Medical Editor: John P. Cunha, DO, FACOEP
What Is Endometrin?
Endometrin (progesterone) Vaginal Insert is a progestin used to help support pregnancy in women who have fertility problems.
What Are Side Effects of Endometrin?
Common side effects of Endometrin include:
- bloating,
- stomach pain or cramps,
- nausea,
- vomiting,
- diarrhea,
- constipation,
- breast pain/swelling/tenderness,
- headache,
- drowsiness,
- dizziness,
- tired feeling,
- mood swings,
- irritability,
- vaginal or rectal pain or discomfort,
- pain during intercourse,
- loss of interest in sex,
- joint or muscle pain,
- increased night-time urination, or
- vaginal itching, burning, or discharge.
Tell your doctor if you have unlikely but serious side effects of Endometrin including:
- unusual vaginal bleeding,
- severe mental/mood changes (e.g., depression),
- swelling ankles or feet,
- yellowing eyes or skin, or
- breast lumps.
Endometrin may cause serious side effects including:
- unusual vaginal bleeding,
- pain or burning when you urinate,
- depression,
- sleep problems,
- weakness,
- mood changes,
- breast lump,
- sudden vision problems,
- severe headache,
- pain behind your eyes,
- chest pain or pressure,
- pain spreading to your jaw or shoulder,
- nausea,
- sweating,
- upper stomach pain,
- itching,
- tired feeling,
- loss of appetite,
- dark urine,
- clay-colored stools,
- yellowing of the skin or eyes (jaundice),
- sudden numbness or weakness (especially on the side of the body),
- slurred speech,
- problems with speech or balance,
- sudden cough,
- wheezing,
- rapid breathing,
- coughing up blood, and
- pain, swelling, warmth, or redness in one or both legs
Get medical help right away, if you have any of the symptoms listed above.
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Endometrin
The recommended dosage of Endometrin is one 100 mg application 2 to 3 times per day. If you become pregnant continue using Endometrin for 10 weeks.
What Drugs, Substances, or Supplements Interact with Endometrin?
Rifampin, St. John's wort, azoles, itraconazole, carbamazepine, phenobarbital, and phenytoin may interact with Endometrin. Tell your doctor all medications you take. Do not drive, use machinery, or do any activity that requires alertness after taking Endometrin. Avoid alcohol while taking Endometrin.
Endometrin During Pregnancy or Breastfeeding
Talk to your doctor if you are breastfeeding while taking Endometrin.
Additional Information
Our Endometrin (progesterone) Vaginal Insert 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
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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- unusual vaginal bleeding;
- pain or burning when you urinate;
- symptoms of depression (sleep problems, weakness, mood changes);
- a breast lump;
- sudden vision problems, severe headache or pain behind your eyes;
- heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
- liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with speech or balance;
- signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
- signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.
Common side effects may include:
- dizziness, confusion, drowsiness, tiredness;
- headache, mood changes, feeling nervous or irritable;
- stomach pain, nausea, diarrhea, constipation;
- bloating, swelling in your hands or feet;
- breast pain, swelling, or tenderness;
- cramps, pelvic pain; or
- vaginal itching, burning, or discharge.
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.

QUESTION
Men and women are equally likely to have fertility problems. See AnswerSIDE EFFECTS
Clinical Study 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 data reflect exposure to ENDOMETRIN in 808 infertile women (74.9% White, 10.3% Hispanic, 5.4% Black, 5% Asian, and 4.6% Other) in a single Assisted Reproductive Technology 10 week clinical study conducted in the U.S. ENDOMETRIN was studied at doses of 100 mg twice daily and 100 mg three times daily. The adverse reactions that occurred at a rate greater than or equal to 2% in either ENDOMETRIN group are summarized in Table 1.
Table 1: Number and Frequency of Reported Adverse Reactions in Women Treated with ENDOMETRIN in an Assisted Reproductive Technology Study
Body System Preferred Term |
ENDOMETRIN 100 mg twice daily (N=404) |
ENDOMETRIN 100 mg three times daily (N=404) |
Gastrointestinal Disorders | ||
Abdominal pain | 50 (12%) | 50 (12%) |
Nausea | 32 (8%) | 29 (7%) |
Abdominal distension | 18 (4%) | 17 (4%) |
Constipation | 9 (2%) | 14 (3%) |
Vomiting | 13 (3%) | 9 (2%) |
General Disorders and Administration Site Conditions | ||
Fatigue | 7 (2%) | 12 (3%) |
Infections and Infestations | ||
Urinary tract infection | 9 (2%) | 4 (1%) |
Injury, Poisoning and Procedural Complications | ||
Post-oocyte retrieval pain | 115 (28%) | 102 (25%) |
Nervous System Disorders | ||
Headache | 15 (4%) | 13 (3%) |
Reproductive System and Breast Disorders | ||
Ovarian hyperstimulation syndrome | 30 (7%) | 27 (7%) |
Uterine spasm | 15 (4%) | 11 (3%) |
Vaginal bleeding | 13 (3%) | 14 (3%) |
Other less common reported adverse reactions included vaginal irritation, itching, burning, discomfort, urticaria, and peripheral edema.
Expected Adverse Reaction Profile Seen With Progesterone
ENDOMETRIN is also expected to have adverse reactions similar to other drugs containing progesterone that may include breast tenderness, bloating, mood swings, irritability, and drowsiness.
Read the entire FDA prescribing information for Endometrin (Progesterone)
© Endometrin Patient Information is supplied by Cerner Multum, Inc. and Endometrin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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