SIDE EFFECTS
Clinical Adverse Experience
ROWASA® Rectal Suspension Enema is usually well tolerated.
Most adverse effects have been mild and transient.
SIDE EFFECTS
OCCURRING IN MORE THAN 0.1% OF ROWASA® RECTAL
SUSPENSION ENEMA TREATED PATIENTS
(COMPARISON TO PLACEBO)
| SYMPTOM
|
ROWASA®
(N= 815)
N
|
%
|
PLACEBO
(N= 128)
N
|
%
|
| Abdominal
Pain/ Cramps/ Discomfort |
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
|
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
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 associated
with ROWASA® Rectal Suspension Enema and other mesalamine
containing products: 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.
Hair Loss
Mild hair loss characterized by “more hair in the
comb” but no withdrawal from clinical trials has been
observed in seven 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.
| 
