Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Breast tenderness
Less common
Headache
heavy
non-menstrual vaginal bleeding
pain in the pelvis
white or brownish vaginal discharge
Incidence not known
Blurred vision
chest pain
confusion
lightheadedness, dizziness, or fainting
fast or irregular heartbeat
sudden fainting
unusual tiredness or weakness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also:
Proger-F side effects (in more detail)
Side effects of Proger-F in details
A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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The following serious adverse reactions are discussed elsewhere in the labeling:
Cardiovascular Disorders.
Malignant Neoplasms.
Clinical Trials Experience
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 safety of Estradiol (Proger-F) and Progesterone (Proger-F) capsules was assessed in a 1-year, Phase 3 trial that included 1,835 postmenopausal women (1684 were treated with Proger-F (Proger-F) capsules once daily and 151 women received placebo). Most women (~70%) in the active treatment groups were treated for ≥ 326 days.
Treatment related adverse reactions with an incidence of ≥ 3% in the Proger-F (Proger-F (Proger-F)) capsule, 1 mg/100 mg, group and numerically greater than those reported in the placebo group are listed in Table 1.
Table 1: Treatment-Emergent Adverse Reactions Reported at a Frequency of ≥ 3% and Numerically More Common in Women Receiving Proger-F (Proger-F (Proger-F)) 1 mg/100 mg
Preferred Term
Proger-F
1 mg/100 mg
(N=415)
Placebo
(N=151)
Breast tenderness
43 (10.4)
1 (0.7)
Headache
14 (3.4)
1 (0.7)
Vaginal bleeding
14 (3.4)
0
Vaginal discharge
14 (3.4)
1 (0.7)
Pelvic pain
13 (3.1)
0
What is the most important information I should know about Proger-F?
Do not use estrogens with or without progestogens to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function).
Taking estrogens with progestogens may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
Taking estrogens with progestogens may increase your chance of getting dementia, based on a study of women 65 years of age or older.
Taking estrogen-alone may increase your chance of getting cancer of the uterus.
Taking estrogen-alone may increase your chances of getting strokes or blood clots.
Taking estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older.
You and your healthcare provider should talk regularly about whether you still need treatment with Proger-F.
Proger-F contraindications
Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Proger-F (Proger-F (Proger-F)) capsules, 1 mg/100 mg, are contraindicated in women with any of the following conditions:
Undiagnosed abnormal genital bleeding
Known, suspected, or history of cancer of the breast
Known or suspected estrogen-dependent neoplasia
Active DVT, PE, or history of these conditions
Active arterial thromboembolic disease (for example, stroke, MI), or a history of these conditions
Known anaphylactic reaction, angioedema, or hypersensitivity to Proger-F or any of its ingredients
Known liver impairment or disease
Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders
References
DailyMed. "PROGESTERONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
DailyMed. "ESTRADIOL HEMIHYDRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
DTP/NCI. "estradiol: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Proger-F are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Proger-F. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
User reports
Consumer reported side effects
No survey data has been collected yet
Consumer reviews
There are no reviews yet. Be the first to write one!
Information checked by Dr. Sachin Kumar, MD Pharmacology
