Prempro

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• Consumer Information
• Professional Information

 

Prempro Side Effects Center

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?

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

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.

 

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.

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

 

Prempro Professional Information

SIDE EFFECTS

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

• Cardiovascular Disorders [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
• Malignant Neoplasms [see BOXED WARNING, WARNINGS AND PRECAUTIONS]

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)

&Copy; 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.