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Common Side Effects of Prempro, Premphase (Conjugated


Udocheals.orgPrempro
5.19.2017 | Nathan Becker
Prempro
Common Side Effects of Prempro, Premphase (Conjugated

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.

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.

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.

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. In addition, phargyngitis and sinusitis were reported as two of the more frequent adverse events ( > 5 percent) in the PREMPRO clinical study.

Less serious side effects may include:

Prempro may interact with St. Treatment should be with the lowest effective dose and for the shortest duration. l your doctor all medications you are taking. If you become pregnant or think you may be pregnant, l your doctor immediay. Prempro therapy consists of a single tablet to be taken orally once daily. This medication passes into breast milk. Prempro must not be used during pregnancy. It may reduce the quality and amount of breast milk produced. John's wort, carbamazepine, phenobarbital, rifampin, ritonavir, ketoconazole or itraconazole, or antibiotics. Consult your doctor before breast-feeding.

Retinal vascular thrombosis, intolerance of contact lenses.

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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).

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

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

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

home drugs a-z list prempro, premphase (conjugated estrogens, medroxyprogesterone acetate) side effects drug center.

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

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.

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.

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.

Cunha, DO, FACOEP. Medical Editor: John P.

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

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

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

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

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 ). Common side effects of Prempro include:.

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

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

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.

Last reviewed on RxList 7/29/2016.

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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. The following adverse reactions have been identified during post-approval use of PREMPRO or PREMPHASE.

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

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

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

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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%).

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