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Prometrium (Progesterone) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 Placebo
  (n=178) (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
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.



REPORTS OF SUSPECTED PROMETRIUM SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Prometrium. The information is not vetted and should not be considered as verified clinical evidence.

Possible Prometrium side effects / adverse reactions in 54 year old female

Reported by a lawyer from United States on 2011-10-04

Patient: 54 year old female

Reactions: Breast Cancer, Nervous System Disorder, Injury

Suspect drug(s):
Climara
    Dosage: unk
    Start date: 1997-01-01
    End date: 2007-01-01

Cenestin
    Dosage: unk
    Administration route: Oral
    Start date: 1997-01-01
    End date: 2007-01-01

Prometrium
    Dosage: unk
    Start date: 1997-01-01
    End date: 2007-01-01

Estradiol Transdermal
    Dosage: unk
    Start date: 1997-01-01
    End date: 2007-01-01

Premarin
    Dosage: unk
    Administration route: Oral
    Start date: 1997-01-01
    End date: 2007-01-01

Premphase (Premarin;cycrin 14/14)
    Dosage: unk
    Start date: 1997-01-01
    End date: 2007-01-01

Aygestin
    Dosage: unk
    Start date: 1997-01-01
    End date: 2007-01-01

Aygestin

Estrace
    Dosage: unk
    Start date: 1997-01-01
    End date: 2007-01-01

Estradiol
    Dosage: unk
    Administration route: Oral
    Start date: 1997-01-01
    End date: 2007-01-01

Other drugs received by patient: Vitamin TAB; Avelox; Levaquin; Ziac



Possible Prometrium side effects / adverse reactions in 54 year old female

Reported by a consumer/non-health professional from Canada on 2011-10-31

Patient: 54 year old female

Reactions: Confusional State, Speech Disorder, Dyspnoea, Nausea, Palpitations, Hypoaesthesia, Delusion, Arrhythmia

Suspect drug(s):
Prometrium

Other drugs received by patient: Cyclokapron; Diovan HCT; Diclofenac Sodium; Pantoprazole; Calcium W/vitamin D; Diovan; Valsartan; Glucosamine



Possible Prometrium side effects / adverse reactions in 55 year old female

Reported by a consumer/non-health professional from United States on 2011-11-11

Patient: 55 year old female

Reactions: Spinal Compression Fracture

Suspect drug(s):
Pantoprazole

Fosamax
    Dosage: unk ukn, unk

Calcitonin Salmon

Prometrium
    Dosage: unk ukn, unk

Actonel
    Dosage: 1 per week



See index of all Prometrium side effect reports >>

Drug label data at the top of this Page last updated: 2013-01-16

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