A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Elmiron Side Effects, and Drug Interactions - Pentosan
Elmiron Side Effects, and Drug Interactions - Pentosan
SIDE EFFECTS
Elmiron®was evaluated in clinical
trials in a total of 2627 patients (2343 women, 262 men, 22 unknown)
with a mean age
of 47 [range 18 to 88 with 581 (22%) over 60 years of age]. Of the
2627 patients, 128 patients were in a 3 month trial and the remaining
2499 patients were in a long term, unblinded trial.
Deaths occurred in 6/2627 (0.2%) patients who received the drug
over a period of 3 to
75 months. The deaths appear to be related to other concurrent illnesses
or procedures, except in one patient
for whom the cause was
not known.
Serious adverse events occurred in 33/2627 (1.3%) patients. Two
patients had severe abdominal
pain or diarrhea
and dehydration
that required hospitalization. Because there was not a control
group of patients with
interstitial cystitis
who were concurrently evaluated, it is difficult to determine which
events are associated with Elmiron® and which events
are associated with concurrent illness, medicine, or other factors.
Adverse Experience
In Placebo-Controlled
Clinical Trials of Elmiron® 100 mg
Three Times a Day for 3 Months |
Body System/
Adverse Experience |
Elmiron®
n=128 |
Placebo
n=130 |
CNS
Overall Number of Patients*
|
3 |
5 |
Insomnia
Headache
Severe Emotional Lability/Depression
Nystagmus/Dizziness
Hyperkinesia |
1
1
2
1
1 |
0
3
1
1
1 |
GI
Overall Number of Patients* |
7 |
7 |
Nausea
Diarrhea
Dyspepsia
Jaundice
Vomiting |
3
3
1
0
0 |
3
6
0
1
2 |
Skin / Allergic
Overall Number of Patients* |
2 |
4 |
Rash
Pruritus
Lacrimation
Rhinitis
Increased Sweating |
0
0
1
1
1 |
2
2
1
1
0 |
Other
Overall Number of Patients* |
1 |
3 |
Amenorrhea
Arthralgia
Vaginitis |
0
0
1 |
1
1
1 |
| Total Events |
17 |
27 |
Total Number of Patients
Reporting Adverse Events |
13 |
19 |
* Within a body system,
the individual events do not sum to equal overall number of patients
because a patient may
have more than one event.
The adverse events described below were reported in an unblinded
clinical trial of 2499 interstitial
cystitis patients treated
with Elmiron®. Of the original 2499 patients, 1192
(48%) received Elmiron® for 3 months; 892 (36%) received
Elmiron® for 6 months; and 598 (24%) received Elmiron®
for one year, 355 (14%) received Elmiron® for 2 years,
and 145 (6%) for 4 years.
Frequency (1 to 4%): Alopecia (4%), diarrhea
(4%), nausea (4%), headache
(3%), rash (3%), dyspepsia
(2%), abdominal pain
(2%), liver function
abnormalities (1%), dizziness
(1%).
Frequency (£ 1%):
Digestive: Vomiting, mouth
ulcer, colitis,
esophagitis, gastritis,
flatulence, constipation,
anorexia, gum
hemorrhage.
Hematologic: Anemia, ecchymosis,
increased prothrombin
time, increased partial thromboplastin
time, leukopenia,
thrombocytopenia.
Hypersensitive Reactions: Allergic reaction,
photosensitivity.
Respiratory System: Pharyngitis, rhinitis,
epistaxis, dyspnea.
Skin and Appendages: Pruritus, urticaria.
Special Senses: Conjunctivitis, tinnitus,
optic neuritis,
amblyopia, retinal hemorrhage.
DRUG INTERACTIONS
Drug-Drug Interactions: Not studied.
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