Prometrium Side Effects (Guide)

Discussing Prometrium with Your Patient: Fertility and Hormonal Support

Prometrium (progesterone) is a prescription medication that belongs to the progestin drug class, which consists of synthetic and bioidentical forms of the hormone progesterone. It is commonly used for hormone replacement therapy (HRT) in menopausal women, to support pregnancy in cases of progesterone deficiency, and to treat secondary amenorrhea (absence of menstrual periods). Prometrium is available in oral capsule form and is typically taken once daily, either with or without food, depending on the prescribed use. 

In some cases, it may also be used vaginally as a suppository for fertility treatments. The medication works by mimicking natural progesterone, regulating the menstrual cycle, preparing the uterus for pregnancy, and balancing estrogen effects in hormone therapy. Proper use and dosage should be determined by a healthcare provider based on individual medical needs.

Key Takeaways

  • Prometrium (progesterone) helps regulate menstrual cycles, supports pregnancy in women with progesterone deficiency, and is used in hormone replacement therapy (HRT) to reduce the risk of endometrial hyperplasia in postmenopausal women taking estrogen.

  • Common side effects include dizziness, drowsiness, nausea, breast tenderness, bloating, headaches, mood changes, and vaginal bleeding or discharge.

  • Less common side effects include severe dizziness, confusion, fluid retention, weight changes, hair loss, liver issues (e.g., jaundice), and abnormal blood clotting, which may lead to stroke or heart attack in rare cases.

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Prometrium (Progesterone) Side Effects

Below is a summary of potential side effects, categorized by their seriousness and how commonly they occur:

Common Side Effects (in around 5% of patients):

  • Headache: Reported by approximately 31% of patients.

  • Breast tenderness: Experienced by about 27% of patients.

  • Dizziness: Occurs in around 15% of patients.

  • Abdominal bloating: Reported by 12% of patients.

  • Depression: Reported by 19% of patients.

  • Joint pain: Experienced by 20% of patients.

  • Vaginal discharge: Occurs in about 10% of patients.

  • Nausea/Vomiting: Reported by 8% of patients.

  • Fatigue: Experienced by 8% of patients.

  • Musculoskeletal pain: Reported by 12% of patients.

  • Irritability: Reported by 8% of patients.

These statistics are derived from clinical trials and are documented in the FDA-approved labeling for Prometrium.

Less Common But Serious Side Effects:

  • Risk to the fetus: Rare cases of congenital anomalies such as cleft palate, cleft lip, and various heart defects have been reported.

  • Abnormal blood clotting: Events like stroke, heart attack, pulmonary embolism, and vision loss due to blood clots have been noted.

While these serious side effects are less common, it's crucial to be aware of them. If you experience symptoms such as unusual vaginal bleeding, severe headaches, chest pain, shortness of breath, or changes in vision, seek medical attention promptly.

Related: Gonal-F RFF Pen Price (Guide)

What to Know About Prometrium Side Effects

Here is what you should know about Prometrium (progesterone) side effects:

1. Breast Tenderness and Changes

Breast tenderness is a common side effect of Prometrium, affecting up to 27% of patients (FDA, 2009). This discomfort can often be managed by wearing a well-fitted sports bra, applying warm or cool compresses, and using over-the-counter pain relievers like ibuprofen. 

In less common cases, patients may notice unusual lumps, nipple discharge, or dimpling of the breast tissue. While these changes are rare, they should be reported to a healthcare provider, as they can indicate more serious conditions, including breast cancer. 

The Women’s Health Initiative (WHI) study linked combined Premarin (estrogen) and Provera (medroxyprogesterone) use to an increased risk of breast cancer. However, Prometrium, a bioidentical progesterone, does not show the same level of risk (Chlebowski et al., 2015).

2. Vaginal Bleeding and Discharge

Light spotting or breakthrough bleeding occurs in 5-10% of premenopausal patients taking Prometrium. This irregular bleeding may resolve on its own as the body adjusts to the medication. However, postmenopausal bleeding or excessive bleeding should be reported to a healthcare provider, as it may indicate an underlying condition. 

Vaginal discharge may also increase while using Prometrium. Although this is typically harmless, any discharge that has an unusual color or odor could signal an infection and should be evaluated by a doctor.

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3. Dizziness and Drowsiness

Dizziness and drowsiness are reported by 15-20% of patients taking Prometrium (FDA, 2009). Taking medication at bedtime can help minimize these effects during the day. Until you know how Prometrium affects you, it's best to use caution when driving or operating machinery.

In rare cases, patients may experience extreme dizziness, confusion, or a sensation similar to intoxication. If these symptoms become severe, medical attention is recommended.

4. Nausea

Nausea affects approximately 8-12% of patients and is caused by progesterone slowing down digestion, leading to bloating and discomfort. Eating small, frequent meals and avoiding spicy, fried, or greasy foods can help manage this symptom. 

Many individuals find relief with ginger supplements or tea. In most cases, nausea improves over time as the body adjusts to the medication.

5. Mood Changes

Mood changes, including depression, anxiety, and irritability, are reported by 8-19% of Prometrium patients. While these symptoms are usually mild, managing stress through regular exercise, proper sleep, and relaxation techniques may help. 

In rare instances, Prometrium can cause severe mood disturbances, including aggression or suicidal thoughts. If this occurs, immediate medical care is necessary.

6. Weight Changes and Fluid Retention

Weight changes, including both slight gain and loss, have been reported in 5-10% of patients. This is often due to fluid retention, which can cause bloating and puffiness. Reducing salt intake, staying hydrated, and engaging in moderate exercise may help minimize this effect. 

Individuals with heart or kidney conditions should inform their healthcare provider before starting Prometrium, as severe fluid retention can pose additional risks. If swelling persists or worsens, medical evaluation is recommended.

7. Liver Problems (Rare but Serious)

Liver issues are rare, occurring in less than 1% of patients, but the risk increases with high doses or concurrent use of estrogen or tamoxifen (NAMS, 2020). Symptoms of liver problems typically appear within one to two weeks of starting Prometrium and may include abdominal pain, itchy skin, jaundice (yellowing of the skin and eyes), fever, vomiting, or diarrhea. 

Healthcare providers often monitor liver enzyme levels in long-term patients. If any of these symptoms occur, immediate medical attention is needed.

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Sources

  1. Davison, S. L., & Davis, S. R. (2020). Hormone therapy for menopausal symptoms: Benefits, risks, and individualized treatment options. National Center for Biotechnology Information (NCBI). Retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC7475284/

  2. U.S. Food and Drug Administration (FDA). (2009). Prometrium (progesterone) Capsules Labeling Information. FDA Drug Label Database. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019781s013lbl.pdf

  3. Chlebowski, R. T., Anderson, G. L., Aragaki, A. K., et al. (2015). Menopausal hormone therapy and breast cancer: A meta-analysis of randomized trials and observational studies. PubMed - National Library of Medicine. Retrieved from https://pubmed.ncbi.nlm.nih.gov/26181174/

  4. Pinkerton, J. V., & Santoro, N. (2023). Update on menopause management: Hormone therapy and beyond. PubMed - National Library of Medicine. Retrieved from https://pubmed.ncbi.nlm.nih.gov/36727752/


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The content on this page is for informational and educational purposes only and does not constitute professional medical advice. Patients should not use the information presented on this page for diagnosing a health-related issue or disease. Before taking any medication or supplements, patients should always consult a physician or qualified healthcare professional for medical advice or information about whether a drug is safe, appropriate or effective.