Medical Editor: John P. Cunha, DO, FACOEP
What Is Rowasa?
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.
What Are Side Effects of Rowasa?
Common side effects of Rowasa include:
- rectal pain,
- pain while inserting the bottle tip,
- gas,
- joint or leg pain,
- nausea,
- vomiting,
- stomach cramps,
- diarrhea,
- fever,
- sore throat,
- flu symptoms,
- constipation,
- headache,
- dizziness,
- 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.
Dosage for Rowasa
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.
What Drugs, Substances, or Supplements Interact with Rowasa?
Other drugs may interact with Rowasa rectal. Tell your doctor all prescription and over-the-counter medications and supplements you use.
Rowasa During Pregnancy or Breastfeeding
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.
Additional Information
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.
QUESTION
Ulcerative colitis affects the colon. The colon is also referred to as the... See AnswerGet emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using mesalamine and call your doctor at once if you have:
- severe stomach pain, cramping, bloody diarrhea;
- fever, headache, general ill feeling;
- rash, itching, eye redness;
- 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; or
- kidney problems--increased or decreased urination, swelling, weight gain.
Low white blood cell counts may be more likely in older adults.
Common side effects may include:
- fever;
- dizziness;
- rectal pain, colitis;
- rash; or
- acne.
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 Rowasa (Mesalamine Rectal Suspension Enema)
SLIDESHOW
Inflammatory Bowel Disease (IBD) Causes, Symptoms, Treatment See SlideshowSIDE EFFECTS
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)
| SYMPTOM | ROWASA® N = 815 |
PLACEBO N = 128 |
||
| N | % | N | % | |
| Abdominal | 66 | 8.10 | 10 | 7.81 |
| Pain/Cramps/Discomfort | ||||
| Headache | 53 | 6.50 | 16 | 12.50 |
| Gas/Flatulence | 50 | 6.13 | 5 | 3.91 |
| Nausea | 47 | 5.77 | 12 | 9.38 |
| Flu | 43 | 5.28 | 1 | 0.78 |
| Tired/Weak/Malaise/Fatigue | 28 | 3.44 | 8 | 6.25 |
| Fever | 26 | 3.19 | 0 | 0.00 |
| Rash/Spots | 23 | 2.82 | 4 | 3.12 |
| Cold/Sore Throat | 19 | 2.33 | 9 | 7.03 |
| Diarrhea | 17 | 2.09 | 5 | 3.91 |
| Leg/Joint Pain | 17 | 2.09 | 1 | 0.78 |
| Dizziness | 15 | 1.84 | 3 | 2.34 |
| Bloating | 12 | 1.47 | 2 | 1.56 |
| Back Pain | 11 | 1.35 | 1 | 0.78 |
| Pain on Insertion of Enema | 11 | 1.35 | 1 | 0.78 |
| Tip | ||||
| Hemorrhoids | 11 | 1.35 | 0 | 0.00 |
| Itching | 10 | 1.23 | 1 | 0.78 |
| Rectal Pain | 10 | 1.23 | 0 | 0.00 |
| Constipation | 8 | 0.98 | 4 | 3.12 |
| Hair Loss | 7 | 0.86 | 0 | 0.00 |
| Peripheral Edema | 5 | 0.61 | 11 | 8.59 |
| UTI/Urinary Burning | 5 | 0.61 | 4 | 3.12 |
| Rectal | 5 | 0.61 | 3 | 2.34 |
| Pain/Soreness/Burning | ||||
| Asthenia | 1 | 0.12 | 4 | 3.12 |
| Insomnia | 1 | 0.12 | 3 | 2.34 |
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, elevated liver enzymes, nephrogenic diabetes insipidus, intracranial hypertension and nephrolithiasis. 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.
Postmarketing cases of severe cutaneous adverse reactions (SJS/TEN, DRESS, and AGEP) and pleurisy/pleuritis have been reported.
Hair Loss
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.
DRUG INTERACTIONS
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 ROWASA and azathioprine or 6mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts.
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.
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