Does Prometrium (progesterone) cause side effects?
Prometrium (progesterone) is a man-made medication derived from a plant source and is identical to the female hormone progesterone produced in the ovaries used to help regulate the uterine lining in post-menopausal women.
Progesterone is involved in the following:
- promoting the development of the mammary glands,
- causing changes in the endometrium, which lines the uterus,
- relaxing uterine smooth muscles,
- blocking ovulation within the ovaries, and
- maintaining pregnancy.
Common side effects of Prometrium include
- headache,
- dizziness,
- fatigue,
- abdominal pain,
- nausea,
- breast tenderness,
- joint pain,
- depression,
- mood swings, and
- hot flashes.
Serious side effects of Prometrium include
- cardiovascular disorders,
- breast cancer, and
- possibly dementia in postmenopausal women.
Drug interactions of Prometrium include
- ketoconazole,
- clarithromycin, and
- erythromycin because they slow the breakdown of progesterone and increase its levels in the body.
Prometrium should not be used during pregnancy. Prometrium may be found in trace amounts in breast milk. Consult your doctor before breastfeeding.
What are the important side effects of Prometrium (progesterone)?
Side effects of progesterone are
- headache,
- dizziness,
- fatigue,
- abdominal pain,
- nausea,
- breast tenderness,
- joint pain,
- depression,
- mood swings, and
- hot flashes.
Progesterone also is associated with
- cardiovascular disorders,
- breast cancer, and
- possibly dementia in postmenopausal women.
Prometrium (progesterone) side effects list for healthcare professionals
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In a multicenter, randomized, double-blind, placebo-controlled clinical trial, the effects of Prometrium Capsules on the endometrium was studied in a total of 875 postmenopausal women.
Table 6 lists adverse reactions greater than or equal to 2 percent of women who received cyclic Prometrium Capsules 200 mg daily (12 days per calendar month cycle) with 0.625 mg conjugated estrogens or placebo.
TABLE 6. Adverse Reactions (≥ 2%) Reported in an 875 Patient Placebo-Controlled Trial in Postmenopausal Women Over a 3-Year Period [Percentage (%) of Patients Reporting]
Prometrium Capsules 200 mg with Conjugated Estrogens 0.625 mg | Placebo | |
(n=178) | (n=174) | |
Headache | 31 | 27 |
Breast T enderness | 27 | 6 |
Joint Pain | 20 | 29 |
Depression | 19 | 12 |
Dizziness | 15 | 9 |
Abd! minal Bloating | 12 | 5 |
HogT'lashes | 11 | 35 |
Urinary Problems | 11 | 9 |
Abdominal Pain | 10 | 10 |
Vaginal Discharge | 10 | 3 |
Nausea / Vomiting | 8 | 7 |
Worry | 8 | 4 |
Chest Pain | 7 | 5 |
Diarrhea | 7 | 4 |
Night Sweats | 7 | 17 |
Breast Pain | 6 | 2 |
Swelling of Hands and Feet | 6 | 9 |
Vaginal Dryness | 6 | 10 |
Constipation | 3 | 2 |
Breast Carcinoma | 2 | <1 |
Breast Excisional Biopsy | 2 | <1 |
Cholecystectomy | 2 | <1 |
Effects On Secondary Amenorrhea
In a multicenter, randomized, double-blind, placebo-controlled clinical trial, the effects of Prometrium Capsules on secondary amenorrhea was studied in 49 estrogen-primed postmenopausal women.
Table 7 lists adverse reactions greater than or equal to 5 percent of women who received Prometrium Capsules or placebo.
TABLE 7. Adverse Reactions (≥ 5%) Reported in Patients Using 400 mg/day in a Placebo- Controlled Trial in Estrogen-Primed Postmenopausal Women
Adverse Experience | Prometrium Capsules 400 mg | Placebo |
n=25 | n=24 | |
Percentage (%) of Patients | ||
Fatigue | 8 | 4 |
Headache | 16 | 8 |
Dizziness | 24 | 4 |
Abdominal Distention (Bloating) | 8 | 8 |
Abdominal Pain (Cramping) | 20 | 13 |
Diarrhea | 8 | 4 |
Nausea | 8 | 0 |
Back Pain | 8 | 8 |
Musculoskeletal Pain | 12 | 4 |
Irritability | 8 | 4 |
Breast Pain | 16 | 8 |
Infection Viral | 12 | 0 |
Coughing | 8 | 0 |
In a multicenter, parallel-group, open label postmarketing dosing study consisting of three consecutive 28-day treatment cycles, 220 premenopausal women with secondary amenorrhea were randomized to receive daily conjugated estrogens therapy (0.625 mg conjugated estrogens) and Prometrium Capsules, 300 mg per day (n=113) or Prometrium Capsules, 400 mg per /day (n=107) for 10 days of each treatment cycle.
Overall, the most frequently reported treatment-emergent adverse reactions, reported in greater than or equal to 5 percent of subjects, were
- nausea,
- fatigue,
- vaginal mycosis,
- nasopharyngitis,
- upper respiratory tract infection,
- headache, dizziness,
- breast tenderness,
- abdominal distension,
- acne,
- dysmenorrhea,
- mood swing, and
- urinary tract infection.
Postmarketing Experience
The following additional adverse reactions have been reported with Prometrium Capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.
Genitourinary System
endometrial carcinoma, hypospadia, intra-uterine death, menorrhagia, menstrual disorder, metrorrhagia, ovarian cyst, spontaneous abortion.
Cardiovascular
circulatory collapse, congenital heart disease (including ventricular septal defect and patent ductus arteriosus), hypertension, hypotension, tachycardia.
Gastrointestinal
acute pancreatitis, cholestasis, cholestatic hepatitis, dysphagia, hepatic failure, hepatic necrosis, hepatitis, increased liver function tests (including alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased), jaundice, swollen tongue.
Skin
alopecia, pruritus, urticaria.
Eyes
blurred vision, diplopia, visual disturbance.
Central Nervous System
aggression, convulsion, depersonalization, depressed consciousness, disorientation, dysarthria, loss of consciousness, paresthesia, sedation, stupor, syncope (with and without hypotension), transient ischemic attack, suicidal ideation.
During initial therapy, a few women have experienced a constellation of many or all of the following symptoms: extreme dizziness and/or drowsiness, blurred vision, slurred speech, difficulty walking, loss of consciousness, vertigo, confusion, disorientation, feeling drunk, and shortness of breath.
Miscellaneous
abnormal gait, anaphylactic reaction, arthralgia, blood glucose increased, choking, cleft lip, cleft palate, difficulty walking, dyspnea, face edema, feeling abnormal, feeling drunk, hypersensitivity, asthma, muscle cramp, throat tightness, tinnitus, vertigo, weight decreased, weight increased.
What drugs interact with Prometrium (progesterone)?
Drug-Laboratory Test Interactions
The following laboratory results may be altered by the use of estrogen plus progestin therapy:
- Increased sulfobromophthalein retention and other hepatic function tests.
- Coagulation tests: increase in prothrombin factors VII, VIII, IX and X.
- Pregnanediol determination.
- Thyroid function: increase in PBI, and butanol extractable protein bound iodine and decrease in T3 uptake values.
Summary
Prometrium (progesterone) is a man-made medication derived from a plant source and is identical to the female hormone progesterone produced in the ovaries used to help regulate the uterine lining in post-menopausal women. Common side effects of Prometrium include headache, dizziness, fatigue, abdominal pain, nausea, breast tenderness, joint pain, depression, mood swings, and hot flashes. Prometrium should not be used during pregnancy. Prometrium may be found in trace amounts in breast milk.
Multimedia: Slideshows, Images & Quizzes
-
Menopause & Perimenopause: Symptoms, Signs
What is menopause? What are the signs of menopause? What age does menopause start? Learn about menopause and perimenopause...
-
Menopause Quiz: Symptoms & Signs
The Menopause Quiz challenges your knowledge about the time in a woman’s life when menstruation ceases. Menopause can bring many...
-
9 Signs of Perimenopause
Perimenopause occurs before menopause as estrogen levels begin to change. This can cause menopause like symptoms such as hot...
-
Women's Health: 10 Tips to Ease Menopause Symptoms
What happens during menopause? At what age do menopause symptoms start? Women in their 40s or 50s may begin to have hot flashes,...
Related Disease Conditions
-
Menopause
Menopause is the time in a woman's life when menstrual periods permanently stop, also called the "change of life." Menopause symptoms and signs include hot flashes, night sweats, irregular vaginal bleeding, vaginal dryness, painful intercourse, urinary incontinence, weight gain, and emotional symptoms such as mood swings. Treatment of menopausal symptoms varies and should be discussed with your physician.
-
Sex and Menopause
-
Perimenopause
Perimenopause is the time in a woman's life when she is approaching menopause. During this time a woman starts to develop symptoms of declining estrogen levels that may include mood swings, painful sex, night sweats, hot flashes, and weight gain. Every adult woman eventually will experience perimenopause.
-
Premature Menopause
Premature menopause is when menopause occurs in a woman before the age of 40. Causes of premature menopause include premature ovarian failure, treatments for cancer and other conditions, surgical removal of the ovaries, chronic diseases of the pituitary or thyroid gland, or psychiatric disorders. Treatment is directed at menopausal symptoms.
-
Sex and Menopause
Menopause is often associated with a change in sexual functioning. Loss of estrogen, bladder control issues, anxiety, stress, health concerns, medications, and sleep disturbances often result in a decrease in libido. Though there are currently no good drugs for treating sexual problems in women, there are ways to increase intimacy with a partner and treat vaginal dryness.
Treatment & Diagnosis
- Menopause
- Menopause: Making it the Best Years of Your Life
- Perimenopause: Signs of Change: Perimenopause -- Laura Corio, MD -- 02/20/03
- Menopause and Perimenopause, A Woman's Guide to
- Perimenopause
- Menopause: The Men's Guide to Understanding It
- Menopause: Super Nutrition for Menopause
- Menopause: A New Perspective
- Hormone Therapy After Menopause -- Susan Love, MD
- Menopause: Taking Charge
- Menopause Made Easy with Carolle Jean-Murat
- Menopause: Change of Life, Change of Diet
- Menopause FAQs
- Thyroid Disease and Menopause
- The Women's Health Initiative in Perspective: The Last Straw for Estrogen Therapy?
- Menopause: Home Menopause Test Kits, Are They Worth It?
- Hot Flashes: Anxiety Worsens Hot Flashes
- Can Menopause Cause High Cholesterol?
- How Is Menopause Diagnosed After a Hysterectomy?
- How Does Menopause Affect Polycystic Ovarian Syndrome (PCOS)?
- Does Vaginal Moisture Change During Perimenopause?
- Do Soy Isoflavones Treat Menopause Hot Flashes?
- Can You Go Through Menopause at 40?
- Does Perimenopause Cause Mood Swings?
- Does Menopause Cause Pain During Sex?
- Does Menopause Affect Memory?
- Are Night Sweats a Sign of Menopause?
- Can Soy Help Menopause Symptoms?
- Do I Need Birth Control After Menopause?
- Does Menopause Cause High Blood Pressure?
- Do You Get More UTIs During Menopause?
- Can You Still Get Menopause After Hysterectomy?
- Do All Women Get Menopause?
- Menopause: 10 Questions To Ask Your Doctor
- Menopause Symptoms
- Ask the Experts - Menopause
- Menopause: Change of Life, Change of Diet
Medications & Supplements

Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.