cause excessive production of chemicals, for example, prostaglandins, that produce inflammation in the colon.
Prostaglandins are produced by the enzymes, cyclooxygenase and lipoxygenase. These enzymes are overactive in individuals with ulcerative colitis. Mesalamine may work by blocking the activity of cyclooxygenase and lipoxygenase, thereby reducing the production of prostaglandins. Reduced production of prostaglandins decreases inflammation in the colon and symptoms associated with ulcerative colitis.
Common side effects of Colazal include:
- abdominal pain,
- respiratory infection,
- joint pain,
- runny or stuffy nose, and
Serious side effects of Colazal include:
Animal studies have not demonstrated any adverse effects from Colazal on a fetus; however, there have been no studies in pregnant women. Colazal should only be used during pregnancy if the benefit outweighs the risks.
What are the important side effects of Colazal (balsalazide disodium)?
Contact your doctor if:
- You experience a worsening of your ulcerative colitis symptoms.
- You are diagnosed with pyloric stenosis, because balsalazide disodium capsules may be slow to pass through your digestive tract.
- You are diagnosed with renal dysfunction. Damage to the kidney has been observed in people given medications similar to balsalazide disodium.
- You are diagnosed with liver disease. Worsening liver disease has been observed in some people given medications similar to balsalazide disodium.
In adult clinical trials the most common side effects were:
In the pediatric clinical trial the most common side effects were:
This is not a complete list of side effects. Discuss potential side effects with your doctor.
Colazal (balsalazide disodium) side effects list for healthcare professionals
Clinical Studies 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.
Adult Ulcerative Colitis
During clinical development, 259 adult patients with active ulcerative colitis were exposed to 6.75 g/day COLAZAL in 4 controlled trials.
In the 4 controlled clinical trials patients receiving a COLAZAL dose of 6.75 g/day most frequently reported the following adverse reactions: headache (8%), abdominal pain (6%), diarrhea (5%), nausea (5%), vomiting (4%), respiratory infection (4%), and arthralgia (4%). Withdrawal from therapy due to adverse reactions was comparable among patients on COLAZAL and placebo.
Adverse reactions reported by 1% or more of patients who participated in the 4 well-controlled, Phase 3 trials are presented by treatment group (Table 1).
The number of placebo patients (35), however, is too small for valid comparisons. Some adverse reactions, such as abdominal pain, fatigue, and nausea were reported more frequently in women than in men. Abdominal pain, rectal bleeding, and anemia can be part of the clinical presentation of ulcerative colitis.
Table 1: Adverse Reactions Occurring in ≥1% of Adult COLAZAL Patients in Controlled Trials*
|Adverse Reaction||COLAZAL 6.75 g/day|
|Abdominal pain||16 (6%)||1 (3%)|
|Diarrhea||14 (5%)||1 (3%)|
|Urinary tract infection||3 (1%)||0%|
|Flu-like disorder||3 (1%)||0%|
|Dry mouth||3 (1%)||0%|
|*Adverse reactions occurring in at least 1% of COLAZAL patients which were less frequent than placebo for the same adverse reaction were not included in the table.|
Pediatric Ulcerative Colitis
In a clinical trial in 68 pediatric patients aged 5 to 17 years with mildly to moderately active ulcerative colitis who received 6.75 g/day or 2.25 g/day COLAZAL for 8 weeks, the most frequently reported adverse reactions were headache (15%), abdominal pain upper (13%), abdominal pain (12%), vomiting (10%), diarrhea (9%), colitis ulcerative (6%), nasopharyngitis (6%), and pyrexia (6%) [see Table 2].
One patient who received COLAZAL 6.75 g/day and 3 patients who received COLAZAL 2.25 g/day discontinued treatment because of adverse reactions. In addition, 2 patients in each dose group discontinued because of a lack of efficacy.
Adverse reactions reported by 3% or more of pediatric patients within either treatment group in the Phase 3 trial are presented in Table 2.
Table 2: Treatment-Emergent Adverse Reactions Reported by ≥3% of Patients in Either Treatment Group in a Controlled Study of 68 Pediatric Patients
|Headache||5 (15%)||5 (14%)||10 (15%)|
|Abdominal pain upper||3 (9%)||6 (17%)||9 (13%)|
|Abdominal pain||4 (12%)||4 (11%)||8 (12%)|
|Vomiting||1 (3%)||6 (17%)||7 (10%)|
|Diarrhea||2 (6%)||4 (11%)||6 (9%)|
|Colitis ulcerative||2 (6%)||2 (6%)||4 (6%)|
|Nasopharyngitis||3 (9%)||1 (3%)||4 (6%)|
|Pyrexia||0 (0%)||4 (11%)||4 (6%)|
|Hematochezia||0 (0%)||3 (9%)||3 (4%)|
|Nausea||0 (0%)||3 (9%)||3 (4%)|
|Influenza||1 (3%)||2 (6%)||3 (4%)|
|Fatigue||2 (6%)||1 (3%)||3 (4%)|
|Stomatitis||0 (0%)||2 (6%)||2 (3%)|
|Cough||0 (0%)||2 (6%)||2 (3%)|
|Pharyngolaryngeal pain||2 (6%)||0 (0%)||2 (3%)|
|Dysmenorrhea||2 (6%)||0 (0%)||2 (3%)|
The following adverse reactions have been identified during post-approval use of balsalazide in clinical practice. 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.
- pleural effusion,
- pneumonia (with and without eosinophilia),
- renal failure,
- interstitial nephritis,
- pancreatitis, and
Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions have been chosen for inclusion due to a combination of seriousness, frequency of reporting, or potential causal connection to balsalazide.
Postmarketing adverse reactions of hepatotoxicity have been reported for products which contain (or are metabolized to) mesalamine, including:
- elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin),
- cholestatic jaundice,
- hepatocellular damage including:
- liver necrosis and liver failure.
Some of these cases were fatal; however, no fatalities associated with these adverse reactions were reported in COLAZAL clinical trials.
One case of Kawasaki-like syndrome which included hepatic function changes was also reported, however, this adverse reaction was not reported in COLAZAL clinical trials.
Colazal (balsalazide disodium) is an oral anti-inflammatory drug used to treat ulcerative colitis. It is a form of mesalamine (5-aminosalicyclic acid) that is activated by colonic bacteria when it reaches the colon. Ulcerative colitis and other inflammatory diseases cause excessive production of chemicals, for example, prostaglandins, that produce inflammation in the colon. Common side effects of Colazal include headache, abdominal pain, diarrhea, nausea, vomiting, respiratory infection, joint pain, runny or stuffy nose, and fever. There are no listed drug interactions of Colazal. Colazal should only be used during pregnancy if the benefit outweighs the risks. It is unknown if Colazal is secreted into breast milk.
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Related Disease Conditions
Ulcerative Colitis Diet Plan
An ulcerative colitis diet plan can help a person with the disease avoid foods and drinks that trigger flares. There also are foods that can soothe ulcerative colitis symptoms during a flare. Types of ulcerative colitis plans include a high-calorie diet, a lactose-free diet, a low-fat diet, a low-fiber diet (low-residue diet), or a low-salt diet. Self-management of ulcerative colitis using healthy lifestyle habits and a nutrient rich diet can be effective in management of the disease. Learn what foods to avoid that aggravate, and what foods help symptoms of the disease and increase bowel inflammation.
Colon cancer (bowel cancer) is a malignancy that arises from the inner lining of the colon. Most, if not all, of these cancers develop from colonic polyps. Removal of these precancerous polyps can prevent colon cancer.
Colon Polyps: Symptoms, Causes, Cancer Risk, Treatment, and Prevention
Colon polyps are common growths on the inner lining of the colon. Colon polyps may become cancerous. There are several different types of colon polyps, and the chance of the polyp becoming cancerous depends on the type, size, and histology. Blood in the stool or rectal bleeding are the most common symptoms of colon polyps. Treatment for colon polyps depend on the type, size, and histology.
Ulcerative colitis is a chronic inflammation of the colon. Symptoms include abdominal pain, diarrhea, and rectal bleeding. Ulcerative colitis is closely related to Crohn's disease, and together they are referred to as inflammatory bowel disease. Treatment depends upon the type of ulcerative colitis diagnosed.
Crohn's Disease vs. Ulcerative Colitis (UC)
Crohn's disease and ulcerative colitis are diseases that cause inflammation of part of or the entire digestive tract (GI). Crohn's affects the entire GI tract (from the mouth to the anus), while ulcerative colitis or ulcerative colitis only affects the large and small intestine and ilium. Researchers do not know the exact cause of either disease. About 20% of people with Crohn's disease also have a family member with the disease. Researchers believe that certain factors may play a role in causing UC. Both Crohn's disease and ulcerative colitis are a type of inflammatory bowel disease, or IBD. Crohn's disease and ulcerative colitis both have similar symptoms and signs, for example, nausea, loss of appetite, fatigue, weight loss, episodic and/or persistent diarrhea, fever, abdominal pain and cramping, rectal bleeding, bloody stools, joint pain and soreness, eye redness, or pain. Symptoms unique to Crohn’s disease include anemia and skin changes. Symptoms of unique to ulcerative colitis include, certain rashes, an urgency to defecate (have a bowel movement). Doctors diagnose both diseases with similar tests and procedures. While there is no cure for either disease, doctors and other health care professionals can help you treat disease flares, and manage your Crohn's or ulcerative colitis with medication, diet, nutritional supplements, and/or surgery.
Early Warning Signs and Stages of Colon Cancer
Colon cancer or colorectal cancer, is a type of cancer that begins in the cells lining the large intestine (colon). In the early stages of colon cancer, warning signs and symptoms usually don’t occur. Colon cancer usually does not have any signs or symptoms. As the cancer grows and expands it may begin to produce signs and symptoms, for example, diarrhea, constipation, blood in the stool, and narrow or pencil-thin stools.There are four stages of colon cancer; however, The term Stage 0 is sometimes used for a very early cancer that only affects the lining of the intestine. The other stages of colon cancer are stage 1, 2, 3, and 4.
Colon Cancer Prevention
Colorectal cancer is both curable and preventable if it is detected early and completely removed before the cancerous cells metastasize to other parts of the body. Colonoscopy and flexible sigmoidoscopy (along with digital rectal examination and stool occult blood testing) are both effective at preventing colo-rectal cancers and detecting early colo-rectal cancers.
Treatment & Diagnosis
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Medications & Supplements
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.