Mesalamine is used to help with an inflammatory bowel disease called ulcerative colitis (UC). It helps relieve symptoms of mild or moderate UC, such as stomach pain, diarrhea, and gut inflammation. This medication can also be used to maintain remission (prevent UC flare-ups) in adults. There are many brand names for mesalamine on the market, and they all have lower-cost generics available. The dosage depends on the brand and formulation of mesalamine you have. In general, this medication can cause side effects like headache and indigestion.
Mesalamine is an aminosalicylate. It's unclear how mesalamine exactly works. But it appears to work inside the bowels (gut) to lower gut inflammation, which helps relieve symptoms of UC.
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Contact your healthcare provider immediately if you experience any of the following.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
Bloody stools
bloody urine
blurred vision
chest tightness
chills
clay-colored stools
dark urine
difficulty with breathing
dizziness
full or bloated feeling
general feeling of discomfort or illness
headache
itching, skin rash
joint pain
loss of appetite
muscle aches and pains
nervousness
pain or tenderness around the eyes and cheekbones
pounding in the ears
pressure in the stomach
runny or stuffy nose
shivering
slow or fast heartbeat
stomach cramps
sweating
swelling of the stomach area
trouble sleeping
unpleasant breath odor
unusual tiredness or weakness
vomiting
vomiting of blood
yellow eyes or skin
Incidence not known
Black, tarry stools
blistering, peeling, or loosening of the skin
change in the ability to see colors, especially blue or yellow
chest discomfort
decreased frequency or amount of urine
greatly increased frequency of urination or amount of urine
hives or welts
hoarseness
inability to move the arms and legs
increased thirst
indigestion
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
light-colored stools
lower back or side pain
muscle weakness, sudden and progressing
pain in the ankles or knees
painful or difficult urination
painful, red lumps under the skin, mostly on the legs
rapid breathing
red skin lesions, often with a purple center
red, irritated eyes
severe nausea or vomiting
sores, ulcers, or white spots in the mouth or on the lips
stomach tenderness
sudden numbness and weakness in the arms and legs
swelling of the feet or lower legs
swollen or painful glands
thickening of bronchial secretions
unusual bleeding or bruising
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
belching
continuing ringing or buzzing or other unexplained noise in the ears
difficulty with moving
dizziness or lightheadedness
excess air or gas in the stomach or bowels
feeling of constant movement of self or surroundings
hair loss or thinning of the hair
hearing loss
muscle stiffness
passing gas
sensation of spinning
stomach discomfort or upset
Incidence not known
Burning, numbness, tingling, or painful sensations
unsteadiness or awkwardness
weakness in the arms, hands, legs, or feet
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Tips for all generics and brands of mesalamine:
Tips for Apriso and its generic extended-release capsule:
Tips for Asacol HD and its generic delayed-release tablet:
Tips for Delzicol and its generic delayed-release capsule:
Tips for Pentasa brand and its generic extended-release capsule:
The exact dosage and duration of your mesalamine treatment depends on your UC symptoms and how severe they are. It also varies depending on whether you're taking mesalamine to treat UC symptoms or prevent flare-ups. The dosing schedule will also depend on the formulation or brand of mesalamine that you're prescribed to take. For example, there are some situations where mesalamine is taken specifically for 6 or 8 weeks. But there are other times where you'll continue to take the medication for as long as it's helping your gut problem and as long as the side effects are tolerable. Discuss with your provider about your dosage and how long you should take mesalamine for your specific condition.
It can take a couple weeks for mesalamine to relieve your UC symptoms. In separate studies for different oral forms of mesalamine, people taking the medication had improvements in their UC symptoms after 6 or 8 weeks of treatment. Some people taking a higher dose of mesalamine might see results as soon as within 2 weeks of treatment. Because it can take a couple weeks to see improvements, don't get discouraged, and continue to take the medication as prescribed by your healthcare provider. Make sure to check in with your provider about your UC symptoms and whether mesalamine is helping.
In general, the best time you should take mesalamine is a time when it's easy for you to remember. Certain forms of mesalamine require you to take the medication once a day, three or four times a day, with meals, or without meals. For example, it's recommended to take Asacol HD delayed-release tablets three times a day on an empty stomach (1 hour before or 2 hours after meals). But Apriso extended-release capsules are taken once every morning with or without food. Check out the Pharmacist tips for more information on how to take each form or brand of mesalamine. Ask your pharmacist or provider to help you come up with a medication schedule that works best for you.
No, mesalamine isn't considered an immunosuppressant. It doesn't work by weakening the immune system to lower inflammation in the gut. Although mesalamine doesn't suppress the immune system, there are many other medications for UC that can. Some examples include corticosteroids and Humira (adalimumab).
No, mesalamine isn't a steroid. Instead, mesalamine is a type of medication called an aminosalicylate. Both steroids and aminosalicylates lower swelling and inflammation, but they work slightly differently in the body to do so.
Weight gain wasn't one of the reported side effects of mesalamine in clinical studies. Keep in mind that some people did report swelling of the body (possibly from fluid buildup in the body), which could appear as weight gain. Talk to your provider if you experience unexpected weight gain while you're taking mesalamine. They can help figure out what might be causing your change in weight.
You should generally avoid taking mesalamine with azathioprine (Imuran), mercaptopurine, or other medications that can cause blood problems; there might be a higher risk for blood problems if you take them together. Additionally, it's best not to take medications that can harm the kidneys, like nonsteroidal anti‑inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin). Taking mesalamine with these medications might raise your risk for kidney problems. For Apriso extended-release capsules, avoid taking the medication with antacids because they can affect how well mesalamine gets absorbed into your body. Make sure your providers and pharmacists have your up-to-date medication list so they can check for drug interactions and recommend safer medications for you to take.
Many providers often prescribe mesalamine to treat the inflammatory bowel disease called Crohn's disease (CD), even though it isn't FDA-approved for this purpose. This is known as an "off-label" use of mesalamine. Using mesalamine for Crohn's is controversial because studies haven't consistently found that the medication helps treat the gut condition well in most cases. In fact, the American College of Gastroenterology guidelines don't recommend using mesalamine to treat adults with active Crohn's disease. Ask your healthcare provider whether mesalamine is right for you if you have Crohn's disease.
Mesalamine can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Some people taking mesalamine developed kidney problems during treatment. These problems can include kidney stones, kidney damage, and sometimes even kidney failure. Your risk for kidney damage is higher if you have a history of kidney problems or if you're taking other medications that can harm the kidneys, such as nonsteroidal anti‑inflammatory drugs (NSAIDs) like ibuprofen (Advil, Motrin). Let your healthcare provider know about your medical history and all the medications you take or plan to take.
Your provider will check your kidney function through blood work before you start mesalamine and periodically throughout treatment. Make sure to drink enough fluids each day to prevent kidney stones. Contact your provider if you have trouble urinating, notice a change in how much you urinate, have blood in the urine, or feel back or side pain. These can be signs of kidney problems.
Some people can have an abnormal reaction to mesalamine called acute intolerance syndrome. This reaction can be hard to tell apart from a flare-up of UC. Symptoms include stomach cramping or pain, bloody diarrhea, and sometimes fever, headache, and rash. Let your healthcare provider know if you notice these symptoms. You might need to stop treatment with mesalamine to help these symptoms go away.
While uncommon, some people taking mesalamine developed liver problems during treatment. In addition, some people who already had liver problems later had liver failure after they started taking mesalamine. Let your healthcare provider know if you have liver problems before starting this medication so they can discuss the risks and benefits with you. Contact your provider right away if you notice signs of liver problems, like yellowing of the skin or eyes, dark urine, tiredness, or right-sided stomach pain, during treatment with mesalamine.
Though rare, it's possible to have an allergic reaction to mesalamine. These reactions can be serious and sometimes life-threatening. Allergic reactions can make it difficult to breathe, cause a severe rash, or even affect some of your organs (e.g., heart, liver, kidneys). Get medical help right away if you have any symptoms of an allergic reaction, such as itchiness; hives; shortness of breath; chest tightness; and swelling of your lips, tongue, face, or eyes.
Mesalamine can also possibly cause severe skin reactions to happen. Stop taking mesalamine and seek emergency medical help as soon as possible if you experience rash, discolored patches of skin, skin peeling, blisters, or painful mouth sores. Sometimes, these skin reactions can happen along with fever and body aches.
Some tablet and capsule forms of mesalamine have coatings that contain iron oxide for coloring. Tell your healthcare provider if you take or plan to take any iron supplementation (by mouth or by infusion through the vein) or if you have medical conditions that raise your risk for too much iron in your body. To avoid the harmful effects of taking too much iron, your provider should discuss with you about being aware of all your sources of iron.
The Apriso extended-release capsules contain phenylalanine. This ingredient can be harmful for people with a genetic condition called phenylketonuria (PKU). Talk to your healthcare provider if you have PKU so they can prescribe a different version of mesalamine that's safer for you.
Each oral form and brand of mesalamine has specific dosing instructions. Make sure to read your dosing instructions carefully, and refer to the Pharmacist tips for more information about how to take the mesalamine form you have.
Treatment of mild or moderate UC
Asacol HD and its generics (delayed-release tablet):
Delzicol and its generics (delayed-release capsule):
Pentasa and its generics (extended-release capsule):
Maintenance of remission of UC
Apriso and its generics (extended-release capsule):
Delzicol and its generics (delayed-release capsule):
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Mesalamine will not be safe for you to take.