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Side Effects of Prempro, Premphase (Conjugated Estrogens, Medroxyprogesterone Acetate), Warnings, Uses
08
Oct
Oct
| Body System Adverse event | PREMPRO 0.625/2.5 continuous (N=331) |
PREMPRO 0.45/1.5 continuous (N=331) |
PREMPRO 0.3/1.5 continuous (N=327) |
PLACEBO daily (N=332) |
| Any adverse event | 214 (65) | 208 (63) | 188 (57) | 164 (49) |
| Body as a Whole | ||||
| Abdominal pain | 38 (11) | 33 (10) | 24 (7) | 21 (6) |
| Asthenia | 11 (3) | 11 (3) | 12 (4) | 3 (1) |
| Back pain | 12 (4) | 12 (4) | 8 (2) | 4 (1) |
| Chest pain | 4 (1) | 2 (1) | 1 (0) | 2 (1) |
| Generalized edema | 7 (2) | 5 (2) | 6 (2) | 8 (2) |
| Headache | 45 (14) | 45 (14) | 57 (17) | 46 (14) |
| Moniliasis | 3 (1) | 6 (2) | 4 (1) | 1 (0) |
| Pain | 9 (3) | 10 (3) | 17 (5) | 14 (4) |
| Pelvic pain | 9 (3) | 7 (2) | 5 (2) | 4 (1) |
| Cardiovascular System | ||||
| Hypertension | 2 (1) | 3 (1) | 1 (0) | 5 (2) |
| Migraine | 11 (3) | 8 (2) | 5 (2) | 3 (1) |
| Palpitation | 1 (0) | 1 (0) | 2 (1) | 4 (1) |
| Vasodilatation | 0 | 3 (1) | 1 (0) | 5 (2) |
| Digestive System | ||||
| Constipation | 5 (2) | 7 (2) | 6 (2) | 3 (1) |
| Diarrhea | 5 (2) | 2 (1) | 6 (2) | 8 (2) |
| Dyspepsia | 10 (3) | 9 (3) | 6 (2) | 14 (4) |
| Flatulence | 16 (5) | 18 (5) | 13 (4) | 8 (2) |
| Increased appetite | 6 (2) | 2 (1) | 0 | 2 (1) |
| Nausea | 13 (4) | 13 (4) | 16 (5) | 16 (5) |
| Metabolic and nutritional | ||||
| Peripheral edema | 7 (2) | 8 (2) | 4 (1) | 3 (1) |
| Weight gain | 9 (3) | 8 (2) | 6 (2) | 14 (4) |
| Musculoskeletal System | ||||
| Arthralgia | 2 (1) | 3 (1) | 3 (1) | 5 (2) |
| Leg cramps | 13 (4) | 7 (2) | 10 (3) | 4 (1) |
| Nervous System | ||||
| Anxiety | 5 (2) | 4 (1) | 1 (0) | 4 (1) |
| Depression | 23 (7) | 11 (3) | 11 (3) | 17 (5) |
| Dizziness | 3 (1) | 8 (2) | 6 (2) | 5 (2) |
| Emotional lability | 10 (3) | 10 (3) | 9 (3) | 8 (2) |
| Insomnia | 8 (2) | 7 (2) | 9 (3) | 14 (4) |
| Nervousness | 6 (2) | 3 (1) | 4 (1) | 6 (2) |
| Skin and Appendages | ||||
| Acne | 7 (2) | 3 (1) | 0 | 3 (1) |
| Alopecia | 1 (0) | 6 (2) | 4 (1) | 2 (1) |
| Pruritus | 8 (2) | 10 (3) | 9 (3) | 3 (1) |
| Rash | 0 | 6 (2) | 4 (1) | 2 (1) |
| Skin discoloration | 5 (2) | 1 (0) | 3 (1) | 1 (0) |
| Sweating | 3 (1) | 1 (0) | 0 | 4 (1) |
| Urogenital System | ||||
| Breast disorder | 7 (2) | 6 (2) | 5 (2) | 6 (2) |
| Breast enlargement | 18 (5) | 9 (3) | 5 (2) | 3 (1) |
| Breast neoplasm | 8 (2) | 7 (2) | 5 (2) | 7 (2) |
| Breast pain | 87 (26) | 66 (20) | 41 (13) | 26 (8) |
| Cervix disorder | 7 (2) | 2 (1) | 2 (1) | 0 |
| Dysmenorrhea | 14 (4) | 18 (5) | 9 (3) | 2 (1) |
| Hematuria | 4 (1) | 3 (1) | 1 (0) | 2 (1) |
| Leukorrhea | 7 (2) | 14 (4) | 9 (3) | 6 (2) |
| Metrorrhagia | 7 (2) | 14 (4) | 4 (1) | 1 (0) |
| Urinary tract infection | 0 | 1 (0) | 1 (0) | 4 (1) |
| Uterine spasm | 13 (4) | 11 (3) | 7 (2) | 2 (1) |
| Vaginal dryness | 2 (1) | 1 (0) | 0 | 6 (2) |
| Vaginal hemorrhage | 18 (5) | 14 (4) | 7 (2) | 0 |
| Vaginal moniliasis | 13 (4) | 11 (3) | 8 (2) | 5 (2) |
| Vaginitis | 6 (2) | 8 (2) | 7 (2) | 1 (0) |
