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Estrace (Estradiol Vaginal) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Estrace (Estradiol Vaginal) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (62)
Life Threatening Events (1)
Disability (5)

Reports by Reaction Type

Breast Cancer Female (16)Headache (6)Breast Cancer (5)Dizziness (4)Abdominal Distension (4)Muscle Spasms (4)Back Pain (4)Drug Ineffective (3)Osteoporosis (3)Pain (3)Drug Interaction (3)Cyst (3)

Below are a few examples of reports where side effects / adverse reactions may be related to Estrace (Estradiol Vaginal). For a complete list or a specific selection of reports, please use the links above.

Possible Estrace side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Pain, Aphasia, Abasia, Fall, Loss of Consciousness, Rash Pruritic, Myalgia, Eye Disorder, Muscle Spasms, Blood Glucose Increased, Amnesia, Epigastric Discomfort, Arthralgia, Gait Disturbance, DRY Eye, Arthritis

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Estrace
    Dosage: unk
    Administration route: Topical
    Indication: Hypertonic Bladder
    Start date: 2008-01-01

Unspecified Diabetic Medications
    Dosage: unk
    Indication: Diabetes Mellitus

Vesicare
    Dosage: unk
    Administration route: Oral
    Indication: Hypertonic Bladder
    Start date: 2008-08-04



Possible Estrace side effects in 75 year old female

Reported by a physician from United States on 2012-08-22

Patient: 75 year old female, weighing 54.4 kg (119.7 pounds)

Reactions: Fatigue, Drug Ineffective, Sluggishness

Drug(s) suspected as cause:
Estrace
    Dosage: 0.5 mg, daily
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 2012-04-09
    End date: 2012-07-06

Premarin
    Dosage: 0.625 mg, every other day
    Indication: Hormone Replacement Therapy
    End date: 2012-06-01

Other drugs received by patient: Vitamin D; Singulair; Singulair; Vitamin B Complex CAP; Flovent; Tramadol; Flonase; Biotin



Possible Estrace side effects in 57 year old female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: 57 year old female, weighing 45.0 kg (99.0 pounds)

Reactions: Abdominal Discomfort, Tablet Physical Issue

Drug(s) suspected as cause:
Estrace

Other drugs received by patient: Divigel; Thyroid TAB; Spiriva



Possible Estrace side effects in 54 year old female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 54 year old female, weighing 62.0 kg (136.4 pounds)

Reactions: Adverse Event

Drug(s) suspected as cause:
Estrace

Other drugs received by patient: Ibuprofen (Advil); Ambien; Aspirin; Nexium



Possible Estrace side effects in 48 year old female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 48 year old female

Reactions: Drug Effect Decreased

Drug(s) suspected as cause:
Estrace



Possible Estrace side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: female

Reactions: Hot Flush, Vulvovaginal Burning Sensation, Withdrawal Syndrome

Drug(s) suspected as cause:
Estrace



Possible Estrace side effects in 67 year old female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 67 year old female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Cenestin
    Indication: Menopausal Symptoms

Estrace
    Indication: Menopausal Symptoms



Possible Estrace side effects in 49 year old female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 49 year old female

Reactions: Malaise, Nausea

Drug(s) suspected as cause:
Estrace

Estradiol

Premarin

Vivelle
    Dosage: 0.1mg patches on arms, feet, legs except breast



Possible Estrace side effects in female

Reported by a lawyer from United States on 2012-07-10

Patient: female, weighing 52.0 kg (114.4 pounds)

Reactions: Breast Cancer Female

Drug(s) suspected as cause:
Activella
    Dosage: 1mg/0.5mg
    Indication: Hormone Replacement Therapy
    Start date: 2003-01-01
    End date: 2003-08-01

Cycrin
    Dosage: 2.5 mg, unk
    Indication: Hormone Replacement Therapy
    Start date: 1995-02-01
    End date: 1997-02-01

Estrace
    Dosage: 0.1mg/gm
    Indication: Hormone Replacement Therapy

Medroxyprogesterone Acetate
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1995-01-01
    End date: 2003-09-01

Premarin
    Dosage: 0.625 mg, unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1995-02-01
    End date: 1997-02-01

Prempro
    Dosage: 0.625/2.5mg
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1997-02-01
    End date: 2003-10-01

Provera
    Dosage: 2.5 mg, unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1995-04-01
    End date: 1996-06-01

Other drugs received by patient: Fosamax



Possible Estrace side effects in female

Reported by a lawyer from United States on 2012-07-05

Patient: female, weighing 52.0 kg (114.4 pounds)

Reactions: Breast Cancer Female

Drug(s) suspected as cause:
Activella
    Dosage: 1mg/0.5mg
    Indication: Hormone Replacement Therapy
    Start date: 2003-01-01
    End date: 2003-08-01

Cycrin
    Dosage: 2.5 mg, unk
    Indication: Hormone Replacement Therapy
    Start date: 1995-02-01
    End date: 1997-02-01

Estrace
    Dosage: 0.1mg/gm
    Indication: Hormone Replacement Therapy

Medroxyprogesterone Acetate
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1995-01-01
    End date: 2003-09-01

Premarin
    Dosage: 0.625 mg, unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1995-02-01
    End date: 1997-02-01

Prempro
    Dosage: 0.625/2.5mg
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1997-02-01
    End date: 2003-10-01

Provera
    Dosage: 2.5 mg, unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1995-04-01
    End date: 1996-06-01

Other drugs received by patient: Fosamax



Possible Estrace side effects in female

Reported by a lawyer from United States on 2012-07-05

Patient: female, weighing 52.0 kg (114.4 pounds)

Reactions: Breast Cancer Metastatic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Activella
    Dosage: 1mg/0.5mg
    Indication: Hormone Replacement Therapy
    Start date: 2003-01-01
    End date: 2003-08-01

Cycrin
    Dosage: 2.5 mg unk
    Indication: Hormone Replacement Therapy
    Start date: 1995-02-01
    End date: 1997-02-01

Estrace
    Dosage: 0.1mg/gm
    Indication: Hormone Replacement Therapy
    Start date: 2002-03-01

Medroxyprogesterone
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1995-01-01
    End date: 2003-09-01

Premarin
    Dosage: 0.625 mg, unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1995-02-01
    End date: 1997-02-01

Prempro
    Dosage: 0.625/2.5mg
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1997-02-01
    End date: 2003-01-01

Prempro
    Dosage: 0.45mg/1.5mg
    Start date: 2003-08-01
    End date: 2003-10-01

Provera
    Dosage: 2.5 mg, unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1995-04-01
    End date: 1996-06-01

Other drugs received by patient: Fosamax



Possible Estrace side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-29

Patient: female

Reactions: Weight Increased, Insomnia, Drug Hypersensitivity, Infection

Drug(s) suspected as cause:
Estrace
    Dosage: unk
    Indication: Hormone Replacement Therapy

Premarin
    Dosage: unk
    Indication: Hormone Replacement Therapy



Possible Estrace side effects in 38 year old female

Reported by a individual with unspecified qualification from United States on 2012-06-20

Patient: 38 year old female, weighing 55.8 kg (122.7 pounds)

Reactions: Asthma

Drug(s) suspected as cause:
Estrace



Possible Estrace side effects in 60 year old female

Reported by a consumer/non-health professional from United States on 2012-06-18

Patient: 60 year old female, weighing 78.9 kg (173.6 pounds)

Reactions: Irritability, Night Sweats, Product Substitution Issue, Product Quality Issue, Nausea, Abdominal Distension, Headache

Drug(s) suspected as cause:
Estrace

Estradiol
    Dosage: one tab daily po
    Administration route: Oral
    Indication: Irritability
    Start date: 2012-05-17
    End date: 2012-06-14

Estradiol
    Dosage: one tab daily po
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 2012-05-17
    End date: 2012-06-14

Estradiol
    Dosage: one tab daily po
    Administration route: Oral
    Indication: Night Sweats
    Start date: 2012-05-17
    End date: 2012-06-14



Possible Estrace side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-08

Patient: female

Reactions: Drug Ineffective, Hyperhidrosis

Drug(s) suspected as cause:
Estrace
    Dosage: unk

Premarin
    Dosage: unk



Possible Estrace side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-05

Patient: female, weighing 62.1 kg (136.7 pounds)

Reactions: Bunion, Vulvovaginal Mycotic Infection, Circumstance or Information Capable of Leading To Medication Error, Skin Lesion, Pain of Skin, Skin Disorder, Application Site Pain, Vulvovaginal Pruritus

Drug(s) suspected as cause:
Estrace
    Dosage: unk
    Start date: 2011-08-01
    End date: 2011-08-01

Estring
    Dosage: 2 mg, unk
    Indication: Vulvitis
    Start date: 2011-07-01
    End date: 2011-07-01

Estring
    Dosage: unk
    Start date: 2012-02-01
    End date: 2012-05-01

Estring
    Dosage: unk
    Start date: 2011-09-01
    End date: 2011-12-01

Other drugs received by patient: Nexium; Ibuprofen (Advil); Ambien; Acetylsalicylic Acid



Possible Estrace side effects in female

Reported by a individual with unspecified qualification from United States on 2012-04-26

Patient: female, weighing 122.5 kg (269.4 pounds)

Reactions: Endometrial Cancer, Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Estrace



Possible Estrace side effects in 72 year old female

Reported by a physician from United States on 2012-04-26

Patient: 72 year old female, weighing 82.7 kg (181.9 pounds)

Reactions: Pulmonary Embolism

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Estrace

Other drugs received by patient: Celexa; Lovoyl



Possible Estrace side effects in female

Reported by a lawyer from United States on 2012-04-25

Patient: female, weighing 64.0 kg (140.8 pounds)

Reactions: Breast Cancer Female, Depression

Drug(s) suspected as cause:
Estrace
    Dosage: unk
    Indication: Hormone Replacement Therapy
    Start date: 2003-01-01

Medroxyprogesterone Acetate
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1982-01-01
    End date: 1997-01-01

Premarin
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1982-01-01
    End date: 1997-01-01

Prempro
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1997-01-01
    End date: 2003-01-01

Provera
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1982-01-01
    End date: 1997-01-01



Possible Estrace side effects in 43 year old female

Reported by a consumer/non-health professional from United States on 2012-04-13

Patient: 43 year old female, weighing 69.4 kg (152.7 pounds)

Reactions: Weight Decreased, Aphagia, Wrong Technique in Drug Usage Process, Mouth Ulceration, Drug Ineffective FOR Unapproved Indication, Drug Interaction, Cyst, Treatment Noncompliance, Malaise, Incorrect Drug Administration Duration, Fungal Infection, Mobility Decreased

Drug(s) suspected as cause:
Estrace

Other drugs received by patient possibly interacting with the suspect drug:
Diflucan
    Dosage: 1df

Prevacid 24 HR
    Dosage: 15mg per day
    Administration route: Oral
    Indication: Dyspepsia
    Start date: 2012-01-01

Other drugs received by patient: Clindamycin



Possible Estrace side effects in female

Reported by a physician from United States on 2012-04-12

Patient: female, weighing 51.7 kg (113.8 pounds)

Reactions: Product Substitution Issue, Uterine Disorder

Drug(s) suspected as cause:
Estrace



Possible Estrace side effects in 87 year old female

Reported by a consumer/non-health professional from United States on 2012-04-02

Patient: 87 year old female

Reactions: Skin Discolouration, Breast Mass, Rash Pruritic

Drug(s) suspected as cause:
Estrace

Other drugs received by patient: Atenolol



Possible Estrace side effects in 58 year old female

Reported by a consumer/non-health professional from United States on 2012-04-02

Patient: 58 year old female

Reactions: Breast Cancer Stage I

Drug(s) suspected as cause:
Estrace
    Dosage: 0.01% used daily then 3 times weekly, vaginal; 0.01% unknown, vaginal
    Indication: Vulvovaginal Dryness
    Start date: 2012-01-05

Estrace
    Dosage: 0.01% used daily then 3 times weekly, vaginal; 0.01% unknown, vaginal
    Indication: Uterine Prolapse
    Start date: 2012-01-05

Estrace
    Dosage: 0.01% used daily then 3 times weekly, vaginal; 0.01% unknown, vaginal
    Indication: Cystocele
    Start date: 2012-01-05

Estrace
    Dosage: 0.01% used daily then 3 times weekly, vaginal; 0.01% unknown, vaginal
    Indication: Vulvovaginal Dryness
    Start date: 2010-09-01
    End date: 2011-01-01

Estrace
    Dosage: 0.01% used daily then 3 times weekly, vaginal; 0.01% unknown, vaginal
    Indication: Uterine Prolapse
    Start date: 2010-09-01
    End date: 2011-01-01

Estrace
    Dosage: 0.01% used daily then 3 times weekly, vaginal; 0.01% unknown, vaginal
    Indication: Cystocele
    Start date: 2010-09-01
    End date: 2011-01-01

Other drugs received by patient: Iron; Vitamins NOS; Calcium Carbonate; Vesicare; Synthroid; Lamictal



Possible Estrace side effects in 54 year old female

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: 54 year old female, weighing 52.6 kg (115.7 pounds)

Reactions: Spinal Osteoarthritis

Drug(s) suspected as cause:
Estrace



Possible Estrace side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: female

Reactions: Breast Cancer

Drug(s) suspected as cause:
Aygestin
    Indication: Hormone Replacement Therapy
    Start date: 1997-01-01
    End date: 2007-01-01

Cenestin
    Indication: Hormone Replacement Therapy
    Start date: 1997-01-01
    End date: 2007-01-01

Climara
    Indication: Hormone Replacement Therapy
    Start date: 1997-01-01
    End date: 2007-01-01

Estrace
    Indication: Hormone Replacement Therapy
    Start date: 1997-01-01
    End date: 2007-01-01

Estradiol
    Indication: Hormone Replacement Therapy
    Start date: 1997-01-01
    End date: 2007-01-01

Estradiol
    Indication: Hormone Replacement Therapy
    Start date: 1997-01-01
    End date: 2007-01-01

Premarin
    Indication: Hormone Replacement Therapy
    Start date: 1997-01-01
    End date: 2007-01-01

Premphase (Premarin;cycrin 14 / 14)
    Indication: Hormone Replacement Therapy
    Start date: 1997-01-01
    End date: 2007-01-01

Prometrium
    Indication: Hormone Replacement Therapy
    Start date: 1997-01-01
    End date: 2007-01-01



Possible Estrace side effects in 18 year old female

Reported by a consumer/non-health professional from United States on 2012-03-26

Patient: 18 year old female, weighing 63.5 kg (139.7 pounds)

Reactions: Educational Problem, Impaired Work Ability, Quality of Life Decreased, Genital Burning Sensation

Drug(s) suspected as cause:
Estrace



Possible Estrace side effects in female

Reported by a lawyer from United States on 2012-03-23

Patient: female

Reactions: Breast Cancer Female

Drug(s) suspected as cause:
Delestrogen
    Dosage: unk
    Indication: Hormone Replacement Therapy
    Start date: 1994-01-01
    End date: 1995-01-01

Estrace
    Dosage: 2 mg, unk
    Indication: Hormone Replacement Therapy
    Start date: 1994-01-01
    End date: 1995-01-01

Prempro
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1996-01-01
    End date: 1998-03-01

Provera
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1994-01-01
    End date: 1995-01-01



Possible Estrace side effects in female

Reported by a lawyer from United States on 2012-03-16

Patient: female

Reactions: Breast Cancer Female

Drug(s) suspected as cause:
Delestrogen
    Dosage: unk
    Indication: Hormone Replacement Therapy
    Start date: 1994-01-01
    End date: 1995-01-01

Estrace
    Dosage: 2 mg, unk
    Indication: Hormone Replacement Therapy
    Start date: 1994-01-01
    End date: 1995-01-01

Prempro
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1996-01-01
    End date: 1998-03-01

Provera
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1994-01-01
    End date: 1995-01-01



Possible Estrace side effects in female

Reported by a lawyer from United States on 2012-03-16

Patient: female, weighing 70.0 kg (154.0 pounds)

Reactions: Anxiety, Breast Cancer, Bone Neoplasm Malignant, Neoplasm Malignant, Hepatic Lesion, Depression

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Delestrogen
    Dosage: unk
    Indication: Hormone Replacement Therapy
    Start date: 1994-01-01
    End date: 1995-01-01

Estrace
    Dosage: unk
    Indication: Hormone Replacement Therapy
    Start date: 1994-01-01
    End date: 1995-01-01

Premarin
    Dosage: unk
    Indication: Hormone Replacement Therapy

Prempro
    Dosage: 0.625/2.5mg
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1996-01-01
    End date: 1998-03-01

Provera
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1994-01-01
    End date: 1995-01-01

Other drugs received by patient: Prinzide



Possible Estrace side effects in 59 year old female

Reported by a physician from United States on 2012-03-02

Patient: 59 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Contusion, Femur Fracture, Joint Hyperextension, Hand Fracture, Cyst, Loss of Consciousness, Breast Cyst, Tongue Disorder, DRY Mouth, Muscle Injury, Cervical Spinal Stenosis, LOW Turnover Osteopathy, Muscle Spasms, Pain in Extremity, Laceration, Bursitis, Stress, Seasonal Allergy, Stress Fracture, Osteoporosis, Haemorrhage, Drug Interaction, Fracture Nonunion, Fall, Periodontitis, Foot Fracture, Limb Crushing Injury, Bone Loss, Fibrocystic Breast Disease, Malignant Melanoma, Blood Cholesterol Increased, Humerus Fracture, Tooth Fracture, Breast Disorder, Dental Caries, Bruxism, Meniscus Lesion, Osteoarthritis, Gingival Recession, Impaired Healing, Spinal Osteoarthritis, Tooth Disorder, Hypertension

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Estrace

Femhrt

Fosamax
    Administration route: Oral
    Start date: 2001-01-01
    End date: 2002-04-01

Fosamax
    Administration route: Oral
    Start date: 2003-05-01
    End date: 2005-04-01

Fosamax
    Administration route: Oral
    Indication: Osteopenia
    Start date: 1996-01-01
    End date: 2001-01-01

Other drugs received by patient: Progesterone; Vioxx; Premarin; Calcium (Unspecified)

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