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Premarin

"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 "...

Premarin

Premarin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Premarin (conjugated estrogens) is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. It is also used to prevent osteoporosis in postmenopausal women, and replace of estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body. Conjugated estrogens are sometimes used as part of cancer treatment in women and men. Estrogen is a female hormone. Common side effects include stomach upset, nausea/vomiting, bloating, breast tenderness, headache, or weight changes.

Women should be started at 0.3 mg Premarin daily. Dosage adjustment may be made based on patient response. Dose may vary depending on the condition being treated. Premarin may interact with blood thinners, thyroid medications, insulin or oral diabetes medicine, rifampin, ketoconazole or itraconazole, seizure medicines, barbiturates, or antidepressants. Tell your doctor all medications you use. Premarin must not be used during pregnancy. This medication passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breast-feeding.

Our Premarin (conjugated estrogens) 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.

Premarin in Detail - Patient Information: Side Effects

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

Stop using conjugated estrogens and call your doctor at once if you have a serious side effect such as:

  • 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 severe headache, confusion, problems with vision, speech, or balance;
  • pain, swelling, warmth, or redness in one or both legs;
  • 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 cramps;
  • breast pain, tenderness, or swelling;
  • freckles or darkening of facial skin;
  • 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
  • mild 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 Premarin (Conjugated Estrogens) »

What is Patient Information Overview?

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

Premarin 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.

Tell your doctor promptly if you see the tablet in your stool.

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 product 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 Premarin (Conjugated Estrogens)»

What is Prescribing information?

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

Premarin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

See BOXED WARNINGS, WARNINGS, and PRECAUTIONS.

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

During the first year of a 2-year clinical trial with 2,333 postmenopausal women between 40 and 65 years of age (88 percent Caucasian), 1,012 women were treated with conjugated estrogens and 332 were treated with placebo. Table 6 summarizes adverse events that occurred at a rate of ≥ 5 percent.

TABLE 6. NUMBER (%) OF PATIENTS REPORTING ≥ 5 PERCENT TREATMENT EMERGENT ADVERSE EVENTS

Body System
  Adverse event
--Conjugated Estrogens Treatment Group--
0.625 mg
(n = 348)
0.45 mg
(n = 338)
0.3 mg
(n = 326)
Placebo
(n = 332)
Any adverse event 323 (93%) 305 (90%) 292 (90%) 281 (85%)
Body as a Whole
  Abdominal pain 56 (16%) 50 (15%) 54 (17%) 37(11%)
  Accidental injury 21 (6%) 41 (12%) 20 (6%) 29 (9%)
  Asthenia 25 (7%) 23 (7%) 25 (8%) 16 (5%)
  Back pain 49 (14%) 43 (13%) 43 (13%) 39 (12%)
  Flu syndrome 37(11%) 38(11%) 33 (10%) 35(11%)
  Headache 90 (26%) 109 (32%) 96 (29%) 93 (28%)
  Infection 61 (18%) 75 (22%) 74 (23%) 74 (22%)
  Pain 58 (17%) 61 (18%) 66 (20%) 61 (18%)
Digestive System
  Diarrhea 21 (6%) 25 (7%) 19 (6%) 21 (6%)
  Dyspepsia 33 (9%) 32 (9%) 36(11%) 46 (14%)
  Flatulence 24 (7%) 23 (7%) 18(6%) 9 (3%)
  Nausea 32 (9%) 21 (6%) 21 (6%) 30 (9%)
Musculoskeletal System
  Arthralgia 47 (14%) 42 (12%) 22 (7%) 39 (12%)
  Leg cramps 19 (5%) 23 (7%) 11(3%) 7 (2%)
  Myalgia 18(5%) 18(5%) 29 (9%) 25 (8%)
Nervous System
  Depression 25 (7%) 27 (8%) 17 (5%) 22 (7%)
  Dizziness 19 (5%) 20 (6%) 12 (4%) 17 (5%)
  Insomnia 21 (6%) 25 (7%) 24 (7%) 33 (10%)
  Nervousness 12 (3%) 17 (5%) 6 (2%) 7 (2%)
Respiratory System
  Cough increased 13 (4%) 22 (7%) 14 (4%) 14 (4%)
  Pharyngitis 35 (10%) 35 (10%) 40 (12%) 38(11%)
  Rhinitis 21 (6%) 30 (9%) 31 (10%) 42 (13%)
  Sinusitis 22 (6%) 36(11%) 24 (7%) 24 (7%)
  Upper respiratory infection 42 (12%) 34 (10%) 28 (9%) 35(11%)
Skin and Appendages
  Pruritus 14 (4%) 17 (5%) 16(5%) 7 (2%)
Urogenital System
  Breast pain 38(11%) 41 (12%) 24 (7%) 29 (9%)
  Leukorrhea 18(5%) 22 (7%) 13 (4%) 9 (3%)
  Vaginal hemorrhage 47 (14%) 14 (4%) 7 (2%) 0
  Vaginal moniliasis 20 (6%) 18(5%) 17 (5%) 6 (2%)
  Vaginitis 24 (7%) 20 (6%) 16(5%) 4 (1%)

Postmarketing Experience

The following additional adverse reactions have been identified during post approval use of PREMARIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not 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, including vaginal candidiasis, change in cervical secretion, ovarian cancer, endometrial hyperplasia, endometrial cancer, leukorrhea.

Breast

Tenderness, enlargement, pain, discharge, galactorrhea, fibrocystic breast changes, breast cancer, gynecomastia in males.

Cardiovascular

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

Gastrointestinal

Nausea, vomiting, abdominal pain, bloating, cholestatic jaundice, increased incidence of gallbladder disease, pancreatitis, enlargement of hepatic hemangiomas, ischemic colitis.

Skin

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

Eyes

Retinal vascular thrombosis, intolerance to contact lenses.

Central Nervous System

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

Miscellaneous

Increase or decrease in weight, glucose intolerance, aggravation of porphyria, edema, arthralgias, leg cramps, changes in libido, urticaria, 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 Premarin (Conjugated Estrogens) »

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Premarin - User Reviews

Premarin 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 Premarin 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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