SIDE EFFECTS: Bloating, stomach/abdominal pain, nausea, breast tenderness, headache, drowsiness, mood swings, irritability, or vaginal discomfort may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if any of these unlikely but serious side effects occur: unusual vaginal bleeding, severe mental/mood changes (e.g., depression), swelling ankles/feet, yellowing eyes/skin, breast lumps. This medication may rarely cause very serious problems from blood clots (e.g., heart attack, stroke, blood clots in the lungs/legs, blindness). Seek immediate medical attention if you have any of the following symptoms: chest/jaw/left arm pain, weakness on one side of the body, slurred speech, difficulty walking, sudden vision/eye changes (e.g., blurred/double vision, loss of vision, bulging eyes), confusion, sudden severe headache, severe dizziness, fainting, trouble breathing, coughing up blood, pain/redness/swelling/weakness of the arms/legs, calf pain/swelling that is warm to the touch. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using progesterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of blood clots, recent stroke or heart attack (within 1 year), liver disease, cancer of the breast or other female organs, vaginal bleeding of unknown cause, a loss of pregnancy with some tissue remaining in the uterus ("missed abortion"), an abnormal pregnancy where the fertilized egg is outside of the uterus (ectopic pregnancy). Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, heart disease (e.g., past heart attacks, congestive heart failure), high blood pressure, seizures, migraine headaches, asthma, depression, diabetes, strokes, high level of fats in the blood (high cholesterol/triglycerides). This drug may make you drowsy. Alcohol or marijuana can make you more drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana. In general, alcohol is not recommended for pregnant or possibly pregnant women due to increased risk of harm to the baby. Although unlikely, blood clots may occur with this medication. Your risk is increased if you have surgery or if you stay in a chair or bed for a long time (e.g., a long plane flight). Tell your doctor beforehand of any of these events because you may need special precautions. This medication may be used during pregnancy, but only as directed by your doctor. Discuss the risks and benefits with your doctor. This drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: drugs affecting liver enzymes that remove progesterone from your body (such as rifampin, St. John's wort, azole antifungals including itraconazole, certain anti-seizure medicines including carbamazepine/phenobarbital/phenytoin). Do not use other vaginal products during treatment with this medication unless otherwise directed by your doctor. Doing so may affect how well the drug is absorbed by your body.

OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.