Medical Editor: John P. Cunha, DO, FACOEP
Rowasa (mesalamine) Rectal Suspension Enema is an aminosalicylate anti-inflammatory drug used to treat ulcerative colitis, proctitis, and proctosigmoiditis, and is also used to prevent the symptoms of ulcerative colitis from recurring. Rowasa is available in generic form. Common side effects of Rowasa include:
- rectal pain,
- pain while inserting the bottle tip,
- joint or leg pain,
- stomach cramps,
- sore throat,
- flu symptoms,
- tired feeling, or
- skin rash.
Infrequently, Rowasa may make symptoms of your condition worse rather than better (acute intolerance syndrome or sensitivity reaction). Tell your doctor if you have unlikely but serious side effects of Rowasa including:
- worsening stomach pain or cramping,
- worsening bloody diarrhea,
- fever, or
- severe or prolonged headache.
The usual dosage of Rowasa Rectal Suspension Enema in 60 ml units is one rectal instillation (4 grams) once a day, preferably at bedtime, and retained for approximately eight hours. Other drugs may interact with Rowasa rectal. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Rowasa 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 Rowasa (mesalamine) 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.
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 using mesalamine rectal and call your doctor at once if you have 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;
- rectal pain, constipation;
- headache or dizziness;
- tired feeling; or
- skin rash.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Rowasa (Mesalamine Rectal Suspension Enema)
Clinical Adverse Experience
ROWASA® (mesalamine) Rectal Suspension Enema is usually well tolerated. Most adverse effects have been mild and transient.
ADVERSE REACTIONS OCCURRING IN MORE THAN 0.1% OF ROWASA®
(MESALAMINE) RECTAL SUSPENSION
ENEMA TREATED PATIENTS (COMPARISON TO PLACEBO)
|N =815||N =128|
|Pain on Insertion of Enema Tip||11||1.35||1||0.78|
In addition, the following adverse events have been identified during post approval use of products which contain (or are metabolized to) mesalamine in clinical practice: nephrotoxicity, pancreatitis, fibrosing alveolitis and elevated liver enzymes. Cases of pancreatitis and fibrosing alveolitis have been reported as manifestations of inflammatory bowel disease as well. Published case reports and/or spontaneous post marketing surveillance have described rare instances of aplastic anemia, agranulocytosis, thrombocytopenia, eosinophilia, pancytopenia, neutropenia, oligospermia, and infertility in men. Anemia, leukocytosis, and thrombocytosis can be part of the clinical presentation of inflammatory bowel disease.
Mild hair loss characterized by "more hair in the comb" but no withdrawal from clinical trials has been observed in 7 of 815 mesalamine patients but none of the placebo-treated patients. In the literature there are at least six additional patients with mild hair loss who received either mesalamine or sulfasalazine. Retreatment is not always associated with repeated hair loss.
Read the entire FDA prescribing information for Rowasa (Mesalamine Rectal Suspension Enema)
© Rowasa Patient Information is supplied by Cerner Multum, Inc. and Rowasa Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.