Brand Names: First Progesterone MC10, First Progesterone MC5, Progest, Prometrium

Generic Name: progesterone (Pronunciation: proe JESS te role)

• What is progesterone (Prometrium)?
• What are the possible side effects of progesterone (Prometrium)?
• What is the most important information I should know about progesterone (Prometrium)?
• What should I discuss with my healthcare provider before using progesterone (Prometrium)?
• How should I use progesterone (Prometrium)?
• What happens if I miss a dose (Prometrium)?
• What happens if I overdose (Prometrium)?
• What should I avoid while using progesterone (Prometrium)?
• What other drugs will affect progesterone (Prometrium)?
• Where can I get more information?

What is progesterone (Prometrium)?

Progesterone is a female hormone important for the regulation of ovulation and menstruation.

Progesterone is used to cause menstrual periods in women who have not yet reached menopause but are not having periods due to a lack of progesterone in the body. Progesterone is also used to prevent overgrowth in the lining of the uterus in postmenopausal women who are receiving estrogen hormone replacement therapy.

Progesterone should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

Progesterone may also be used for other purposes not listed in this medication guide.

Prometrium 100 mg

spherical, peach, imprinted with SV

Prometrium 200 mg

oval, yellow, imprinted with SV2

What are the possible side effects of progesterone (Prometrium)?

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.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;
• fast or pounding heartbeats;
• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• unusual or unexpected vaginal bleeding;
• migraine headache;
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• swelling in your hands, ankles, or feet;
• fever, chills, body aches, flu symptoms;
• a breast lump; or
• symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

• mild nausea, diarrhea, bloating, stomach cramps;
• dizziness, spinning sensation;
• hot flashes;
• mild headache;
• joint pain;
• breast pain or tenderness;
• cough;
• acne or increased hair growth;
• changes in weight; or
• vaginal itching, dryness, or discharge.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about progesterone (Prometrium)?

Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Some forms of this medication may contain peanut oil. Do not use progesterone without telling your doctor if you have a peanut allergy.

Using progesterone can increase your risk of blood clots, stroke, heart attack, or breast cancer.

Do not use this medication if you have any of the following conditions: a history of breast cancer, abnormal vaginal bleeding, liver disease, if you are pregnant, or if you have had a stroke, heart attack, or blood clot within the past year.

Progesterone is sometimes given for only a short period of time, such as 6 to 12 days at a time during each menstrual cycle. Following your dosing schedule is very important for this medication to be effective. Try not to miss any doses.

Progesterone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Progesterone should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.