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Estrofem Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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(8390170-5)
on May 24, 2012 Female from NETHERLANDS , 45 years of age, weighting 146.4 lb, was diagnosed with
  • hypogonadism
  • blood follicle stimulating hormone decreased
  • blood corticotrophin decreased
  • primary hypothyroidism
  • blood thyroid stimulating hormone decreased
  • hypopituitarism
  • prophylaxis
  • blood luteinising hormone decreased
and was treated with Estrofem. . Estrofem dosage: N/A.
Associated medications used:
  • Provera
  • Hydrocortisone (Unk)
  • Levothyroxine (Unk)
  • Levothyroxine
  • Somatropin (0.3 Mg, 1x/day, 7 Injections Per Week)
  • Ascal (Unk)


Blood Pressure Decreased (8388379-X)
Patient was taking Estrofem. Patient felt the following Estrofem side effects: blood pressure decreased on May 14, 2012 from FINLAND Additional patient health information: Female , 58 years of age, . Estrofem dosage: 1 Mg, Qd.
Multiple prescriptions taken:
  • Cymbalta (60 Mg, Unk)
  • Cymbalta (30 Mg, Unk)
  • Orloc (2.5 Mg, Qd)


Benign Ovarian Tumour (7553706-X)
Adverse event was reported on Jun 10, 2011 by a Female taking Estrofem (Dosage: 2 Mg, Qd) was diagnosed with
  • menopausal symptoms
and. Location: ITALY , 45 years of age, After Estrofem was administered, patient encountered several Estrofem side effects: benign ovarian tumour. Patient was hospitalized.

Diverticulitis, Muscular Weakness, Muscle Atrophy, Sepsis (7345526-6)
on Mar 03, 2011 Female from SOUTH AFRICA , 65 years of age, was treated with Estrofem. Directly after, patient experienced the unwanted or unexpected Estrofem side effects: diverticulitis, muscular weakness, muscle atrophy, sepsis. Estrofem dosage: N/A.
Associated medications used:
  • Pravastatin
  • Lansoprazole
  • Methotrexate
  • Prednisone
  • Diclofenac
  • Nsaids
  • Chloroquine
  • Lipitor



Deep Vein Thrombosis (6068196-6)
on Jan 29, 2009 Female from SWITZERLAND , 78 years of age, was treated with Estrofem. Patient felt the following Estrofem side effects: deep vein thrombosis. Estrofem dosage: N/A.
Multiple prescriptions taken:
  • Enatec
  • Calcimagon-d 3
  • Prednisone
  • Fosamax
  • Antra /00661201/
Patient was hospitalized.

Breast Cancer Metastatic (5727237-3)
Patient was taking Estrofem. After Estrofem was administered, patient encountered several Estrofem side effects: breast cancer metastatic on Apr 29, 2008 from SWITZERLAND Additional patient health information: Female , 86 years of age, was diagnosed with
  • menopausal disorder
  • hypertension
and. Estrofem dosage: 1 Mg, Qd.
Multiple concurrent drugs taken:
  • Atacand (16 Mg, Qd)
  • Plendil Plain (10 Mg, Qd)
  • Diamicron Mr (120 Mg, Qd)
  • Biotin-mepha (2.5 Mg, Qd)
Patient was hospitalized.

Breast Cancer, Breast Cancer Female (5582712-X)
Adverse event was reported on Dec 27, 2007 by a Female taking Estrofem (Dosage: 2 Mg, Qd) was diagnosed with
  • artificial menopause
  • osteopenia
  • hypothyroidism
and. Location: TURKEY , 46 years of age, weighting 154.3 lb, Directly after, patient experienced the unwanted or unexpected Estrofem side effects: breast cancer, breast cancer female.
Associated medications used:
  • Calcimax D3 /00944201/ (2500 Mg+880 Iu, Unk)
  • Tefor (.75 Tab, Qd)
Patient was hospitalized and became disabled.

Breast Cancer (5513705-6)
on Nov 01, 2007 Female from TURKEY , 46 years of age, weighting 154.3 lb, was diagnosed with
  • artificial menopause
  • osteopenia
  • hypothyroidism
and was treated with Estrofem. Patient felt the following Estrofem side effects: breast cancer. Estrofem dosage: N/A.
Multiple prescriptions taken:
  • Calcimax D3 /00944201/ (2500 Mg+880 Iu, Unk)
  • Tefor (.75 Tab, Qd)
Patient was hospitalized and became disabled.

Cerebrovascular Accident (5238788-2)
on Feb 04, 2007 Female from ISRAEL , 33 years of age, was diagnosed with
  • infertility
and was treated with Estrofem. After Estrofem was administered, patient encountered several Estrofem side effects: cerebrovascular accident. Estrofem dosage: 6 Mg/4 Days Each Mont During One Year. Patient was hospitalized.

Deafness (5222517-2)
Patient was taking Estrofem. Directly after, patient experienced the unwanted or unexpected Estrofem side effects: deafness on Jan 17, 2007 from SWITZERLAND Additional patient health information: Female , 59 years of age, weighting 141.1 lb, was diagnosed with
  • hot flush
and. Estrofem dosage: 2 Mg, Unk.

Deafness, Deafness Unilateral, Infection (5168439-7)
Adverse event was reported on Oct 02, 2006 by a Female taking Estrofem (Dosage: 2 Mg, Unk) was diagnosed with
  • hot flush
and. Location: SWITZERLAND , 59 years of age, weighting 141.1 lb, Patient felt the following Estrofem side effects: deafness, deafness unilateral, infection.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

Estrofem Information

More About Estrofem

Side Effects reported to FDA: 11. View Estrofem Adverse Reports

Estrofem safety alerts: No

Reported deaths: 2

Reported hospitalizations: 6

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