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Prempro

"March 14, 2013 -- Hormone replacement therapy is the most effective treatment for symptoms like hot flashes, and the benefits are likely to outweigh the risks, major medical societies say.

The statement was published in the April issue "...

Prempro, Premphase

Prempro, Premphase

Prempro Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Prempro (conjugated estrogens/medroxyprogesterone acetate) is 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). Prempro is a combination of conjugated estrogens, which is a mixture of female sex hormones, and medroxyprogesterone, another female hormone, called progesterone. Common side effects include stomach upset, nausea/vomiting, bloating, breast tenderness, headache, or weight changes.

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. 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 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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Prempro in Detail - Patient Information: Side Effects

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

Stop taking this medication and call your doctor at once if you have any of these serious side effects:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • pain or swelling in your lower leg;
  • abnormal vaginal bleeding;
  • migraine headache;
  • pain, swelling, or tenderness in your stomach;
  • confusion, problems with memory or concentration;
  • jaundice (yellowing of the skin or eyes);
  • swelling in your hands, ankles, or feet; or
  • a breast lump.

Less serious side effects may include:

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

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.

Read the entire detailed patient monograph for Prempro (Conjugated Estrogens, Medroxyprogesterone Acetate) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Prempro Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Stomach upset, nausea/vomiting, bloating, breast tenderness, headache, or weight changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, memory loss), breast lumps, unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged/recurrent bleeding), increased or new vaginal irritation/itching/odor/discharge, severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine, swelling hands/ankles/feet, increased thirst/urination.

This medication may rarely cause serious problems from blood clots (such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism). Get medical help right away if you have any serious side effects, including: chest/jaw/left arm pain, unusual sweating, sudden/severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (such as partial/complete blindness), pain/redness/swelling of legs, tingling/weakness/numbness in the arms/legs, trouble breathing, coughing up blood, sudden dizziness/fainting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Prempro (Conjugated Estrogens, Medroxyprogesterone Acetate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Prempro FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 PREMPRO PREMPRO PREMPHASE

Body System
Adverse event
0.625 mg/2.5 mg
continuous
(n = 340)
0.625 mg/5 mg
continuous
(n = 338)
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) »

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Prempro, Premphase - User Reviews

Prempro, Premphase User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Prempro, Premphase sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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