"An experimental oral lymphocyte trafficking agent, ozanimod (Receptos), showed modest activity against ulcerative colitis (UC) in a small, early-stage clinical trial.
In the double-blind, placebo-controlled phase 2 trial in adults wit"...
Canasa Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Canasa (mesalamine) is an anti-inflammatory drug used to treat ulcerative colitis, proctitis, and proctosigmoiditis. Canasa is also used to prevent the symptoms of ulcerative colitis from recurring. Common side effects of Canasa include:
- rectal pain,
- pain when inserting the suppository,
- stomach pain or cramps,
- sore throat,
- flu symptoms,
- tired feeling, or
- skin rash.
Tell your doctor if you have unlikely but serious side effects of Canasa including:
- worsening stomach pain or cramping,
- worsening bloody diarrhea, fever, and
- severe or prolonged headache.
The usual dosage of Canasa 1000 mg suppositories is one rectal suppository 1 time daily at bedtime. Other drugs may interact with Canasa rectal. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Canasa should be used only when prescribed. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.
Our Canasa (mesalamine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Canasa in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using mesalamine rectal and call your doctor at once if you have severe stomach pain, cramping, fever, headache, and bloody diarrhea.
Less serious side effects may include:
- mild nausea, vomiting, stomach cramps, diarrhea, gas;
- fever, sore throat, or other flu symptoms;
- rectal pain, constipation;
- headache or dizziness;
- tired feeling; or
- skin rash.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Canasa (Mesalamine)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Canasa Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Infrequently, this medication may make symptoms of your condition worse rather than better (acute intolerance syndrome or sensitivity reaction). Tell your doctor immediately if you experience any of these unlikely but serious side effects: worsening stomach pain/cramping, worsening bloody diarrhea, fever, severe/prolonged headache.
Tell your doctor immediately if any of these rare but very serious side effects occur: chest pain, trouble breathing, severe stomach/abdominal pain (especially if spreading to the back), change in the amount of urine.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Canasa (Mesalamine)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Canasa FDA Prescribing Information: Side Effects
The most serious adverse reactions seen in CANASA clinical trials or with other products that contain or are metabolized to mesalamine are:
- Renal Impairment [see WARNINGS AND PRECAUTIONS]
- Mesalamine-Induced Acute Intolerance Syndrome [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Hepatic Failure [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most common adverse reactions in adult patients with mildly to moderately active ulcerative proctitis in double-blind, placebo-controlled trials are summarized in the Table 1 below.
Table 1: Adverse Reactions Occurring In More Than 1% of Mesalamine Suppository Treated Patients (Comparison to Placebo)
(n = 177)
(n = 84)
In a multicenter, open-label, randomized, parallel group study in 99 patients comparing the CANASA 1000 mg suppository administered nightly to that of the mesalamine 500 mg suppository twice daily. The most common adverse reactions in both groups were headache (14%), flatulence (5%), abdominal pain (5%), diarrhea (3%), and nausea (3%). Three (3) patients discontinued medication because of an adverse reaction; one of these adverse reactions (headache) was deemed possibly related to study medication. The recommended dosage of CANASA is 1000 mg administered rectally once daily at bedtime [see DOSAGE AND ADMINISTRATION].
In addition to the adverse reactions reported above in clinical trials involving CANASA, the adverse reactions listed below have been identified during post-approval use of CANASA and other mesalamine-containing products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Body as a Whole: drug fever, fatigue, lupus-like syndrome, medication residue
- Cardiac Disorders: myocarditis, pericarditis, pericardial effusion [see WARNINGS AND PRECAUTIONS]
- Eye disorders: eye swelling
- Gastrointestinal Disorders: abdominal cramps, abdominal distension, anal pruritus, anorectal discomfort, constipation, feces discolored, flatulence, frequent bowel movements, gastrointestinal bleeding, mucus stools, nausea, painful defecation, pancreatitis, proctalgia, rectal discharge, rectal tenesmus, stomach discomfort, vomiting
- Hepatic Disorders: cholestatic jaundice, hepatitis, jaundice, Kawasaki-like syndrome including changes in liver enzymes, liver necrosis, liver failure
- Hematologic Disorders: agranulocytosis, aplastic anemia, thrombocytopenia
- Neurological/Psychiatric Disorders: Guillain-Barre syndrome, peripheral neuropathy, transverse myelitis
- Renal Disorders: interstitial nephritis, renal failure, minimal change nephropathy [see WARNINGS AND PRECAUTIONS]
- Respiratory, Thoracic and Mediastinal Disorders: hypersensitivity pneumonitis (including allergic alveolitis, eosinophilic pneumonitis, interstitial pneumonitis)
- Skin and Subcutaneous Tissue Disorder: alopecia, erythema, erythema nodosum, pruritus, psoriasis, pyoderma gangrenosum, urticaria
- Urogenital: reversible oligospermia
Read the entire FDA prescribing information for Canasa (Mesalamine)
Additional Canasa Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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