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Does Lialda (mesalamine) cause side effects?
Lialda is mesalamine in a form that is slowly released in the intestine so that it can be given just once-a-day. Other oral drugs containing mesalamine that are similar to Lialda include Asacol, Pentasa, and Apriso. Asacol and Pentasa, however, are given as multiple daily doses.
The exact mechanism of Lialda 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 (i.e., prostaglandins) that produce inflammation in the colon.
Prostaglandins are produced by cyclooxygenase and lipoxygenase enzymes. These enzymes are over-active in individuals with ulcerative colitis. Lialda may work by blocking the activity of cyclooxygenase and lipoxygenase, therefore, reducing the production of prostaglandins. Reduced prostaglandin production reduces inflammation in the colon and other symptoms associated with ulcerative colitis.
Common side effects of Lialda include
Less common side effects of Lialda include
Serious side effects of Lialda include
- blood disorders,
- kidney dysfunction and
- an acute intolerance syndrome that resembles a flare of inflammatory bowel disease. Symptoms include
Specific drug interaction studies have not been conducted with Lialda. Other mesalamine medications have been associated with several drug interactions.
Combining mesalamine with drugs that affect kidney function, for example, nonsteroidal anti-inflammatory drugs (for example, ibuprofen), may increase the likelihood of kidney dysfunction. Concurrent use of mesalamine and 6-mercaptopurine or azathioprine may increase the likelihood of blood disorders. Mesalamine may increase the blood thinning effect of warfarin.
There are no adequate human studies of Lialda use during pregnancy. Lialda 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 Lialda (mesalamine)?
The most common side effects are:
Other less common side effects include:
- increased heart rate,
- back pain,
- ear pain,
- blood disorders, and
- kidney dysfunction.
Possible serious side effects include an acute intolerance syndrome that resembles a flare of inflammatory bowel disease. Symptoms include:
Lialda (mesalamine) side effects list for healthcare professionals
The most serious adverse reactions seen in Lialda clinical trials or with other products that contain or are metabolized to mesalamine are:
- Renal impairment, including renal failure
- Mesalamine-induced acute intolerance syndrome
- Hypersensitivity reactions
- Hepatic impairment
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.
The most common adverse reactions occurring in at least 1% of Lialda- or placebo-treated adult patients with mildly to moderately active ulcerative colitis in two eight-week, randomized, double-blind, placebo-controlled trials (Study 1 and Study 2) are listed in Table 2.
Table 2: Adverse Reactions* in Two Eight-Week, Placebo-Controlled Trials of Induction Therapy (Study 1 and Study 2) in Adults with Mildly to Moderately Active Ulcerative Colitis
Lialda 2.4 g once daily|
Lialda 4.8 g once daily|
|Liver Function Test Abnormal||<1%||2%||1%|
|*Reported in at least 1% of patients in at least one Lialda group and greater than placebo|
Pancreatitis occurred in less than 1% of patients during induction in clinical trials and resulted in discontinuation of therapy with Lialda in patients experiencing this event.
Maintenance Of Remission
A Lialda dosage of 2.4 g/day, administered as either 1.2 g twice daily or 2.4 g once daily, was evaluated for safety in three maintenance trials in patients with mildly to moderately active ulcerative colitis: a 6-month double-blind, active-controlled study (Study 3) and two 12- to 14-month open-label studies. The most common adverse reactions with Lialda in these maintenance trials are listed in Table 3.
Table 3: Adverse Reactions in Three Trials of Maintenance of Remission in Adults with Ulcerative Colitis
Lialda 2.4 g/day†|
|Liver function test abnormal||2%|
|Abdominal pain upper||1%|
|*Reported in at least 1% of patients|
†Administered either as 1.2 g twice daily or 2.4 g once daily
The following adverse reactions, presented by body system, were reported in less than 1% of Lialda-treated patients with ulcerative colitis in either induction or maintenance trials:
Cardiac Disorder: tachycardia
Ear and Labyrinth Disorders: ear pain
Investigations: decreased platelet count
Nervous System Disorders: dizziness, somnolence, tremor
Respiratory, Thoracic and Mediastinal Disorders: pharyngolaryngeal pain
Lialda was evaluated in 105 pediatric patients 5 through 17 years of age with mildly to moderately active ulcerative colitis. The adverse reaction profile was similar to that of adults. The most common adverse reactions reported in at least 5% of pediatric patients treated with Lialda were: abdominal pain, upper respiratory tract infection, vomiting, anemia, headache, and viral infection.
In addition to the adverse reactions reported above in clinical trials involving Lialda, the adverse reactions listed below have been identified during postapproval use of Lialda and other mesalamine-containing 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.
Body as a Whole: lupus-like syndrome, drug fever
Hematologic: agranulocytosis, aplastic anemia
Immune System Disorders: anaphylactic reaction, angioedema, Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS)
Renal Disorders: renal failure, interstitial nephritis, nephrogenic diabetes insipidus
Urogenital: reversible oligospermia
What drugs interact with Lialda (mesalamine)?
Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs
The concurrent use of mesalamine with known nephrotoxic agents, including non-steroidal anti-inflammatory drugs (NSAIDs), may increase the risk of nephrotoxicity. Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions.
Azathioprine And 6-Mercaptopurine
The concurrent use of mesalamine with azathioprine or 6-mercaptopurine and/or any other drugs known to cause myelotoxicity may increase the risk for blood disorders, bone marrow failure, and associated complications. If concomitant use of Lialda and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts.
Interference With Laboratory Tests
Use of Lialda may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection. Consider an alternative, selective assay for normetanephrine.
Lialda (mesalamine) is an anti-inflammatory agent used to treat active, mild to moderate ulcerative colitis. Common side effects of Lialda include headache, gas (flatulence), hair loss, and itching. Less common side effects of Lialda include increased heart rate, acne, back pain, fatigue, tremor, and ear pain. Lialda should only be used during pregnancy or when breastfeeding if it is felt that the benefit of its use justifies the unknown risks.
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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.
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, and 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 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.
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.
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
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.