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Premphase Side Effects

Generic name: conjugated estrogens / medroxyprogesterone

Medically reviewed by Last updated on Jul 28, 2023.

Note: This document contains side effect information about conjugated estrogens / medroxyprogesterone. Some dosage forms listed on this page may not apply to the brand name Premphase.

Applies to conjugated estrogens / medroxyprogesterone: oral tablet, oral tablet chewable. Other dosage forms:

Serious side effects of Premphase

Along with its needed effects, conjugated estrogens/medroxyprogesterone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Healthy women rarely have severe side effects from taking conjugated estrogens or medroxyprogesterone to replace estrogen.

Check with your doctor immediately if any of the following side effects occur while taking conjugated estrogens / medroxyprogesterone:

More common

Less common


Incidence not known

Other side effects of Premphase

Some side effects of conjugated estrogens / medroxyprogesterone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

Incidence not known

For Healthcare Professionals

Applies to conjugated estrogens / medroxyprogesterone: oral tablet.


The most commonly reported adverse events have included abdominal pain, asthenia, back pain, headache, flatulence, nausea, depression, pruritus, breast pain, dysmenorrhea, and leukorrhea.[Ref]


Common (1% to 10%): Chest pain, generalized edema, hypertension, vasodilation, edema

Uncommon (0.1% to 1%): Palpitation

Postmarketing reports: Deep and superficial venous thrombosis, pulmonary embolism, superficial thrombophlebitis, myocardial infarction, stroke, increase in blood pressure[Ref]

The Women's Health Initiative (WHI) sub-study reports an increased risk of deep vein thrombosis, pulmonary embolism, stroke, and myocardial infarction in postmenopausal women 50 to 79 years old with a duration of 5.6 years of daily conjugated estrogen 0.625 mg-medroxyprogesterone 2.5 mg use compared with placebo. The WHI estrogen-alone study reported increased risks of stroke and DVT during 7.1 years of daily conjugated estrogen treatment.

-Stroke Risk (WHI substudy; conjugated estrogen 0.625 mg-medroxyprogesterone 2.5 mg daily): A statistically significant increased stroke risk: 33 versus 25 per 10,000 women-years

-Coronary Heart Disease (WHI substudy; conjugated estrogen 0.625 mg-medroxyprogesterone 2.5 mg): A statistically non-significant increased risk: 41 versus 34 per 10,000 women-years

-Venous Thromboembolism (VTE): (WHI substudy; conjugated estrogen 0.625 mg-medroxyprogesterone 2.5 mg): A statistically significant (VTE) risk: 35 versus 17 per 10,000 women-years. Specifically, DVT: 26 versus 13 per 10,000 women-years and PE:18 versus 8 per 10,000 women-years

The Heart and Estrogen/Progestin Replacement Study (HERS) demonstrated no cardiovascular benefit in postmenopausal women with established coronary heart disease (CHD) taking daily conjugated estrogen 0.625 mg-medroxyprogesterone 2.5 mg (average follow-up of 4.1 years). In the HERS II study, an open label extension of HERS, an additional 2.7 years of follow-up showed rates of CHD remained comparable to placebo.[Ref]


Common (1% to 10%): Breast neoplasm

Uncommon (0.1% to 1%): Endometrial hyperplasia

Postmarketing reports: Ovarian cancer, endometrial hyperplasia, endometrial cancer, breast cancer[Ref]

Breast Cancer: An increased risk of breast cancer was reported in the WHI substudy of daily conjugated estrogen 0.626 mg-medroxyprogesterone 2.5 mg use. After a mean follow-up of 5.6 years, the risk was 41 versus 33 cases per 10,000 women. In the women taking conjugated estrogen-medroxyprogesterone, invasive breast cancers were larger, were more likely to be node positive, and were diagnosed at a more advanced stage. Metastatic disease was rate and not different compared to placebo.

Ovarian Cancer: A statistically non-significant risk of ovarian cancer was reported in the WHI substudy of daily conjugated estrogen 0.626 mg-medroxyprogesterone 2.5 mg use. After a mean follow-up of 5.6 years, the risk was 4 versus 3 cases per 10,000 women. A large meta-analysis showed a significant increased risk of ovarian cancer in women using both estrogen-alone and estrogen plus progestin. The duration of hormone therapy use associated with an increased risk of ovarian cancer is unknown.[Ref]


Very common (10% or more): Breast pain (up to 36%)

Common (1% to 10%): Breast enlargement

Uncommon (0.1% to 1%): Breast engorgement

Postmarketing reports: Breast tenderness, breast enlargement, breast pain, nipple discharge, galactorrhea, fibrocystic breast changes, changes in libido[Ref]


Very common (10% or more): Dysmenorrhea (up to 13%)

Common (1% to 10%): Pelvic pain, cervix disorder, leukorrhea, menstrual disorder, metrorrhagia, suspicious PAP smear, vaginal moniliasis, vaginitis, uterine spasm, vaginal hemorrhage

Uncommon (0.1% to 1%): Menorrhagia, urinary incontinence, hematuria, urinary tract infection, vaginal dryness

Postmarketing reports: Abnormal uterine bleeding, dysmenorrhea or pelvic pain, increase in size of uterine leiomyomata, vaginitis, vaginal candidiasis, amenorrhea, changes in cervical secretion[Ref]


Postmarketing reports: Anaphylaxis, angioedema, hypersensitivity[Ref]


Common (1% to 10%): Decreased glucose tolerance (hyperglycemia), weight gain

Uncommon (0.1% to 1%): Increased appetite

Postmarketing reports: Appetite changes, weight increases and decreases, glucose intolerance, increased triglycerides[Ref]


Very common (10% or more): Abdominal pain (up to 17%)

Common (1% to 10%): Diarrhea, dyspepsia, eructation, flatulence, nausea

Frequency not reported: Gallbladder disease

Postmarketing reports: Nausea, vomiting, abdominal pain, bloating, increased incidence of gallbladder disease, pancreatitis ischemic colitis[Ref]


Common (1% to 10%): Pruritus, Rash

Uncommon (0.1% to 1%): Acne, alopecia, dry skin, sweating, skin discoloration

Postmarketing reports: Chloasma or melasma that may persist when drug is discontinue, erythema multiforme, erythema nodosum, loss of scalp hair, hirsutism, pruritus, urticaria, rash, acne[Ref]


Common (1% to 10%): Back pain, arthralgia, leg cramps

Postmarketing reports: Arthralgia[Ref]

Nervous system

In the WHIMS (Women's Health Initiative Memory Study) an ancillary study of WHI, the absolute risk of probable dementia for conjugated estrogen 0.625 mg-medroxyprogesterone 2.5 mg was 45 versus 22 cases per 10,000 women-years. These studies were conducted in women 65 to 79 years old and therefore it is unknown if this risk applies to younger postmenopausal women.[Ref]

Very common (10% or more): Headache (up to 19%)

Common (1% to 10%): Migraine, dizziness, hypertonia

Postmarketing reports: Headache, migraine, dizziness, exacerbation of chorea, exacerbation of epilepsy, growth potentiation of benign meningioma[Ref]


Common (1% to 10%): Emotional lability, depression, Insomnia, nervousness, anxiety

Postmarketing reports: Mental depression, mood disturbances, anxiety, irritability, dementia[Ref]


Postmarketing reports: Cholestatic jaundice[Ref]


Common (1% to 10%): Pharyngitis, sinusitis

Postmarketing reports: Asthma exacerbation[Ref]


Common (1% to 10%): Asthenia, pain[Ref]


Common (1% to 10%): Flu syndrome

Uncommon (0.1% to 1%): Infection, moniliasis


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100. Jick SS, Walker AM, Jick H (1986) "Conjugated estrogens and fibrocystic breast disease." Am J Epidemiol, 124, p. 746-51

101. Pastides H, Najjar MA, Kelsey JL (1987) "Estrogen replacement therapy and fibrocystic breast disease." Am J Prev Med, 3, p. 282-6

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.