Your safety is our first priority. Learn more about key medication details, possible side effects, warnings, and other important information about progesterone below.
Prescribing Information
Progesterone capsules are prescription hormones available in strengths including 100 mg and 200 mg. FDA-approved uses include prevention of endometrial hyperplasia in certain postmenopausal women taking estrogen and treatment of secondary amenorrhea. Other hormone-care uses may be off-label.
Black Box Warning
Progesterone labeling includes a boxed warning addressing the increased risks observed with estrogen-plus-progestin therapy, including cardiovascular events, breast cancer, and probable dementia in certain postmenopausal women. Estrogen plus progestin should not be used to prevent cardiovascular disease or dementia.
Common Side Effects
Common or possible side effects may include:
- Drowsiness
- Dizziness
- Headache
- Nausea
- Fatigue
- Breast tenderness
- Abdominal bloating
- Mood changes
- Spotting or menstrual changes
- Acne
Important Safety Information
Do not use progesterone if you have unexplained vaginal bleeding, known or suspected breast cancer, active or prior blood clots or stroke, significant liver disease, a known allergy, or another contraindication identified by your provider. FDA-approved capsules should not be used during pregnancy.
Tell your provider about migraine, depression, seizure disorders, asthma, diabetes, heart or kidney disease, clotting history, abnormal bleeding, cancer risk, pregnancy, and breastfeeding.
Progesterone can cause marked dizziness or drowsiness. Take it exactly as directed, often at bedtime, and avoid driving or hazardous activity until you know how it affects you.
Seek urgent medical help for chest pain, shortness of breath, one-sided weakness, severe headache, vision changes, leg swelling, fainting, severe allergic symptoms, or signs of liver injury.
To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
