Apriso (mesalamine)

Apriso generic

Apriso contains the active ingredient mesalamine.

A generic version of Apriso capsules has been approved under the name mesalamine. Keep in mind that Apriso capsules are an extended-release and delayed-release* form of mesalamine.

A generic drug is an exact copy of the active ingredient in a brand-name medication. The generic is considered to be as safe and effective as the original drug.

Generic mesalamine is also available as tablets. And it comes in capsules of different strengths and formulations than Apriso capsules.

Other brand-name versions of mesalamine are also available. These include Lialda, Delzicol, and Pentasa.

* Extended release means the capsule releases the drug slowly over a certain period of time. Delayed release means the capsule passes through the stomach before dissolving.

Apriso side effects

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

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

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

More common side effects

The more common side effects of Apriso can include:

• headache
• diarrhea
• upper abdominal pain
• nausea
• cold or flu-like symptoms

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 Apriso 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:

• Kidney problems, including kidney failure. Symptoms can include:
  • passing less urine than usual
  • swollen ankles, feet, or legs
  • shortness of breath
  • feeling unusually tired
  • nausea
  • confusion
• 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
• Mesalamine-induced acute intolerance syndrome. Symptoms can be similar to a flare-up of ulcerative colitis. They can include:
  • abdominal cramps or pain
  • diarrhea that contains blood
  • fever
  • headache
  • rash
• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis. Symptoms can include:
  • skin rash that may blister or peel
  • fever
  • body ache
  • cough
• Severe allergic reaction. Symptoms are discussed in more detail below.

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 more detailed information on some 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 Apriso. 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 other medications containing mesalamine (the active drug in Apriso). These include myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining of the heart). Symptoms can include:

• abnormal heartbeat
• chest pain
• trouble breathing

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

Hair loss

Hair loss is possible while taking Apriso. In clinical trials, hair loss was rare. More research is needed to confirm whether Apriso directly causes hair loss or whether other factors might account for hair loss seen in trials.

Hair loss is common among people who have inflammatory bowel disease (IBD), such as ulcerative colitis.

Talk with your doctor if you’re worried about hair loss while taking Apriso.

Fatigue

Apriso could cause fatigue (lack of energy). This wasn’t considered common in clinical trials. Fatigue can also be a symptom of ulcerative colitis.

Talk with your doctor if you’re experiencing fatigue. They might do tests to rule out other possible causes, such as anemia. Your doctor may also suggest ways to help improve your energy levels.

Mesalamine-induced acute intolerance syndrome

Mesalamine (the active ingredient in Apriso) can sometimes cause acute intolerance syndrome, which occurs when your body is intolerant to the medication. This condition causes symptoms that are very similar to a flare-up of ulcerative colitis. Symptoms can include:

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

Tell your doctor if you get new or worsening ulcerative colitis symptoms, such as those listed above, while you’re taking Apriso. If your doctor thinks you have acute intolerance syndrome, you’ll need to stop taking Apriso.

Weight gain (not a side effect)

Weight gain was not reported in clinical trials of Apriso. However, taking Apriso can keep your ulcerative colitis in remission (prevent symptoms from returning). You may find you gain weight as your ulcerative colitis symptoms ease and you can eat foods you couldn’t before.

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

Apriso 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 fit your needs.

Drug form and strengths

Apriso comes as oral capsules that have both extended-release and delayed-release coatings. Extended release means the capsules release the drug slowly over a certain period of time. Delayed release means the capsules pass through your stomach without being digested and then release the medication as they pass through your intestine.

Apriso capsules are only available in one strength: 0.375 grams (g).

Dosage for ulcerative colitis

The usual dosage of Apriso is four capsules (a total dose of 1.5 g) taken once per day in the morning.

What if I miss a dose?

If you forget to take your dose of Apriso in the morning, take it as soon as you remember that day. However, if it’s almost time for your next dose, just skip the dose you missed. Take your next dose at the usual time.

Never take two doses together to make up for a missed dose. This can increase your risk of side effects.

To help make sure you don’t miss a dose, try setting a reminder in your phone.

Will I need to take this drug long term?

Apriso is meant to be taken as a long-term treatment. It works to keep your ulcerative colitis in remission (to stop your symptoms from coming back). If you and your doctor determine that Apriso is safe and effective for you, you’ll likely take it long term.

Alternatives to Apriso

Other drugs are available that can keep ulcerative colitis in remission (prevent symptoms from returning). Some drugs may be a better fit for you than others.

If you’re interested in finding an alternative to Apriso, 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 prescribed off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is prescribed to treat a different condition.

Alternatives for ulcerative colitis

Examples of other drugs that may be used to keep ulcerative colitis in remission include:

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

Apriso vs. Lialda

You may wonder how Apriso compares to other medications that are prescribed for similar uses. Here we look at how Apriso and Lialda are alike and different.

About

Apriso and Lialda both contain the active drug mesalamine. They belong to a group of medications called aminosalicylates.

Uses

Apriso is approved to maintain remission of ulcerative colitis (prevent symptoms from returning). Lialda is also approved to maintain remission of ulcerative colitis.

In addition, Lialda is approved to induce remission of mild to moderate ulcerative colitis. Inducing remission means treating active symptoms until they get better.

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

Drug forms and administration

Apriso comes as extended-release capsules containing 0.375 grams (g) of mesalamine. An extended-release form of a drug means it releases the drug slowly over a certain period of time. Apriso capsules are also delayed-release, which means they have a coating that allows them to pass through the stomach before dissolving.

Apriso’s approved dose to maintain remission is four capsules (1.5 g) taken once a day in the morning. Apriso can be taken either with or without food.

Lialda comes as tablets containing 1.2 g of mesalamine. Like Apriso, Lialda tablets are both extended-release and delayed-release.

The dose to induce remission in adults is two to four Lialda tablets (2.4 g to 4.8 g) taken once a day. The dose to maintain remission in adults is two tablets (2.4 g) taken once a day. Lialda should be taken with food.

Side effects and risks

Apriso and Lialda have some similar side effects and others that differ. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Apriso, with Lialda, or with both drugs (when taken individually).

• Can occur with Apriso:
  • nausea
  • cold or flu-like symptoms
• Can occur with Lialda:
  • flatulence (passing gas)
  • abnormal results in liver function tests, which could be a sign of liver problems
• Can occur with both Apriso and Lialda:
  • headache
  • diarrhea
  • abdominal pain

Serious side effects

This list contains examples of serious side effects that can occur with both Apriso and Lialda (when taken individually).

Can occur with both Apriso and Lialda:

• kidney problems
• liver problems
• mesalamine-induced acute intolerance syndrome, which means your body is intolerant to the medication
• severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis
• serious allergic reaction

Effectiveness

Apriso and Lialda have slightly different FDA-approved uses, but they’re both used to maintain remission of ulcerative colitis.

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

Costs

Apriso and Lialda are both brand-name drugs that are also available in generic forms. Brand-name medications usually cost more than generics.

The actual price you’ll pay for either drug will depend on:

• your insurance plan
• your location
• the pharmacy you use

Visit Optum Perks to find coupons and savings for Apriso and Lialda.

Apriso vs. sulfasalazine

Apriso and sulfasalazine are prescribed for similar uses. Below are details of how these medications are alike and different.

About

Apriso is a brand-name medication that contains the active drug mesalamine. Sulfasalazine, on the other hand, is a generic drug. It’s available as the brand-name drugs Azulfidine and Azulfidine EN-tabs.

Sulfasalazine is a prodrug of mesalamine. A prodrug is a medication that’s changed into an active drug once it’s inside your body.

Sulfasalazine passes through your digestive system to your colon. Once there, the bacteria in your colon split the sulfasalazine into the active drug mesalamine and another drug called sulfapyridine.

The mesalamine part produces the anti-inflammatory effect in your colon. The sulfapyridine part gets absorbed into your blood and may reduce inflammation in other parts of your body.

Uses

Apriso and sulfasalazine are both used to treat ulcerative colitis, but they’re approved for use in slightly different ways.

Apriso is approved to maintain remission (prevent symptoms from returning) of ulcerative colitis in adults.

Sulfasalazine is approved for use in adults and in children ages 6 years and older. It’s used to maintain remission and to induce remission (treat active symptoms) of ulcerative colitis.

In addition, delayed-release forms of sulfasalazine are approved to treat certain types of rheumatoid arthritis in adults and children ages 6 years and older. (A delayed-release form of a drug has a coating that allows it to pass through the stomach before it dissolves.)

Drug forms and administration

Apriso comes as extended-release capsules containing 0.375 g of mesalamine. An extended-release form of a drug means it releases the drug slowly over a certain period of time. Apriso capsules are also delayed-release, which means they have a coating that allows them to pass through the stomach before dissolving.

The approved dose to maintain remission of ulcerative colitis in adults is four Apriso capsules (1.5 g) taken once a day in the morning.

Sulfasalazine comes as immediate-release tablets and delayed-release tablets, both containing 500 mg of sulfasalazine. The approved dosage to maintain remission of ulcerative colitis in adults is 2 g daily, usually as one tablet taken four times a day. (This is approximately equivalent to 800 mg of mesalamine per day).

Side effects and risks

Apriso and sulfasalazine have some similar side effects and others that differ. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Apriso, with sulfasalazine, or with both drugs (when taken individually).

• Can occur with Apriso:
  • diarrhea
  • cold or flu-like symptoms
• Can occur with sulfasalazine:
  • orange or yellow discoloration of your urine or skin
  • vomiting
  • loss of appetite
  • reduced sperm count in males,* which is reversible when you stop taking the drug
• Can occur with both Apriso and sulfasalazine:
  • headache
  • nausea
  • abdominal pain

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

Serious side effects

These lists contain examples of serious side effects that can occur with Apriso, with sulfasalazine, or with both drugs (when taken individually).

• Can occur with Apriso:
  • mesalamine-induced acute intolerance syndrome, which means your body is intolerant to the medication
• Can occur with sulfasalazine:
  • serious blood disorders, such as reduced levels of blood cells
  • lung problems, such as lung inflammation or pneumonia
  • nerve problems
• Can occur with both Apriso and sulfasalazine:
  • kidney problems
  • liver problems
  • severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis
  • serious allergic reactions

Effectiveness

Apriso and sulfasalazine have different FDA-approved uses, but they’re both used to maintain remission of ulcerative colitis.

One review of 12 clinical studies found mesalamine (the active drug in Apriso) to be less effective than sulfasalazine at maintaining remission of ulcerative colitis. However, the American College of Gastroenterology (ACG) and the American Gastroenterology Association (AGA) guidelines both recommend using mesalamine to maintain remission of ulcerative colitis. This is because sulfasalazine can cause more serious side effects.

The AGA does note that people who are already taking sulfasalazine and are in remission can keep taking the medication. And sulfasalazine might be a good option for people with ulcerative colitis who also have arthritis.

Costs

Apriso is a brand-name drug that’s also available as the generic drug mesalamine. Sulfasalazine is a generic drug that’s also available as the brand name medications Azulfidine and Azulfidine EN-tabs. Brand-name medications usually cost more than generics.

Apriso may be significantly more expensive than sulfasalazine. The actual price you’ll pay for either drug will depend on:

• your insurance plan
• your location
• the pharmacy you use

Visit Optum Perks to find coupons and savings for Apriso, Azulfidine, and Azulfidine EN-tabs.

Apriso for ulcerative colitis

The Food and Drug Administration (FDA) approves prescription drugs such as Apriso to treat certain conditions.

Apriso has been approved by the FDA to maintain remission (prevent symptoms from returning) of ulcerative colitis in adults.

Ulcerative colitis is a chronic (long-term) condition that’s a type of inflammatory bowel disease (IBD). With ulcerative colitis, the lining of your colon (large intestine) and rectum become inflamed (swollen). The inflammation can cause small sores, called ulcers, to develop in these parts of your bowel.

Symptoms of ulcerative colitis can include:

• abdominal pain
• rectal bleeding
• diarrhea that may contain blood or mucus
• nausea
• loss of appetite
• weight loss
• fatigue
• fever
• skin problems
• joint pain

Ulcerative colitis affects people in different ways, and it tends to change over time.

You may have periods where the inflammation and ulcers in your bowel get worse, and your symptoms flare up. When this happens, your doctor can induce remission by treating these flare-ups until your symptoms go away. Remission refers to having no symptoms or few symptoms that don’t interfere with your daily life.

Once you’re in remission, taking medication such as Apriso can help you maintain remission. This means managing the inflammation in your bowel to help prevent flare-ups.

You can learn more about ulcerative colitis from our IBD hub.

Effectiveness

In two clinical trials, Apriso was found to be effective at maintaining remission of ulcerative colitis. In these studies, people whose ulcerative colitis was in remission took Apriso or a placebo (a treatment with no active drug) for 6 months. In both studies, more people who took Apriso were still in remission (with no active symptoms) after 6 months, compared with people who took a placebo.

Apriso off-label use to treat ulcerative colitis

Apriso is FDA-approved to maintain remission of ulcerative colitis in adults. Other forms of mesalamine (the active drug in Apriso) are also approved to induce remission. That means they treat active symptoms of ulcerative colitis. In fact, mesalamine is the preferred treatment for active symptoms of ulcerative colitis, according to clinical guidelines.

Research has shown that off-label use of Apriso to treat active ulcerative colitis may be effective. However, the dose of Apriso that was used in these studies (3 g per day) is higher than the dose used to maintain remission (1.5 g per day). More studies are needed to determine the right way to take Apriso to induce remission of ulcerative colitis.

If you’re interested in taking Apriso off-label to treat active symptoms of ulcerative colitis, talk with your doctor.

Apriso and alcohol

There’s no known interaction between Apriso and alcohol. However, some people find that drinking alcohol can cause their ulcerative colitis to flare up.

In some people, alcohol may also cause symptoms like:

• diarrhea
• cramping
• bloating

If you get headaches or feel nauseated from taking Apriso, drinking alcohol could make these side effects worse.

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

Apriso interactions

Apriso 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.

Apriso and other medications

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

Before taking Apriso, 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.

Apriso and antacids

Antacids are drugs that lower the acid levels in your stomach. They can help relieve heartburn or indigestion (abdominal pain, discomfort, or bloating). Taking antacids at the same time as Apriso can stop Apriso from working properly.

Apriso capsules have an acid-resistant coating that allows them to pass through your stomach without dissolving. The coating dissolves in your intestine, where there’s less acid. This releases the drug exactly where it’s needed.

Taking Apriso with antacids (which lower the acid levels in your stomach) could allow Apriso to dissolve in your stomach. This means it won’t reach the part of your intestine it’s supposed to treat.

Examples of antacids that can make Apriso less effective include:

• sodium bicarbonate (an ingredient in some Alka-Seltzer products)
• aluminum hydroxide/magnesium hydroxide/simethicone liquid (Maalox, Mylanta)
• calcium carbonate/magnesium hydroxide (Rolaids)
• calcium carbonate (Tums)

Apriso and NSAIDs

NSAIDs (nonsteroidal anti-inflammatory drugs) are pain-relieving drugs that reduce inflammation. NSAIDs and Apriso can both cause kidney problems. Taking an NSAID with Apriso may increase your risk of having kidney problems.

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

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

If you take an NSAID, talk with your doctor before you start Apriso. They may suggest a different medication to relieve your pain.

Apriso and azathioprine

Azathioprine (Imuran, Azasan) 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.

Drugs that contain mesalamine, such as Apriso, can increase levels of azathioprine in your blood. This may raise your risk of having problems with your blood cells. If you take Apriso with azathioprine, you may need blood tests to monitor your blood cells from time to time.

If you have questions about taking azathioprine with Apriso, talk with your doctor.

Apriso and 6-mercaptopurine

The drug 6-mercaptopurine (6-MP) is sometimes used to treat ulcerative colitis. It can cause problems with your blood cells, such as lowered blood cell counts.

Drugs that contain mesalamine, such as Apriso, can increase levels of 6-MP in your blood. This may raise your risk of having problems with your blood cells. If you take Apriso with 6-MP, you may need blood tests to monitor your blood cells from time to time.

If you have questions about taking 6-MP with Apriso, talk with your doctor.

Apriso and herbs and supplements

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

Apriso and lab tests

Apriso may interact with a lab test used to check your normetanephrine level. (Normetanephrine is a substance that’s made when your body breaks down norepinephrine, which is also called noradrenaline.)

If you’ll be having any lab tests done while taking Apriso, be sure to discuss this with your doctor.

Apriso and pregnancy

Apriso hasn’t been studied in pregnant people. However, there have been limited clinical trials of mesalamine (the active drug in Apriso) in pregnant people and in animals.

The results of these studies do not suggest that mesalamine has harmful effects on pregnant people or fetuses. However, as the safety of Apriso during pregnancy is not fully established, it should only be prescribed if it’s clearly needed.

Although Apriso hasn’t been studied in pregnant people, it’s important that your ulcerative colitis is well-managed during your pregnancy. If your ulcerative colitis is active during your pregnancy, studies suggest this may increase your risk of having a premature birth.

Active ulcerative colitis could also cause your baby to have a low birth weight. Current guidance from the American Gastroenterological Association (AGA) suggests that females* should avoid becoming pregnant until their condition has been in remission for at least 3 months.

For these reasons, the AGA states that mesalamine (the active drug in Apriso) can be taken during pregnancy to help keep ulcerative colitis in remission. Current evidence suggests that the benefits of taking the drug for this purpose outweigh the possible risks.

If you’re pregnant or planning a pregnancy, talk with your doctor about the risks and benefits of taking Apriso during pregnancy.

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

Apriso and birth control

Apriso hasn’t been studied in pregnant people. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re taking Apriso.

Apriso and breastfeeding

Mesalamine, the active drug in Apriso, passes into breast milk in small amounts. Diarrhea has been reported in some children breastfed by people taking mesalamine.

Current guidance from the American Gastroenterological Association states that people can breastfeed while taking mesalamine if the child is monitored for diarrhea.

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

Apriso cost

As with all medications, the cost of Apriso can vary. The actual price you’ll pay will depend on:

• your insurance plan
• your location
• the pharmacy you use

Your insurance plan may require you to get prior authorization before it’ll approve coverage for Apriso. This means that your doctor will need to send a request to your insurance company asking it to cover the drug.

The insurance company will review the request and let you and your doctor know if your plan will cover Apriso.

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

Financial and insurance assistance

If you need help to pay for Apriso, financial assistance may be available. Visit Medicine Assistance Tool’s website to learn about possible cost assistance for Apriso.

You can also visit Optum Perks for price estimates of Apriso (see below). These estimates are based on the use of Optum Perks coupons. Note: Optum Perks coupons cannot be used with any insurance copays or benefits.

How to take Apriso

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

When to take

Take your dose of Apriso once a day, in the morning.

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

Don’t take antacid medications at the same time as Apriso.

Taking Apriso with food

You can take Apriso with or without food.

Can Apriso be crushed, split, or chewed?

No, Apriso capsules should be swallowed whole.

The capsules have a coating that lets them pass through your stomach without being digested. The coating dissolves in your intestine, allowing the drug to be released where it’s needed. If you crush, split, or chew the capsules, you’ll damage the coating and prevent Apriso from working properly.

How Apriso works

Apriso is approved to treat ulcerative colitis in adults.

What happens in ulcerative colitis

Ulcerative colitis is a form of inflammatory bowel disease (IBD) that affects your colon (large intestine) and rectum. With this condition, the lining of these parts of your bowel becomes inflamed (swollen). The inflammation causes small sores, called ulcers, to develop on the lining.

An inflamed and irritated bowel causes symptoms such as abdominal pain, rectal bleeding, and diarrhea that may contain blood or mucus.

Ulcerative colitis is a chronic (long-term) condition. You may have periods of time when your symptoms go away and times when they return.

When the inflammation in your bowel is active, your symptoms can flare up. At this point, you’ll need treatment to help reduce the inflammation in your bowel. Once your condition is in remission (symptoms have gone away), you’ll take treatment to help keep the condition in remission.

What Apriso does

Apriso contains the active drug mesalamine, also known as 5-aminosalicylic acid or 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 reduce inflammation in the lining of your colon and rectum, which may allow ulcers to heal. These drugs help reduce flare-ups, which can make symptoms go away over time. However, the way aminosalicylates (such as Apriso) work is not fully understood.

Once ulcerative colitis is in remission, taking Apriso every day helps keep the inflammation in your bowel from worsening. This helps prevent your symptoms from flaring up again.

How long does it take to work?

Apriso will start working to reduce inflammation in your bowel soon after you take it. However, it might take a few weeks before you notice your symptoms get better.

Common questions about Apriso

Here are answers to some frequently asked questions about Apriso.

Do I need to take Apriso at a certain time of the day?

Yes, you should take your dose of Apriso in the morning. You can take it before, after, or with your breakfast.

Is Apriso a steroid?

No, Apriso is not a steroid.

It belongs to a class of drugs called aminosalicylates. (A class of drugs is a group of medications that work in a similar way.) Like steroids, aminosalicylates reduce inflammation in your bowel. However, they work in a different way than steroids and usually have fewer side effects.

Will Apriso cure my ulcerative colitis?

No. It’s not currently possible to cure ulcerative colitis.

However, you can treat the condition until you no longer have symptoms. This is called inducing remission.

It’s also possible to keep ulcerative colitis well-managed and stop your symptoms from flaring up again. This is called maintaining remission. According to studies, taking Apriso every day is effective for maintaining remission of ulcerative colitis in about 70% of people.

Is Apriso safe for use by older adults?

Yes, older adults can take Apriso. However, as with all drugs, your doctor may take extra precautions when prescribing it.

Your kidneys, liver, and heart get less effective as you age, and this can make certain side effects more likely. In rare cases, mesalamine (the active drug in Apriso) can affect your blood cells, and this side effect may be more likely in people ages 65 and older.

Older adults are also more likely to have other conditions and to be taking other drugs that could affect how Apriso works.

If you’re 65 years or older, your doctor may order extra tests before you start taking Apriso to make sure it’s safe for you. They may also order extra tests throughout your treatment with Apriso to make sure it’s not having unwanted effects.

Apriso precautions

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

• An allergy to salicylate drugs. These drugs include aspirin, mesalamine (Apriso), balsalazide (Colazal), olsalazine (Dipentum), and sulfasalazine (Azulfidine). Apriso is a salicylate, so do not take it if you’ve ever had an allergic reaction to a salicylate medication.
• Current or past kidney problems or use of other drugs that can harm your kidneys. Apriso can cause kidney problems and could worsen any kidney problems you already have. Your doctor will regularly check how well your kidneys are working before and during your treatment with Apriso. If any kidney problems get worse, your doctor may have you stop taking Apriso. Also, be sure that your doctor knows about all the medications you’re taking before you start Apriso treatment.
• Liver problems. Apriso can cause liver problems and could worsen any liver problems you already have. You may need blood tests to check your liver function from time to time while taking Apriso. If any liver problems get worse, you may need to stop taking Apriso.
• Heart problems. In rare cases, mesalamine (the active drug in Apriso) can cause myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining of the heart). Talk with your doctor if you’ve ever had heart problems so they can determine if Apriso is safe for you.
• Phenylketonuria (PKU). This is a disorder where your body can’t process an amino acid called phenylalanine. (Amino acids are the building blocks that make up proteins.) If you have PKU, you need to minimize the amount of phenylalanine you consume to avoid it building up in your body. You also need to avoid consuming aspartame because your body breaks this down into phenylalanine. Apriso capsules contain aspartame, equivalent to 0.56 mg of phenylalanine. If you have PKU, talk with your doctor about whether Apriso is safe for you to take.
• Pregnancy. Apriso hasn’t been studied in pregnant people. For more information, see the “Apriso and pregnancy” section above.
• Breastfeeding. Mesalamine, the active drug in Apriso, passes into breast milk in small amounts. For more information, see the “Apriso and breastfeeding” section above.

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

Apriso overdose

Taking more than the recommended dosage of Apriso can lead to serious side effects.

Overdose symptoms

Symptoms of an overdose of Apriso can include:

• ringing in your ears or trouble hearing
• confusion
• drowsiness
• seizures
• fast breathing
• trouble breathing
• vomiting

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 America’s Poison Centers at 800-222-1222 or use its online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.