ADVERSE REACTIONS
See BOXED WARNINGS, WARNINGS and PRECAUTIONS.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
In two 12-week clinical trials that included 327 postmenopausal women treated with Femtrace and 221 women treated with placebo tablets, adverse events that occurred in any treatment group at a rate of ≥ 2% regardless of drug relationship are summarized in Table 5. Incidence of AEs Occurring in ≥ 2% of Subjects in Any Treatment Group Presented in Descending Frequency of Preferred Term.
Table 5. Incidence of AEs Occurring in ≥ 2% of Subjects in Any Treatment Group Presented in Descending Frequency of Preferred Term | Adverse Event
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Placebo
(n = 221)
|
Femtrace
0.45 mg/day
(n = 132)
|
Femtrace
0.9 mg/day
(n = 100)
|
Femtrace
1.8 mg/day
(n = 95)
|
| n (%) | n (%) | n (%) | n (%) |
| Headache (NOS) | 12 (5.4) | 4 (3.0) | 5 (5.0) | 4 (4.2) |
| Vaginal Bleeding | 3 (1.4) | 1 (0.8) | 4 (4.0) | 7 (7.4) |
| Breast Tenderness | 3 (1.4) | 1 (0.8) | 0 (0.0) | 6 (6.3) |
| Influenza | 3 (1.4) | 3 (2.3) | 0 (0.0) | 4 (4.2) |
| Vaginal Discharge | 0 (0.0) | 3 (2.3) | 4 (4.0) | 3 (3.2) |
| Abdominal Pain (NOS) | 4 (1.8) | 1 (0.8) | 0 (0.0) | 3 (3.2) |
| Fungal Infection (NOS) | 2 (0.9) | 4 (3.0) | 1 (1.0) | 1 (1.1) |
| Nasopharyngitis | 5 (2.3) | 2 (1.5) | 0 (0.0) | 1 (1.1) |
| Nausea | 3 (1.4) | 3 (2.3) | 0 (0.0) | 2 (2.1) |
| Intermenstrual Bleeding | 2 (0.9) | 0 (0.0) | 2 (2.0) | 3 (3.2) |
| Sinusitis (NOS) | 3 (1.4) | 2 (1.5) | 1 (1.0) | 1 (1.1) |
| Upper Respiratory Tract Infection (NOS) | 3 (1.4) | 1 (0.8) | 3 (3.0) | 0 (0.0) |
| Back Pain | 1 (0.5) | 0 (0.0) | 3 (3.0) | 2 (2.1) |
| Bronchitis (NOS) | 1 (0.5) | 2 (1.5) | 2 (2.0) | 1 (1.1) |
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AE = adverse event; NOS = not otherwise specified
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The following additional adverse reactions have been reported with estrogen and/or progestin therapy.
1. Genitourinary system
Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea; increase in size of uterine leiomyomata; vaginitis including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer.
2. Breasts
Enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.
3. Cardiovascular
Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.
4. Gastrointestinal
Vomiting, abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis; enlargement of hepatic hemangiomas.
5. Skin
Chloasma or melasma that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritis, rash.
6. Eyes
Retinal vascular thrombosis; intolerance to contact lenses.
7. Central nervous system
Migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia.
8. Miscellaneous
Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthralgias; leg cramps; changes in libido; urticaria; angioedema; anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.
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