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Apriso

Last reviewed on RxList: 8/7/2017
Apriso Side Effects Center

Last reviewed on RxList 8/7/2017

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. 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.

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. 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. 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.

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.

Apriso Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking mesalamine and call your doctor at once if you have a serious side effect such as:

  • severe stomach pain, cramping, fever, headache, and bloody diarrhea.

Less serious side effects may include:

  • mild nausea, vomiting, stomach cramps, diarrhea, gas;
  • fever, sore throat, or other flu symptoms;
  • constipation;
  • headache or dizziness;
  • tired feeling; or
  • skin rash.

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)

Apriso Professional Information

SIDE EFFECTS

Clinical Studies Experience

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 placebocontrolled 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 openlabel study.

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.

In the two placebo-controlled trials, 59% of APRISO-treated patients experienced an adverse reaction compared with 64% of placebo patients. Most adverse reactions with APRISO were mild or moderate in severity. Severe adverse reactions occurred in 6% of APRISO-treated patients and 5% of placebotreated patients. Discontinuations due to adverse reactions occurred in 11% of APRISO-treated patients and 17% of placebo-treated patients; the most common adverse reaction resulting in study discontinuation was recurrence of ulcerative colitis (APRISO 6%, placebo 14%). The most common reactions reported with APRISO (≥ 3%) are shown in Table 1 below.

Table 1: Treatment-Emergent Adverse Reactions during Clinical Trials Occurring in at Least 3% of APRISO-Treated Patients and at a Greater Rate than with Placebo

MedDRA Preferred T erm APRISO 1.5 g/day
N=367
Placebo
N=185
Headache 11% 8%
Diarrhea 8% 7%
Abdominal Pain Upper 5% 3%
Nausea 4% 3%
Nasopharyngitis 4% 3%
Influenza & Influenza-like illness 4% 4%
Sinusitis 3% 3%

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: abdominal pain lower, 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

Adverse Reaction Information From Other Sources

The following adverse reactions have been identified during clinical trials of a product similar to APRISO and post approval use of other mesalamine-containing products such as APRISO. 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

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-Barr´┐Ż syndrome, transverse myelitis

Renal and Urinary: nephrogenic diabetes insipidus

Respiratory/Pulmonary: eosinophilic pneumonia, interstitial pneumonitis

Skin: psoriasis, pyoderma gangrenosum, erythema nodosum

Renal/Urogenital: reversible oligospermia

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

Related Resources for Apriso

Read the Apriso User Reviews »

© 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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