Apriso Side Effects Center

Last updated on RxList: 11/12/2021
Apriso Side Effects Center

What Is Apriso?

Apriso (mesalamine extended-release capsules) is an aminosalicylate anti-inflammatory drug used to treat ulcerative colitis, proctitis, and proctosigmoiditis. Apriso is also used to prevent the symptoms of ulcerative colitis from recurring.

What Are Side Effects of Apriso?

Common side effects of Apriso include:

Tell your doctor if you have serious side effects of Apriso including:

  • changes in the amount of urine,
  • dark urine,
  • persistent nausea or vomiting,
  • severe stomach or abdominal pain or cramping,
  • yellowing eyes or skin (jaundice),
  • chest pain,
  • shortness of breath, or
  • bloody diarrhea.

Dosage for Apriso

The recommended dose for maintenance of remission of ulcerative colitis in adult patients is 1.5 g (four Apriso capsules) orally once daily in the morning.

What Drugs, Substances, or Supplements Interact with Apriso?

Apriso may interact with azathioprine, mercaptopurine, pentamidine, tacrolimus, amphotericin B, antibiotics, antiviral medicines, cancer medicines, aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs). Tell your doctor all medications and supplements you use.

Apriso During Pregnancy or Breastfeeding

During pregnancy, Apriso should be used only when prescribed. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Additional Information

Our Apriso (mesalamine extended-release capsules) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Apriso Consumer Information

Get emergency medical help if you have signs of an allergic reaction: 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, stomach cramping, bloody diarrhea;
  • fever, headache, general ill feeling;
  • rash, itching, eye redness;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • low white blood cell counts--fever, chills, mouth sores, skin sores, sore throat, cough, feeling light-headed, trouble breathing;
  • signs of a kidney stone--severe pain in your side and back, frequent need to urinate, foul-smelling urine, dark or cloudy urine;
  • kidney problems--increased or decreased urination, swelling, weight gain; or
  • liver problems--loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Low white blood cell counts may be more likely in older adults.

Common side effects may include:

  • burping, constipation, nausea, vomiting, stomach pain, diarrhea, gas;
  • dizziness;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • back pain;
  • headache;
  • rash; or
  • abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Apriso (Mesalamine Extended-Release Capsules)

QUESTION

Ulcerative colitis affects the colon. The colon is also referred to as the... See Answer
Apriso Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in labeling:

  • Renal Impairment [see WARNINGS AND PRECAUTIONS]
  • Mesalamine-Induced Acute Intolerance Syndrome [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Hepatic Failure [see WARNINGS AND PRECAUTIONS]
  • Severe Cutaneous Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Photosensitivity [see WARNINGS AND PRECAUTIONS]
  • Nephrolithiasis [see WARNINGS AND PRECAUTIONS]
  • Risks in Patients with Phenylketonuria [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical studies 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 data described below reflect exposure to APRISO in 557 patients, including 354 exposed for at least 6 months and 250 exposed for greater than one year. APRISO was studied in two placebo-controlled trials (n=367 treated with APRISO) and in one open-label, long-term study (n=190 additional patients). The population consisted of patients with ulcerative colitis; the mean age was 47 years, 54% were female, and 93% were white. Patients received doses of APRISO 1.5 g administered orally once per day for six months in the placebo-controlled trials and for up to 24 months in the open-label study.

In the two placebo-controlled trials, the most common reactions reported in at least 3% of APRISO-treated patients and at a greater rate than placebo are shown in Table 1 below.

Table 1: Common Adverse Reactions* in Clinical Trials of Adults with Ulcerative Colitis

APRISO
1.5 g once daily
N=367
Placebo
N=185
Headache 11% 8%
Diarrhea 8% 7%
Upper Abdominal Pain 5% 3%
Nausea 4% 3%
Nasopharyngitis 4% 3%
* Reported in at least 3% of APRISO-treated patients and at a greater rate than with placebo

The following adverse reactions, presented by body system, were reported at a frequency less than 3% in patients treated with APRISO for up to 24 months in controlled and open-label trials.

Ear and Labyrinth Disorders: tinnitus, vertigo

Dermatological Disorder: alopecia

Gastrointestinal: lower abdominal pain, rectal hemorrhage

Laboratory Abnormalities: increased triglycerides, decreased hematocrit and hemoglobin

General Disorders and Administration Site Disorders: fatigue

Hepatic: hepatitis cholestatic, transaminases increased

Renal Disorders: creatinine clearance decreased, hematuria

Musculoskeletal: pain, arthralgia

Respiratory: dyspnea

Postmarketing Experience

The following adverse reactions have been identified during post approval use of APRISO or other mesalaminecontaining products. Because many of these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole: lupus-like syndrome, drug fever

Cardiovascular: pericarditis, pericardial effusion, myocarditis [see WARNINGS AND PRECAUTIONS]

Gastrointestinal: pancreatitis, cholecystitis, gastritis, gastroenteritis, gastrointestinal bleeding, perforated peptic ulcer

Hepatic: jaundice, cholestatic jaundice, hepatitis, liver necrosis, liver failure, Kawasaki-like syndrome including changes in liver enzymes

Hematologic: agranulocytosis, aplastic anemia

Nervous System: intracranial hypertension

Neurological/Psychiatric: peripheral neuropathy, Guillain-Barré syndrome, transverse myelitis

Renal and Urinary: nephrogenic diabetes insipidus, interstitial nephritis, renal failure, minimal change disease, nephrolithiasis [see WARNINGS AND PRECAUTIONS]

Respiratory/Pulmonary: eosinophilic pneumonia, interstitial pneumonitis, pleurisy/pleuritis

Skin: psoriasis, pyoderma gangrenosum, erythema nodosum, SJS/TEN, DRESS, and AGEP [see WARNINGS AND PRECAUTIONS]

Renal/Urogenital: reversible oligospermia

DRUG INTERACTIONS

Antacids

Because the dissolution of the coating of the granules in APRISO capsules depends on pH, avoid co-administration of APRISO capsules with antacids [see DOSAGE AND ADMINISTRATION].

Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs

The concurrent use of mesalamine with known nephrotoxic agents, including non-steroidal 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].

Azathioprine Or 6-Mercaptopurine

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 APRISO and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts.

Interference With Urinary Normetanephrine Measurements

Use of APRISO may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection [see WARNINGS AND PRECAUTIONS]. Consider an alternative, selective assay for normetanephrine.

Read the entire FDA prescribing information for Apriso (Mesalamine Extended-Release Capsules)

© Apriso Patient Information is supplied by Cerner Multum, Inc. and Apriso Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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