This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.
Brand Names: US
Crinone; Endometrin; Prometrium
Brand Names: Canada
ACT Progesterone; AURO-Progesterone; Crinone; Endometrin; PMS-Progesterone; Prometrium; REDDY-Progesterone; TEVA-Progesterone
Capsules and injection:
- Do not use this drug with an estrogen to prevent heart disease or dementia. A study of women taking an estrogen with a progestin showed a raised chance of heart attack, stroke, breast cancer, a blood clot, and dementia.
- Use this drug for the shortest time needed at the lowest useful dose. Your doctor will talk with you on a regular basis to see if you need to keep taking this drug.
What is this drug used for?
- It is used to help you get and stay pregnant.
- It is used to lower the chance of endometrial changes after menopause in people who are getting estrogen therapy.
- It is used to treat uterine bleeding due to hormonal imbalance.
- It is used to treat people who do not have a monthly period cycle.
- It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
All products:
- If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If you have a peanut allergy and are taking the capsules. The capsules have peanut oil in them.
- If you have had any of these health problems: Bleeding disorder; blood clots or risk of having a blood clot; breast cancer or other cancer; liver disease; heart attack; stroke; or tumor where estrogen or progesterone make it grow.
- If you have unexplained vaginal bleeding.
- If you are pregnant or may be pregnant.
Injection and all vaginal products:
- If you have had a recent miscarriage.
All vaginal products:
- If you are using any other vaginal products. This includes drugs to treat fungal infections, vaginal lubricants, diaphragms, and condoms.
Vaginal insert:
- If you have had a pregnancy that is not inside the uterus (ectopic pregnancy).
This is not a list of all drugs or health problems that interact with this drug.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
All products:
- Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists. This drug may need to be stopped before certain types of surgery as your doctor has told you. If this drug is stopped, your doctor will tell you when to start taking this drug again after your surgery or procedure.
- Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
- If you have an allergy to any type of nuts or seeds, talk with your doctor.
- If you have high blood sugar (diabetes), talk with your doctor. This drug may raise blood sugar.
- Be sure to have regular breast exams and gynecology check-ups. You will also need to do breast self-exams as you have been told.
- This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
- Blood clots have happened with this drug. These clots have included heart attack, stroke, and clots in the leg, lung, or eye. Sometimes blood clots can be deadly. Tell your doctor if you have ever had a blood clot. Talk with your doctor.
- Talk with your doctor if you will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Not moving for long periods may raise your chance of blood clots.
- If you are 65 or older, use this drug with care. You could have more side effects.
- This drug is not a method of birth control and will not prevent pregnancy. If you have questions, talk with the doctor.
- Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
Vaginal insert:
- Ovarian hyperstimulation syndrome (OHSS) is a severe side effect that may happen in some people who use this drug. Call your doctor right away if you have severe stomach pain or bloating; very upset stomach, throwing up, or diarrhea; a big weight gain; shortness of breath; or change in how much urine is passed.
Capsules and injection:
- Certain side effects like heart attack, stroke, breast cancer, and others have been seen in some people taking a certain estrogen with a progestin. The risk may not be the same for everyone. Factors like how long the treatment is, if an estrogen is taken with or without a progestin, and other factors may affect the risk for certain side effects. Talk with your doctor about the benefits and risks of using this drug.
Injection:
- A type of pneumonia has happened with this drug. Call your doctor right away if you have shortness of breath or other trouble breathing, cough, or fever.
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
All products:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of liver problems like dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- Shortness of breath, a big weight gain, or swelling in the arms or legs.
- Trouble walking.
- Very bad dizziness or passing out.
- Eyesight changes or loss, bulging eyes, or change in how contact lenses feel.
- A lump in the breast, breast pain or soreness, or nipple discharge.
- Vaginal itching or discharge.
- Vaginal bleeding that is not normal.
- Pain when passing urine.
- Passing urine more often.
- Depression or other mood changes.
- Memory problems or loss.
- This drug may cause you to swell or keep fluid in your body. Tell your doctor if you have swelling, weight gain, or trouble breathing.
- Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.
Vaginal insert and ring:
- Pelvic pain.
Vaginal ring:
- Toxic shock syndrome (TSS) has happened in a few patients using vaginal rings. TSS is rare, but can be deadly. Tell your doctor right away if you have diarrhea, dizziness or light-headedness, passing out, fever, muscle pain, upset stomach, throwing up, or a sunburn-like rash.
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
All products:
- Feeling dizzy, sleepy, tired, or weak.
- Headache.
- Constipation, diarrhea, throwing up, or upset stomach.
- Stomach pain or cramps.
- Bloating.
- Enlarged breasts.
- Tender breasts.
- Muscle pain.
- Weight gain.
- Vaginal bleeding or spotting.
- Lowered interest in sex.
Injection and all vaginal products:
- Irritation where this drug was used.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to your national health agency.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
How is this drug best taken?
Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
Capsules:
- Take at bedtime if taking once a day.
- Take with or without food. Take with food if it causes an upset stomach.
- Take with a full glass of water.
- If you have trouble swallowing, talk with your doctor.
Injection:
- It is given as a shot into a muscle.
- If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
- Wash your hands before and after use.
- Do not use if the solution is cloudy, leaking, or has particles.
- Do not use if solution changes color.
- Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
Vaginal gel or vaginal insert:
- Do not take this drug by mouth. For vaginal use only. Keep out of your mouth, nose, and eyes (may burn).
- Wash hands before and after use.
- Do not use the applicators more than 1 time.
Vaginal gel:
- Do not take other vaginal drugs within 6 hours of this drug.
Vaginal ring:
- For vaginal use only.
- To use, wash your hands and take ring from the pouch. Keep the pouch to throw away the ring later.
- Press sides of ring at the same time between thumb and index finger and put folded ring into the vagina.
- Put the ring into the vagina as far as you can. If you can feel the ring, use your finger to push back a bit more. If you have trouble putting the ring in or if it comes out, you can rinse with cool to lukewarm water and put back in. Do not rinse with hot water.
- The ring needs to stay in place for at least 23 hours each day. It can be taken out during sex but you do not need to. Take out when you have been told and put a new ring in.
- To take out, hook your index finger through the ring and pull out.
- Do not throw the vaginal ring in the toilet.
- Wash your hands after use.
What do I do if I miss a dose?
- Take a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
All products:
- Store at room temperature. Do not refrigerate or freeze.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
Vaginal ring:
- Protect from heat.
General drug facts
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else’s drugs.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
- Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Consumer Information Use and Disclaimer
This generalized information is a limited summary of diagnosis, treatment, and/or medication information. It is not meant to be comprehensive and should be used as a tool to help the user understand and/or assess potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a specific patient. It is not intended to be medical advice or a substitute for the medical advice, diagnosis, or treatment of a health care provider based on the health care provider’s examination and assessment of a patient’s specific and unique circumstances. Patients must speak with a health care provider for complete information about their health, medical questions, and treatment options, including any risks or benefits regarding use of medications. This information does not endorse any treatments or medications as safe, effective, or approved for treating a specific patient. UpToDate, Inc. and its affiliates disclaim any warranty or liability relating to this information or the use thereof. The use of this information is governed by the Terms of Use, available at https://www.wolterskluwer.com/en/know/clinical-effectiveness-terms.
Last Reviewed Date
2024-03-19
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