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Estrofem Side Effects

Common Estrofem Side Effects


The most commonly reported Estrofem side effects (click to view or check a box to report):

Deafness (2)
Breast Cancer (2)
Breast Cancer Metastatic (1)
Cerebrovascular Accident (1)
Breast Cancer Female (1)
Blood Pressure Decreased (1)
Transient Ischaemic Attack (1)
Benign Ovarian Tumour (1)
Deafness Unilateral (1)
Deep Vein Thrombosis (1)
Muscular Weakness (1)
Sepsis (1)
Muscle Atrophy (1)
Migraine With Aura (1)
Diverticulitis (1)
Infection (1)
Death (1)


If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Estrofem Side Effects Reported to FDA

The following Estrofem reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Estrofem on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Migraine With Aura, Transient Ischaemic Attack
This is a report of a female patient (weight: NA) from AT, suffering from the following symptoms/conditions: menopausal symptoms,hypercholesterolaemia, who was treated with Estrofem (dosage: NA, start time: NS), combined with:
  • Sortis (20 Mg, Qd)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Migraine With Aura
  • Transient Ischaemic Attack
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Estrofem treatment in female patients, resulting in migraine with aura side effect. The patient was hospitalized.


This report suggests a potential Estrofem side effect(s) that can have serious consequences. A 45-year-old female patient (weight: NA) from NETHERLANDS was diagnosed with the following symptoms/conditions: hypogonadism,blood follicle stimulating hormone decreased,blood corticotrophin decreased,primary hypothyroidism,blood thyroid stimulating hormone decreased,hypopituitarism,prophylaxis,blood luteinising hormone decreased and used Estrofem (dosage: NA) starting Oct 15, 1984. Soon after starting Estrofem the patient began experiencing various side effects, including:
    Drugs used concurrently:
    • Provera
    • Hydrocortisone (Unk)
    • Levothyroxine (Unk)
    • Levothyroxine
    • Somatropin (0.3 Mg, 1x/day, 7 Injections Per Week)
    • Ascal (Unk)
    Although Estrofem demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as death, may still occur.

    Blood Pressure Decreased
    This Blood Pressure Decreased problem was reported by a physician from FINLAND. A 58-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Oct 25, 2011 this consumer started treatment with Estrofem (dosage: 1 Mg, Qd). The following drugs were being taken at the same time:
    • Cymbalta (60 Mg, Unk)
    • Cymbalta (30 Mg, Unk)
    • Orloc (2.5 Mg, Qd)
    When commencing Estrofem, the patient experienced the following unwanted symptoms/side effects:
    • Blood Pressure Decreased
    Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as blood pressure decreased, may become evident only after a product is in use by the general population.

    Benign Ovarian Tumour
    This is a report of a 45-year-old female patient (weight: NA) from ITALY. The patient developed the following symptoms/conditions: menopausal symptoms and was treated with Estrofem (dosage: 2 Mg, Qd) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
    • Benign Ovarian Tumour
    The patient was hospitalized. This opens a possibility that Estrofem treatment could cause the above reactions, including benign ovarian tumour, and some female subjects may be more susceptible.


    Diverticulitis, Muscular Weakness, Muscle Atrophy, Sepsis
    A 65-year-old female patient (weight: NA) from SOUTH AFRICA with the following symptoms/conditions: NA started Estrofem treatment (dosage: NA) on Oct 27, 2009. Soon after starting Estrofem treatment, the subject experienced various side effects, including:
    • Diverticulitis
    • Muscular Weakness
    • Muscle Atrophy
    • Sepsis
    Concurrently used drugs:
    • Pravastatin
    • Lansoprazole
    • Methotrexate
    • Prednisone
    • Diclofenac
    • Nsaids
    • Chloroquine
    • Lipitor
    This finding indicates that some female patients could be more vulnerable to Estrofem.

    Deep Vein Thrombosis
    A 78-year-old female patient from SWITZERLAND (weight: NA) experienced symptoms, such as: NA and was treated with Estrofem(dosage: NA). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
    • Deep Vein Thrombosis
    Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Estrofem efficacy:
    • Enatec
    • Calcimagon-d 3
    • Prednisone
    • Fosamax
    • Antra /00661201/
    The patient was hospitalized.

    Breast Cancer Metastatic
    In this report, Estrofem was administered for the following condition: menopausal disorder,hypertension.A 86-year-old female consumer from SWITZERLAND (weight: NA) started Estrofem treatment (dosage: 1 Mg, Qd) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
    • Breast Cancer Metastatic
    A possible interaction with other drugs could have contributed to this reaction:
    • Atacand (16 Mg, Qd)
    • Plendil Plain (10 Mg, Qd)
    • Diamicron Mr (120 Mg, Qd)
    • Biotin-mepha (2.5 Mg, Qd)
    The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Estrofem treatment could be related to the listed above side effect(s).

    Breast Cancer, Breast Cancer Female
    This is a report of the following Estrofem side effect(s):
    • Breast Cancer
    • Breast Cancer Female
    A 46-year-old female patient from TURKEY (weight: NA) presented with the following condition: artificial menopause,osteopenia,hypothyroidism and received a treatment with Estrofem (dosage: 2 Mg, Qd) starting: Oct 07, 2004.The following concurrently used drugs could have generated interactions:
    • Calcimax D3 /00944201/ (2500 Mg+880 Iu, Unk)
    • Tefor (.75 Tab, Qd)
    The patient was hospitalized and became disabled.This report suggests that a Estrofem treatment could be associated with the listed above side effect(s).

    Breast Cancer
    This Estrofem report was submitted by a 46-year-old female consumer from TURKEY (weight: NA). The patient was diagnosed with: artificial menopause,osteopenia,hypothyroidism and Estrofem was administered (dosage: NA) starting: Oct 07, 2004. The consumer developed a set of symptoms:
    • Breast Cancer
    Other drugs used simultaneously:
    • Calcimax D3 /00944201/ (2500 Mg+880 Iu, Unk)
    • Tefor (.75 Tab, Qd)
    The patient was hospitalized and became disabled.Those unexpected symptoms could be linked to a Estrofem treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

    Cerebrovascular Accident
    This is a report of a possible correlation between Estrofem use and the following symptoms/side effect(s):
    • Cerebrovascular Accident
    which could contribute to an assessment of Estrofem risk profile.A 33-year-old female consumer from ISRAEL (weight: NA) was suffering from infertility and was treated with Estrofem (dosage: 6 Mg/4 Days Each Mont During One Year) starting NS.Other concurrent medications: NA.The patient was hospitalized.

    Deafness
    A 59-year-old female patient from SWITZERLAND (weight: NA) presented with the following symptoms: hot flush and after a treatment with Estrofem (dosage: 2 Mg, Unk) experienced the following side effect(s):
    • Deafness
    The treatment was started on Sep 17, 2006. Estrofem was used in combination with the following drugs: NA.This report could alert potential Estrofem consumers.

    Deafness, Deafness Unilateral, Infection
    In this report, a 59-year-old female patient from SWITZERLAND (weight: NA) was affected by a possible Estrofem side effect.The patient was diagnosed with hot flush. After a treatment with Estrofem (dosage: 2 Mg, Unk, start date: Sep 17, 2006), the patient experienced the following side effect(s):
    • Deafness
    • Deafness Unilateral
    • Infection
    The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Estrofem treatment.



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    Keep Track of Side Effects

    Note Your Observations

    It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

    Why Your Notes are Important

    Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    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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