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Synthetic Conjugated Estrogens (Synthetic Conjugated Estrogens) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

See BOX 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 a 12-week clinical trial that included 72 women treated with 0.625 mg and 2 x 0.625 mg Cenestin and 48 women treated with placebo, adverse events that occurred at a rate of >/= 5% are summarized in Table 5.

Table 5 Number (%) of Patients with Adverse Events With >/=5% Occurrence Rate By
Body System and Treatment Group
Body System   Adverse Event Cenestin *
0.625 mg and
2 × 0.625 mg n (%)
Placebo n (%) Total n (%)
Number of Patients Who Received Medication 72 (100) 48 (100) 120 (100)
Number of Patients With Adverse Events 68  (94) 43  (90) 111  (93)
Number of Patients Without Any Adverse Events 4   (6) 5  (10) 9   (8)
Body As A Whole
  Abdominal Pain 20  (28) 11  (23) 31  (26)
  Asthenia 24  (33) 20  (42) 44  (37)
  Back Pain 10  (14) 6  (13) 16  (13)
  Fever 1   (1) 3   (6) 4   (3)
  Headache 49  (68) 32  (67) 81  (68)
  Infection 10  (14) 5  (10) 15  (13)
  Pain 8  (11) 9  (19) 17  (14)
Cardiovascular System
  Palpitation 15  (21) 13  (27) 28  (23)
Digestive System
  Constipation 4   (6) 2   (4) 6   (5)
  Diarrhea 4   (6) 0   (0) 4   (3)
  Dyspepsia 7  (10) 3   (6) 10   (8)
  Flatulence 21  (29) 14  (29) 35  (29)
  Nausea 13  (18) 9  (19) 22  (18)
  Vomiting 5   (7) 1   (2) 6   (5)
Metabolic and Nutritional
  Peripheral Edema 7  (10) 6  (13) 13  (11)
Musculoskeletal System
  Arthralgia 18  (25) 13  (27) 31  (26)
  Myalgia 20  (28) 15  (31) 35  (29)
Nervous System
  Depression 20  (28) 18  (38) 38  (32)
  Dizziness 8  (11) 5  (10) 13  (11)
  Hypertonia 4   (6) 0   (0) 4   (3)
  Insomnia 30  (42) 23  (48) 53  (44)
  Leg Cramps 7  (10) 3   (6) 10   (8)
  Nervousness 20  (28) 20  (42) 40  (33)
  Paresthesia 24  (33) 15  (31) 39  (33)
  Vertigo 12  (17) 12  (25) 24  (20)
Respiratory System
  Cough Increased 4   (6) 1   (2) 5   (4)
  Pharyngitis 6   (8) 4   (8) 10   (8)
  Rhinitis 6   (8) 7  (15) 13  (11)
Skin and Appendages
  Rash 3   (4) 3   (6) 6   (5)
Urogenital System
  Breast Pain 21  (29) 7  (15) 28  (23)
  Dysmenorrhea 4   (6) 3   (6) 7   (6)
  Metrorrhagia 10  (14) 3   (6) 13  (11)
*Combined results for 0.625 mg and 2 × 0.625 mg Cenestin Tablets

In a second 12-week clinical trial that included 52 women treated with 0.45 mg Cenestin and 51 women treated with placebo, adverse events that occurred at a rate of >5% are summarized in Table 6

Table 6
Number (%) of Patients with a >/=5% Occurrence Rate By Body System and Treatment Group
Body System and Term        Cenestin         0.45 mg          Control      p-value
  Any Adverse Event % 40 (75.5%) 39 (76.5%) 1.0000
Body As A Whole 20 (37.7%) 24 (47.1%) 0.4275
  Asthenia 6 (11.3%) 7 (13.7%) 0.7731
  Headache 6 (11.3%) 8 (15.7%) 0.5748
  Infection 1  (1.9%) 6 (11.8%) 0.0576
  Pain 6 (11.3%) 1  (2.0%) 0.1128
  Pain abdominal 5  (9.4%) 3  (5.9%) 0.7159
Cardiovascular 5  (9.4%) 10 (19.6%) 0.1695
  Palpitations 3  (5.7%) 3  (5.9%) 1.0000
  Vasodilations 2  (3.8%) 4  (7.8%) 0.4324
Digestive 8 (15.1%) 7 (13.7%) 1.0000
  Nausea 5  (9.4%) 2  (3.9%) 0.4374
Metabolic and Nutritional 5  (9.4%) 3  (5.9%) 0.7159
  Weight increase 3  (5.7%) 2  (3.9%) 1.0000
Musculoskeletal 5  (9.4%) 6 (11.8%) 0.7582
  Arthralgia 5  (9.4%) 5  (9.8%) 1.0000
  Myalgia 2  (3.8%) 6 (11.8%) 0.1566
Neurological 15 (28.3%) 19 (37.3%) 0.4044
  Anxiety 3  (5.7%) 1  (2.0%) 0.6179
  Depression 2  (3.8%) 7 (13.7%) 0.0895
  Insomnia 3  (5.7%) 5  (9.8%) 0.4839
  Nervousness 2  (3.8%) 7 (13.7%) 0.0895
  Paresthesia 4  (7.5%) 3  (5.9%) 1.0000
  Vertigo 3  (5.7%) 3  (5.9%) 1.0000
Respiratory 10 (18.9%) 6 (11.8%) 0.4173
  Upper Respiratory Tract Infection 7 (13.2%) 1  (2.0%) 0.0603
  Rhinitis 3  (5.7%) 2  (3.9%) 1.0000
  Pharyngitis 1  (1.9%) 3  (5.9%) 0.3581
Urogenital 19 (35.8%) 7 (13.7%) 0.0124
  Endometrial thickening 10 (18.9%) 4  (7.8%) 0.1503
  Vaginitis 4  (7.5%) 1  (2.0%) 0.3632
P-value by Fisher's Exact (2-tail) Test
If a subject experiences the same event more than once, the first occurrence is tabulated.

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.
    Tenderness, 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.
    Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis, enlargement of hepatic hemangiomas.
  5. Skin.
    Chloasma or melasma, which 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; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy.
  8. Miscellaneous.
    Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthalgias; leg cramps; changes in libido; anaphylactoid/anaphylactic reactions including urticaria and angioedema; hypocalcemia; exacerbation of asthma; increased triglycerides.

Drug label data at the top of this Page last updated: 2006-05-05

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