"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.
Prefest Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Prefest (estradiol/norgestimate) Tablets is a combination of female sex hormones used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. It is also used to prevent osteoporosis. This medication is available in generic form. Common side effects include stomach upset, nausea/vomiting, bloating, breast tenderness, headache, or weight changes.
Prefest regimen consists of the daily dose of a single tablet containing 1 mg estradiol (pink color) for three days followed by a single tablet of 1 mg estradiol combined with 0.09 mg norgestimate (white color) for three days. This regimen is repeated continuously without interruption. Prefest may interact with St. John's wort, antibiotics, antidepressants, antifungals, barbiturates, heart or blood pressure medications, HIV/AIDS medicines, or seizure medications. Tell your doctor all medications and supplements you use. Prefest 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 breastfeeding.
Our Prefest (estradiol/norgestimate) Tablets 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.
Prefest 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 using this medication and call your doctor at once if you have a serious side effect such as:
- unusual vaginal bleeding (especially if you are past menopause);
- 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;
- stabbing chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
- pain, swelling, warmth, or redness in one or both legs;
- nausea, vomiting, loss of appetite, increased thirst, muscle weakness, confusion, and feeling tired or restless;
- pain in your upper stomach, jaundice (yellowing of the skin or eyes);
- swelling in your hands, ankles, or feet; or
- a lump in your breast.
Less serious side effects may include:
- mild stomach pain, bloating;
- back pain, joint pain;
- flu symptoms;
- breast pain;
- loss of scalp hair;
- vaginal itching or discharge; or
- cold symptoms such as stuffy nose, sneezing, sore throat.
Read the entire detailed patient monograph for Prefest (Estradiol, Norgestimate) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Prefest 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.
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 Prefest (Estradiol, Norgestimate)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Prefest 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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Table 7. ALL TREATMENT-EMERGENT ADVERSE EVENTS REGARDLESS
OF DRUG RELATIONSHIP REPORTED AT A FREQUENCY OF ≥ 5% WITH PREFEST (estradiol, norgestimate)
|FOUR 12-MONTH CLINICAL TRIALS|
| PREFEST (estradiol, norgestimate) (Estradiol and NGM)
(N = 579)
|Body as a Whole|
|Back pain||69 (12%)|
|Fatigue||32 ( 6%)|
|Influenza-like symptoms||64 (11%)|
|Pain||37 ( 6%)|
|Abdominal pain||70 (12%)|
|Flatulence<||29 ( 5%)|
|Nausea||34 ( 6%)|
|Tooth disorder||27 ( 5%)|
|Arthralgia||51 ( 9%)|
|Myalgia||30 ( 5%)|
|Breast pain||92 (16%)|
|Dysmenorrhea||48 ( 8%)|
|Vaginal bleeding (all)||52 ( 9%)|
|Vaginitis||42 ( 7%)|
|Resistance Mechanism Disorders|
|Viral infection||35 ( 6%)|
|Coughing||28 ( 5%)|
|Pharyngitis||38 ( 7%)|
|Sinusitis||44 ( 8%)|
|Upper respiratory-tract infection||121 (21%)|
The following additional adverse reactions have been reported with estrogen and/or progestin therapy:
Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea, increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer.
Retinal vascular thrombosis, intolerance to contact lenses.
Central nervous system
Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthalgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.
Read the entire FDA prescribing information for Prefest (Estradiol, Norgestimate) »
Additional Prefest Information
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