Contraindications, Pregnancy ( |
06/2018 |
Warnings and Precautions, Premenopausal Use ( |
06/2018 |
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Infection | A | A | 15.1 | 14.6 |
Flu Syndrome | 13.5 | 11.4 | 14.6 | 13.5 |
Headache | 9.2 | 8.5 | A | A |
Leg Cramps | 7.0 | 3.7 | 5.9 | 1.9 |
Chest Pain | A | A | 4.0 | 3.6 |
Fever | 3.9 | 3.8 | 3.1 | 2.6 |
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Hot Flashes | 9.7 | 6.4 | 24.6 | 18.3 |
Migraine | A | A | 2.4 | 2.1 |
Syncope | 2.3 | 2.1 | B | B |
Varicose Vein | 2.2 | 1.5 | A | A |
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Nausea | 8.3 | 7.8 | 8.8 | 8.6 |
Diarrhea | 7.2 | 6.9 | A | A |
Dyspepsia | A | A | 5.9 | 5.8 |
Vomiting | 4.8 | 4.3 | 3.4 | 3.3 |
Flatulence | A | A | 3.1 | 2.4 |
Gastrointestinal Disorder | A | A | 3.3 | 2.1 |
Gastroenteritis | B | B | 2.6 | 2.1 |
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Weight Gain | A | A | 8.8 | 6.8 |
Peripheral Edema | 5.2 | 4.4 | 3.3 | 1.9 |
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Arthralgia | 15.5 | 14.0 | 10.7 | 10.1 |
Myalgia | A | A | 7.7 | 6.2 |
Arthritis | A | A | 4.0 | 3.6 |
Tendon Disorder | 3.6 | 3.1 | A | A |
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Depression | A | A | 6.4 | 6.0 |
Insomnia | A | A | 5.5 | 4.3 |
Vertigo | 4.1 | 3.7 | A | A |
Neuralgia | 2.4 | 1.9 | B | B |
Hypesthesia | 2.1 | 2.0 | B | B |
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Sinusitis | 7.9 | 7.5 | 10.3 | 6.5 |
Rhinitis | 10.2 | 10.1 | A | A |
Bronchitis | 9.5 | 8.6 | A | A |
Pharyngitis | 5.3 | 5.1 | 7.6 | 7.2 |
Cough Increased | 9.3 | 9.2 | 6.0 | 5.7 |
Pneumonia | A | A | 2.6 | 1.5 |
Laryngitis | B | B | 2.2 | 1.4 |
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Rash | A | A | 5.5 | 3.8 |
Sweating | 2.5 | 2.0 | 3.1 | 1.7 |
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Conjunctivitis | 2.2 | 1.7 | A | A |
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Vaginitis | A | A | 4.3 | 3.6 |
Urinary Tract Infection | A | A | 4.0 | 3.9 |
Cystitis | 4.6 | 4.5 | 3.3 | 3.1 |
Leukorrhea | A | A | 3.3 | 1.7 |
Uterine Disorderb, c | 3.3 | 2.3 | A | A |
Endometrial Disorderb | B | B | 3.1 | 1.9 |
Vaginal Hemorrhage | 2.5 | 2.4 | A | A |
Urinary Tract Disorder | 2.5 | 2.1 | A | A |
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Breast Pain | 4.4 | 37.5 | 29.7 |
Vaginal Bleedingd | 6.2 | 64.2 | 88.5 |
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Flatulence | 1.6 | 12.5 | 6.4 |
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Hot Flashes | 28.7 | 3.1 | 5.9 |
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Infection | 11.0 | 0 | 6.8 |
Abdominal Pain | 6.6 | 10.4 | 18.7 |
Chest Pain | 2.8 | 0 | 0.5 |
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Mean |
0.50 | 27.7 | 27.2 | 44.1 | 2348 |
CVa (%) | 52 | 10.7 to 273c | 44 | 46 | 52 |
Mean |
1.36 | 32.5 | 24.2 | 47.4 | 2853 |
CVa (%) | 37 | 15.8 to 86.6c | 36 | 41 | 56 |
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Patients with no baseline fracturea | n=1401 | n=1457 | ||
Number (%) of patients with ≥1 new vertebral fracture | 27 (1.9%) | 62 (4.3%) | 2.4% | 55% (29%, 71%) |
Patients with ≥1 baseline fracturea | n=858 | n=835 | ||
Number (%) of patients with ≥1 new vertebral fracture | 121 (14.1%) | 169 (20.2%) | 6.1% | 30% (14%, 44%) |
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All randomized patients | n=2557 | n=2576 | ||
Number (%) of patients with ≥1 new clinical (painful) vertebral fracture |
47 (1.8%) | 81 (3.1%) | 1.3% | 41% (17%, 59%) |
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% |
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Lumbar Spine | 2.0 | 2.6 | 2.6 |
Femoral Neck | 1.3 | 1.9 | 2.1 |
Ultradistal Radius | NDd | 2.2 | NDd |
Distal Radius | NDd | 0.9 | NDd |
Total Body | NDd | 1.1 | NDd |
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% |
% |
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Total Hip | 2.0 | 2.4 | 1.3 |
Femoral Neck | 2.1 | 2.5 | 1.6 |
Trochanter | 2.2 | 2.7 | 1.3 |
Intertrochanter | 2.3 | 2.4 | 1.3 |
Lumbar Spine | 2.0 | 2.4 | 1.8 |
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4 years |
4 years |
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(N=2576) |
(N=2557) |
(95% CI)b |
(N=1286) |
(N=2725) |
(95% CI)b |
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Invasivec breast cancer | 38 | 4.36 | 11 | 1.26 | 0.29 (0.15, 0.56)d |
20 | 5.41 | 19 | 2.43 | 0.44 (0.24, 0.83)d |
ERb, c positive | 29 | 3.33 | 6 | 0.69 | 0.20 (0.08, 0.49) |
15 | 4.05 | 12 | 1.54 | 0.37 (0.17, 0.79) |
ERb, c negative | 4 | 0.46 | 5 | 0.57 | 1.23 (0.33, 4.60) |
3 | 0.81 | 6 | 0.77 | 0.95 (0.24, 3.79) |
ERb, c unknown | 5 | 0.57 | 0 | 0.00 | N/Ab | 2 | 0.54 | 1 | 0.13 | N/Ab |
Noninvasivec, e breast cancer | 5 | 0.57 | 3 | 0.34 | 0.59 (0.14, 2.47) |
2 | 0.54 | 5 | 0.64 | 1.18 (0.23, 6.07) |
Clinical vertebral fractures | 107 | 12.27 | 62 | 7.08 | 0.57 (0.42, 0.78) |
N/Ab | N/Ab | N/Ab | N/Ab | N/Ab |
Death | 36 | 4.13 | 23 | 2.63 | 0.63 (0.38, 1.07) |
29 | 7.76 | 47 | 5.99 | 0.77 (0.49, 1.23) |
Death due to stroke | 6 | 0.69 | 3 | 0.34 | 0.49 (0.12, 1.98) |
1 | 0.27 | 6 | 0.76 | 2.87 (0.35, 23.80) |
Stroke | 56 | 6.42 | 43 | 4.91 | 0.76 (0.51, 1.14) |
14 | 3.75 | 49 | 6.24 | 1.67 (0.92, 3.03) |
Deep vein thrombosis | 8 | 0.92 | 20 | 2.28 | 2.50 (1.10, 5.68) |
4 | 1.07 | 17 | 2.17 | 2.03 (0.68, 6.03) |
Pulmonary embolism | 4 | 0.46 | 11 | 1.26 | 2.76 (0.88, 8.67) |
0 | 0.00 | 9 | 1.15 | N/Ab |
Endometrial and uterine cancerf | 5 | 0.74 | 5 | 0.74 | 1.01 (0.29, 3.49) |
3 | 1.02 | 4 | 0.65 | 0.64 (0.14, 2.85) |
Ovarian cancer | 6 | 0.69 | 3 | 0.34 | 0.49 (0.12, 1.95) |
2 | 0.54 | 2 | 0.25 | 0.47 (0.07, 3.36) |
Hot flashes | 151 | 17.31 | 237 | 27.06 | 1.61 (1.31, 1.97) |
11 | 2.94 | 26 | 3.31 | 1.12 (0.55, 2.27) |
Peripheral edema | 134 | 15.36 | 164 | 18.73 | 1.23 (0.98, 1.54) |
30 | 8.03 | 61 | 7.77 | 0.96 (0.62, 1.49) |
Cholelithiasis | 45 | 5.16 | 53 | 6.05 | 1.18 (0.79, 1.75) |
12 | 3.21 | 35 | 4.46 | 1.39 (0.72, 2.67) |
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(N=5057) |
(N=5044) |
(95% CI)b |
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Invasive breast cancer | 70 | 2.66 | 40 | 1.50 | 0.56 (0.38, 0.83)c |
ERb positive | 55 | 2.09 | 25 | 0.94 | 0.45 (0.28, 0.72) |
ERb negative | 9 | 0.34 | 13 | 0.49 | 1.44 (0.61, 3.36) |
ERb unknown | 6 | 0.23 | 2 | 0.07 | 0.33 (0.07, 1.63) |
Noninvasived breast cancer | 5 | 0.19 | 11 | 0.41 | 2.17 (0.75, 6.24) |
Clinical vertebral fractures | 97 | 3.70 | 64 | 2.40 | 0.65 (0.47, 0.89) |
Death | 595 | 22.45 | 554 | 20.68 | 0.92 (0.82, 1.03) |
Death due to stroke | 39 | 1.47 | 59 | 2.20 | 1.49 (1.00, 2.24) |
Stroke | 224 | 8.60 | 249 | 9.46 | 1.10 (0.92, 1.32) |
Deep vein thrombosis | 47 | 1.78 | 65 | 2.44 | 1.37 (0.94, 1.99) |
Pulmonary embolism | 24 | 0.91 | 36 | 1.35 | 1.49 (0.89, 2.49) |
Endometrial and uterine cancere | 17 | 0.83 | 21 | 1.01 | 1.21 (0.64 - 2.30) |
Ovarian cancerf | 10 | 0.41 | 17 | 0.70 | 1.69 (0.78, 3.70) |
Hot flashes | 241 | 9.09 | 397 | 14.82 | 1.68 (1.43, 1.97) |
Peripheral edema | 583 | 22.00 | 706 | 26.36 | 1.22 (1.09, 1.36) |
Cholelithiasisg | 131 | 6.20 | 168 | 7.83 | 1.26 (1.01, 1.59) |
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(N=9751) |
(N=9736) |
(95% CI)a |
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Invasive breast cancer | 173 | 4.40 | 168 | 4.30 | 1.02 (0.82, 1.27) |
ERa positive | 115 | 2.93 | 120 | 3.07 | 0.95 (0.73, 1.24) |
ERa negative | 52 | 1.32 | 46 | 1.18 | 1.12 (0.74, 1.71) |
ERa unknown | 6 | 0.15 | 2 | 0.05 | 2.98 (0.53, 30.21) |
Noninvasive breast cancerb | 83 | 2.12 | 60 | 1.54 | 1.38 (0.98, 1.95) |
DCISa | 47 | 1.20 | 32 | 0.82 | 1.46 (0.91, 2.37) |
LCISa | 29 | 0.74 | 23 | 0.59 | 1.26 (0.70, 2.27) |
Uterine cancerc | 23 | 1.21 | 37 | 1.99 | 0.61 (0.34, 1.05) |
Endometrial hyperplasiac | 17 | 0.90 | 100 | 5.42 | 0.17 (0.09, 0.28) |
Hysterectomyc | 92 | 4.84 | 246 | 13.25 | 0.37 (0.28, 0.47) |
Ovarian cancerd | 18 | 0.66 | 14 | 0.52 | 1.27 (0.60, 2.76) |
Ischemic heart diseasee | 138 | 3.50 | 125 | 3.19 | 1.10 (0.86, 1.41) |
Stroke | 54 | 1.36 | 56 | 1.42 | 0.96 (0.65, 1.42) |
Deep vein thrombosis | 67 | 1.69 | 92 | 2.35 | 0.72 (0.52, 1.00) |
Pulmonary embolism | 38 | 0.96 | 58 | 1.47 | 0.65 (0.42, 1.00) |
Clinical vertebral fractures | 58 | 1.46 | 58 | 1.47 | 0.99 (0.68, 1.46) |
Cataractsf | 343 | 10.34 | 435 | 13.19 | 0.78 (0.68, 0.91) |
Cataract surgeryf | 240 | 7.17 | 295 | 8.85 | 0.81 (0.68, 0.96) |
Death | 104 | 2.62 | 109 | 2.76 | 0.95 (0.72, 1.25) |
Edemag | 741 | 18.66 | 664 | 16.83 | 1.11 (1.00, 1.23) |
Hot flashes | 6748 | 169.91 | 7170 | 181.71 | 0.94 (0.90, 0.97) |
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Bottles of 30 (unit of use) | 0002-4165-30 | 0002-4184-30 |
Bottles of 100 (unit of use) | 0002-4165-02 | 0002-4184-02 |
Bottles of 2000 | 0002-4165-07 | 0002-4184-07 |