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.
During the first year of a 2-year clinical trial with 2,333 postmenopausal women between 40 and 65 years of age (88% Caucasian), 1,012 women were treated with conjugated estrogens and 332 were treated with placebo. Table 6 summarizes adverse events that occurred at a rate of ≥ 5%.
TABLE 6. NUMBER (%) OF PATIENTS REPORTING ≥ 5% TREATMENT EMERGENT ADVERSE EVENTS | --Conjugated Estrogens Treatment Group-- | |
| Body System | 0.625 mg | 0.45 mg | 0.3 mg | Placebo |
| Adverse event | (n = 348) | (n = 338) | (n = 326) | (n = 332) |
| Any adverse event | 323 (93%) | 305 (90%) | 292 (90%) | 281 (85%) |
| Body as a Whole | | | | |
Abdominal pain
Accidental injury
Asthenia
Back pain
Flu syndrome
Headache
Infection
Pain | 56 (16%)
21 (6%)
25 (7%)
49 (14%)
37 (11%)
90 (26%)
61 (18%)
58 (17%) | 50 (15%)
41 (12%)
23 (7%)
43 (13%)
38 (11%)
109 (32%)
75 (22%)
61 (18%) | 54 (17%)
20 (6%)
25 (8%)
43 (13%)
33 (10%)
96 (29%)
74 (23%)
66 (20%) | 37 (11%)
29 (9%)
16 (5%)
39 (12%)
35 (11%)
93 (28%)
74 (22%)
61 (18%) |
| Digestive System | | | | |
Diarrhea
Dyspepsia
Flatulence
Nausea | 21 (6%)
33 (9%)
24 (7%)
32 (9%) | 25 (7%)
32 (9%)
23 (7%)
21 (6%) | 19 (6%)
36 (11%)
18 (6%)
21 (6%) | 21 (6%)
46 (14%)
9 (3%)
30 (9%) |
| Musculoskeletal System | | | | |
Arthralgia
Leg cramps
Myalgia | 47 (14%)
19 (5%)
18 (5%) | 42 (12%)
23 (7%)
18 (5%) | 22 (7%)
11 (3%)
29 (9%) | 39 (12%)
7 (2%)
25 (8%) |
| Nervous System | | | | |
Depression
Dizziness
Insomnia
Nervousness | 25 (7%)
19 (5%)
21 (6%)
12 (3%) | 27 (8%)
20 (6%)
25 (7%)
17 (5%) | 17 (5%)
12 (4%)
24 (7%)
6 (2%) | 22 (7%)
17 (5%)
33 (10%)
7 (2%) |
| Respiratory System | | | | |
Cough increased
Pharyngitis
Rhinitis
Sinusitis
Upper respiratory infection | 13 (4%)
35 (10%)
21 (6%)
22 (6%)
42 (12%) | 22 (7%)
35 (10%)
30 (9%)
36 (11%)
34 (10%) | 14 (4%)
40 (12%)
31 (10%)
24 (7%)
28 (9%) | 14 (4%)
38 (11%)
42 (13%)
24 (7%)
35 (11%) |
| Skin and Appendages | | | | |
| Pruritus | 14 (4%) | 17 (5%) | 16 (5%) | 7 (2%) |
| Urogenital System | | | | |
Breast pain
Leukorrhea
Vaginal hemorrhage
Vaginal moniliasis
Vaginitis | 38 (11%)
18 (5%)
47 (14%)
20 (6%)
24 (7%) | 41 (12%)
22 (7%)
14 (4%)
18 (5%)
20 (6%) | 24 (7%)
13 (4%)
7 (2%)
17 (5%)
16 (5%) | 29 (9%)
9 (3%)
0
6 (2%)
4 (1%) |
The following additional adverse reactions have been reported with estrogen and/or progestin therapy:
1. Genitourinary system
Abnormal uterine bleeding/spotting
Dysmenorrhea/pelvic pain
Increase in size of uterine leiomyomata
Vaginitis, including vaginal candidiasis
Change in amount of cervical secretion
Change in cervical ectropion
Ovarian cancer
Endometrial hyperplasia
Endometrial cancer
2. Breasts
Tenderness, enlargement, pain, 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
Nausea, vomiting
Abdominal cramps, bloating
Cholestatic jaundice
Increased incidence of gallbladder disease
Pancreatitis
Enlargement of hepatic hemangiomas
Ischemic colitis
5. Skin
Chloasma or melasma that may persist when drug is discontinued
Erythema multiforme
Erythema nodosum
Hemorrhagic eruption
Loss of scalp hair
Hirsutism
Pruritus, rash
6. Eyes
Retinal vascular thrombosis
Intolerance to contact lenses
7. Central Nervous System
Headache
Migraine
Dizziness
Mental depression
Exacerbation of chorea
Nervousness
Mood disturbances
Irritability
Exacerbation of epilepsy
Dementia
Possible growth potentiation of benign meningioma
8. Miscellaneous
Increase or decrease in weight
Glucose intolerance
Aggravation of porphyria
Edema
Arthralgias
Leg cramps
Changes in libido
Urticaria, angioedema, anaphylactoid/anaphylactic reactions
Hypocalcemia (preexisting condition)
Exacerbation of asthma
Increased triglycerides
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