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Rowasa

Side Effects & Drug Interactions
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SIDE EFFECTS

Clinical Adverse Experience

ROWASAÒ (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 ROWASAÒ (MESALAMINE) RECTAL SUSPENSION ENEMA TREATED PATIENTS (COMPARISON TO PLACEBO)

ROWASAÒ
N=815
N
%
PLACEBO
N=128
N
%
Abdominal Pain/Cramps/Discomfort
66
8.10
10
7.81
53
6.50
16
12.50
Gas/Flatulence
50
6.13
5
3.91
47
5.77
12
9.38
43
5.28
1
0.78
Tired/Weak/Malaise/Fatigue
28
3.44
8
6.25
26
3.19
0
0.00
Rash/Spots
23
2.82
4
3.12
Cold/Sore Throat
19
2.33
9
7.03
17
2.09
5
3.91
Leg/Joint Pain
17
2.09
1
0.78
15
1.84
3
2.34
Bloating
12
1.47
2
1.56
11
1.35
1
0.78
Pain on Insertion of Enema Tip
11
1.35
1
0.78
11
1.35
0
0.00
10
1.23
1
0.78
Rectal Pain
10
1.23
0
0.00
8
0.98
4
3.12
7
0.86
0
0.00
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
1
0.12
4
3.12
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.

DRUG INTERACTIONS

No information provided.

Brand Name: Rowasa
Generic Name: Mesalamine Rectal Suspension Enema
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