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Does Pentasa (mesalamine) cause side effects?
The exact mechanism of Pentasa is not known but is believed to be by reducing inflammation in 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 over-active in individuals with ulcerative colitis.
Pentasa 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 the symptoms associated with ulcerative colitis.
Available forms of mesalamine differ in their route of administration and how often they are administered.
Common side effects of Pentasa include
Less common side effects include
Serious side effects of Pentasa include
- blood disorders,
- kidney dysfunction, and
- an acute intolerance syndrome that resembles a flare of inflammatory bowel disease (Crohn's disease or ulcerative colitis) with cramping, abdominal pain, and bloody diarrhea.
Drug interactions of Pentasa include drugs that affect kidney function, for example, nonsteroidal anti-inflammatory drugs (NSAIDs) or ibuprofen, because it may increase the likelihood of reduced function of the kidneys.
Pentasa may increase the blood-thinning effect of warfarin.
There are no adequate human studies of Pentasa during pregnancy. Pentasa is known to cross the placenta into the fetus, but animal studies revealed no evidence of harm to the fetus. Pentasa should only be used during pregnancy if it is felt that the benefit of its use justifies the unknown risks.
What are the important side effects of Pentasa (mesalamine)?
The most common side effects of mesalamine are:
Infrequent side effects include:
Kidney dysfunction has been associated with mesalamine. Kidney function should be evaluated prior to and periodically during mesalamine therapy.
Mesalamine may cause an acute intolerance syndrome that resembles a flare of inflammatory bowel disease (Crohn's disease or ulcerative colitis) with cramping, abdominal pain, and bloody diarrhea. Fever, headache, itching, and rash also may occur. Symptoms usually subside once mesalamine is discontinued.
Mesalamine enemas contain sulfites and should be avoided in persons who are sensitive to sulfites.
Pentasa (mesalamine) side effects list for healthcare professionals
In combined domestic and foreign clinical trials, more than 2100 patients with ulcerative colitis or Crohn's disease received Pentasa therapy. Generally, Pentasa therapy was well tolerated. The most common events (ie, greater than or equal to 1%) were
- diarrhea (3.4%),
- headache (2.0%),
- nausea (1.8%),
- abdominal pain (1.7%),
- dyspepsia (1.6%),
- vomiting (1.5%), and
- rash (1.0%).
In two domestic placebo-controlled trials involving over 600 ulcerative colitis patients, adverse events were fewer in Pentasa (mesalamine)-treated patients than in the placebo group (Pentasa 14% vs placebo 18%) and were not dose-related.
Events occurring in more than 1% are shown in the table below. Of these, only nausea and vomiting were more frequent in the Pentasa group. Withdrawal from therapy due to adverse events was more common on placebo than Pentasa (7% vs 4%).
Table 1: Adverse Events Occurring in More than 1% of Either Placebo or Pentasa Patients in Domestic Placebo-controlled Ulcerative Colitis Trials. (Pentasa Comparison to Placebo)
|Diarrhea||16 (3.5%)||13 (7.5%)|
|Headache||10 (2.2%)||6 (3.5%)|
|Abdominal Pain||5 (1.1%)||7 (4.0%)|
|Melena (Bloody Diarrhea)||4 (0.9%)||6 (3.5%)|
|Rash||6 (1.3%)||2 (1.2%)|
|Anorexia||5 (1.1%)||2 (1.2%)|
|Fever||4 (0.9%)||2 (1.2%)|
|Rectal Urgency||1 (0.2%)||4 (2.3%)|
|Nausea and Vomiting||5 (1.1%)||-|
|Worsening of Ulcerative Colitis||2 (0.4%)||2 (1.2%)|
|Acne||1 (0.2%)||2 (1.2%)|
Clinical laboratory measurements showed no significant abnormal trends for any test, including measurement of hematological, liver, and kidney function.
The following adverse events, presented by body system, were reported infrequently (ie, less than 1%) during domestic ulcerative colitis and Crohn's disease trials. In many cases, the relationship to Pentasa has not been established.
Gastrointestinal: abdominal distention, anorexia, constipation, duodenal ulcer, dysphagia, eructation, esophageal ulcer, fecal incontinence, GGTP increase, GI bleeding, increased alkaline phosphatase, LDH increase, mouth ulcer, oral moniliasis, pancreatitis, rectal bleeding, SGOT increase, SGPT increase, stool abnormalities (color or texture change), thirst
Other: albuminuria, amenorrhea, amylase increase, arthralgia, asthenia, breast pain, conjunctivitis, ecchymosis, edema, fever, hematuria, hypomenorrhea, Kawasaki-like syndrome, leg cramps, lichen planus, lipase increase, malaise, menorrhagia, metrorrhagia, myalgia, pulmonary infiltrates, thrombocythemia, thrombocytopenia, urinary frequency
One week after completion of an 8-week ulcerative colitis study, a 72-year-old male, with no previous history of pulmonary problems, developed dyspnea. The patient was subsequently diagnosed with interstitial pulmonary fibrosis without eosinophilia by one physician and bronchiolitis obliterans with organizing pneumonitis by a second physician. A causal relationship between this event and mesalamine therapy has not been established.
Published case reports and/or spontaneous postmarketing surveillance have described infrequent instances of pericarditis, fatal myocarditis, chest pain and T-wave abnormalities, hypersensitivity pneumonitis, pancreatitis, nephrotic syndrome, interstitial nephritis, hepatitis, aplastic anemia, pancytopenia, leukopenia, agranulocytosis, or anemia while receiving mesalamine therapy. Anemia can be a part of the clinical presentation of inflammatory bowel disease. Allergic reactions, which could involve eosinophilia, can be seen in connection with Pentasa therapy.
The following events have been identified during post-approval use of the Pentasa brand of mesalamine in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of seriousness, frequency of reporting, or potential causal connection to mesalamine:
Reports of hepatotoxicity, including elevated liver enzymes (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), hepatitis, jaundice, cholestatic jaundice, cirrhosis, and possible hepatocellular damage including liver necrosis and liver failure. Some of these cases were fatal. One case of Kawasaki-like syndrome which included hepatic function changes was also reported.
Postmarketing reports of anaphylactic reaction, Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), pneumonitis, granulocytopenia, systemic lupus erythematosus, lupus-like syndrome, acute renal failure, interstitial lung disease, Hypersensitivity pneumonitis (including interstitial pneumonitis, allergic alveolitis, eosinophilic pneumonitis), chronic renal failure, nephrogenic diabetes insipidus, intracranial hypertension, angioedema and oligospermia (reversible) have been received in patients taking Pentasa.
Pentasa (mesalamine) is an anti-inflammatory agent used to treat ulcerative colitis and mild to moderate Crohn's disease. Common side effects of Pentasa include headache, gas (flatulence), hair loss, and itching. Less common side effects include increased heart rate, acne, back pain, fatigue, tremor, and ear pain. Pentasa should only be used during pregnancy if it is felt that the benefit of its use justifies the unknown risks. Pentasa is excreted in breast milk.
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Related Disease Conditions
Second Source WebMD Medical Reference
Second Source article from Government
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.
Crohn's disease is a chronic inflammatory disease, primarily involving the small and large intestine, but which can affect other parts of the digestive system as well. Abdominal pain, diarrhea, vomiting, fever, and weight loss are common symptoms.
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.
What Are the Five Types of Crohn's Disease?
The five types of Crohn's disease are ileocolitis, ileitis, gastroduodenal Crohn’s disease, jejunoileitis, Crohn's (granulomatous) colitis. Each have different characteristic symptoms and signs.
Is Ulcerative Colitis Curable?
Ulcerative colitis is an inflammatory bowel disease (IBD) that affects the inner lining of the large intestine (large bowel or colon) leading to erosion and ulcers. It is also associated with various manifestations outside of the colon, such as inflammation of the eyes, joints, skin, and lungs. Ulcerative colitis is a lifelong illness with no specific cause or cure. Patients have repeated cycles of flare-ups and disappearance of the disease.
Is Crohn's Disease Contagious?
Crohn's disease, a form of inflammatory bowel disease (IBD), and is characterized by symptoms and signs that include diarrhea, fever, weight loss, vomiting, and abdominal pain. Though Crohn's disease is not contagious it can spread throughout a person's gastrointestinal tract. An increase in the above symptoms and signs warrants a visit to a doctor's office.
What Is the Life Expectancy of Someone with Crohn's Disease?
Crohn’s disease is a chronic condition that causes inflammation in the gut (digestive tract).Crohn’s disease belongs to a group of conditions known as inflammatory bowel disease (IBD). With appropriate management, patients with Crohn’s disease may expect a normal life expectancy and a good quality of life.
What Is the Life Expectancy of Someone With Ulcerative Colitis?
Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) that affects the inner lining of the large intestine (large bowel) leading to erosion and ulcers. It is a lifelong illness with no specific cause or cure.
How Serious Is Ulcerative Colitis?
Ulcerative colitis (UC) is a lifelong disease with constant periods of flare-ups and remissions (periods without symptoms, which may last for weeks or years). Presently, there is no permanent medical cure for it, but there are various medications that can provide symptomatic relief, reduce inflammation and manage flare-ups.
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.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.