Prempro Side Effects Center

Last updated on RxList: 2/14/2023
Prempro Side Effects Center

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What Is Prempro?

Prempro (conjugated estrogens/medroxyprogesterone acetate) is a combination of conjugated estrogens, which is a mixture of female sex hormones, and another female hormone called progesterone used to treat the symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation, and to prevent thinning of the bones (osteoporosis).

What Are Side Effects of Prempro?

Prempro may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • chest pain or pressure,
  • pain spreading to your jaw or shoulder,
  • nausea,
  • sweating,
  • sudden numbness or weakness (especially one side of the body),
  • sudden severe headache,
  • slurred speech,
  • problems with vision or balance,
  • sudden vision loss,
  • stabbing chest pain,
  • shortness of breath,
  • coughing up blood,
  • pain or warmth in one or both legs,
  • swelling or tenderness in your stomach,
  • yellowing of the skin or eyes (jaundice),
  • memory problems,
  • confusion,
  • unusual behavior,
  • unusual vaginal bleeding,
  • pelvic pain,
  • lump in your breast,
  • vomiting,
  • constipation,
  • increased thirst or urination,
  • muscle weakness,
  • bone pain, and
  • lack of energy

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Prempro include:

  • stomach upset or pain
  • nausea
  • vomiting
  • bloating
  • breast tenderness/pain/swelling
  • headache
  • weight or appetite changes
  • freckles or darkening of facial skin
  • acne
  • increased hair growth
  • loss of scalp hair
  • problems with contact lenses
  • vaginal itching or discharge
  • changes in your menstrual periods
  • decreased sex drive
  • nervousness
  • dizziness, or
  • tired feeling

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Prempro

Prempro therapy consists of a single tablet to be taken orally once daily. Treatment should be with the lowest effective dose and for the shortest duration.

What Drugs, Substances, or Supplements Interact with Prempro?

Prempro may interact with St. John's wort, carbamazepine, phenobarbital, rifampin, ritonavir, ketoconazole or itraconazole, or antibiotics. Tell your doctor all medications you are taking.

Prempro During Pregnancy or Breastfeeding

Prempro must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. This medication passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breast-feeding.

Additional Information

Our Prempro (conjugated estrogens/medroxyprogesterone acetate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

If menopause occurs in a woman younger than ___ years, it is considered to be premature. See Answer
Prempro Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
  • swelling or tenderness in your stomach;
  • jaundice (yellowing of the skin or eyes);
  • memory problems, confusion, unusual behavior;
  • unusual vaginal bleeding, pelvic pain;
  • a lump in your breast; or
  • high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects may include:

  • nausea, gas, stomach pain;
  • headache, back pain;
  • depression, weakness;
  • breast pain;
  • itching, thinning scalp hair; or
  • vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

What Is Osteoporosis? Treatment, Symptoms, Medication See Slideshow
Prempro Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trial 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.

In a 1-year clinical trial that included 678 postmenopausal women treated with PREMPRO and 351 postmenopausal women treated with PREMPHASE, the following adverse reactions occurred at a rate ≥ 1 percent, see Table 1.

TABLE 1: ALL TREATMENT RELATED ADVERSE REACTIONS AT A FREQUENCY ≥ 1 PERCENT

Body System Adverse event PREMPRO 0.625 mg/2.5 mg continuous
(n = 340)		 PREMPRO 0.625 mg/5 mg continuous
(n = 338)		 PREMPHASE 0.625 mg/5 mg sequential
(n = 351)
Body As A Whole
  Abdominal pain 35 (10%) 51 (15%) 58 (17%)
  Asthenia 13 (4%) 18 (5%) 21 (6%)
  Back pain 19 (6%) 16 (5%) 23 (7%)
  Chest pain 5 (1%) 4 (1%) 4 (1%)
  Flu syndrome 1 ( < 1%) 1 ( < 1%) 4 (1%)
  Generalized edema 12 (4%) 12 (4%) 8 (2%)
  Headache 64 (19%) 52 (15%) 66 (19%)
  Infection 2 ( < 1%) 4 (1)% 0
  Moniliasis 4 (1%) 3 ( < 1%) 4 (1%)
  Pain 12 (4%) 14 (4%) 15 (4%)
  Pelvic pain 11 (3%) 13 (4%) 16 (5%)
Cardiovascular System
  Hypertension 7 (2%) 7 (2%) 6 (2%)
  Migraine 6 (2%) 8 (2%) 7 (2%)
  Palpitation 2 ( < 1%) 3 ( < 1%) 4 (1%)
  Vasodilatation 2 ( < 1%) 7 (2%) 2 ( < 1%)
Digestive System
  Diarrhea 4 (1%) 3 ( < 1%) 7 (2%)
  Dyspepsia 5 (1%) 5 (1%) 7 (2%)
  Eructation 0 2 ( < 1%) 4 (1%)
  Flatulence 25 (7%) 27 (8%) 24 (7%)
  Increased appetite 1 ( < 1%) 5 (1%) 5 (1%)
  Nausea 26 (8%) 19 (6%) 26 (7%)
Metabolic and Nutritional
  Edema 5 (1%) 6 (2%) 3 ( < 1%)
  Glucose tolerance decreased 2 ( < 1%) 5 (1%) 4 (1%)
  Peripheral edema 11 (3%) 10 (3%) 11 (3%)
  Weight gain 9 (3%) 10 (3%) 11 (3%)
Musculoskeletal System
  Arthralgia 6 (2%) 2 ( < 1%) 7 (2%)
  Leg cramps 8 (2%) 11 (3%) 12 (3%)
Nervous System
  Depression 14 (4%) 26 (8%) 29 (8%)
  Dizziness 9 (3%) 8 (2%) 7 (2%)
  Emotional lability 5 (1%) 5 (1%) 6 (2%)
  Hypertonia 4 (1%) 4 (1%) 7 (2%)
  Insomnia 7 (2%) 6 (2%) 4 (1%)
  Nervousness 4 (1%) 9 (3%) 6 (2%)
Skin and Appendages
  Acne 1 ( < 1%) 5 (1%) 4 (1%)
  Alopecia 3 ( < 1%) 4 (1%) 0
  Dry skin 2 ( < 1%) 3 ( < 1%) 4 (1%)
  Pruritus 20 (6%) 18 (5%) 13 (4%)
  Rash 8 (2%) 6 (2%) 7 (2%)
  Sweating 2 ( < 1%) 4 (1%) 2 ( < 1%)
Urogenital System
  Breast engorgement 5 (1%) 5 (1%) 0
  Breast enlargement 14 (4%) 14 (4%) 14 (4%)
  Breast neoplasm 2 ( < 1%) 2 ( < 1%) 4 (1%)
  Breast pain 110 (32%) 123 (36%) 109 (31%)
  Cervix disorder 10 (3%) 6 (2%) 10 (3%)
  Dysmenorrhea 26 (8%) 18 (5%) 44 (13%)
  Leukorrhea 19 (6%) 13 (4%) 29 (8%)
  Menstrual disorder 7 (2%) 1 ( < 1%) 5 (1%)
  Menorrhagia 0 1 ( < 1%) 5 (1%)
  Metrorrhagia 13 (4%) 5 (1%) 7 (1%)
  Papanicolaou smear suspicious 5 (1%) 0 8 (2%)
  Urinary incontinence 4 (1%) 2 ( < 1%) 1 ( < 1%)
  Uterine spasm 7 (2%) 4 (1%) 7 (2%)
  Vaginal hemorrhage 5 (1%) 3 ( < 1%) 8 (2%)
  Vaginal moniliasis 5 (1%) 6 (2%) 7 (2%)
  Vaginitis 13 (4%) 13 (4%) 10 (3%)

In addition, phargyngitis and sinusitis were reported as two of the more frequent adverse events ( > 5 percent) in the PREMPRO clinical study. For pharyngitis, of the 121 events, six events were considered by the investigator causally related to study drug. For sinusitis, of the 73 events, one event was considered as casually related to study drug.

During the first year of a 2-year clinical trial with postmenopausal women between 40 and 65 years of age (88 percent Caucasian), 989 postmenopausal women received continuous regimens of PREMPRO, and 332 received placebo tablets. Table 2 summarizes adverse reactions that occurred at a rate ≥ 1 percent in at least 1 treatment group.

TABLE 2: ALL TREATMENT RELATED ADVERSE REACTIONS AT A FREQUENCY OF ≥ 1 PERCENT

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)

In addition, the following events were considered as related to the study drug with an incidence less than 1 percent, including accidental injury, infection, myalgia, cough increased, rhinitis, sinusitis, and upper respiratory infection.

Postmarketing Experience

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

Genitourinary System

Abnormal uterine bleeding, dysmenorrhea or pelvic pain, increase in size of uterine leiomyomata, vaginitis, vaginal candidiasis, amenorrhea, changes in cervical secretion, ovarian cancer, endometrial hyperplasia, endometrial cancer.

Breasts

Tenderness, enlargement, pain, nipple discharge, galactorrhea, fibrocystic breast changes, breast cancer.

Cardiovascular

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

Gastrointestinal

Nausea, vomiting, abdominal pain, bloating, cholestatic jaundice, increased incidence of gallbladder disease, pancreatitis, changes in appetite, ischemic colitis.

Skin

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

Eyes

Retinal vascular thrombosis, intolerance of contact lenses.

Central Nervous System

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

Miscellaneous

Increase or decrease in weight, arthralgia, glucose intolerance, edema, changes in libido, exacerbation of asthma, increased triglycerides, hypersensitivity.

Additional postmarketing adverse reactions have been reported in patients receiving other forms of hormone therapy.

Read the entire FDA prescribing information for Prempro (Conjugated Estrogens, Medroxyprogesterone Acetate)

Read More »

© Prempro Patient Information is supplied by Cerner Multum, Inc. and Prempro Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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