Canasa Side Effects Center

Last updated on RxList: 11/29/2022
Canasa Side Effects Center

What Is Canasa?

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.

What Are Side Effects of Canasa?

Common side effects of Canasa include:

  • rectal pain,
  • pain when inserting the suppository,
  • headache,
  • gas,
  • nausea,
  • vomiting,
  • stomach pain or cramps,
  • diarrhea,
  • constipation,
  • fever,
  • sore throat,
  • flu symptoms,
  • dizziness,
  • 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.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Canasa

The usual dosage of Canasa 1000 mg suppositories is one rectal suppository 1 time daily at bedtime.

What Drugs, Substances, or Supplements Interact with Canasa?

Other drugs may interact with Canasa rectal. Tell your doctor all prescription and over-the-counter medications and supplements you use.

Canasa During Pregnancy or Breastfeeding

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.

Additional Information

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.

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Canasa Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using mesalamine and call your doctor at once if you have:

  • severe stomach pain, cramping, bloody diarrhea;
  • fever, headache, general ill feeling;
  • rash, itching, eye redness;
  • low white blood cell counts--fever, chills, mouth sores, skin sores, sore throat, cough, feeling light-headed, trouble breathing;
  • signs of a kidney stone--severe pain in your side and back, frequent need to urinate, foul-smelling urine, dark or cloudy urine; or
  • kidney problems--increased or decreased urination, swelling, weight gain.

Low white blood cell counts may be more likely in older adults.

Common side effects may include:

  • fever;
  • dizziness;
  • rectal pain, colitis;
  • rash; or
  • acne.

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.

QUESTION

Ulcerative colitis affects the colon. The colon is also referred to as the... See Answer
Canasa Professional Information

SIDE EFFECTS

The following serious or clinically significant adverse reactions are described elsewhere in labeling:

  • 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]
  • Severe Cutaneous Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Photosensitivity [see WARNINGS AND PRECAUTIONS]
  • Nephrolithiasis [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, placebocontrolled 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)

Symptom Mesalamine
(n =177)
Placebo
(n =84)
N % N %
Dizziness 5 3 2 2.4
Rectal Pain 3 1.8 0 0
Fever 2 1.2 0 0
Rash 2 1.2 0 0
Acne 2 1.2 0 0
Colitis 2 1.2 0 0

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].

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of CANASA or 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]
  • Endocrine: Nephrogenic diabetes insipidus
  • 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, intracranial hypertension
  • Renal Disorders: interstitial nephritis, renal failure, minimal change disease, nephrolithiasis [see WARNINGS AND PRECAUTIONS]
  • Respiratory, Thoracic and Mediastinal Disorders: hypersensitivity pneumonitis (including allergic alveolitis, eosinophilic pneumonitis, interstitial pneumonitis), pleuritis/pleurisy
  • Skin and Subcutaneous Tissue Disorder: alopecia, erythema, erythema nodosum, pruritus, psoriasis, pyoderma gangrenosum, urticaria, SJS/TEN, DRESS and AGEP [see WARNINGS AND PRECAUTIONS]
  • Urogenital: reversible oligospermia

DRUG INTERACTIONS

Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs

The concurrent use of mesalamine with known nephrotoxic agents, including nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of nephrotoxicity. Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions [see WARNINGS AND PRECAUTIONS].

Azathioprine Or 6-Mercaptopurine

The concurrent use of mesalamine with azathioprine or 6-mercaptopurine and/or other drugs known to cause myelotoxicity may increase the risk for blood disorders, bone marrow failure, and associated complications. If concomitant use of CANASA and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts.

Interference With Urinary Normetanephrine Measurements

Use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection, because of the similarity in the chromatograms of normetanephrine and mesalamine's main metabolite, N-acetylaminosalicylic acid. Consider an alternative, selective assay for normetanephrine [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Canasa (Mesalamine)

© Canasa Patient Information is supplied by Cerner Multum, Inc. and Canasa Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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