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

Summary

Common side effects of Apriso include: headache. Continue reading for a comprehensive list of adverse effects.

Applies to mesalamine: oral capsule delayed release, oral capsule extended release, oral tablet delayed release, oral tablet enteric coated. Other dosage forms:

• rectal enema, rectal suppository

Serious side effects of Apriso

Along with its needed effects, mesalamine (the active ingredient contained in Apriso) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking mesalamine:

More common

• Bloody diarrhea
• rectal bleeding
• stomach pain

Less common

• Bloody stools
• bloody urine
• blurred vision
• chest tightness
• chills
• clay-colored stools
• cough
• dark urine
• diarrhea
• difficulty with breathing
• dizziness
• fever
• full or bloated feeling
• general feeling of discomfort or illness
• headache
• itching, skin rash
• joint pain
• loss of appetite
• muscle aches and pains
• nausea
• nervousness
• pain or tenderness around the eyes and cheekbones
• pounding in the ears
• pressure in the stomach
• runny or stuffy nose
• shivering
• slow or fast heartbeat
• sore throat
• stomach cramps
• sweating
• swelling of the stomach area
• trouble sleeping
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting
• vomiting of blood
• yellow eyes or skin

Rare

• Anxiety
• back pain
• blue or pale skin
• chest pain, possibly moving to the left arm, neck, or shoulder

Incidence not known

• Black, tarry stools
• blistering, peeling, or loosening of the skin
• bloating
• change in the ability to see colors, especially blue or yellow
• chest discomfort
• constipation
• decreased frequency or amount of urine
• dry cough
• greatly increased frequency of urination or amount of urine
• hives or welts
• hoarseness
• inability to move the arms and legs
• increased thirst
• indigestion
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• light-colored stools
• lower back or side pain
• muscle weakness, sudden and progressing
• pain in the ankles or knees
• painful or difficult urination
• painful, red lumps under the skin, mostly on the legs
• rapid breathing
• red, irritated eyes
• red skin lesions, often with a purple center
• severe nausea or vomiting
• sores, ulcers, or white spots in the mouth or on the lips
• stomach tenderness
• sudden numbness and weakness in the arms and legs
• swelling of the feet or lower legs
• swollen or painful glands
• thickening of bronchial secretions
• unusual bleeding or bruising
• weight gain

Other side effects of Apriso

Some side effects of mesalamine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Sneezing

Less common

• Acne
• belching
• continuing ringing or buzzing or other unexplained noise in the ears
• difficulty with moving
• dizziness or lightheadedness
• excess air or gas in the stomach or bowels
• feeling of constant movement of self or surroundings
• hair loss or thinning of the hair
• hearing loss
• heartburn
• muscle stiffness
• passing gas
• sensation of spinning
• stomach discomfort or upset

Incidence not known

• Burning, numbness, tingling, or painful sensations
• unsteadiness or awkwardness
• weakness in the arms, hands, legs, or feet

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]