Vagifem

• Overview
• Consumer Information
• Professional Information

 

Vagifem Side Effects Center

What Is Vagifem?

Vagifem (estradiol vaginal) is a female hormone (estrogen) used by women to help reduce vaginal symptoms of menopause (such as vaginal dryness/burning/itching).

What Are Side Effects of Vagifem?

Common side effects of Vagifem include:

• nausea,
• stomach cramps,
• vomiting,
• bloating,
• diarrhea,
• breast swelling or tenderness,
• nipple discharge,
• vaginal itching or discharge,
• swelling of your ankles or feet,
• headache (including migraines),
• weight changes,
• dizziness,
• cold symptoms (stuffy nose, sneezing, sore throat),
• acne,
• skin color changes,
• increased facial hair,
• thinning scalp hair,
• depression,
• changes in your menstrual periods, or
• break-through bleeding.

Tell your doctor if you have serious side effects of Vagifem including:

• mental/mood changes (such as depression, memory loss),
• breast lumps,
• unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged or recurrent bleeding),
• increased or new vaginal irritation/itching/odor/discharge,
• severe stomach or abdominal pain,
• persistent nausea or vomiting,
• yellowing eyes or skin,
• dark urine,
• swelling hands/ankles/feet, or
• increased thirst or urination.

Dosage for Vagifem

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.

What Drugs, Substances, or Supplements Interact with Vagifem?

Some products that may interact with Vagfem include aromatase inhibitors, fulvestrant, raloxifene, tamoxifen, or toremifene. Tell your doctor all medications you are taking.

Vagifem During Pregnancy and Breastfeeding

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 breastfeeding.

Additional Information

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.

 

Vagifem Consumer Information

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.

Remove the vaginal ring and seek emergency medical attention if you have: fever with nausea, vomiting, diarrhea, muscle pain, dizziness, fainting, and/or sunburn-like skin rash. These may be signs of a life-threatening disease called toxic shock syndrome.

Call your doctor at once if you have:

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
• swelling or tenderness in your stomach;
• jaundice (yellowing of the skin or eyes);
• memory problems, confusion, unusual behavior;
• unusual vaginal bleeding, pelvic pain;
• a lump in your breast; or
• high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects may include:

• nausea, vomiting, bloating, stomach cramps;
• headache;
• swelling in your hands or feet, weight gain;
• breast pain; or
• vaginal itching or discharge, changes in your menstrual periods, breakthrough 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)

 

Vagifem Professional Information

SIDE EFFECTS

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

• Cardiovascular Disorders [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
• Malignant Neoplasms [see BOXED WARNING, WARNINGS AND PRECAUTIONS]

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 inserts. 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 inserts. 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)

&Copy; Vagifem Patient Information is supplied by Cerner Multum, Inc. and Vagifem Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.