Lialda (mesalamine)

What is Lialda?

Lialda is a brand-name prescription medication. It’s used to treat ulcerative colitis in adults and some children.

Ulcerative colitis is a type of inflammatory bowel disease. It causes inflammation (swelling) and small sores called ulcers in the lining of your colon (large intestine). Symptoms include abdominal (belly) pain and diarrhea that contains blood or mucus.

Ulcerative colitis is a chronic (long-term) condition, and your symptoms may change over time. You may have periods when the disease is active and you have lots of symptoms. This is called a flare-up. You may also have periods when your symptoms get better. This is called being in remission.

Lialda is used in two ways to treat ulcerative colitis in adults:

• Induction of remission. This means causing remission. Lialda treats mild to moderate symptoms of ulcerative colitis until they get better or go away.
• Maintenance of remission. This means keeping you in remission. Lialda helps you remain free from symptoms of mild to moderate ulcerative colitis.

Lialda is also used to treat mild to moderately active ulcerative colitis in children who weigh at least 24 kilograms. (This equals about 53 pounds.)

Drug details

Lialda contains the drug mesalamine. It belongs to a class of drugs called aminosalicylates. A class of drugs is a group of medications that act in a similar way. Aminosalicylates help reduce the inflammation in your bowel.

Lialda comes as delayed-release tablets that you take once a day. The tablets are available in one strength: 1.2 grams.

Effectiveness

In two 8-week clinical studies, Lialda was found to be effective at inducing remission from ulcerative colitis. A 6-month study also found Lialda to be effective at maintaining remission from ulcerative colitis.

To learn more, see the “Lialda for ulcerative colitis” section.

Lialda generic

Lialda contains the active drug mesalamine. Generic forms are available and come in the same strength as Lialda.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs

Other brand-name versions of mesalamine are also available. These include Asacol HD, Apriso, Delzicol, and Pentasa. If you’d like to know about these other drugs and find out possible dosage conversions between them, ask your doctor.

Lialda side effects

Lialda can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Lialda. These lists do not include all possible side effects.

Most of the drug’s side effects aren’t long term. However, some can be long lasting. These include certain liver problems and kidney problems. See the “Serious side effects” list below to learn more.

For more information on the possible side effects of Lialda, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Association (FDA) tracks side effects of drugs they have approved. If you would like to report to the FDA a side effect you’ve had with Lialda, you can do so through MedWatch.

More common side effects

The more common side effects of Lialda in adults can include:

• flatulence (passing gas)
• abnormal results in liver function tests, which could be a sign of liver problems
• worsening of ulcerative colitis symptoms, such as abdominal (belly) pain or diarrhea
• headache (see “Side effect details” below)

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Lialda aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include the following:

• Liver problems, including liver failure in people who already have liver problems. Symptoms can include:
  • jaundice (yellowing of your skin or the whites of your eyes)
  • pain in the right side of your upper abdomen

Other serious side effects are discussed in more detail below. They include:

• mesalamine-induced acute intolerance syndrome (see the “Diarrhea” section below)
• kidney problems, including kidney failure and kidney stones
• skin rashes, including severe rashes from Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS)
• severe allergic reaction

Side effects in children

Lialda is used to treat active ulcerative colitis in children who weigh at least 24 kilograms. (This is about 53 pounds.) In general, Lialda’s side effects in children are similar to those seen in adults.

More common side effects of Lialda in children may include:

• pain in the abdomen (belly)
• infection, such as upper respiratory infection
• vomiting
• headache
• anemia (low red blood cell level)

These side effects are usually mild. If they occur, they should ease within a few days or a couple of weeks. But if they’re severe or don’t go away, talk with your child’s doctor.

Side effect details

You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here’s some detail on several of the side effects this drug may or may not cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Lialda. Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Allergic reactions that affect the heart have also been reported with Lialda. These include myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining of your heart).

Symptoms can include:

• abnormal heartbeat
• chest pain
• trouble breathing

Call your doctor right away if you have a severe allergic reaction to Lialda. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Hair loss

Hair loss is possible while taking Lialda, but this was rare in clinical studies of the drug.

Hair loss was reported in 1% of people who took 4.8 g of Lialda per day to induce remission (treat active symptoms) of ulcerative colitis. Hair loss wasn’t reported in people who took 2.4 g of Lialda per day to induce remission. It also wasn’t reported in people who took a placebo (a treatment with no active drug).

Hair loss was reported in less than 1% of people who took Lialda to maintain remission of ulcerative colitis (stop symptoms from coming back). None of the people taking a placebo had any hair loss.

If you’re concerned about hair loss, talk with your doctor. They may suggest tests to see why you’re having hair loss. They may also recommend ways to help you manage this problem.

Headache

Lialda may cause headaches. This side effect was common in clinical studies of Lialda.

Headaches were reported in 6% of people who took 2.4 g of Lialda per day to induce remission of ulcerative colitis. They were reported in 3% of people who took 4.8 g of Lialda per day and in less than 1% of people who took a placebo.

Headaches were reported in 3% of people who took Lialda to maintain remission of ulcerative colitis.

If you get headaches while taking Lialda, ask your doctor or pharmacist about ways to manage them.

Skin rash, including severe rashes

Some people may get a skin rash while taking Lialda. This may be caused by the medication, or it may be caused by ulcerative colitis itself. Skin issues (such as painful rashes) are common in people with ulcerative colitis, especially during flare-ups of the disease.

In clinical studies, skin rashes were reported in up to 1% of people who took 2.4 g or 4.8 g of Lialda to induce or maintain remission of ulcerative colitis.

Severe skin rashes have been reported in people taking Lialda. These rashes include those caused by Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS).

Symptoms of severe skin rashes may include:

• rash that peels or has blisters
• fever
• body aches

If you get a skin rash while taking Lialda, talk with your doctor about ways to manage it. They may prescribe medications to treat the rash. However, if you have symptoms of a severe rash, call your doctor right away. If your symptoms feel life threatening, call 911 or your local emergency number instead.

Kidney problems

In rare cases, Lialda can cause or worsen kidney problems, such as kidney inflammation (swelling) or kidney failure. It’s not known how often these problems occur.

Your doctor will check for any problems with your kidneys before you start taking Lialda. You’ll also need to have blood or urine tests to monitor your kidney function from time to time during treatment.

See your doctor if you get symptoms of kidney problems while taking Lialda. These may include:

• passing less urine than usual
• swollen ankles, feet, or legs
• shortness of breath
• feeling unusually sleepy
• nausea
• confusion

Additionally, it’s possible to develop kidney stones with Lialda. These are mineral deposits that form in your kidneys. They can sometimes block urine from leaving your body.

Possible symptoms of kidney stones include:

• pain in your belly, back, or pelvis
• frequent need to urinate, but passing only small amounts of urine
• blood in your urine

To help prevent kidney stones, your doctor will encourage you to drink plenty of water while you’re taking Lialda.

Joint pain

Joint pain is possible while taking Lialda. This may be caused by the medication or by ulcerative colitis itself.

In clinical studies, joint pain was reported in up to 1% of people taking Lialda to induce or maintain remission of ulcerative colitis.

If you have joint pain, talk with your doctor about ways to manage it.

Diarrhea

Some people may get diarrhea while taking Lialda. This may be caused by the medication, but it’s also a common symptom of ulcerative colitis itself.

In clinical studies, diarrhea was reported in less than 1% of people taking Lialda to induce remission. It was reported in 2% of people taking Lialda to maintain remission.

If your diarrhea contains blood, it could be a sign of mesalamine-induced acute intolerance syndrome. This is a serious side effect that can occur in some people. It’s not known exactly how often it happens with Lialda. In clinical studies, this side effect occurred in 3% of people who took either mesalamine (the active drug in Lialda) or sulfasalazine (a drug that’s changed into mesalamine in the body).

It can be hard to tell the symptoms of mesalamine-induced acute intolerance syndrome apart from a flare-up of ulcerative colitis. Symptoms can include:

• abdominal pain or cramping
• bloody diarrhea
• fever
• headache
• rash

Talk with your doctor if you get new or worsening diarrhea while taking Lialda, especially if the diarrhea contains blood.

Pancreatitis

Pancreatitis (inflammation of the pancreas) can occur while taking Lialda. In clinical studies, pancreatitis occurred in less than 1% of people taking Lialda.

Symptoms of pancreatitis may include:

• pain in the upper abdomen and back
• nausea and vomiting
• indigestion
• bloating

Talk with your doctor if you get symptoms of pancreatitis while taking Lialda.

Weight gain (not a side effect)

Weight gain was not reported as a side effect in clinical studies of Lialda. However, you may find that you gain weight as your ulcerative colitis symptoms improve and your diet is less restricted.

Talk with your doctor if you’re concerned about gaining weight while managing your ulcerative colitis.

Lialda dosage

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Lialda comes as delayed-release tablets, which means they have a special coating that allows them to pass through the stomach before dissolving. The tablets are only available in one strength: 1.2 grams (g).

Dosage for induction of ulcerative colitis remission in adults

Induction of ulcerative colitis remission means treating your symptoms until they get better or go away.

The usual dosage for inducing remission is two to four Lialda tablets taken once a day with a meal. So, your prescribed dosage may be 2.4 g to 4.8 g daily.

It’s best to take your dose at the same time each day. You should continue taking the prescribed dose each day for as long as your doctor recommends.

Dosage for maintenance of ulcerative colitis remission in adults

Maintenance of ulcerative colitis remission is when you take Lialda on a long-term basis, even when you don’t have symptoms. This keeps the disease under control and can help keep your symptoms from coming back.

The usual dose for maintenance of remission is two Lialda tablets taken once a day with a meal. So, your prescribed dosage would be 2.4 g daily.

It’s best to take your dose at the same time each day. You should continue taking the prescribed dose each day for as long as your doctor recommends.

Children’s dosage for ulcerative colitis

Recommended dosages of Lialda for children are based on body weight. This drug is prescribed for children who can swallow tablets whole and weigh at least 24 kilograms (kg). This is about 53 pounds (lb). (One kg equals about 2.2 lb.)

For the first 8 weeks, the typical recommended daily dosage of Lialda for children is as follows:

• For children weighing 24 kg to 35 kg, their daily dose is 2.4 g.
• For children weighing more than 35 kg to 50 kg, their daily dose is 3.6 g.
• For children weighing more than 50 kg, their daily dose is 4.8 g.

After 8 weeks of treatment, your child’s doctor will likely reduce the dosage of Lialda as follows:

• For children weighing 24 kg to 35 kg, their daily dose is 1.2 g.
• For children weighing more than 35 kg to 50 kg, their daily dose is 2.4 g.
• For children weighing more than 50 kg, their daily dose is 2.4 g.

Your child will continue taking the prescribed dose each day for as long as their doctor recommends.

What if I miss a dose?

If you forget to take a dose of Lialda at your usual time, take it as soon as you remember. However, if it’s almost time for your next dose, just skip the missed dose. Then, take your next dose at your usual time.

Never take two doses at once to make up for a missed dose. Doing this can increase your risk of certain side effects.

To help make sure you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Will I need to use this drug long term?

Lialda is meant to be used as a long-term treatment. If you and your doctor determine that Lialda is safe and effective for you, you’ll likely take it long term.

Alternatives to Lialda

Other drugs are available that can treat ulcerative colitis. Some may be a better fit for you than others. If you’re interested in finding an alternative to Lialda, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Alternatives for induction of ulcerative colitis remission

Inducing remission means treating active ulcerative colitis symptoms until they get better or go away.

Examples of other drugs that may be used to induce the remission of ulcerative colitis include:

• other aminosalicylates taken by mouth, such as:
  • balsalazide (Colazal)
  • olsalazine (Dipentum)
  • sulfasalazine (Azulfidine)
  • other forms of mesalamine (Asacol HD, Delzicol, Pentasa)
• aminosalicylates taken rectally, such as:
  • mesalamine (Rowasa, sfRowasa, Canasa)
• corticosteroids taken by mouth, such as:
  • budesonide (Uceris)
  • hydrocortisone (Cortef)
  • methylprednisolone (Medrol)
  • prednisone (Rayos)
• corticosteroids taken rectally, such as:
  • budesonide (Uceris rectal foam)
  • hydrocortisone (Colocort, Cortenema)
• immunomodulators, such as:
  • azathioprine (Imuran, Azasan)
  • 6-mercaptopurine (6-MP)
• biologic therapies, such as:
  • adalimumab (Humira)
  • infliximab (Inflectra, Remicade, Renflexis)
  • golimumab (Simponi)
  • vedolizumab (Entyvio)

Alternatives for maintenance of ulcerative colitis remission

Maintaining remission means keeping the inflammation in your bowel under control to help prevent your symptoms from coming back. Examples of other drugs that may be used to maintain remission of ulcerative colitis include:

• other aminosalicylates taken by mouth, such as:
  • balsalazide (Colazal)
  • olsalazine (Dipentum)
  • sulfasalazine (Azulfidine)
  • other forms of mesalamine (Apriso, Delzicol)
• aminosalicylates taken rectally, such as:
  • mesalamine (Rowasa, sfRowasa, Canasa)
• immunomodulators, such as:
  • azathioprine (Imuran, Azasan)
  • 6-mercaptopurine (6-MP)
• biologic therapies, such as:
  • adalimumab (Humira, Imraldi)
  • infliximab (Inflectra, Remicade, Renflexis)
  • golimumab (Simponi)
  • vedolizumab (Entyvio)

Lialda cost

As with all medications, the cost of Lialda can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Your insurance plan may require you to get prior authorization before approving coverage for Lialda. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the request and let you and your doctor know if your plan will cover Lialda.

If you’re not sure if you’ll need to get prior authorization for Lialda, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Lialda, or if you need help understanding your insurance coverage, help is available.

Takeda Pharmaceutical Ltd., the manufacturer of Lialda, offers a program called Help at Hand. For more information and to find out if you’re eligible for support, call 800-830-9159 or visit the program website.

Lialda for ulcerative colitis

The Food and Drug Administration (FDA) approves prescription drugs such as Lialda to treat certain conditions. Lialda may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Lialda has been approved by the FDA to treat ulcerative colitis in adults and some children.

About ulcerative colitis

Ulcerative colitis is a form of inflammatory bowel disease. With ulcerative colitis, you have inflammation (swelling) in the lining of your colon, rectum, or both. You may also develop small sores, called ulcers, in these linings.

Ulcerative colitis can cause abdominal (belly) pain, frequent bowel movements, and diarrhea that may contain blood or mucus. You may also have other symptoms that don’t directly involve your bowel. These include fatigue (lack of energy), loss of appetite, nausea, weight loss, fever, skin problems, and joint pain.

Ulcerative colitis is a chronic (long-term) condition. You may have periods when your symptoms are particularly active. This is called a flare-up. You may also have times when you don’t have any symptoms. This is called being in remission.

Lialda for induction of ulcerative colitis remission in adults

Lialda is FDA-approved for inducing remission of active mild to moderate ulcerative colitis in adults. Inducing remission means treating your symptoms until they get better or go away.

Effectiveness

In two 8-week clinical studies, Lialda was found effective at inducing remission from ulcerative colitis symptoms. In both studies, adults with mild to moderate symptoms of ulcerative colitis took either 2.4 g of Lialda per day, 4.8 g of Lialda per day, or a placebo (a treatment with no active drug).

At the end of the first 8-week study, remission from symptoms was achieved in:

• 34% of people who took 2.4 g of Lialda per day
• 29% of people who took 4.8 g of Lialda per day
• 13% of people who took a placebo

At the end of the second 8-week study, remission from symptoms was achieved in:

• 41% of people who took 2.4 g of Lialda per day
• 41% of people who took 4.8 g of Lialda per day
• 22% of people who took a placebo

In these studies, the people who had remission from their symptoms had less frequent bowel movements and less rectal bleeding. The lining of their colon was also assessed with a sigmoidoscopy. In this procedure, a camera and light on a thin, flexible tube is inserted into your colon through your rectum. The people in remission had less inflammation and fewer ulcers in the lining of their colon.

Lialda for maintenance of ulcerative colitis remission in adults

Lialda is also FDA-approved for the maintenance of mild to moderate ulcerative colitis remission in adults. Maintenance of remission means taking Lialda on a long-term basis, even when you don’t have symptoms. This keeps the disease under control and helps prevent your symptoms from coming back.

Effectiveness

One 6-month clinical study found Lialda to be effective at maintaining remission from ulcerative colitis. In this study, adults who had minimal or no symptoms took either 2.4 g of Lialda per day or 1.6 g of mesalamine delayed-release. (Mesalamine is the active drug in Lialda.)

After 6 months, 84% of people taking 2.4 g of Lialda per day were still in remission. Of those taking 1.6 g of mesalamine delayed-release per day, 82% were still in remission after 6 months.

Lialda for ulcerative colitis in children

Lialda is FDA-approved for use in certain children to treat mild to moderately active ulcerative colitis. (When the disease is active, you have lots of symptoms.)

Lialda is prescribed for children who:

• can swallow tablets whole, and
• weigh at least 24 kilograms, which equals about 53 pounds

Effectiveness

To learn about Lialda’s effectiveness in children for treating ulcerative colitis, see the drug’s prescribing information.

Lialda vs. Apriso vs. Asacol HD

You may wonder how Lialda compares to other medications that are prescribed for ulcerative colitis. Here we look at how Lialda, Apriso, and Asacol HD are alike and different.

Ingredients

Lialda, Apriso, and Asacol HD all contain the active drug mesalamine.

Uses

Lialda, Apriso and Asacol HD are all used to treat ulcerative colitis in adults. However, these drugs contain different doses and are approved for use in slightly different ways:

• Lialda is approved to:
  • induce remission (treat active symptoms) of mild to moderate ulcerative colitis
  • maintain remission (help prevent symptoms from coming back) of mild to moderate ulcerative colitis
• Asacol HD is only approved to induce remission of moderately active ulcerative colitis.
• Apriso is only approved to maintain remission of ulcerative colitis.

Additionally, Lialda is approved to treat active ulcerative colitis in children who weigh at least 24 kilograms (about 53 pounds). Apriso and Asacol HD are not approved for use in children.

Since these medications all contain the same active drug, all three drugs can cause very similar side effects.

Drug forms and administration

The drug forms and how they’re given differ slightly between the three drugs.

Here’s a summary of forms and dosage schedules for Lialda, Apriso, and Asacol HD:

• Lialda
  • Form: tablet that’s both delayed-release (passes through the stomach before dissolving) and extended-release (releases slowly into the body over time)
  • Typical dosage: taken once daily
• Apriso
  • Form: capsule that’s both delayed-release and extended-release
  • Typical dosage: taken once daily
• Asacol HD
  • Form: tablet that’s delayed-release
  • Typical dosage: taken three times daily

Effectiveness

In clinical studies, Lialda, Apriso, and Asacol HD have all been found to be effective for treating ulcerative colitis.

One review looked at how effective different forms of mesalamine are for inducing and maintaining ulcerative colitis remission. It found that the different forms of oral mesalamine seem to be similarly effective and safe when equal doses are compared.

Talk with your doctor if you would prefer to take one brand of mesalamine over another.

Costs

Lialda, Apriso, and Asacol HD are all brand-name drugs. Lialda and Asacol HD are also available in generic form. There is currently no generic form of Apriso. Brand-name medications usually cost more than generics.

Lialda may be the most expensive of the three brand-name drugs. Asacol HD generally costs less than Lialda but more than Apriso. The actual price you’ll pay for any of these drugs depends on your dosage, insurance plan, your location, and the pharmacy you use.

Common questions about Lialda

Here are answers to some frequently asked questions about Lialda.

Can I take Lialda with prednisone?

Yes, in some cases you can take these drugs together for a short time.

Most people don’t need to use corticosteroid medications, such as prednisone, while taking Lialda. However, sometimes your ulcerative colitis symptoms may not improve with Lialda alone. In this case, your doctor may prescribe a rectal form of mesalamine (a suppository or enema) to use as well. If this combined treatment doesn’t work, your doctor might also prescribe an oral corticosteroid, such as prednisone or budesonide.

Prednisone can help relieve your ulcerative colitis symptoms. However, corticosteroids such as prednisone shouldn’t be used as a long-term treatment to prevent flare-ups. If you do take prednisone with Lialda, it should only be for a short period of time.

Your doctor can determine how long it’s safe for you to take these drugs together.

Is Lialda a biologic?

No, Lialda is not a biologic. Biologic medications are made using living organisms. They’re designed to act on specific substances in your immune system. Biologics for ulcerative colitis target the substances that are causing the inflammation (swelling) in your bowel. They tend to be used for more severe forms of ulcerative colitis, when other drugs haven’t worked.

Lialda is a type of medication called an aminosalicylate. It also reduces bowel inflammation, but it does this in a less targeted way than biologics.

Do I need to worry about sun exposure if I’m taking Lialda?

Yes. Lialda may make your skin burn more easily in the sun. This is because it can make your skin more sensitive to sunlight. This side effect wasn’t reported in clinical studies of Lialda. However, it has been reported since the drug has been on the market.

It’s not known how often this side effect occurs. You’re more likely to have this problem if you already have any skin issues, such as eczema or dermatitis.

Skin issues are common in people with ulcerative colitis. If you have a skin problem, you should avoid exposing your skin to excessive sunlight. Protect your skin with clothing or sunscreen, and try to stay out of strong sunlight. If you don’t have any skin issues, you should still follow these tips until you know whether Lialda affects your skin.

Is Lialda a blood thinner or an NSAID?

No, Lialda is not a blood thinner or a nonsteroidal anti-inflammatory drug (NSAID).

Instead, Lialda is an aminosalicylate medication that’s used to reduce inflammation (swelling) in your colon and rectum.

Lialda contains the active drug mesalamine. This drug is structurally related to aspirin, which is a blood thinner and an NSAID. However, Lialda works differently in your body than aspirin.

Very rarely, Lialda may cause a drop in the number of platelets (a type of cell) in your blood. This could make you bruise or bleed more easily, because platelets usually help your blood to clot. However, Lialda is not used as a blood thinner.

Can Lialda be used for Crohn’s disease or IBS?

No. Lialda isn’t FDA-approved for Crohn’s disease or irritable bowel syndrome (IBS). Instead, Lialda is approved to treat mild to moderate ulcerative colitis.

Crohn’s disease and ulcerative colitis are the two main types of inflammatory bowel disease (IBD). Some drugs, such as adalimumab (Humira), can be used to treat either type of IBD. But Lialda isn’t one of them. Mesalamine (the active drug in Lialda) isn’t as effective as other treatments for Crohn’s disease, according to a review of separate studies.

People often confuse IBD with IBS, but they are different conditions. IBS is a gut disorder that causes changes in your bowel movements among other symptoms.

Some people with IBS may have some low-grade inflammation in their bowel. Mesalamine is being investigated as a possible treatment for this type of IBS. However, more studies are needed before it’s known if mesalamine is effective for IBS.

If you have IBS or Crohn’s disease, talk with your doctor about your treatment options.

Can Lialda cause constipation?

It’s not likely. Constipation was not reported in clinical studies of Lialda. However, constipation has been reported with some other medications that contain mesalamine (the active drug in Lialda). These include Delzicol and Pentasa.

Talk with your doctor if you’re concerned about constipation as a side effect of your medications.

Lialda and alcohol

There are no known interactions between alcohol and Lialda. However, if you get headaches or feel nauseated while taking Lialda, drinking alcohol could make this worse.

Some people also find that drinking alcohol can cause a flare-up of ulcerative colitis. In some people, alcohol may also trigger symptoms like diarrhea, cramping, or bloating.

If you drink alcohol, talk with your doctor about how much is safe for you to drink.

Lialda vs. balsalazide

Lialda and balsalazide are prescribed for similar uses. Below are details of how these medications are alike and different.

Ingredients

Lialda is a brand-name medication that contains the active drug mesalamine. Balsalazide is a generic drug that also comes as the brand-name medication Colazal.

Balsalazide is a prodrug of mesalamine. A prodrug is a medication that’s changed into an active drug once it’s inside your body. Balsalazide is changed into the active drug mesalamine by the bacteria found naturally in your colon.

Uses

Lialda and balsalazide are both used to treat ulcerative colitis. However, they’re approved for use in slightly different ways.

Lialda is approved for use in adults to:

• induce remission (treat active symptoms until they go away) of mild to moderate ulcerative colitis
• maintain remission (help prevent symptoms from coming back) of mild to moderate ulcerative colitis

Lialda is also approved to treat mild to moderately active ulcerative colitis in children who weigh at least 24 kilograms. (This is about 53 pounds.)

Balsalazide is approved to treat mild to moderately active ulcerative colitis symptoms in adults and in children ages 5 years and older. Balsalazide is not approved to maintain remission, but it has been studied (and may be used off-label) for this purpose.

Drug forms and administration

Lialda comes as delayed-release tablets. The dose to induce remission in adults is two to four tablets taken once a day. To maintain remission in adults, the dose is two tablets taken once a day.

For children, Lialda doses depend on body weight, and they range from one to four tablets taken once daily.

You should take Lialda with food.

Balsalazide comes as capsules. The dose to induce remission in adults is three capsules taken three times a day. For children, the dose is either one or three capsules taken three times a day.

Balsalazide can be taken with or without food.

Side effects

Because their effects are produced by the same active drug, Lialda and balsalazide have very similar side effects. (See “Lialda side effects” above.)

Effectiveness

Lialda and balsalazide have both been found effective for treating ulcerative colitis.

One review of several studies looked at how effective different forms of mesalamine are for inducing and maintaining ulcerative colitis remission. It found that different forms of oral mesalamine, including Lialda and prodrugs such as balsalazide, seem to be similarly effective and safe.

Guidelines for treating ulcerative colitis have been published by the American College of Gastroenterology (ACG) and the American Gastroenterology Association (AGA). Both recommend using a form of oral mesalamine (which includes Lialda and prodrugs such as balsalazide) to treat ulcerative colitis.

You and your doctor can decide if Lialda or balsalazide would be a better fit for you.

Costs

Lialda is a brand-name drug that’s also available in generic form. Balsalazide is a generic drug that’s also available under the brand-name Colazal. Brand-name medications usually cost more than generics.

Lialda is significantly more expensive than balsalazide. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Lialda and pregnancy

There have been limited clinical studies of mesalamine (the active drug in Lialda) in pregnant females* and in animals. These studies do not suggest that mesalamine causes development problems in fetuses, miscarriages, or other problems in pregnancy.

However, because the safety of Lialda in pregnancy is not known for certain, it should only be used if the benefits outweigh any possible risks.

There is some evidence that if ulcerative colitis isn’t treated during pregnancy, it can be associated with a higher risk of premature birth and low birth weight in infants. Keep in mind that Lialda is used to treat ulcerative colitis.

Current guidance from the American Gastroenterological Association (AGA) suggests that people should avoid getting pregnant until their disease has been in remission for at least 3 months.

The AGA recommends that mesalamine (the active drug in Lialda) can be used during pregnancy to help maintain remission. Current evidence suggests that the benefits of taking mesalamine to help keep ulcerative colitis in remission outweigh the possible risks.

If you’re pregnant or plan to become pregnant, talk with your doctor about the possible risks and benefits of taking Lialda during pregnancy.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Lialda and birth control

It’s not known if Lialda is safe to take during pregnancy. If you or your sexual partner can become pregnant, talk with your doctor about your birth control needs while you’re using Lialda.

Lialda and breastfeeding

It’s not yet known if it’s safe to take Lialda while breastfeeding. Mesalamine, the active drug in Lialda, can pass into breast milk in small amounts. Diarrhea has been reported in some children breastfed by people taking mesalamine.

Talk with your doctor about the best way to feed your child while you’re taking Lialda. If you decide to breastfeed while taking Lialda, tell your doctor if your child gets diarrhea.

How Lialda works

Lialda is approved to treat ulcerative colitis in adults and some children.

What happens in ulcerative colitis

Ulcerative colitis is a type of inflammatory bowel disease. With ulcerative colitis, the lining of your colon (large intestine) becomes inflamed (swollen and irritated). The inflammation can cause small sores, called ulcers, to develop in your colon.

The inflammation causes symptoms such as frequent bowel movements or diarrhea, which can contain mucus. The ulcers can bleed, causing bloody stools. Other symptoms, such as fatigue, anemia, nausea, and weight loss, are also possible.

Ulcerative colitis is a chronic (long-term) condition. You may have periods where your symptoms are bad (called flare-ups) and periods when your symptoms get better or go away (called remission).

What Lialda does

The active drug in Lialda is called mesalamine, also known as 5-aminosalicylic acid (5-ASA). It belongs to a class of medications called aminosalicylates. A class of medications is a group of drugs that work in a similar way.

Aminosalicylates such as Lialda work by reducing and preventing inflammation (swelling) and lesions in the lining of your colon. Lialda tablets are designed to release the drug directly to this area of your bowel. The medication stops the cells in the lining of the colon from producing certain substances that cause inflammation. However, the way it works is not fully understood.

Once your bowel lining starts to heal and become less inflamed, your ulcerative colitis symptoms should start to clear up.

How long does it take to work?

Lialda will start to reduce the inflammation in your bowel as soon as you start taking it. However, it may take a few weeks before your symptoms improve.

Lialda interactions

Lialda can interact with other medications. Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Lialda and other medications

Below is a list of medications that can interact with Lialda. This list does not contain all drugs that may interact with Lialda.

Before taking Lialda, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Lialda and NSAIDs

Nonsteroidal anti-inflammatory drugs (NSAIDs) are a group of pain relievers that reduce inflammation (swelling). NSAIDs and Lialda can both cause kidney problems. Taking an NSAID with Lialda may increase your risk of having kidney problems.

Examples of NSAIDs that may increase the risk of kidney problems if taken with Lialda include:

• ibuprofen (Motrin, Advil)
• naproxen (Naprosyn, Aleve, Anaprox DS)
• diclofenac (Zorvolex, Zipsor)
• celecoxib (Celebrex)

If you’re taking an NSAID, talk with your doctor before you start taking Lialda. They may recommend using a different medication to treat your pain.

Lialda and azathioprine

Azathioprine (Imuran, Azasan) is a medication that’s sometimes used to treat ulcerative colitis. Azathioprine can cause problems with your blood cells, such as lowered blood cell counts. In rare cases, Lialda may also affect your blood cells. Taking these two medications together may raise your risk of having problems with your blood cells.

Talk with your doctor if you plan to take Lialda with azathioprine. You may need to have extra blood tests done to monitor your blood cells.

Lialda and 6-mercaptopurine

6-mercaptopurine (6-MP) is a medication that’s sometimes used to treat ulcerative colitis. It can cause problems with your blood cells, such as lowered blood cell counts. In rare cases, Lialda may also affect your blood cells. If you take these medications together, you may be more at risk of having blood cell problems.

Talk with your doctor if you plan to take Lialda with 6-mercaptopurine. You may need to have extra blood tests done to monitor your blood cells.

Lialda and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Lialda. However, you should still check with your doctor or pharmacist before using any of these products while taking Lialda.

How to take Lialda

You should take Lialda according to your doctor’s or another healthcare professional’s instructions.

When to take

You should take your prescribed dose of Lialda once a day with food. You can take your dose at any time of day, but try to take it at the same time each day.

To help make sure you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Keep taking the Lialda dose you’ve been prescribed every day, even when you don’t have symptoms.

Taking Lialda with food

You should take Lialda with a meal or snack.

Can Lialda be crushed, split, or chewed?

No, you should swallow Lialda tablets whole with a drink. Do not crush, split, chew, or try to dissolve the tablets.

Lialda is a delayed-release tablet. It has a special coating that allows it to pass through your stomach and upper intestine without being digested. The tablet releases the drug in your lower intestine so it can act directly where it’s needed. If you damage the tablet by crushing, splitting, dissolving, or chewing it, you’ll stop the delayed-release design from working properly.

Lialda precautions

Before taking Lialda, talk with your doctor about your health history. Lialda may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

• An allergy to salicylate medications. These include aspirin, mesalamine, sulfasalazine (Azulfidine), olsalazine (Dipentum), and balsalazide (Colazal). Lialda is also a salicylate. If you’ve ever had an allergic reaction to a salicylate medication, you should not take Lialda. You could have an allergic reaction to it.
• Kidney problems. Lialda can cause kidney problems and could worsen any kidney problems you already have. Your doctor will want to monitor your kidney function while you take Lialda. If your kidney problems get worse, you may need to stop taking Lialda.
• Liver problems. Liver failure has been reported in people who already had liver problems and took mesalamine (the active drug in Lialda). It isn’t known for sure if the drug was a factor. If you have liver problems, tell your doctor before taking Lialda. They’ll likely monitor your liver function while you take the drug. If your liver problems get worse, you may need to stop treatment with Lialda.
• Heart problems. In rare cases, Lialda can cause myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining of the heart). Before using Lialda, talk with your doctor about any heart problems you’ve had to make sure this drug is safe for you.
• Narrowing or blockage in your stomach or upper intestine. Lialda tablets release the drug in your lower intestine. If you have a blockage or narrowing in your stomach or upper intestine, this will make it harder for Lialda tablets to pass through. This means the tablets will take longer to start working in your bowel. Talk with your doctor about whether Lialda is the best option for you.
• Skin conditions such as eczema or dermatitis. Lialda may make your skin more sensitive to the sun or UV light. If you already have a skin condition such as eczema, your skin may react more severely. Talk with your doctor about how to protect your skin while taking Lialda.
• Being 65 years of age or older. In clinical studies of Lialda, there weren’t enough older people involved to know if the drug affected them differently than younger people. If you’re age 65 years or older, your doctor may start you on a dosage of Lialda that’s lower than usual. And they’ll closely monitor you during treatment.
• Pregnancy. The safety of Lialda during pregnancy is not known for certain. For more information, see the “Lialda and pregnancy” section above.
• Breastfeeding. Lialda may pass into breast milk in small amounts. For more information, see the “Lialda and breastfeeding” section above.

Note: For more information about the potential negative effects of Lialda, see the “Lialda side effects” section above.

Lialda overdose

Using more than the recommended dosage of Lialda can lead to serious side effects.

Overdose symptoms

Symptoms of an overdose can include:

• ringing in the ears
• spinning sensation
• headache
• confusion
• seizures
• fast breathing
• trouble breathing
• nausea
• vomiting
• damage to the kidneys or liver

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

Lialda expiration, storage, and disposal

When you get Lialda from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee the medication will be effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Lialda tablets should be stored at room temperature (no higher than 86°F/30°C) in a tightly sealed container away from light. Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take Lialda and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.