Patient Medication Information: uses, side effects, how to take - Mezavant
What is MEZAVANT used for?
- To treat symptoms related to ulcerative colitis in adults. Ulcerative colitis is a condition where the large bowel (colon) and back passage (rectum) becomes red and swollen (inflamed).
- To help prevent the recurrence of ulcerative colitis in adults.
MEZAVANT is not for use in children under the age of 18.
How does MEZAVANT work?
MEZAVANT is an anti-inflammatory drug. MEZAVANT is believed to stop the production of certain substances in your body that cause swelling (inflammation). MEZAVANT tablets use a technology called Multi Matrix System®. This system prevents the medicine from being released early. It also allows the medicine to work for an extended period of time throughout the colon and rectum.
What are the ingredients in MEZAVANT?
Medicinal ingredients: mesalamine
Non-medicinal ingredients: carnauba wax, magnesium stearate, methacrylic acid – methyl methacrylate copolymer (1:1), methacrylic acid – methyl methacrylate copolymer (1:2), polyethylene glycol (macrogol) 6000, red ferric oxide (E172), silica (colloidal hydrated), sodium carboxymethylcellulose, sodium starch glycolate (type A), stearic acid, talc, titanium dioxide (E171) and triethylcitrate.
MEZAVANT tablets do not contain gluten, lactose or phthalates.
MEZAVANT comes in the following dosage forms:
MEZAVANT 1.2 g delayed- and extended-release tablets.
Do not use MEZAVANT if:
- you are allergic to mesalamine or any of the ingredients in MEZAVANT
- you are allergic to a family of drugs known as salicylates [which includes acetylsalicylic acid (i.e., Aspirin®2)]
- you have severe liver problems
- you have severe kidney problems.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MEZAVANT. Talk about any health conditions or problems you may have, including if you:
- have a narrow or blocked upper digestive tube (e.g., pyloric stenosis).
- have any kidney or liver problems.
- have a chronic lung condition (e.g., asthma).
- have ulcers in your stomach or in the first part of the small intestines.
- have a blocked urinary tract.
- had a heart condition that causes inflammation of the heart (which may be the results of an infection of the heart).
- have eczema. A condition that causes dry, itchy rashes on your skin. Your skin may be more sensitive to sunlight when taking MEZAVANT.
- have had previous allergy (hypersensitivity reaction) to sulfasalazine. Sulfasalazine is an ingredient in other medicines used to treat ulcerative colitis.
Other warnings you should know about:
Treatment with MEZAVANT can increase your risk of certain side effects, including:
Blood Disorder: Treatment with MEZAVANT can cause serious blood disorders. The risk of this side effect is increased when you take immunosuppressant drugs that contain 6-mercaptopurine (e.g., Purinethol) or azathioprine (e.g., Imuran). Speak to your doctor immediately if you experience any of the following symptoms:
- Unexplained bleeding
- Bruising
- Fever
- Sore throat
Kidney stones: You may develop kidney stones when using MEZAVANT. Be sure to drink enough liquids while you are taking MEZAVANT. Speak to your doctor immediately if you experience any of the following symptoms:
- Blood in urine
- Urinating more often
- Pain in your back, stomach, side or groin
Pregnancy and breastfeeding
If you are pregnant, able to get pregnant or think you are pregnant, there are specific risks you should discuss with your doctor.
- Avoid becoming pregnant while you are taking MEZAVANT. It may harm your unborn baby.
- 2 Aspirin is a registered trade-mark of Bayer Aktiengesellschaft
- Tell your doctor right away if you become pregnant or think you may be pregnant during treatment with MEZAVANT.
Taking MEZAVANT during pregnancy have been reported to cause
- early labor
- birth defects in babies. The baby may develop kidney and heart issues.
- You should not breastfeed or plan to breastfeed during treatment. If you breastfeed your baby while taking MEZAVANT your baby could develop / start to have diarrhea. It is important to monitor your baby’s stool and contact your doctor right away if they have diarrhea. Your doctor may advise you to stop breastfeeding your baby.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with MEZAVANT:
- Azathioprine (e.g., Imuran) or 6-mercaptopurine (e.g., Purinethol) or other drugs known to affect your bone marrow. The bone marrow is responsible for creating blood cells. Taking MEZAVANT with these drugs may increase your risk of having a blood disorder, bone marrow problems or other problems.
- Drugs known to affect the kidney. This can include anti-inflammatory drugs (Nonsteroidal anti-inflammatory drugs (NSAIDs)) and azathioprine drugs. Taking MEZAVANT with these drugs may increase your risk of side effects to your kidneys.
Treatment with MEZAVANT can affect the results of a urine test. Tell your doctor or nurse that you are taking MEZAVANT when taking a urine test.
How to take MEZAVANT:
- Take MEZAVANT exactly as your doctor tells you to take it. Do NOT take more of it than prescribed. Speak to your doctor or pharmacist if you are not sure.
Take MEZAVANT with food. Swallow tablets whole with liquids. Do NOT crush or chew the tablets.
Usual dose:
Adult Dose to treat a sudden onset of ulcerative colitis symptoms
Take two to four 1.2 g tablets (equal to 2.4 g to 4.8 g) once a day.
Maintenance Adult Dose to prevent the recurrence of ulcerative colitis
Take two 1.2 g tablets (equal to 2.4 g) once a day.
Overdose:
If you think you, or a person you are caring for, have taken too much MEZAVANT, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
If you forget to take your medicine, then take it as usual the next day. Do not take two doses to make up for a forgotten dose.
What are possible side effects from using MEZAVANT?
These are not all the possible side effects you may have when taking MEZAVANT. If you experience any side effects not listed here, tell your healthcare professional.
The most common side effects of MEZAVANT are:
- Diarrhea
- Headache
- Nausea
- Stomach pain
Other possible side effects of MEZAVANT may include:
- Acne or itchy skin
Digestive tract problems
- gas
- upset or bloated stomach
- vomiting
- Dizziness
- Ear or throat pain
- Feeling weak, sleepy or tired
- Fever
- Hair loss
- Muscle, joint and back pain
- Skin is sensitive to sunlight
- Trembling or shaking
- Urine discolouration (urine may become discolored reddish-brown when MEZAVANT comes in contact with sodium hypochlorite, bleach in the toilet water)
Your doctor may run tests, including a blood test, to check your liver function and blood cell counts.
Serious side effects and what to do about them
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Serious side effects and what to do about them | |||
| Serious side effects and what to do about them | |||
| Serious side effects and what to do about them | |||
| Serious side effects and what to do about them | |||
| Talk to your healthcare professional | |||
| Talk to your healthcare professional | |||
| Talk to your healthcare professional | |||
| Talk to your healthcare professional | |||
| Talk to your healthcare professional | |||
| Talk to your healthcare professional | |||
| Symptom / effect | Only if severe | In all cases | Stop taking drug and get immediate medical help |
| Symptom / effect | Only if severe | In all cases | Stop taking drug and get immediate medical help |
| Symptom / effect | Only if severe | In all cases | Stop taking drug and get immediate medical help |
| Symptom / effect | Only if severe | In all cases | Stop taking drug and get immediate medical help |
| Symptom / effect | Only if severe | In all cases | Stop taking drug and get immediate medical help |
| Symptom / effect | Only if severe | In all cases | Stop taking drug and get immediate medical help |
COMMON Allergic reaction: hives, rash, swollen face | √ | ||
Unknown Other allergic reaction: swelling of the mouth, throat, difficulty in breathing and worsening asthma | √ | ||
| Colitis (inflamed colon): diarrhea, blood in stool, abdominal pain, cramping, nausea and vomiting, fever | √ | ||
| High blood pressure: shortness of breath, fatigue, dizziness or fainting, chest pain or pressure, swelling in your ankles and legs, bluish colour to your lips and skin, racing pulse or heart palpitations | √ | ||
COMMON Acute Intolerance Syndrome: cramping, acute stomach pain, bloody and excessive stools (diarrhea), fever, headache and rash. These symptoms could be a sign of a serious condition which occurs rarely but means your treatment would have to be stopped immediately | √ | ||
UNCOMMON Blood problems: unexplained bruising, unusual bleeding (for example, nose bleeds), fever, sore throat | √ | ||
| Worsening of Ulcerative Colitis (inflamed rectum and colon): severe or persistent | √ | ||
| diarrhea, abdominal pain, nausea and vomiting, fever | |||
| Pancreatitis (inflamed or swollen pancreas): abdominal pain and feeling sick | √ | ||
| Tachycardia (abnormal heartbeat): dizziness, light headedness, shortness of breath, racing heart | √ | ||
| Rectal polyp (a non- cancerous growth in the back passage): constipation and bleeding | √ | ||
| Low blood pressure: dizziness, light headedness, fainting | √ | ||
RARE Kidney problems (such as inflammation and scarring of the kidney or kidney failure): blood in the urine, fever, increased or decreased urine output, mental status changes (drowsiness, confusion, coma), nausea, vomiting, rash, swelling of the body, weight gain (from retaining fluid) | √ | ||
| Kidney stones (hard little pebbles that form in your kidneys): blood in urine, urinating more often, pain in your back, side, belly or groin | √ | ||
UNKNOWN FREQUENCY Hepatitis (inflammation of the liver): jaundice (yellowing of the skin and eyes) and flu-like symptoms | √ | ||
| Reversible decline in sperm production | √ | ||
| Nephrogenic diabetes insipidus (diabetes caused by kidney problems): increased thirst, frequent urination, waking up during the night to urinate, possible bed wetting, tiredness, loss of appetite and weight loss | √ | ||
| Lupus-Like Syndrome: butterfly shaped skin rash typically on face, skin sensitive to sunlight, joint pain and/or arthritis | √ | ||
| Abnormal or damaged nerves: numbness and tingling sensation | √ | ||
| Hepatotoxicity (liver damage): stomach pain, nausea, vomiting, loss of appetite, jaundice (yellow skin or eyes), dark-coloured urine, light-coloured stool | √ | ||
| Myocarditis/ Pericarditis (inflammation of the heart muscle and lining around the heart): abnormal heartbeat, chest pain that may resemble a heart attack, fatigue, fever and other signs of infection including headache, muscle aches, sore throat, diarrhea, or rashes, joint pain or swelling, leg swelling, shortness of breath | √ | ||
| Pleurisy (inflammation of the sheet like layers that cover the lungs): difficulty in breathing or wheezing, sometimes with chest pain | √ | ||
| Hypersensitivity pneumonitis (inflammation of lungs due to an allergic reaction): fever, cough, chills, and shortness of breath | √ | ||
| Serious Skin Conditions (Stevens-Johnson syndrome, Drug Reaction with Eosinophilia and Systemic Symptoms): swelling of the skin or serious skin rash seen as severe blisters of the skin and mucous membranes | √ | ||
| Toxic epidermal necrolysis (TEN) (rare and serious skin condition): peeling of the skin, painful raw areas | √ | ||
| Increased pressure in brain causing headache which may originate behind your eyes and worsen with eye movements, with blurred or dimmed vision, double vision, seeing light flashes, difficulty seeing to the side, and brief or permanent vision loss. These may be associated with dizziness, nausea, vomiting, ringing in ears | √ | ||
| Infant diarrhea when breastfeeding | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store at room temperature (15°C to 25°C), excursions permitted to 30°C.
Keep out of the reach and sight of children.
If you want more information about MEZAVANT:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.takeda.com/en-ca, or by calling 1-800-268-2772.
Last Revised: DEC 11, 2025
MEZAVANT® and the MEZAVANT Logo® are registered trademarks of Nogra Pharma Limited, used under license.
MMX® is a registered trademark of Cosmo Technologies, Ltd., used under license.
TAKEDA™ and the TAKEDA Logo® are registered trademarks of Takeda Pharmaceutical Company Limited, used under license.
