"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
Premarin Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Premarin (conjugated estrogens) is a female hormone used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. Premarin is also used to prevent osteoporosis in postmenopausal women, and replace 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. Common side effects of Premarin include stomach upset or cramps, nausea/vomiting, bloating, breast tenderness or swelling, headache, weight or appetite changes, freckles or darkening of facial skin, 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.
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.
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
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
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
|--Conjugated Estrogens Treatment Group--|
| 0.625 mg
(n = 348)
| 0.45 mg
(n = 338)
| 0.3 mg
(n = 326)
(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%)|
|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%)|
|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%)|
|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%)|
|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%)|
|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%)|
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.
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.
Retinal vascular thrombosis, intolerance to contact lenses.
Central Nervous System
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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