Canasa Pac Side Effects

Generic Name: mesalamine

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

Not all side effects for Canasa Pac may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

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

In addition to its needed effects, some unwanted effects may be caused by mesalamine (the active ingredient contained in Canasa Pac). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking mesalamine:

More common
  • Abdominal or stomach pain (severe)
  • bloody diarrhea
  • rectal bleeding
Less common
  • Abdominal or stomach cramps (severe)
  • blurred vision
  • dizziness
  • fever
  • full or bloated feeling
  • headache (severe)
  • nervousness
  • pounding in the ears
  • pressure in the stomach
  • skin rash and itching
  • slow or fast heartbeat
  • swelling of the abdominal or stomach area
  • unusual tiredness or weakness
Rare
  • Anxiety
  • back pain (severe)
  • blue or pale skin
  • chest pain, possibly moving to the left arm, neck, or shoulder
  • chills
  • nausea or vomiting
  • yellow eyes or skin

Some of the side effects that can occur with mesalamine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Abdominal or stomach cramps or pain (mild)
  • diarrhea (mild)
  • headache (mild)
  • runny or stuffy nose
  • sneezing
Less common
  • Acid or sour stomach
  • acne
  • back or joint pain
  • belching
  • difficulty with moving
  • excess air or gas in the stomach or intestines
  • hair loss or thinning of the hair
  • heartburn
  • indigestion
  • loss of appetite
  • muscle pain or stiffness
  • passing gas
  • stomach discomfort or upset

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

General

The most common adverse events were headache, eructation, and aggravation of ulcerative colitis.[Ref]

Gastrointestinal

Very common (10% or more): Eructation (up to 16%), ulcerative colitis aggravated (up to 15%)
Common (1% to 10%): Abdominal pain/cramps/discomfort, diarrhea, flatulence, nausea, gastroenteritis, gastrointestinal hemorrhage, rectal disorder, stool abnormalities (color or texture change), urinary frequency, dyspepsia, vomiting, bloating, rectal distension, pain on insertion of tip (enema formulation), hemorrhoids, rectal pain, colitis, constipation, abdominal distension
Uncommon (0.1% to 1%): Acute pancreatitis, melena (bloody diarrhea), rectal pain/soreness/burning, pancolitis, neonate diarrhea, anal discomfort, defecation urgency, colitis ulcer (proctitis ulcer), glossitis, rectal polyp, pancreatitis, application site irritation (rectal foam formulation), painful rectal tenesmus, rectal urgency
Rare (less than 0.1%): Increased amylase
Frequency not reported: Duodenal ulcer, dysphagia, esophageal ulcer, fecal incontinence, GI bleeding, mouth ulcer, oral candidiasis, rectal bleeding, rectal polyp, mild indigestion and cramping, bloody diarrhea, stomatitis, abdominal enlargement, lipase increase
Postmarketing reports: Frequent bowel movements, mucus stools, painful defecation, proctalgia, rectal discharge, stomach discomfort, gastritis, dry mouth, oral ulcers, perforated peptic ulcer, amylase increased[Ref]

Nervous system

Very common (10% or more): Headache (up to 24%)
Common (1% to 10%): Dizziness
Uncommon (0.1% to 1%): Paresthesia, peripheral neuropathy, somnolence, tremor,
Very rare (less than 0.01%): Vertigo
Frequency not reported: Neuropathy, mild disorientation
Postmarketing reports: Guillain-Barre syndrome, hypertonia, transverse myelitis, hyperesthesia, taste perversion, tinnitus[Ref]

Other

Very common (10% or more): Pain (up to 14%)
Common (1% to 10%): Asthenia, fatigue, pyrexia, infection
Uncommon (0.1% to 1%): Ear pain, peripheral edema
Rare (less than 0.1%): Drug fever
Frequency not reported: Malaise, mesalamine-induced acute intolerance syndrome, plugged ears, adenovirus infection, aching, decreased body mass index,
Postmarketing reports: Medication residue, elevated alkaline phosphatase, elevated GGT, elevated LDH, ear congestion[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (up to 15%)
Common (1% to 10%): Upper respiratory tract infection, influenza like symptoms, rhinitis, cold/sore throat
Uncommon (0.1% to 1%): Allergic and fibrotic lung reactions, dyspnea, cough, bronchospasm, pleural effusion, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis, pharyngolaryngeal pain
Very rare (less than 0.01%): Eosinophilic pneumonia
Frequency not reported: Hypersensitivity pneumonitis (including interstitial pneumonitis, allergic alveolitis, eosinophilic pneumonitis, stuffy head, interstitial pulmonary fibrosis, bronchiolitis obliterans, sinusitis
Postmarketing reports: Fibrosing alveolitis, asthma exacerbation, pleuritis, bronchitis[Ref]

Cardiovascular

Common (1% to 10%): Hypertension, vasodilation,
Uncommon (0.1% to 1%): Pericarditis, myocarditis, pericardial effusion, tachycardia, hypotension
Frequency not reported: Chest pain, T-wave abnormalities, Kawasaki-like syndrome[Ref]

Dermatologic

Common (1% to 10%): Rash, alopecia, urticaria, pruritus, acne
Uncommon (0.1% to 1%): Lupus erythematosus syndrome, allergic exanthema, increased sweating, angioedema, Stevens-Johnson syndrome, face edema
Very rare (less than 0.01%): Reversible alopecia, bullous skin reactions including erythema multiforme
Frequency not reported: Dry skin, eczema, erythema nodosum, nail disorder, photosensitivity, lichen planus, ecchymosis
Postmarketing reports: Prurigo, erythema, psoriasis, pyoderma gangrenosum[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia, leg/joint pain
Uncommon (0.1% to 1%): Myalgia, chills, myositis, arthritis
Frequency not reported: Leg cramps, lower back discomfort, muscle cramps, neck pain
Postmarketing reports: Joint disorder, rheumatoid arthritis[Ref]

Hepatic

Common (1% to 10%): Hepatic function abnormal, increased alanine aminotransferase
Uncommon (0.1% to 1%): Hepatitis, increased liver enzymes (transaminase activity), intrahepatic cholestasis, increased bilirubin
Very rare (less than 0.01%): Hepatotoxicity (including cirrhosis, hepatic failure), changes in liver function parameters
Frequency not reported: GGTP increase, SGOT increase, SGPT increase, sclerosing cholangitis, increased alkaline phosphatase
Postmarketing reports: Jaundice, cholestatic jaundice, liver necrosis, cholecystitis[Ref]

Metabolic

Common (1% to 10%): Anorexia
Frequency not reported: Thirst, edema
Postmarketing reports: Increased appetite, gout[Ref]

Ocular

Common (1% to 10%): Vision abnormalities
Uncommon (0.1% to 1%): Conjunctivitis
Postmarketing reports: Blurred vision, eye pain[Ref]

Renal

Uncommon (0.1% to 1%): Acute or chronic interstitial nephritis, renal insufficiency, renal failure, nephrotoxicity
Very rare (less than 0.01%): Nephrotic syndrome, urine discoloration
Frequency not reported: Creatinine clearance decreased
Postmarketing reports: Minimal change nephropathy, elevated serum creatinine and BUN[Ref]

Hematologic

Uncommon (0.1% to 1%): Thrombocytopenia, aplastic anemia, hemolytic anemia, agranulocytosis, leukopenia, neutropenia, pancytopenia, platelet count decreased
Very rare (less than 0.01%): Eosinophilia (as part of an allergic reaction), anemia, bone marrow depression
Frequency not reported: Thrombocythemia
Postmarketing reports: Granulocytopenia, lymphadenopathy[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reaction, anaphylactic reaction, drug reaction with eosinophilia and systemic symptoms (DRESS)
Frequency not reported: Anaphylactic shock, angioedema[Ref]

Genitourinary

Uncommon (0.1% to 1%): Oligospermia (reversible), UTI/urinary burning
Frequency not reported: Albuminuria, amenorrhea, breast pain, hematuria, hypomenorrhea, menorrhagia, metrorrhagia, urinary frequency
Postmarketing reports: Dysuria, urinary urgency, epididymitis[Ref]

Psychiatric

Uncommon (0.1% to 1%): Insomnia
Frequency not reported: Depression, anxiety, decreased libido
Postmarketing reports: Nervousness, confusion, emotional lability, confusion[Ref]

References

1. "Product Information. Lialda (mesalamine (5-aminosalicylic acid))." Shire US Inc, Florence, KY.

2. "Product Information. Rowasa product information (mesalamine)." Solvay Pharmaceuticals Inc, Marietta, GA.

3. "Product Information. Asacol product information (mesalamine)." Procter and Gamble Pharmaceuticals, Cincinnati, OH.

4. "Product Information. Pentasa Product Information (mesalamine)." Hoechst Marion-Roussel Inc, Kansas City, MO.

5. Cerner Multum, Inc. "Australian Product Information." O 0

6. "Product Information. Delzicol (mesalamine (5-aminosalicylic acid))." Warner Chilcott Laboratories, Rockaway, NJ.

7. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

8. "Product Information. Canasa (mesalamine (5-aminosalicylic acid))." Axcan Scandipharm Inc, Birmingham, AL.

9. "Product Information. Apriso (mesalamine (5-aminosalicylic acid))." Salix Pharmaceuticals, Raleigh, NC.

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