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Prometrium

Last reviewed on RxList: 9/12/2016
Prometrium Side Effects Center
Premenstrual Syndrome:A Visual Guide to PMS Symptoms, Causes and Treatments

Last reviewed on RxList 9/12/2016

Prometrium (progesterone) is a progestin, a female hormone, prescribed for the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving conjugated estrogens tablets and also for secondary amenorrhea. Prometrium is available as a generic drug. Common side effects of Prometrium include:

Prometrium dose depends on the condition that is being treated. Drug interactions include inhibitors of cytochrome P450 3A4 (for example, ketoconazole), colchicine, dabigatran etexilate (Pradaxa), silodosin (Rapaflo) and aminoglutethimide (Cytadren). Do not use Prometrium without your doctor's consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Talk to your doctor about using birth control while you are using Prometrium. Prometrium passes into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.

Our Prometrium Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Prometrium Consumer Information
Premenstrual Syndrome:A Visual Guide to PMS Symptoms, Causes and Treatments

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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Prometrium (Progesterone)

Prometrium Professional Information
Premenstrual Syndrome:A Visual Guide to PMS Symptoms, Causes and Treatments

SIDE EFFECTS

See BOX WARNING, WARNINGS and PRECAUTIONS.

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.

Read the entire FDA prescribing information for Prometrium (Progesterone)

Related Resources for Prometrium
Premenstrual Syndrome:A Visual Guide to PMS Symptoms, Causes and Treatments

Read the Prometrium User Reviews »

© Prometrium Patient Information is supplied by Cerner Multum, Inc. and Prometrium Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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