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Pentasa

Pentasa (Mesalamine) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Pentasa Side Effects Center

What Is Pentasa?

Pentasa (mesalamine) is an anti-inflammatory agent used to treat ulcerative colitis, proctitis, and proctosigmoiditis. Pentasa is also used to prevent the symptoms of ulcerative colitis from recurring.

What Are Side Effects of Pentasa?

Common side effects of Pentasa include:

Infrequently, Pentasa can worsen ulcerative colitis. Tell your doctor if your symptoms worsen after starting Pentasa (such as increased abdominal pain or cramping, bloody diarrhea, and fever). Tell your doctor if you have serious side effects of Pentasa including:

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

NONSTEROIDAL

Dosage for Pentasa

The recommended dosage of Pentasa for the induction of remission and the symptomatic treatment of mildly to moderately active ulcerative colitis is 1g (four 250 mg capsules or two 500 mg capsules) 4 times a day for a total daily dosage of 4g. Treatment duration may be up to 8 weeks.

What Drugs, Substances, or Supplements Interact with Pentasa?

Pazathioprine or mercaptopurine, pentamidine, tacrolimus, amphotericin B, antibiotics, antiviral medicines, cancer medicine, or aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs). Tell your doctor all medications you are taking.

Pentasa During Pregnancy and Breastfeeding

During pregnancy, Pentasa 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 Pentasa (mesalamine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Pentasa 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 Pentasa (Mesalamine)

 

Pentasa Professional Information

SIDE EFFECTS

In combined domestic and foreign clinical trials, more than 2100 patients with ulcerative colitis or Crohn’s disease received PENTASA therapy. Generally, PENTASA therapy was well tolerated. The most common events (i.e., greater than or equal to 1%) were diarrhea (3.4%), headache (2.0%), nausea (1.8%), abdominal pain (1.7%), dyspepsia (1.6%), vomiting (1.5%), and rash (1.0%).

In two domestic placebo-controlled trials involving over 600 patients with ulcerative colitis, adverse events were fewer in PENTASA (mesalamine)-treated patients than in the placebo group (PENTASA 14% vs placebo 18%) and were not dose-related. Events occurring in more than 1% are shown in the table below. Of these, only nausea and vomiting were more frequent in the PENTASA group. Withdrawal from therapy due to adverse events was more common on placebo than PENTASA (7% vs 4%).

Table 1. Adverse Events Occurring in More than 1% of Either Placebo or PENTASA Patients in Domestic Placebo-controlled Ulcerative Colitis Trials. (PENTASA Comparison to Placebo)

Event PENTASA
n=451		 Placebo
n=173
Diarrhea 16 (3.5%) 13 (7.5%)
Headache 10 (2.2%) 6 (3.5%)
Nausea 14 (3.1%) -
Abdominal Pain 5 (1.1%) 7 (4.0%)
Melena (Bloody Diarrhea) 4 (0.9%) 6 (3.5%)
Rash 6 (1.3%) 2 (1.2%)
Anorexia 5 (1.1%) 2 (1.2%)
Fever 4 (0.9%) 2 (1.2%)
Rectal Urgency 1 (0.2%) 4 (2.3%)
Nausea and Vomiting 5 (1.1%) -
Worsening of Ulcerative Colitis 2 (0.4%) 2 (1.2%)
Acne 1 (0.2%) 2 (1.2%)

Clinical laboratory measurements showed no significant abnormal trends for any test, including measurement of hematological, liver, and kidney function.

The following adverse events, presented by body system, were reported infrequently (i.e., less than 1%) during domestic ulcerative colitis and Crohn’s disease trials. In many cases, the relationship to PENTASA has not been established.

Gastrointestinal: abdominal distention, anorexia, constipation, duodenal ulcer, dysphagia, eructation, esophageal ulcer, fecal incontinence, GGTP increase, GI bleeding, increased alkaline phosphatase, LDH increase, mouth ulcer, oral moniliasis, pancreatitis, rectal bleeding, SGOT increase, SGPT increase, stool abnormalities (color or texture change), thirst

Dermatological: acne, alopecia, dry skin, eczema, erythema nodosum, nail disorder, photosensitivity, pruritus, sweating, urticaria

Nervous System: depression, dizziness, insomnia, somnolence, paresthesia

Cardiovascular: palpitations, pericarditis, vasodilation

Other: albuminuria, amenorrhea, amylase increase, arthralgia, asthenia, breast pain, conjunctivitis, ecchymosis, edema, fever, hematuria, hypomenorrhea, Kawasaki-like syndrome, leg cramps, lichen planus, lipase increase, malaise, menorrhagia, metrorrhagia, myalgia, pulmonary infiltrates, thrombocythemia, thrombocytopenia, urinary frequency

One week after completion of an 8-week ulcerative colitis study, a 72-year-old male, with no previous history of pulmonary problems, developed dyspnea. The patient was subsequently diagnosed with interstitial pulmonary fibrosis without eosinophilia by one physician and bronchiolitis obliterans with organizing pneumonitis by a second physician. A causal relationship between this event and mesalamine therapy has not been established.

Published case reports and/or spontaneous postmarketing surveillance have described infrequent instances of pericarditis, fatal myocarditis, chest pain and T-wave abnormalities, hypersensitivity pneumonitis, pancreatitis, nephrotic syndrome, interstitial nephritis, hepatitis, aplastic anemia, pancytopenia, leukopenia, agranulocytosis, or anemia while receiving mesalamine therapy. Anemia can be a part of the clinical presentation of inflammatory bowel disease. Allergic reactions, which could involve eosinophilia, can be seen in connection with PENTASA therapy.

Postmarketing Reports

The following events have been identified during post-approval use of the PENTASA brand of mesalamine in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of seriousness, frequency of reporting, or potential causal connection to mesalamine:

Gastrointestinal: Reports of hepatotoxicity, including elevated liver enzymes (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), hepatitis, jaundice, cholestatic jaundice, cirrhosis, and possible hepatocellular damage including liver necrosis and liver failure. Some of these cases were fatal. One case of Kawasaki-like syndrome which included hepatic function changes was also reported.

Other: anaphylactic reaction, SJS/TEN, DRESS, AGEP, pleurisy/pleuritis, pneumonitis, granulocytopenia, systemic lupus erythematosus, lupus-like syndrome, acute renal failure, interstitial lung disease, hypersensitivity pneumonitis (including interstitial pneumonitis, allergic alveolitis, eosinophilic pneumonitis), chronic renal failure, nephrogenic diabetes insipidus, nephrolithiasis, intracranial hypertension, angioedema, and oligospermia (reversible).

DRUG INTERACTIONS

No investigations of interactions between PENTASA and other drugs have been performed; however, the following drug-drug interactions have been reported for products containing mesalamine:

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.

Azathioprine Or 6-Mercaptopurine

The concurrent use of mesalamine with azathioprine or 6-mercaptopurine and/or any other drugs known to cause myelotoxicity may increase the risk for blood disorders, bone marrow failure, and associated complications. If concomitant use of PENTASA and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts.

Read the entire FDA prescribing information for Pentasa (Mesalamine)

&Copy; Pentasa Patient Information is supplied by Cerner Multum, Inc. and Pentasa Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.