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
Vagifem Side Effects, and Drug Interactions - Estradiol
Vagifem Side Effects, and Drug Interactions - Estradiol
SIDE EFFECTS
Adverse events generally have been mild: vaginal spotting, vaginal discharge,
allergic reaction and skin rash. Adverse events with an incidence of 5% or greater
are reported for two comparative trials. Data for patients receiving either
VAGIFEM or placebo in the double blind study are listed in Table 5, and data
for patients receiving VAGIFEM in the open label comparator study are listed
in Table 6.
Table 5:
ADVERSE EVENTS REPORTED
IN 5% OR GREATER NUMBER
OF PATIENTS RECEIVING
VAGIFEM® IN THE PLACEBO
CONTROLLED TRIAL.
|
|
VAGIFEM |
Placebo |
|
|
(n=91) |
(n=47) |
|
ADVERSE EVENT
|
% |
% |
|
HEADACHE
|
9 |
6 |
|
ABDOMINAL PAIN
|
7 |
4 |
|
UPPER RESPIRATORY TRACT INFECTION
|
5 |
4 |
|
MONILIASIS GENITAL
|
5 |
2 |
|
BACK PAIN
|
7 |
6 |
Table 6:
ADVERSE EVENTS REPORTED
IN 5% OR GREATER NUMBER
OF PATIENTS RECEIVING
VAGIFEM® IN THE OPEN
LABEL STUDY.
| |
VAGIFEM |
| |
(n=80) |
|
ADVERSE EVENT
|
% |
|
PRURITUS GENITAL
|
6 |
|
HEADACHE
|
10 |
|
UPPER RESPIRATORY TRACT INFECTION
|
11 |
Other adverse events that occurred in 3-5% of VAGIFEM subjects included: allergy,
bronchitis, dyspepsia, haematuria, hot flashes, insomnia, pain, sinusitis, vaginal
discomfort, vaginitis. A causal relationship to VAGIFEM has not been established.
DRUG INTERACTIONS
No Information Provided.
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