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ESTRACE

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Estrace Adverse Events Reported to the FDA Over Time

How are Estrace adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Estrace, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Estrace is flagged as the suspect drug causing the adverse event.

Most Common Estrace Adverse Events Reported to the FDA

What are the most common Estrace adverse events reported to the FDA?

Breast Cancer
404 (17.49%)
Breast Cancer Female
256 (11.08%)
Ovarian Cancer
53 (2.29%)
Pain
30 (1.3%)
Depression
29 (1.26%)
Breast Cancer Metastatic
27 (1.17%)
Breast Cancer In Situ
22 (.95%)
Headache
21 (.91%)
Hot Flush
21 (.91%)
Drug Ineffective
19 (.82%)
Cerebrovascular Accident
18 (.78%)
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Anxiety
17 (.74%)
Oestrogen Receptor Assay Positive
17 (.74%)
Nausea
16 (.69%)
Breast Disorder
15 (.65%)
Dizziness
15 (.65%)
Pruritus
14 (.61%)
Pulmonary Embolism
14 (.61%)
Back Pain
13 (.56%)
Breast Tenderness
13 (.56%)
Bronchitis
13 (.56%)
Progesterone Receptor Assay Positiv...
13 (.56%)
Dyspnoea
12 (.52%)
Fatigue
12 (.52%)
Feeling Abnormal
12 (.52%)
Abdominal Pain
11 (.48%)
Deep Vein Thrombosis
11 (.48%)
Osteoporosis
11 (.48%)
Rash
11 (.48%)
Biopsy
10 (.43%)
Insomnia
10 (.43%)
Breast Operation
9 (.39%)
Endometrial Cancer
9 (.39%)
Hypertension
9 (.39%)
Radiotherapy
9 (.39%)
Breast Pain
8 (.35%)
Drug Hypersensitivity
8 (.35%)
Erythema
8 (.35%)
Heart Rate Irregular
8 (.35%)
Muscle Spasms
8 (.35%)
Transient Ischaemic Attack
8 (.35%)
Alopecia
7 (.3%)
Arthralgia
7 (.3%)
Asthma
7 (.3%)
Breast Mass
7 (.3%)
Cholelithiasis
7 (.3%)
Death
7 (.3%)
Dyspepsia
7 (.3%)
Mastectomy
7 (.3%)
Myocardial Infarction
7 (.3%)
Palpitations
7 (.3%)
Scar
7 (.3%)
Vaginal Infection
7 (.3%)
Weight Increased
7 (.3%)
Abdominal Distension
6 (.26%)
Bone Density Decreased
6 (.26%)
Burning Sensation
6 (.26%)
Cough
6 (.26%)
Diarrhoea
6 (.26%)
Fall
6 (.26%)
Fungal Infection
6 (.26%)
Heart Rate Increased
6 (.26%)
Injury
6 (.26%)
Malignant Breast Lump Removal
6 (.26%)
Memory Impairment
6 (.26%)
Oedema Peripheral
6 (.26%)
Osteopenia
6 (.26%)
Paraesthesia
6 (.26%)
Road Traffic Accident
6 (.26%)
Speech Disorder
6 (.26%)
Swelling Face
6 (.26%)
Systemic Lupus Erythematosus
6 (.26%)
Vaginal Haemorrhage
6 (.26%)
Vulvovaginal Burning Sensation
6 (.26%)
Vulvovaginal Mycotic Infection
6 (.26%)
Vulvovaginal Pruritus
6 (.26%)
Weight Decreased
6 (.26%)
Abortion Spontaneous
5 (.22%)
Biliary Tract Disorder
5 (.22%)
Biopsy Site Unspecified Abnormal
5 (.22%)
Blood Pressure Increased
5 (.22%)
Breast Cancer Stage I
5 (.22%)
Breast Lump Removal
5 (.22%)
Breast Neoplasm
5 (.22%)
Cervix Disorder
5 (.22%)
Colonoscopy
5 (.22%)
Constipation
5 (.22%)
Cystitis
5 (.22%)
Dysuria
5 (.22%)
Gallbladder Cancer
5 (.22%)
Haemorrhoids
5 (.22%)
Hypercholesterolaemia
5 (.22%)
Infection
5 (.22%)
Ligament Sprain
5 (.22%)
Liver Injury
5 (.22%)
Loss Of Consciousness
5 (.22%)
Malaise
5 (.22%)
Migraine
5 (.22%)
Muscular Weakness
5 (.22%)
Nervousness
5 (.22%)
Nosophobia
5 (.22%)

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This graph shows the top adverse events submitted to the FDA for Estrace, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Estrace is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Estrace

What are the most common Estrace adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Estrace, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Estrace is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Estrace According to Those Reporting Adverse Events

Why are people taking Estrace, according to those reporting adverse events to the FDA?

Hormone Replacement Therapy
2066
Menopausal Symptoms
317
Menopause
187
Product Used For Unknown Indication
102
Drug Use For Unknown Indication
71
Vulvovaginal Dryness
45
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Hormone Therapy
40
Oestrogen Replacement Therapy
34
Hot Flush
29
Hysterectomy
19
Atrophic Vulvovaginitis
16
Osteoporosis
15
Postmenopause
14
Night Sweats
10
Hormone Level Abnormal
8
Vaginal Disorder
6
Vaginal Haemorrhage
5
Anxiety
4
Bladder Sphincter Atony
4
Breast Cancer
4
Bladder Disorder
4
Vulvovaginal Pain
4
Cystitis
3
Atrophy
3
Atrophic Vulvitis
3
Back Disorder
3
Infertility
3
Cardiovascular Event Prophylaxis
2
Osteopenia
2
Insomnia
2
Breast Tenderness
2
Vulvovaginal Pruritus
2
Menstrual Disorder
2
Vulvovaginal Erythema
2
Hypertonic Bladder
2
Artificial Menopause
2
Crying
2
Vulvovaginal Discomfort
2
Dyspareunia
2
Oestrogen Therapy
2
Dry Skin
2
Vaginal Infection
2
Prophylaxis
2
Breast Cancer Metastatic
2
Pelvic Floor Muscle Weakness
1
Haemorrhage
1
Urethritis Noninfective
1
Adverse Event
1
Uterovaginal Prolapse
1
Menopausal Symptoms Prophylaxis
1
Flushing
1

Drug Labels

LabelLabelerEffective
EstracePhysicians Total Care, Inc.01-SEP-09
EstracePhysicians Total Care, Inc.17-MAY-10
EstraceWarner Chilcott (US), LLC27-DEC-11
EstraceWarner Chilcott (US), LLC09-JAN-13

Estrace Case Reports

What Estrace safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Estrace. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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