Prometrium dose depends on the condition that is being treated.
What Drugs, Substances, or Supplements Interact with Prometrium?
Drug interactions include inhibitors of cytochrome P450 3A4 (for example, ketoconazole), colchicine, dabigatran etexilate (Pradaxa), silodosin (Rapaflo) and aminoglutethimide (Cytadren).
Prometrium During Pregnancy and Breastfeeding
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.
Additional Information
Our Prometrium Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Prometrium Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
unusual vaginal bleeding;
pain or burning when you urinate;
a breast lump;
sudden vision problems, severe headache or pain behind your eyes;
symptoms of depression (sleep problems, weakness, mood changes);
severe dizziness or drowsiness, spinning sensation, confusion, shortness of breath;
heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with speech or balance;
signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.
Common side effects may include:
drowsiness, dizziness;
breast pain;
mood changes;
headache;
constipation, diarrhea, heartburn;
bloating, swelling in your hands or feet;
joint pain;
hot flashes; or
vaginal 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.
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.
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.
&Copy; 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.
