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 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 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 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 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 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 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 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 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 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 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 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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