Canasa Side Effects

Generic name: mesalamine

Note: This document contains side effect information about mesalamine. Some of the dosage forms listed on this page may not apply to the brand name Canasa.

Some side effects of Canasa may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to mesalamine: oral capsule extended release, oral delayed release capsule, oral delayed release tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking mesalamine (the active ingredient contained in Canasa) hives; difficulty 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, skin rash;

• chest pain, shortness of breath;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• little or no urinating;

• swelling, rapid weight gain; or

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects may include:

• mild stomach discomfort, gas;

• flu symptoms, runny nose;

• diarrhea, constipation;

• headache, dizziness;

• weakness; or

• joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to mesalamine: compounding powder, oral capsule extended release, oral delayed release capsule, oral delayed release tablet, rectal enema, rectal kit, rectal suppository

Gastrointestinal

Very common (10% or more): Abdominal pain (up to 18%), eructation (up to 16%), nausea (up to 13%)
Common (1% to 10%): Diarrhea (up to 8%), dyspepsia (up to 6%), ulcerative colitis (up to 5.8%), vomiting (up to 5%), constipation (up to 5%), upper abdominal pain (up to 5%), gastrointestinal bleeding (up to 5% or greater), flatulence (up to 5% or greater), acute intolerance syndrome (3%), colitis exacerbation (up to 3%), lower abdominal pain (less than 3%), rectal hemorrhage (less than 3%), gastroenteritis (2% or greater), gastrointestinal hemorrhage (2% or greater), stool abnormalities (color or texture change; up to 2% or greater), tenesmus (up to 2% or greater), rectal disorder (2% or greater), abdominal enlargement (up to 2% or greater), abdominal distention (up to 1.3%)
Rare (less than 0.1%): Colitis, pancreatitis, rectal polyp, duodenal ulcer, esophageal ulcer, dysphagia, fecal incontinence, oral moniliasis, thirst, recurrence of ulcerative colitis, gastritis, stomatitis, perforated peptic ulcer
Frequency not reported: Worsening of colitis or symptoms of inflammatory bowel disease (including melena and hematochezia), elevated amylase, elevated lipase
Postmarketing reports: Pancreatitis, gastritis, dry mouth, oral ulcers, gastroenteritis, gastrointestinal bleeding, perforated peptic ulcer, bloody diarrhea, taste perversion

Colitis symptoms (including cramping, acute abdominal pain, and bloody diarrhea, and occasionally fever, headache, malaise, pruritus, rash, and conjunctivitis) have been exacerbated after starting mesalamine or sulfasalazine in 3% of patients in controlled clinical trials. This acute intolerance syndrome may be difficult to distinguish from a flare of inflammatory bowel disease.

Worsening of colitis or symptoms of inflammatory bowel disease, including melena and hematochezia, have also been reported after commencing mesalamine rectal suspension enema.

Nervous system

Very common (10% or more): Headache (up to 35%)
Common (1% to 10%): Dizziness (up to 8%), lightheadedness (8%), faintness (8%), tinnitus (less than 3%), vertigo (less than 3%), migraine (2% or greater), paresthesia (up to 2% or greater), insomnia (up to 2%)
Rare (less than 0.1%): Benign intracranial hypertension (at least 1 case)
Postmarketing reports: Systemic lupus erythematosus, peripheral neuropathy, Guillain-Barre syndrome, transverse myelitis, somnolence, tremor, hyperesthesia, tinnitus, vertigo

A 23-year-old female with ulcerative colitis who had been taking 400 mg mesalamine tablets three times a day developed benign intracranial hypertension. The examination disclosed benign intracranial hypertension that resolved when mesalamine was discontinued and recurred when the drug was restarted.

Musculoskeletal

Very common (10% or more): Muscle aches (21%)
Common (1% to 10%): Back pain (up to 7%), arthralgia (up to 5% or greater), hypertonia (5%), myalgia (up to 3%), joint disorder (2% or greater), arthritis (2%)
Frequency not reported: Leg cramps, rheumatoid arthritis
Postmarketing reports: Gout

Respiratory

A 72-year-old female with ulcerative colitis who had begun taking two 400 mg mesalamine (the active ingredient contained in Canasa) tablets twice daily experienced pleural effusion and pulmonary infiltrates. Chest radiograph showed bilateral pleural effusions and an infiltrate in the lower lobe of the right lung. It was determined that the adverse events described appeared likely to be due to mesalamine therapy.

Pleural effusion and pulmonary infiltrates, generally accompanied by eosinophilia, have been reported rarely. More severe cases have included fibrosing alveolitis.

Very common (10% or more): Nasopharyngitis (up to 11%)
Common (1% to 10%): Rhinitis (up to 9%), influenza and influenza-like illness (up to 5% or greater), sinusitis (3%), dyspnea (less than 3%), bronchitis (2% or greater), increased cough (2%)
Rare (less than 0.1%): Pleural effusion, pulmonary infiltrates, fibrosing alveolitis
Postmarketing reports: Eosinophilic pneumonia, interstitial pneumonitis, asthma exacerbation, pleuritis, pneumonitis, hypersensitivity pneumonitis, allergic alveolitis

Cardiovascular

One 20-year-old patient died of cardiac arrhythmias attributed to myocarditis 13 days after starting mesalamine (the active ingredient contained in Canasa)

A 56-year-old male with hypertension and ulcerative proctitis experienced pleuropericarditis coincident with mesalamine therapy. Evaluation revealed acute pleuropericarditis manifested by ECG changes, pericardial effusion, and a small pleural effusion. All symptoms resolved when mesalamine was discontinued.

Common (1% to 10%): Chest pain of unknown etiology (3%), vasodilation (up to 2% or greater)
Uncommon (0.1% to 1%): Hypertension (up to 1%)
Rare (less than 0.1%): Tachycardia, hypotension, palpitations, pericarditis, pericardial effusion, myocarditis, T-wave abnormalities, severe symptomatic sinus bradycardia (at least 1 case), pleuropericarditis (at least 1 case)
Postmarketing reports: Angioedema, myocarditis, pericardial effusion, pericarditis

Other

Very common (10% or more): Pain (in various parts of the body; up to 14%)
Common (1% to 10%): Asthenia (up to 7%), fever (up to 6%), chills (3%), peripheral edema (3%), fatigue (up to 3%), ear disorder (2% or greater), infection (2% or greater), malaise (2%)
Frequency not reported: Pyrexia, pharyngolaryngeal pain, ear pain, ear congestion
Postmarketing reports: Lupus-like syndrome, drug fever, neck pain, facial edema, edema

Dermatologic

Common (1% to 10%): Rash (up to 7%), sweating (up to 3%), pruritus (up to 3%), alopecia (less than 3%), acne (up to 2%)
Rare (less than 0.1%): Lupus erythematosus-like reactions, prurigo, eczema, lichen planus, nail disorder, photosensitivity, folliculitis
Postmarketing reports: Psoriasis, alopecia, pyoderma gangrenosum, dry skin, erythema nodosum, urticaria

Hematologic

Common (1% to 10%): Decreased hematocrit and hemoglobin (less than 3%)
Rare (less than 0.1%): Agranulocytosis, aplastic anemia
Frequency not reported: Neutropenia, pancytopenia, ecchymosis, thrombocythemia, decreased platelet count
Postmarketing reports: Granulocytopenia, agranulocytosis, aplastic anemia, thrombocytopenia, eosinophilia, leukopenia, anemia, lymphadenopathy

Hypersensitivity

A male patient with ulcerative colitis experienced pruriginous rash coincident with mesalamine (the active ingredient contained in Canasa) therapy. He experienced the cutaneous hypersensitivity reaction 48 hours after initiating therapy with mesalamine 500 mg orally every 8 hours. After mesalamine was suspended and antihistamines were given, the patient recovered. Upon reintroduction of mesalamine, the symptoms appeared again 24 hours later.

Common (1% to 10%): Rash and pruritus (greater than 2%); arthralgias, myalgias, and fever (greater than 1%)
Uncommon (0.1% to 1%): Allergic reactions (which could involve eosinophilia), hepatitis, interstitial pneumonitis, pericarditis
Rare (less than 0.1%): Hypersensitivity reactions (such as hypersensitivity pneumonitis, angioedema, erythroderma, toxic epidermal necrolysis, palmar-plantar erythrodysesthesia, hypereosinophilia), pruriginous rash (at least 2 cases)
Frequency not reported: Mesalamine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis)

Hepatic

Common (1% to 10%): Cholestatic hepatitis (less than 3%), elevated transaminases (less than 3%), abnormal liver function test (up to 2.3%)
Rare (less than 0.1%): Granulomatous hepatitis (at least 1 case)
Frequency not reported: Hepatitis (presenting with rash, fever, abdominal pain, nausea, vomiting, chills, dizziness, hepatomegaly, lymphadenopathy, and laboratory abnormalities [including elevated liver function tests, eosinophilia, and leukocytosis]), hepatic impairment, jaundice, cholestatic jaundice, cirrhosis, liver necrosis, liver failure, Kawasaki-like syndrome (including changes in liver enzymes), transient elevations in liver function tests, hypersensitivity hepatitis, hepatic failure
Postmarketing reports: Elevated AST (SGOT) or ALT (SGPT), elevated gamma-glutamyltransferase, elevated bilirubin, hepatitis, jaundice, cholecystitis, cholestatic jaundice, liver necrosis, liver failure, Kawasaki-like syndrome (including changes in liver enzymes)

A 42-year-old male with ulcerative colitis was admitted for investigation of prolonged fever associated with cholestatic liver tests. Endoscopic retrograde cholangiopancreatography demonstrated a normal biliary tree, and liver biopsy showed granulomata. The symptoms disappeared after cessation of mesalamine therapy and recurred on rechallenge.

Hypersensitivity hepatitis associated with mesalamine appears to occur less commonly than with sulfasalazine.

Hepatic failure has been reported in patients with preexisting liver disease.

Renal

Renal impairment (including minimal change nephropathy, acute and chronic interstitial nephritis, and, rarely, renal failure) has been reported with products that contain mesalamine (the active ingredient contained in Canasa) or are converted to mesalamine.

Renal tubular dysfunction has been reported, although a definitive causality has not been established.

Common (1% to 10%): Decreased creatinine clearance (less than 3%)
Frequency not reported: Nephrogenic diabetes insipidus, nephrotic syndrome, renal impairment, renal tubular dysfunction
Postmarketing reports: Renal failure, interstitial nephritis, minimal change nephropathy, elevated blood urea nitrogen, elevated serum creatinine

Genitourinary

Common (1% to 10%): Dysmenorrhea (3%), hematuria (less than 3%), urinary frequency (2% or greater)
Rare (less than 0.1%): Oligospermia, infertility in men
Frequency not reported: Albuminuria, amenorrhea, breast pain, hypomenorrhea, metrorrhagia, urinary burning
Postmarketing reports: Dysuria, urinary urgency, hematuria, epididymitis, menorrhagia, reversible oligospermia

Rarely, oligospermia and infertility in men have been reported and have been attributed to sulfasalazine.

Psychiatric

Common (1% to 10%): Anxiety (2% or greater), nervousness (2% or greater)
Frequency not reported: Lethargy, mild disorientation, decreased libido
Postmarketing reports: Depression, emotional lability, confusion

Metabolic

Common (1% to 10%): Elevated triglycerides (less than 3%)
Postmarketing reports: Anorexia, increased appetite, elevated alkaline phosphatase, elevated lactate dehydrogenase

Ocular

Common (1% to 10%): Vision abnormalities (2% or greater), conjunctivitis (up to 2%)
Postmarketing reports: Eye pain, blurred vision

Local

Rectal suspension enemas:
Common (1% to 10%): Pain on insertion of enema tip (1.35%), hemorrhoids (1.35%), rectal pain (1.23%)
Uncommon (0.1% to 1%): Rectal pain/soreness/burning (0.61%)
Frequency not reported: Perianal irritation

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