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Prometrium (Progesterone Oral) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

See BOXED WARNINGS, 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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximate rates.

Endometrial Protection: Table 8 lists adverse experiences which were reported in ≥2% of patients (regardless of relationship to treatment) who received cyclic PROMETRIUM Capsules, 200 mg daily (12 days per calendar month cycle) with daily 0.625 mg conjugated estrogen, in a multicenter, randomized, double-blind, placebo-controlled clinical trial in 875 postmenopausal women.

TABLE 8 Adverse Experiences (≥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 Conjugated Estrogens 0.625 mg
(only)
Placebo
(n=178) (n=175) (n=174)
Headache313027
Breast Tenderness27166
Joint Pain202229
Depression191812
Dizziness1559
Abdominal Bloating12105
Hot Flashes111435
Urinary Problems11109
Abdominal Pain101310
Vaginal Discharge10103
Nausea / Vomiting867
Worry854
Chest Pain745
Diarrhea774
Night Sweats7517
Breast Pain662
Swelling of Hands and Feet699
Vaginal Dryness6810
Constipation332
Breast Carcinoma2<1<1
Breast Excisional Biopsy21<1
Cholecystectomy2<1<1

Secondary Amenorrhea: Table 9 lists adverse experiences which were reported in ≥5% of patients receiving PROMETRIUM Capsules, 400 mg/day, in a multicenter, randomized, double-blind, placebo-controlled clinical trial in estrogen-primed (6 weeks) postmenopausal women receiving conjugated estrogens 0.625 mg/day and cyclic (10 days per calendar month cycle) PROMETRIUM Capsules at a dose of 400 mg/day, for three cycles.

TABLE 9 Adverse Experiences (≥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
   Fatigue84
   Headache168
   Dizziness244
   Abdominal Distention (Bloating)88
   Abdominal Pain (Cramping)2013
   Diarrhea84
   Nausea80
   Back Pain88
   Musculoskeletal Pain124
   Irritability84
   Breast Pain168
   Infection Viral120
   Coughing80

The most common adverse experiences reported in ≥5% of patients in all PROMETRIUM Capsules dosage groups studied in this trial (100 mg/day to 400 mg/day) were: dizziness (16%), breast pain (11%), headache (10%), abdominal pain (10%), fatigue (9%), viral infection (7%), abdominal distention (6%), musculoskeletal pain (6%), emotional lability (6%), irritability (5%), and upper respiratory tract infection (5%).

Other adverse events reported in <5% of patients taking PROMETRIUM Capsules include:

Administration Site Conditions: edema, edema peripheral

Blood and Lymphatic System: lymphadenopathy

Cardiac Disorders: angina pectoris, palpitation

Ear and Labyrinth Disorders: earache

Eye Disorders: abnormal vision

Gastrointestinal System Disorders: constipation, dry mouth, dyspepsia, gastroenteritis, hemorrhagic rectum, hiatus hernia, vomiting

General Disorders: chest pain, fever

Infections: abscess, herpes simplex

Injury, Poisoning and Procedural Complications: accidental injury

Musculoskeletal and Connective Tissue Disorders: arthritis, leg cramps, muscle disorder, myalgia

Nervous System Disorders: hypertonia, impaired concentration, somnolence, speech disorder

Psychiatric Disorders: anxiety, confusion, insomnia, personality disorder

Renal and Urinary Disorders: urinary tract infection

Reproductive System Disorders: fungal vaginitis, leukorrhea, uterine fibroid, vaginal dryness, vaginitis

Respiratory System Disorders: bronchitis, nasal congestion, pharyngitis, pneumonitis, sinusitis

Skin and Subcutaneous Tissue Disorders: acne, verruca, wound debridement

Vascular Disorders: hypertension

The following adverse experiences have been reported with PROMETRIUM Capsules in other U.S. clinical trials: increased sweating, asthenia, tooth disorder, anorexia, increased appetite, nervousness, and breast enlargement.

In addition to the adverse events observed in clinical trials, the following spontaneous adverse events have been reported during the marketing of PROMETRIUM Capsules.

Cardiac Disorders: circulatory collapse, tachycardia

Congenital, Familial, and Genetic Disorders: cleft lip, cleft palate, congenital heart disease, patent ductus arteriosus, ventricular septal defect

Ear and Labyrinth Disorders: tinnitus, vertigo

Eye Disorders: blurred vision, diplopia, visual disturbance

Gastrointestinal Disorders: acute pancreatitis, dysphagia, swollen tongue

General Disorders and Administration Site Conditions: abnormal gait, difficulty walking, feeling abnormal, feeling drunk

Hepatobiliary Disorders: cholestasis, cholestatic hepatitis, jaundice, hepatitis, hepatic failure, hepatic necrosis, increased liver function tests

Immune System Disorders: anaphylactic reaction, hypersensitivity

Investigations: alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hepatic enzyme increased, blood glucose increased, weight decreased, weight increased

Musculoskeletal Disorders: arthralgia, muscle cramp

Neoplasms Benign, Malignant, and Unspecified: endometrial carcinoma

Nervous System Disorders: convulsion, depressed consciousness, dysarthria, loss of consciousness, paresthesia, sedation, stupor, syncope (with and without hypotension), transient ischemic attack

Pregnancy, Puerperium, and Perinatal Conditions: intra-uterine death, spontaneous abortion

Psychiatric Disorders: aggression, depersonalization, disorientation, suicidal ideation,

Reproductive System and Breast Disorders: menorrhagia, menstrual disorder, metrorrhagia, ovarian cyst

Respiratory, Thoracic, and Mediastinal Disorders: asthma, choking, dyspnea, face edema, throat tightness

Skin and Subcutaneous Tissue Disorders: alopecia, pruritus, urticaria

Vascular Disorders: hypertension, hypotension

The following additional adverse experiences have been observed in women taking estrogen and/or progestins in general: breakthrough bleeding, spotting, change in menstrual flow, amenorrhea, changes in weight (increase or decrease), changes in the cervical squamo-columnar junction and cervical secretions, cholestatic jaundice, anaphylactoid reactions and anaphylaxis, rash (allergic) with and without pruritus, melasma or chloasma, that may persist when drug is discontinued, dysmenorrhea, increase in size of uterine leiomyomata, ovarian cancer, endometrial hyperplasia, endometrial cancer, galactorrhea, nipple discharge, increased incidence of gallbladder disease, enlargement of hepatic hemangiomas, erythema multiforme, erythema nodosum, hirsutism, hemorrhagic eruption, intolerance to contact lenses, migraine, chorea, reduced carbohydrate tolerance, aggravation of porphyria, changes in libido, hypocalcemia, angioedema, exacerbation of asthma, increased triglycerides.



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: 2008-03-06

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