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Endometrin (Progesterone): Uses, Side Effects and Dosage

Status:
Prescription (Rx) Facts
Strength:
100 mg
Other brand names:
Drug class:
Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Endometrin

What is ENDOMETRIN?

  • ENDOMETRIN is a prescription medicine vaginal insert that contains the hormone progesterone and is used to support embryo implantation in women less than 35 years of age while undergoing treatment for infertility (an Assisted Reproductive Technology (ART) program) and to maintain pregnancy for up to 10 weeks.
  • It is not known if ENDOMETRIN is safe and effective in children.
  • Important: For Vaginal Use Only.

Who should not use ENDOMETRIN?

Do not use ENDOMETRIN if you:

  • are allergic to progesterone or any of the ingredients in ENDOMETRIN. See the end of this leaflet for a complete list of ingredients in ENDOMETRIN.
  • have abnormal, undiagnosed vaginal bleeding.
  • have a known missed abortion or ectopic pregnancy.
  • currently have or have had certain liver problems.
  • currently have or have had cancer that is hormone sensitivity such as breast cancer.
  • currently have or have had blood clots.

Before using ENDOMETRIN, tell your healthcare provider about all of your medical conditions, including if you:

  • have a history of a heart attack, stroke (cerebrovascular disorders), or blood clots.
  • have a history of depression.
  • are currently using any other vaginal products (such as antifungal products).
  • are pregnant.

  • are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby while using ENDOMETRIN.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. You should not use ENDOMETRIN while using other vaginal products. Using ENDOMETRIN with certain other medicines may affect how ENDOMETRIN works.

Know what medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use ENDOMETRIN?

  • Use ENDOMETRIN exactly as your healthcare provider tells you to.
  • ENDOMETRIN is placed in your vagina 2 to 3 times a day for up to a total of 10 weeks.

Do not use any other vaginal products while using ENDOMETRIN.

Follow the steps below:

  1. 1. Unwrap the applicator. Do not use if the contents or packaging are visibly damaged.
  2. 2. Put one vaginal insert in the space provided at the end of the applicator. The insert should fit snugly and not fall out.
  3. 3. Place applicator with the insert into the vagina while you are standing, sitting, or when lying on your back with your knees bent. Gently place the thin end of the applicator well into the vagina.
  4. 4. Push the plunger to release the insert.
  5. 5. Remove the applicator and throw it away in the trash.

Other information for using ENDOMETRIN

  • If you forget a dose of ENDOMETRIN, take the dose as soon as you remember, but do not use more than your daily dose.
  • Call your doctor if you use too much ENDOMETRIN.

What are the possible side effects of ENDOMETRIN?

ENDOMETRIN may cause serious side effects, including:

  • Risk of heart attack, stroke, or blood clots. Your healthcare provider may stop ENDOMETRIN if you have signs of heart attack, stroke, or blood clots. Symptoms of heart attack or blood clots may include:
  • pain in lower leg
  • shortness of breath
  • coughing up blood
  • sudden blindness, partial or complete
  • severe chest pain
  • sudden severe headache, vomiting, dizziness, or fainting
  • weakness in an arm or leg, or trouble speaking
  • D epressed mood. Your healthcare provider may stop ENDOMETRIN if symptoms of depressed mood worsen.

The most common side effects of ENDOMETRIN include:

  • abdominal pain
  • nausea
  • abdominal bloating
  • constipation
  • vomiting
  • fatigue
  • pelvic pain after surgery
  • headache
  • swollen ovaries
  • uterine cramping
  • vaginal bleeding

Call your healthcare provider right away if you have irregular vaginal bleeding.

These are not all of the possible side effects of ENDOMETRIN. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ENDOMETRIN?

  • Store ENDOMETRIN at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep ENDOMETRIN and all medicines out of the reach of children.

General information about the safe and effective use of ENDOMETRIN.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ENDOMETRIN for a condition for which it was not prescribed. Do not give ENDOMETRIN to other women, even if they have the same condition as you do. It may harm them. You can ask your pharmacist or healthcare provider for information about ENDOMETRIN that is written for health professionals.

What are the ingredients in ENDOMETRIN?

Active Ingredient: progesterone

Inactive Ingredients: lactose monohydrate, polyvinylpyrrolidone, adipic acid, sodium bicarbonate, sodium lauryl sulfate, magnesium stearate, pregelatinized starch, and colloidal silicon dioxide

MANUFACTURED FOR:

FERRING PHARMACEUTICALS INC.

PARSIPPANY, NJ 07054

For more information call Ferring Pharmaceuticals Inc. at 1-(888)-FERRING or 1-(888)-337-7464.

This Patient Information has been approved by the U.S. Food and Drug Administration

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 022057 · View the label on DailyMed

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Endometrin

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Progesterone
Active ingredient Progesterone 100 mg
Dosage form Insert
Route Vaginal
Marketing status listed in the FDA NDC Directory
Company (applicant) FERRING
FDA approval NDA 022057New Drug Application (NDA) Approved June 21, 2007
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Progesterone Vaginal with the same TE code
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
100 mg – 1 in 1 blister pack / 21 in 1 carton / 1 in 1 carton NDC 55566-6500-1
100 mg – 1 in 1 blister pack / 21 in 1 carton / 1 in 1 carton NDC 55566-6500-4

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.