canasa
Pharmaranks rates Canasa 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Canasa (Mesalamine) is an aminosalicylate used to treat Ulcerative Colitis, Proctitis, Sigmoid Diseases.
Mesalamine · by Abbvie
Available as a generic: Mesalamine
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Mesalamine
- Drug class
- Aminosalicylate
- Form
- Suppository
- Strength
- Mesalamine 1GM · Mesalamine 500MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- ulcerative colitis, proctitis, sigmoid diseases
- Manufacturer
- Abbvie
- Half-life
- about 7 to 9 hours (apparent terminal half-life) (how long it stays in your system)
- What the pharmacy pays
- ~$26.72 for 30 — not your price
- FDA application
- NDA021252
What is Canasa?
From the FDA label:The active ingredient in CANASA 1000 mg suppositories for rectal use is mesalamine, also known as mesalazine or 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid, and is classified as an aminosalicylate. Each CANASA rectal suppository contains 1000 mg of mesalamine (USP) in a base of Hard Fat, NF. The empirical formula is C 7 H 7 NO 3 , representing a molecular weight of 153.14. The structural formula is: The structural formula for C7H7NO3, representing a molecular weight of 153.14.
How to use
Dosage The recommended dosage of CANASA in adults is 1000 mg administered rectally once daily at bedtime for 3 to 6 weeks depending on symptoms and sigmoidoscopic findings. Safety and effectiveness of CANASA beyond 6 weeks have not been established. Administration Instructions: Evaluate renal function prior to initiation of CANASA therapy [see Warnings and Precautions ( 5.1 )] . Do not cut or break the suppository. Retain the suppository for one to three hours or longer, if possible. Drink an adequate amount of fluids [see Warnings and Precautions ( 5.7 )] If a dose of CANASA is missed, administer as soon as possible, unless it is almost time for next dose. Do not use two CANASA suppositories at the same time to make up for a missed dose. CANASA suppositories will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel. Keep CANASA away from these surfaces to prevent staining. Dosage The recommended adult dosage is 1000 mg administered rectally once daily at bedtime for 3 to 6 weeks. Safety and effectiveness beyond 6 weeks have not been established. ( 2 ) Administration Instructions: Evaluate renal function prior to initiation of CANASA and periodically while on therapy. ( 2 , 5.1 ) Do not cut or break the suppository. ( 2 ) Drink an adequate amount of fluids. ( 2 , 5.7 ) Retain the…
Side effects
The following serious or clinically significant adverse reactions are described elsewhere in labeling: Renal Impairment [ s ee Warnings and Precautions ( 5.1 )] Mesalamine-Induced Acute Intolerance Syndrome [ s ee Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions [ s ee Warnings and Precautions ( 5.3 )] Hepatic Failure [ s ee Warnings and Precautions ( 5.4 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.5 )] Photosensitivity [see Warnings and Precautions ( 5.6 )] Nephrolithiasis [see Warnings and Precautions ( 5.7 )] The most common adverse reactions (≥ 1%) are: dizziness, rectal pain, fever, rash, acne and colitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 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) Symptom…
Warnings
Important safety information
Renal Impairment: Evaluate the risks and benefits in patients with known renal impairment or taking nephrotoxic drugs; monitor renal function. Discontinue CANASA if renal function deteriorates. ( 5.1 , 7.1 , 8.6 ) Mesalamine- Induced Acute Intolerance Syndrome: Symptoms may be difficult to distinguish from an exacerbation of ulcerative colitis; monitor for worsening symptoms; discontinue treatment if acute intolerance syndrome is suspected. ( 5.2 ) Hypersensitivity Reactions, including Myocarditis and Pericarditis: Evaluate patients immediately and discontinue if a hypersensitivity reaction is suspected. ( 5.3 ) Hepatic Failure: Evaluate the risks and benefits in patients with known liver impairment. ( 5.4 ) Severe Cutaneous Adverse Reactions: Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. ( 5.5 ) Photosensitivity : Advise patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors. ( 5.6 ) Nephrolithiasis: Mesalamine-containing stones are undetectable by standard radiography or computed tomography (CT). Ensure adequate hydration during treatment. ( 5.7 ) Interaction with Laboratory Test for Urinary Normetanephrine: Spuriously elevated test results may occur with liquid chromatography with electrochemical detection in patients receiving CANASA; use alternative, selective assay for normetanephrine. ( 5.8 ) 5.1 Renal Impairment Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and renal failure, has been reported in patients given products such as CANASA that contain mesalamine or are converted to mesalamine. In animal studies, the kidney was the principal organ of mesalamine toxicity [see Adverse Reactions ( 6.2 ), Nonclinical Toxicology ( 13.2 )] . Evaluate renal function prior to initiation of CANASA and periodically while on therapy. Evaluate the risks and benefits of using CANASA in patients with known renal impairment or a history of renal disease or taking concomitant nephrotoxic drugs. Discontinue CANASA if renal function deteriorates while on therapy [see Drug Interactions ( 7.1 ), Use in Specific Populations ( 8.6 )] . 5.2 Mesalamine-Induced Acute Intolerance Syndrome Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of ulcerative colitis. Although the exact frequency of occurrence has not been determined, it has occurred in 3% of patients in controlled clinical trials of mesalamine or sulfasalazine. Symptoms include cramping, acute abdominal pain and bloody diarrhea, and sometimes fever, headache, malaise, pruritus, conjunctivitis, and rash. Monitor patients for worsening of these symptoms while on treatment. If acute intolerance syndrome is suspected, promptly discontinue treatment with CANASA. 5.3 Hypersensitivity Reactions Hypersensitivity reactions have been reported in patients taking sulfasalazine. Some patients may have a similar reaction to CANASA or to other compounds that contain or are converted to mesalamine. As with sulfasalazine, mesalamine-induced hypersensitivity reactions may present as internal organ involvement, including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis and hematologic abnormalities. Evaluate patients immediately if signs or symptoms of a hypersensitivity reaction are present. Discontinue CANASA if an alternative etiology for the signs and symptoms cannot be established. 5.4 Hepatic Failure There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered other products containing mesalamine. Evaluate the risks and benefits of using CANASA in patients with known liver impairment. 5.5 Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with the use of mesalamine [see Adverse Reactions ( 6.2 )]. Discontinue CANASA at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. 5.6 Photosensitivity In patients treated with mesalamine or sulfasalazine who have pre-existing skin conditions such as atopic dermatitis and atopic eczema have reported more severe photosensitivity reactions. Advise patients to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors. 5. 7 Nephrolithiasis Cases of nephrolithiasis have been reported with the use of mesalamine, including stones of 100% mesalamine content. Mesalamine-containing stones are radiotransparent and undetectable by standard radiography or computed tomography (CT). Ensure adequate hydration during treatment with CANASA. 5. 8 Interaction with Laboratory Test for Urinary Normetanephrine 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.
Who should not take Canasa
CANASA is contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any ingredients in the suppository vehicle [ s ee Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.2 ), and Description ( 11 )] . Known or suspected hypersensitivity to salicylates or aminosalicylates or to any ingredients in the formulation. ( 4 , 5.3 )
Overdose — what happens if you take too much
Mesalamine absorption from the colon is limited; however, CANASA is an aminosalicylate, and symptoms of salicylate toxicity include nausea, vomiting and abdominal pain, tachypnea, hyperpnea, tinnitus, and neurologic symptoms (headache, dizziness, confusion, seizures). Severe salicylate intoxication may lead to electrolyte and blood pH imbalance and potentially to other organ (e.g., renal and liver) involvement. There is no specific antidote for mesalamine overdose. Correct fluid and electrolyte imbalance by the administration of appropriate intravenous therapy and maintain adequate renal function.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Nephrotoxic A gents including NSAIDs: Increased risk of nephrotoxicity; monitor for changes in renal function and mesalamine-related adverse reactions. ( 7.1 ) Azathioprine or 6- Mercaptopurine : Increased risk of blood disorders; monitor complete blood cell counts and platelet counts. ( 7.2 ) 7.1 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 ( 5.1 )]. 7.2 Azathioprine or 6- M ercaptopurine 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. 7.3 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 ( 5.8 )] .
How long does Mesalamine stay in your body?
The elimination half-life of mesalamine is about 7 to 9 hours (apparent terminal half-life) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the apparent TERMINAL (elimination) half-life of mesalamine (5-ASA) itself, from the delayed-release tablet label after 2.4 g and 4.8 g doses; the per-dose table gives terminal-phase means of 8.56 h (1.2 g), 7.05 h (2.4 g) and 7.25 h (4.8 g), with very large between-person variability (standard deviations of 5-8 hours). Metabolite: the label reports the apparent terminal half-life of the major metabolite, N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA), as 8 to 12 hours — longer than the parent. Mesalamine suppository labels describe N-Ac-5-ASA as "the active metabolite," so the active material can persist somewhat longer than the parent figure alone suggests. Timing caveat: these are delayed-release oral products designed to release drug in the terminal ileum and colon, so absorption is slow and highly variable (median Tmax ~9-24 h depending on product, longer with a high-fat meal) — plasma drug can still be rising many hours after the dose, and the half-life alone does not describe how long drug is present. Older adults: increased age slows apparent elimination — terminal half-life averaged 5.68 h in subjects 18-35 vs 9.68 h at 65-75 and 8.67 h at 75+, with roughly 2-fold higher Cmax. Kidney impairment: the label states systemic exposure is inversely correlated with renal function (lower creatinine clearance, higher exposure); mesalamine is cleared mainly by the kidney as N-Ac-5-ASA. Liver impairment: this label does not state a hepatic-impairment half-life. Mesalamine is not a prodrug (it is the active moiety; sulfasalazine and balsalazide are prodrugs of it). Not a drug-test detection window and not dosing guidance.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Mesalamine delayed-release tablets — FDA label, 12.3 Pharmacokinetics (DailyMed, Camber Pharmaceuticals, eff. 2024-02-15).
Drug class
How this class works, per Mesalamine (USAN) - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Canasa ranks — best-rated aminosalicylate for:
Dosage forms
Suppository
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Canasa treat?
- Canasa (Mesalamine) may be used to treat ulcerative colitis, proctitis, sigmoid diseases, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Canasa work?
- Canasa is a aminosalicylate. Aminosalicylates (5-ASA drugs like mesalamine) act directly on the inflamed lining of the colon, where they are thought to calm the local inflammatory response by blocking several inflammation-driving chemicals and mopping up tissue-damaging free radicals, which helps the gut heal in ulcerative colitis.
- How is Canasa rated?
- pharmaranks gives Canasa a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Canasa cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $26.72 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Azulfidine En-Tabs — about $5.92 on the same basis.
- Is there a coupon or discount for Canasa?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Canasa. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Canasa?
- Canasa is marketed by Abbvie. You can see Abbvie's full profile, rating, and other products on pharmaranks.
- Is Canasa a brand-name or generic drug?
- Canasa is a brand-name product with the active ingredient Mesalamine. Lower-cost generic equivalents containing Mesalamine are available — ask your pharmacist.
- Is Canasa available over the counter?
- No. Canasa is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Canasa come in?
- Canasa is currently marketed as suppository, per the FDA's National Drug Code Directory.
- What class of drug is Canasa?
- Canasa is classified as aminosalicylate, per the FDA's Established Pharmacologic Class.
- Is Canasa FDA-registered?
- Canasa is on record with the U.S. FDA under application number NDA021252. You can verify this on its official FDA label.
- Has Canasa been recalled by the FDA?
- Canasa has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Canasa safe?
- There's no single safe-or-not verdict. pharmaranks gives Canasa a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Canasa?
- Canasa's side effects are taken directly from its FDA label. From the label: The following serious or clinically significant adverse reactions are described elsewhere in labeling: Renal Impairment [ s ee Warnings and Precautions ( 5.1 )] Mesalamine-Induced Acute Intolerance Syndrome [ s ee Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions [ s ee Warnings and Preca… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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canasa
72/100