Patient information: uses, side effects, how to take - Progesterone Vaginal
What is progesterone vaginal insert?
Progesterone is a vaginal insert that contains the hormone progesterone. Progesterone vaginal insert is for women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) program.
Progesterone is one of the hormones essential for helping you to become and to stay pregnant. If you are undergoing ART treatment, your doctor may prescribe progesterone vaginal insert to provide the progesterone your body needs.
Who should not use progesterone vaginal insert?
Do not use progesterone vaginal insert if you:
- Are allergic to anything in progesterone vaginal insert. See the end of this leaflet for a complete list of ingredients.
- Have unusual vaginal bleeding that has not been evaluated by a doctor.
- Currently have or have had liver problems or cancer of the breast or genital organs.
- Have or have had blood clots in the legs, lungs, eyes, or elsewhere in your body.
Progesterone vaginal insert may not be right for you. Before starting progesterone vaginal insert, tell your doctor about all your health problems.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vaginal products, vitamins, and herbal supplements.
Some medicines may affect progesterone vaginal insert.
Know what medicines you take. Keep a list of your medicines to show to the doctor and pharmacist.
How should I use progesterone vaginal insert?
- Use progesterone vaginal insert exactly as prescribed. The usual dose of progesterone vaginal insert is one insert placed in your vagina 2 to 3 times a day for up to a total of 10 weeks, unless your healthcare provider advises otherwise.
- Place an progesterone vaginal insert in your vagina with the disposable applicator provided.
Follow the steps below:
1 Unwrap the applicator. Do not use if the contents or packaging are visibly damaged.
- 2. Put one insert in the space provided at the end of the applicator. The insert should fit snugly and not fall out.
- 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. Push the plunger to release the insert.
- 5. Remove the applicator and throw it away in the trash.
Other information for using progesterone vaginal insert
- If you forget a dose of progesterone vaginal insert, 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 progesterone vaginal insert.
- Do not use any other vaginal products when you are using progesterone vaginal insert.
What are the possible side effects of progesterone vaginal insert?
Common side effects seen with ART and progesterone vaginal insert included pelvic pain after surgery, abdominal pain, nausea, and swollen ovaries (ovarian hyperstimulation syndrome).
Other reported side effects included abdominal bloating, headache, urinary infections, uterine cramping, constipation, vomiting, tiredness, and vaginal bleeding.
Vaginal products with progesterone may also cause vaginal irritation, burning, and discharge.
Serious Risks of Progesterone
Progesterone can increase your chance of getting blood clots. Blood clots can be serious and lead to death.
Serious blood clots include those in the:
- legs (thrombophlebitis)
- lungs (pulmonary embolus)
- eyes (blindness)
- heart (heart attack)
- brain (stroke)
Call your doctor or get medical help right away if you have:
- persistent pain in the lower leg (calf)
- sudden 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
- yellowing of the skin and/or white of the eyes indicating possible liver problem
Other risks of progesterone use include:
- headache
- breast tenderness
- bloating or fluid retention
- mood swings and depression
- irritability
- drowsiness
Call your doctor immediately if you have abnormal vaginal bleeding.
These are not all the side effects with progesterone vaginal insert. Ask your doctor or pharmacist for more information.
How should I store progesterone vaginal insert?
- Store progesterone vaginal insert at room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
- Do not use progesterone vaginal insert after the expiration date that is printed on the carton.
- Keep progesterone vaginal insert and all medicines out of the reach of children.
General information about progesterone vaginal insert
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use progesterone vaginal insert for a condition for which it was not prescribed. Do not give progesterone vaginal insert to other women, even if they have the same condition as you do. It may harm them.
This leaflet summarizes the most important information about progesterone vaginal insert. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about progesterone vaginal insert that was written for healthcare professionals. For more information call Sun Pharmaceutical Industries Inc. at 1-800-818-4555.
What are the ingredients in progesterone vaginal insert?
Active Ingredient:progesterone, USP
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
DISTRIBUTED BY:
SUN PHARMACEUTICAL INDUSTRIES, INC.
CRANBURY, NJ 08512
Revised: 02/2026