Conjugated estrogens / medroxyprogesterone Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 28, 2023.

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

oral tablet

Serious side effects

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

Itching of the vagina or genital area
menstrual periods beginning again, including changing menstrual bleeding pattern for up to 6 months (spotting, breakthrough bleeding, prolonged or heavier vaginal bleeding, or vaginal bleeding completely stopping by 10 months)
pain during sexual intercourse
thick, white vaginal discharge

Less common

Blurred vision
breast lumps
chest pain
discharge from breast
dizziness
feeling faint, dizzy, or light-headed
feeling of warmth or heat
flushing or redness of skin, especially on face and neck
headache
heavy nonmenstrual vaginal bleeding
pounding in the ears
severe cramping of the uterus
slow or fast heartbeat
sweating

Rare

Change in vaginal discharge
pain or feeling of pressure in pelvis
pain or tenderness in stomach, side, or abdomen
yellow eyes or skin

Incidence not known

Abdominal bloating
acid or sour stomach
belching
backache
full or bloated feeling or pressure in the stomach
heartburn
indigestion
loss of appetite
pelvic pain
stomach discomfort, upset or pain
stomach pain
swelling of abdominal or stomach are

Other side effects

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

Abdominal cramps
back pain
body aches or pain
breast pain or tenderness
congestion
chills
cough
crying
depersonalization
diarrhea
dryness or soreness of throat
dysphoria
enlarged breasts
euphoria
feeling faint, dizzy, or light-headedness
feeling of warmth or heat
fever
flushing or redness of skin, especially on face and neck
general feeling of discomfort or illness
headache, severe and throbbing
hoarseness
increase in amount of clear vaginal discharge
itching
joint pain
lack or loss of strength
mental depression
muscle aches and pains
nausea
pain
pain or tenderness around eyes and cheekbones
painful menstrual periods
painful or difficult urination
paranoia
passing of gas
quick to react or overreact emotionally
rapidly changing moods
runny nose
shivering
shortness of breath or troubled breathing
sneezing
sore throat
stuffy nose
stomach discomfort following meals
tender, swollen glands in neck
tightness of chest or wheezing
trouble sleeping
trouble in swallowing
unusual tiredness
voice changes
vomiting

Less common

Acne
bloating or swelling of face, ankles, or feet
cervix disorder
crying
depersonalization
dysphoria
euphoria
increase in sexual desire
leg cramps
mental depression
paranoia
quick to react or overreact emotionally
rapidly changing moods
sleeplessness
tense muscles
trouble sleeping
unable to sleep
unusual weight gain or loss

Incidence not known

Abdominal cramping
bloody or cloudy urine
bloody vaginal discharge
difficult, burning, or painful urination
frequent urge to urinate
light vaginal bleeding between periods and after intercourse

For Healthcare Professionals

Applies to conjugated estrogens / medroxyprogesterone: oral tablet.

General

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

Cardiovascular

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]

Oncologic

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]

Endocrine

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]

Genitourinary

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]

Hypersensitivity

Postmarketing reports: Anaphylaxis, angioedema, hypersensitivity^[Ref]

Metabolic

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]

Gastrointestinal

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]

Dermatologic

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]

Musculoskeletal

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

Postmarketing reports: Arthralgia^[Ref]

Nervous system

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]

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]

Psychiatric

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

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

Hepatic

Postmarketing reports: Cholestatic jaundice^[Ref]

Respiratory

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

Postmarketing reports: Asthma exacerbation^[Ref]

Other

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

Immunologic

Common (1% to 10%): Flu syndrome

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

More about conjugated estrogens / medroxyprogesterone

Patient resources

Other brands

Prempro, Premphase

Professional resources

Premphase Prempro prescribing information

Related treatment guides

References

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