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Vagifem

"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.

Dyspareunia"...

Vagifem

Vagifem Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Vagifem (estradiol vaginal) is used by women to help reduce vaginal symptoms of menopause (such as vaginal dryness/burning/itching). This medication is a female hormone (estrogen). Common side effects include nausea/vomiting, bloating, diarrhea, breast tenderness, headache, or weight changes.

The initial dose of Vagifem is one tablet, inserted vaginally, once daily for two weeks, at the same time each day. The maintenance dose is one tablet, inserted vaginally, twice weekly. Some products that may interact with Vagfem include aromatase inhibitors, fulvestrant, raloxifene, tamoxifen, or toremifene. Tell your doctor all medications you are taking. Vagifem 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.

Our Vagifem (estradiol vaginal) 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.

Vagifem 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.

Call your doctor at once if you have any of these serious side effects:

  • 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 headache, confusion, problems with vision, speech, or balance;
  • pain, swelling, warmth, or redness in one or both legs;
  • abnormal vaginal bleeding;
  • pain, swelling, or tenderness in your stomach;
  • jaundice (yellowing of the skin or eyes); or
  • a lump in your breast.

Less serious side effects may include:

  • nausea, vomiting, loss of appetite;
  • swollen breasts;
  • acne or skin color changes;
  • decreased sex drive, impotence, or difficulty having an orgasm;
  • migraine headaches or dizziness;
  • vaginal pain, dryness, or discomfort;
  • swelling of your ankles or feet;
  • depression; or
  • changes in your menstrual periods, break-through 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 Vagifem (Estradiol Vaginal Tablets) »

What is Patient Information Overview?

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

Vagifem Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea/vomiting, bloating, diarrhea, 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 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 Vagifem (Estradiol Vaginal Tablets)»

What is Prescribing information?

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

Vagifem FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

Clinical Trials Experience

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.

In a 12-month randomized, double-blind, parallel group, placebo-controlled study, a total of 309 postmenopausal women were randomized to receive either placebo or Vagifem 10 mcg tablets. Adverse reactions with an incidence of ≥ 5 percent in the Vagifem 10 mcg group and greater than those reported in the placebo group are listed in Table 1.

Table 1: Treatment-Emergent Adverse Reactions Reported at a Frequency of ≥ 5 Percent in Women Receiving Vagifem 10 mcg

Body System
Adverse Reaction
Treatment
Number (%) of Women
Placebo
N=103
n(%)
Vagifem
N = 205
n(%)
Body As A Whole
  Back Pain 2(2) 14(7)
Digestive System
  Diarrhea 0 11(5)
Urogenital System
  Vulvovaginal Mycotic Infection 3(3) 17(8)
  Vulvovaginal Pruritus 2(2) 16(8)
N = Total number of women in study.
n = Number of women who experienced adverse reactions.

In a 12-week, randomized, double-blind, placebo-controlled study, 138 postmenopausal women were randomized to receive either placebo or Vagifem 25 mcg tablets. Adverse reactions with an incidence of ≥ 5 percent in the Vagifem 25 mcg group and greater than those reported in the placebo group are listed in Table 2.

Table 2: Treatment-Emergent Adverse Reactions Reported at a Frequency of ≥ 5 Percent in Women Receiving Vagifem 25 mcg

Body System
Adverse Reaction
Treatment
Number (%) of Women
Placebo
N = 47
n (%)
Vagifem
N = 91
n (%)
Body As A Whole
  Headache 3(6) 8(9)
  Abdominal Pain 2(4) 6(7)
  Back Pain 3(6) 6(7)
Respiratory System
  Upper Respiratory Tract Infection 2(4) 5(5)
Urogenital System
  Moniliasis Genital 1(2) 5(5)
N = Total number of women in study.
n = Number of women who experienced adverse reactions.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Vagifem 25 mcg. 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

Endometrial cancer, endometrial hyperplasia, vaginal irritation, vaginal pain, vaginismus, vaginal ulceration

Breast

Breast cancer

Cardiovascular

Deep vein thrombosis

Gastrointestinal

Diarrhea

Skin

Urticaria, erythematous or pruritic rash, genital pruritus

Central Nervous System

Aggravated migraine, depression, insomnia

Miscellaneous

Fluid retention, weight increase, drug ineffectiveness, hypersensitivity, blood estrogen increase

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

Read the entire FDA prescribing information for Vagifem (Estradiol Vaginal Tablets) »

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Vagifem - User Reviews

Vagifem 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 Vagifem 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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