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PREMARIN® (conjugated estrogens) Adverse Reactions

6 ADVERSE REACTIONS

The following serious adverse reactions are discussed elsewhere in labeling:

6.1 Clinical Study Experience

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 clinical practice.

During the first year of a 2-year clinical trial with 2,333 postmenopausal women with a uterus between 40 and 65 years of age (88 percent Caucasian), 1,012 women were treated with conjugated estrogens, and 332 were treated with placebo.

Table 1 summarizes treatment-related adverse reactions that occurred at a rate of ≥ 1 percent in any treatment group.

Table 1: TREATMENT RELATED ADVERSE REACTIONS AT A FREQUENCY ≥ 1 PERCENT
PREMARIN
0.625 mg
(n=348)
PREMARIN
0.45 mg (n=338)
PREMARIN
0.3 mg
(n=326)
Placebo
(n=332)
Body as a whole
  Abdominal pain38 (11)28 (8)30 (9)21 (6)
  Asthenia 16 (5)8 (2)14 (4)3 (1)
  Back pain 18 (5)11 (3)13 (4)4 (1)
  Chest pain 2 (1)3 (1)4 (1)2 (1)
  Generalized edema 7 (2)6 (2)4 (1)8 (2)
  Headache 45 (13)47 (14)44 (13)46 (14)
  Moniliasis 5 (1)4 (1)4 (1)1 (0)
  Pain 17 (5)10 (3)12 (4)14 (4)
  Pelvic pain 10 (3)9 (3)8 (2)4 (1)
Cardiovascular system
  Hypertension 4 (1)4 (1)7 (2)5 (2)
  Migraine 7 (2)1 (0)03 (1)
  Palpitation 3 (1)3 (1)3 (1)4 (1)
  Vasodilatation 2 (1)2 (1)3 (1)5 (2)
Digestive system
  Constipation 7 (2)6 (2)4 (1)3 (1)
  Diarrhea 4 (1)5 (1)5 (2)8 (2)
  Dyspepsia 7 (2)5 (1)6 (2)14 (4)
  Eructation 1 (0)1 (0)4 (1)1 (0)
  Flatulence 22 (6)18 (5)13 (4)8 (2)
  Increased appetite 4 (1)1 (0)1 (0)2 (1)
  Nausea 16 (5)10 (3)15 (5)16 (5)
Metabolic and nutritional
  Hyperlipidemia 2 (1)4 (1)3 (1)2 (1)
  Peripheral edema 5 (1)2 (1)4 (1)3 (1)
  Weight gain 11 (3)10 (3)8 (2)14 (4)
Musculoskeletal system
  Arthralgia 6 (2)3 (1)2 (1)5 (2)
  Leg cramps 10 (3)5 (1)9 (3)4 (1)
  Myalgia 2 (1)1 (0)4 (1)1 (0)
Nervous system
  Anxiety 6 (2)4 (1)2 (1)4 (1)
  Depression 17 (5)15 (4)10 (3)17 (5)
  Dizziness9 (3)7 (2)4 (1)5 (2)
  Emotional lability 3 (1)4 (1)5 (2)8 (2)
  Hypertonia 1 (0)1 (0)5 (2)3 (1)
  Insomnia 16 (5)10 (3)13 (4)14 (4)
  Nervousness 9 (3)12 (4)2 (1)6 (2)
Skin and appendages
  Acne 3 (1)1 (0)8 (2)3 (1)
  Alopecia 6 (2)6 (2)5 (2)2 (1)
  Hirsutism 4 (1)2 (1)1 (0)0
  Pruritus 11 (3)11 (3)10 (3)3 (1)
  Rash 6 (2)3 (1)1 (0)2 (1)
  Skin discoloration 4 (1)2 (1)01 (0)
  Sweating 4 (1)1 (0)3 (1)4 (1)
Urogenital system
  Breast disorder 6 (2)3 (1)3 (1)6 (2)
  Breast enlargement 3 (1)4 (1)7 (2)3 (1)
  Breast neoplasm 4 (1)4 (1)7 (2)7 (2)
  Breast pain 37 (11)39 (12)24 (7)26 (8)
  Cervix disorder 8 (2)4 (1)5 (2)0
  Dysmenorrhea 12 (3)10 (3)4 (1)2 (1)
  Endometrial disorder 4 (1)2 (1)2 (1)0
  Endometrial hyperplasia 16 (5)8 (2)1 (0)0
  Leukorrhea 17 (5)17 (5)12 (4)6 (2)
  Metrorrhagia 11 (3)4 (1)3 (1)1 (0)
  Urinary tract infection 1 (0)2 (1)1 (0)4 (1)
  Uterine fibroids enlarged 6 (2)1 (0)2 (1)2 (1)
  Uterine spasm 11 (3)5 (1)3 (1)2 (1)
  Vaginal dryness 1 (0)2 (1)1 (0)6 (2)
  Vaginal hemorrhage 46 (13)13 (4)6 (2)0
  Vaginal moniliasis 14 (4)10 (3)12 (4)5 (2)
  Vaginitis 18 (5)7 (2)9 (3)1 (0)

6.2 Postmarketing Experience

The following additional adverse reactions have been identified during post-approval use of PREMARIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible always to reliably estimate their frequency or establish a causal relationship to drug exposure.

Genitourinary system

Abnormal uterine bleeding; dysmenorrheal or pelvic pain, increase in size of uterine leiomyomata, vaginitis, including vaginal candidiasis, change in cervical secretion, ovarian cancer, endometrial hyperplasia, endometrial cancer, leukorrhea.

Breasts

Tenderness, enlargement, pain, discharge, galactorrhea, fibrocystic breast changes, breast cancer, gynecomastia in males.

Cardiovascular

Deep and superficial venous thrombosis, pulmonary embolism, thrombophlebitis, myocardial infarction, stroke, increase in blood pressure.

Gastrointestinal

Nausea, vomiting, abdominal pain, bloating, cholestatic jaundice, increased incidence of gallbladder disease, pancreatitis, enlargement of hepatic hemangiomas, ischemic colitis.

Skin

Chloasma or melasma that may persist when drug is discontinued, erythema multiforme, erythema nodosum, loss of scalp hair, hirsutism, pruritus, rash.

Eyes

Retinal vascular thrombosis, intolerance to contact lenses.

Central nervous system

Headache, migraine, dizziness , mental depression, nervousness, mood disturbances, irritability, exacerbation of epilepsy, dementia, possible growth potentiation of benign meningioma.

Miscellaneous

Increase or decrease in weight, glucose intolerance, aggravation of porphyria, edema, arthralgias, leg cramps, changes in libido, urticaria, exacerbation of asthma, increased triglycerides, hypersensitivity.

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