Mesalamine, Mesalamine ER

Introduction

Written by Patricia Weiser, PharmD
Medically reviewed by Dena Westphalen, PharmD
Updated on August 28, 2023

Mesalamine (me SAL a meen) is a generic medication prescribed for ulcerative colitis (UC). Mesalamine belongs to a group of drugs called aminosalicylates.

Specifically, the Food and Drug Administration (FDA) has approved mesalamine to:

• treat active flare-ups* of UC in adults and certain children
• treat active flare-ups of:
  • distal UC (UC that only affects a certain area of the colon),
  • proctosigmoiditis (UC that affects the colon and rectum), or
  • proctitis (UC that only affects the rectum) in adults
• maintain remission (keep symptoms from coming back) in adults with UC

* With an active flare-up, symptoms of the disease are present. The goal of treating an active flare-up is to make the symptoms go away.

These approved uses differ based on the form of mesalamine your doctor prescribes.

This article doesn’t provide coupons for all forms of mesalamine. To find coupons for mesalamine extended-release oral capsule, see this article.

Side effects of mesalamine

Mesalamine may cause mild or serious side effects. More common mild side effects of mesalamine and its serious side effects are listed below. This article doesn’t include all possible side effects of the drug. Side effects can vary based on your age, overall health, and any other medications you take.

To learn more about mesalamine’s side effects, see this article or ask your doctor or pharmacist. You can also refer to the prescribing information for mesalamine listed in the “Resources” section.

Mild side effects

More common mild side effects reported with some forms of mesalamine are listed below. These side effects may differ based on the form of mesalamine your doctor prescribes.

This article doesn’t include all possible mild side effects of the drug. To learn more about mesalamine’s side effects based on the form, refer to the prescribing information for mesalamine listed in the “Resources” section.

With many drugs, mild side effects may go away within a few days or a couple of weeks. If the side effects bother you, tell your doctor or pharmacist. They may be able to suggest ways to manage them.

Mesalamine delayed-release oral tablet’s mild side effects include:

• headache
• flatulence (passing gas)
• abdominal pain
• diarrhea
• mild allergic reaction*

Mesalamine rectal suppository’s mild side effects include:

• dizziness
• rectal pain
• fever
• acne
• mild allergic reaction*

* For details about this side effect, see the “Interactions and warnings for mesalamine” section.

Serious side effects

Serious side effects of mesalamine are listed below. These side effects may differ based on the form of mesalamine your doctor prescribes.

This article doesn’t include all possible serious side effects of the drug. To learn more about mesalamine’s side effects based on the form, refer to the prescribing information for mesalamine listed in the “Resources” section.

With many drugs, serious side effects are possible but not common. If you have serious side effects from this drug, call your doctor right away. If you’re having severe symptoms or a medical emergency, call 911 or a local emergency number.

In general, mesalamine’s serious side effects include:

• kidney problems, such as kidney stones
• liver problems
• mesalamine-induced acute intolerance syndrome (a group of symptoms that can happen suddenly after you start taking or using mesalamine)
• serious skin reactions
• severe allergic reaction*

* For details about this side effect, see the “Interactions and warnings for mesalamine” section.

Common questions about mesalamine

Below you’ll find answers to a few commonly asked questions about mesalamine.

What brand names are available for mesalamine?

Several brand names are available for mesalamine, including:

• Apriso extended-release* oral capsule
• Canasa rectal suppository
• Delzicol delayed-release† oral capsule
• Lialda delayed-release oral tablet
• Pentasa extended-release oral capsule
• Rowasa rectal enema

Mesalamine is a generic drug. A generic medication is an identical copy of the active drug in a brand-name medication. (An active drug is the ingredient that makes a medication work.) Generic drugs are believed to be as effective and safe as brand-name drugs. And generic drugs typically cost less compared to brand-name drugs.

If you’d like to know whether the generic or a brand-name version of mesalamine is better for your condition, talk with your doctor.

* “Extended release” means the drug is slowly released into your body over a long period of time.
† “Delayed release” means the drug is released into your body after it passes through your stomach.

How does mesalamine work? And how long does it take to start working?

How mesalamine works isn’t fully known.

With ulcerative colitis (UC), you have inflammation (swelling) and ulcers (sores) in your bowel. Mesalamine is thought to work by reducing inflammation, which helps heal the ulcers. The drug treats active flare-ups of the disease to make the symptoms go away. Mesalamine is also used to maintain remission (keep symptoms from coming back).

Mesalamine starts working right away. But it usually takes 3–8 weeks of mesalamine treatment to treat an active flare-up. This depends on the severity of your UC and the form of mesalamine your doctor prescribes.

If you’d like to know more about mesalamine’s mechanism of action (how it works), talk with your doctor or pharmacist.

Is mesalamine a steroid or an immunosuppressant drug?

No, mesalamine isn’t a steroid or an immunosuppressant. It belongs to a group of drugs called aminosalicylates. Mesalamine works by reducing inflammation in the bowel.

Doctors may prescribe steroids (also called corticosteroids) to treat active flare-ups of UC. Examples are prednisone and budesonide. Steroids work by suppressing the immune system throughout your entire body. In general, steroids have more side effects than mesalamine.

Doctors may also prescribe immunosuppressants to treat UC. Examples include ustekinumab (Stelara) and vedolizumab (Entyvio). With UC, your immune response can be too strong, which can cause inflammation in your body. Immunosuppressants work by limiting your immune response.

If you have questions about treatment options for UC, talk with your doctor or pharmacist.

Uses of mesalamine

The Food and Drug Administration (FDA) approves prescription drugs such as mesalamine for certain conditions. Approved uses for mesalamine are described below. These uses differ based on the form of mesalamine prescribed.

Use for treating active ulcerative colitis, proctosigmoiditis, or proctitis

Doctors may prescribe certain forms of mesalamine for treating active flare-ups of ulcerative colitis (UC). It’s used for this purpose in adults and some children. It’s usually prescribed as a short-term treatment.

With UC, you have inflammation and ulcers (sores) in your colon (large intestine) and/or rectum. It involves periods of active flare-ups (when symptoms are occurring) and periods of remission (when no symptoms are occurring). Common symptoms are abdominal pain, diarrhea, and weight loss.

Doctors may prescribe mesalamine delayed-release oral tablets to treat active-flare ups of UC in adults and children weighing at least 24 kilograms (kg). This is about 53 pounds (lb). Doctors may also prescribe mesalamine delayed-release oral capsules for this purpose in children ages 5 years and older and adults.

Doctors may prescribe mesalamine rectal enema in adults to treat active flare-ups of:

• distal UC (UC that only affects a certain area of the colon),
• proctosigmoiditis (UC that affects the colon and rectum), or
• proctitis (UC that only affects the rectum)

Doctors may prescribe mesalamine rectal suppository in adults to treat active flare-ups of proctitis.

Use for maintaining remission of ulcerative colitis

Doctors may prescribe mesalamine extended-release oral capsules, mesalamine delayed-release oral capsules, or mesalamine delayed-release oral tablets for maintaining remission of mild to moderate UC. It’s used for this purpose in adults. It’s usually prescribed as a long-term treatment.

“Maintaining remission” means to keep the symptoms of UC from coming back.

Interactions and warnings for mesalamine

Below, you’ll find information about mesalamine’s possible interactions and warnings.

Interactions of mesalamine

Certain things may affect how a drug works. These include getting vaccines, consuming alcohol or certain foods, or taking the drug with other medications. This effect is called a drug interaction.

Before you start mesalamine, ask your doctor to check for possible interactions. Be sure to tell them about any of the following you take or use:

• prescription or over-the-counter drugs
• vitamins, herbs, or supplements

To learn about drug-condition interactions, see the “Warnings for mesalamine” section below.

Warnings for mesalamine

Some people should not take or use mesalamine, and others should take or use it cautiously.

Mesalamine could cause harm to people with certain health conditions. This effect is called a drug-condition interaction. Other factors can also affect whether mesalamine is a safe option for you. These warnings may differ based on the form of mesalamine your doctor prescribes.

Ask your doctor about specific warnings for mesalamine, and be sure to tell your doctor about your:

• current health, including any allergies to medications
• past health conditions or surgeries

Allergic reaction

Mesalamine can cause an allergic reaction in some people. Severe allergic reactions are rare but possible.

If you’ve had an allergic reaction to mesalamine or any of its ingredients, your doctor will likely not prescribe mesalamine. They can tell you about medications that are safer options for you.

A mild allergic reaction may cause the following symptoms:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A severe allergic reaction may cause the following symptoms:

• swelling under your skin, usually in your hands, feet, eyelids, or lips
• swelling of your mouth, throat, or tongue, which can cause breathing problems

If you have an allergic reaction to mesalamine, call your doctor right away. If you have severe symptoms, call 911 or a local emergency number.

Overdose of mesalamine

If you take mesalamine by mouth or use it rectally, you should not take or use more mesalamine than your doctor prescribes. For some drugs, doing so may lead to harmful effects or overdose.

If you think you’ve taken or used too much mesalamine, call your doctor or pharmacist right away. Or you could call 800-222-1222 to speak with someone at America’s Poison Centers. You can also use its online resource. If you have concerning symptoms, call 911 or a local emergency number immediately. You can also go to the closest emergency room.

Pregnancy or breastfeeding and mesalamine

Information about mesalamine and pregnancy and breastfeeding is described below.

Mesalamine and pregnancy

In general, mesalamine is considered safe to take or use during pregnancy. That said, ask your doctor about whether they feel it’s safe for you.

Mesalamine and breastfeeding

There may be risks to taking or using mesalamine while breastfeeding. But there are also risks with having untreated ulcerative colitis (UC) during this time. (Keep in mind that mesalamine is used for treating UC.)

For instance, mesalamine may cause diarrhea in a breastfed child.

If you’re planning to breastfeed, talk with your doctor about treatment options for UC. Together, you can discuss the risks and benefits of your treatment options and decide whether you should take mesalamine during this time. Your doctor may recommend other healthy ways to feed your child.

What to ask your doctor

Let your doctor know if you have questions about mesalamine or would like more details about it.

Here’s a list of some possible questions you may want to ask your doctor:

• Should I continue to take or use mesalamine even if I’m not having symptoms?
• How can I tell the difference between side effects of mesalamine and the symptoms of my condition?
• Are rectal forms of mesalamine less likely to cause side effects than oral forms of the drug?
• Would a rectal form of mesalamine work faster for treating my symptoms than an oral form of the drug?

Resources

• Food and Drug Administration. (2023). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
• Mesalamine delayed-release capsules, for oral use. (2023). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/6fd0a906-e1b5-4238-a79b-a195510ddc84/spl-doc
• Mesalamine delayed-release tablets, for oral use. (2023). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/34494be6-3db5-4349-ab2d-57e8ccb383fc/spl-doc
• Mesalamine extended-release capsules, for oral use. (2023). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/87d3d62d-2dc3-4e6f-be33-cabbca12e8f7/spl-doc
• Mesalamine rectal suspension, USP enema. (2022). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/a4ddf68d-1502-4242-89aa-c96436bdcbf6/spl-doc
• Mesalamine suppositories, for rectal use. (2023). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/73317da3-cba0-4106-9e88-79b0e2f642af/spl-doc

Disclaimer: Optum Perks has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.