Imvexxy

Last updated on RxList: 7/18/2021
Imvexxy Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Imvexxy?

Imvexxy (estradiol vaginal inserts) is an estrogen indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.

What Are Side Effects of Imvexxy?

Common side effects of Imvexxy include:

  • headache

Dosage for Imvexxy

Imvexxy should be administered intravaginally at a dose of 1 vaginal insert daily for 2 weeks, followed by 1 insert twice weekly (for example, Monday and Thursday).

What Drugs, Substances, or Supplements Interact with Imvexxy?

Imvexxy may interact with other drugs. Tell your doctor all medications and supplements you use.

Imvexxy During Pregnancy or Breastfeeding

Imvexxy is not indicated for use in pregnancy or for use in females of reproductive potential or who are breastfeeding.

Additional Information

Our Imvexxy (estradiol vaginal inserts) 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.

SLIDESHOW

What Is Osteoporosis? Treatment, Symptoms, Medication See Slideshow
Imvexxy 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 Imvexxy (Estradiol Vaginal Inserts)

QUESTION

If menopause occurs in a woman younger than ___ years, it is considered to be premature. See Answer
Imvexxy Professional Information

SIDE EFFECTS

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

  • Cardiovascular Disorders [see WARNINGS AND PRECAUTIONS].
  • Malignant Neoplasms [see 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.

The safety of IMVEXXY 4 mcg and 10 mcg was assessed in a single, double-blind, parallel-group, placebo-controlled trial (N=382). The duration of treatment in this trial was 12 weeks (dosing occurred every day for 14 days and then twice weekly thereafter for maintenance).

Adverse reactions with an incidence of ≥3 percent in any IMVEXXY group and numerically greater than those reported in the placebo group are listed in Table 1.

Table 1: Treatment-Emergent Adverse Reactions Reported at a Frequency of ≥3% and Numerically More Common in Women Receiving IMVEXXY

System Organ Class
Preferred Term
IMVEXXY
4 mcg
(N=191)
IMVEXXY
10 mcg
(N=191)
Placebo
(N=192)
Nervous system disorders, n (%)
Headache 7 (3.7) 5 (2.6) 6 (3.1)

Read the entire FDA prescribing information for Imvexxy (Estradiol Vaginal Inserts)

© Imvexxy Patient Information is supplied by Cerner Multum, Inc. and Imvexxy Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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