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Prometrium

"Investigators from the Women's Health Initiative (WHI) Hormone Trials are reaffirming conclusions that hormone therapy is not recommended for the prevention of chronic disease, but may remain a reasonable option for the short-term management "...

Prometrium

Prometrium

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 Prometrium (progesterone) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

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.

Read the Prometrium Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 1/19/2012
This monograph has been modified to include the generic and brand name in many instances.

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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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