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,
- 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.
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.
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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have severe stomach pain, cramping, and bloody diarrhea (may occur with fever, headache, and skin rash).
Common side effects may include:
- stomach pain, nausea, gas;
- fever, cold or flu symptoms;
- rash; or
- feeling tired.
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)
QUESTION
Ulcerative colitis affects the colon. The colon is also referred to as the... See AnswerSIDE 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)
| ROWASA® | PLACEBO | |||
| N =815 | N =128 | |||
| SYMPTOM | N | % | N | % |
| Abdominal Pain/Cramps/Discomforl | 66 | 8.10 | 10 | 7.81 |
| 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 Tip | 11 | 1.35 | 1 | 0.78 |
| Hemorrhoids | 11 | 1.35 | 0 | 0.00 |
| Itching | 10 | 1.23 | 1 | 0.78 |
| Rectal Pain | 10 | 1.23 | 0 | 0.00 |
| Constipation | 3 | 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 Pain/Soreness/Burning | 5 | 0.61 | 3 | 2.34 |
| 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 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.
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.
Read the entire FDA prescribing information for Rowasa (Mesalamine Rectal Suspension Enema)
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