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
Estrace Side Effects, and Drug Interactions - Estradiol Vaginal Ring
Estrace Side Effects, and Drug Interactions - Estradiol Vaginal Ring
SIDE EFFECTS
The biological safety of the silicone elastomer has been studied in various in vitro and in vivo test models. The results show that the silicone elastomer is non-toxic, non-pyrogenic, non-irritating, and non-sensitizing. Long-term implantation induced encapsulation equal to or less than the negative control (polyethylene) used in the USP test. No toxic reaction or tumor formation was observed with the silicone elastomer.
In general, ESTRING (estradiol vaginal ring) was well tolerated. In the two pivotal controlled studies, discontinuation of treatment due to an adverse event was required by 5.4% of patients receiving ESTRING and 3.9% of patients receiving conjugated estrogens vaginal cream. The most common reasons for withdrawal from ESTRING treatment due to an adverse event were vaginal discomfort and gastrointestinal symptoms.
The adverse events reported with a frequency of 3% or greater in the two pivotal controlled studies by patients receiving ESTRING or conjugated estrogens vaginal cream are listed in Table 2.
|
Table 2: Adverse Events Reported by 3% or More of Patients Receiving Either ESTRING or Conjugated Estrogens Vaginal Cream in Two Pivotal Controlled Studies
|
ADVERSE EVENT |
Estring (n=257) % |
Conjugated Estrogens Vaginal Cream (n=129) % |
Musculoskeletal |
|
|
Back Pain |
6 |
8 |
Arthritis |
4 |
2 |
Arthralgia |
3 |
5 |
Skeletal Pain |
2 |
4 |
CNS/Peripheral Nervous System |
|
|
Headache |
13 |
16 |
Psychiatric |
|
|
Insomnia |
4 |
0 |
Gastrointestinal |
|
|
Abdominal Pain |
4 |
2 |
Nausea |
3 |
2 |
Respiratory |
|
|
Upper Respiratory Tract Infection |
5 |
6 |
Sinusitis |
4 |
3 |
Pharyngitis |
1 |
3 |
Urinary |
|
|
Urinary Tract Infection |
2 |
7 |
Female Reproductive |
|
|
Leukorrhea |
7 |
3 |
Vaginitis |
5 |
2 |
Vaginal Discomfort/Pain |
5 |
5 |
Vaginal Hemorrhage |
4 |
5 |
Asymptomatic Genital Bacterial Growth |
4 |
6 |
Breast Pain |
1 |
7 |
Resistance Mechanisms |
|
|
Genital Moniliasis |
6 |
7 |
Body as a Whole |
|
|
Flu-Like Symptoms |
3 |
2 |
Hot Flushes |
2 |
3 |
Allergy |
1 |
4 |
Miscellaneous |
|
|
Family Stress |
2 |
3 |
Other adverse events (listed alphabetically) occurring at a frequency of 1 to 3% in the two pivotal controlled studies by patients receiving ESTRING include: anxiety, bronchitis, chest pain, cystitis, dermatitis, diarrhea, dyspepsia, dysuria, flatulence, gastritis, genital eruption, genital pruritus, hemorrhoids, leg edema, migraine, otitis media, skin hypertrophy, syncope, toothache, tooth disorder, urinary incontinence.
The following additional adverse events were reported at least once by patients receiving ESTRING in the worldwide clinical program, which includes controlled and uncontrolled studies. A causal relationship with ESTRING has not been established.
Body as a Whole: allergic reaction
CNS/Peripheral Nervous System: dizziness
Gastrointestinal: enlarged abdomen, vomiting
Metabolic/Nutritional Disorders: weight decrease or increase
Psychiatric: depression, decreased libido, nervousness
Reproductive: breast engorgement, breast enlargement, intermenstrual bleeding, genital edema, vulval disorder
Skin/Appendages: pruritus, pruritus ani
Urinary: micturition frequency, urethral disorder
Vascular: thrombophlebitis
Vision: abnormal vision
DRUG INTERACTIONS
Not applicable.
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