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Canasa

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Canasa

Canasa

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, including renal failure [See WARNINGS AND PRECAUTIONS]
  • Mesalamine-induced acute intolerance syndrome [See WARNINGS AND PRECAUTIONS]
  • Hypersensitivity reactions [See WARNINGS AND PRECAUTIONS]
  • Hepatic impairment, including 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 frequent adverse reactions observed in the 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)

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 comparing the CANASA 1000 mg suppository administered nightly to that of the CANASA 500 mg suppository twice daily, the two treatment groups had similar adverse event profiles. The most frequent AEs were headache (14.4%), flatulence (5.2%), abdominal pain (5.2%), diarrhea (3.1%), and nausea (3.1%). Three (3) patients had to discontinue medication because of an adverse reaction; one of these adverse reactions (headache) was deemed possibly related to study medication.

Postmarketing Experience

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.

Read the Canasa (mesalamine) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No investigations of interaction between CANASA and other drugs have been performed. However, the following interactions between mesalamine medications and other drugs have been reported.

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 renal reactions.

Azathioprine Or 6-mercaptopurine

The concurrent use of mesalamine with azathioprine or 6mercaptopurine may increase the risk for blood disorders.

Read the Canasa Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 1/6/2014
This monograph has been modified to include the generic and brand name in many instances.

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Canasa User Reviews

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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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