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Prometrium

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Prometrium

Prometrium Side Effects Center

Pharmacy Editor: Eni Williams, Pharm.D., Ph.D.

Prometrium (progesterone) is a medication that belongs to the drug class, progestin. Prometrium is available as a generic drug, and is prescribed for the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving conjugated estrogens tablets and also for secondary amenorrhea. Common side effects of Prometrium include dizziness, abdominal pain (cramping), headache, breast pain, musculoskeletal pain, viral infection, diarrhea, nausea, fatigue, and irritability.

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). There are no adequate studies of Prometrium in pregnant women and Prometrium found in breast milk.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Prometrium in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Prometrium Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, bloating, breast tenderness, headache, change in vaginal discharge, mood swings, blurred vision, dizziness, or drowsiness may occur. If any of these effects persist or worsen, notify 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 immediately if any of these serious side effects occur: unusual vaginal bleeding (e.g., spotting, breakthrough bleeding), mental/mood changes (e.g., depression, memory loss), swelling of the hands/feet, frequent/burning/painful urination, breast lumps, dark patches on the skin or face (melasma), yellowing eyes/skin, stomach/abdominal pain, persistent nausea/vomiting, dark urine, unusual tiredness.

This medication may rarely cause very serious (possibly fatal) problems from blood clots (e.g., heart attack, stroke, blood clots in the lungs or legs, blindness). Seek immediate medical attention if you experience any of the following: chest/jaw/left arm pain, weakness on one side of the body, slurred speech, difficulty walking, sudden vision 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Prometrium (Progesterone)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Prometrium FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

See BOXED 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
(n=178)
Placebo
(n=174)
Headache 31 27
Breast Tenderness 27 6
Joint Pain 20 29
Depression 19 12
Dizziness 15 9
Abdominal Bloating 12 5
Hot Flashes 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
n=25
Placebo
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 28­day 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) »

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Prometrium - User Reviews

Prometrium User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Prometrium sorted by most helpful. Patient Discussions FAQs

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.


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