Rowasa
SIDE 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 Rowasa (mesalamine rectal suspension enema) Side Effects Center for a complete guide to possible side effects »
DRUG INTERACTIONS
No information provided.
Last reviewed on RxList: 7/24/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Rowasa Information
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