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Estrogens Adverse Events Reported to the FDA Over Time

How are Estrogens adverse event reports trending over time?

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

Most Common Estrogens Adverse Events Reported to the FDA

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

Breast Cancer
463 (19.84%)
Breast Cancer Female
398 (17.05%)
Breast Operation
87 (3.73%)
Mastectomy
50 (2.14%)
Breast Cancer Metastatic
39 (1.67%)
Oestrogen Receptor Assay Positive
25 (1.07%)
Injury
24 (1.03%)
Thrombosis
23 (.99%)
Breast Cancer In Situ
21 (.9%)
Dyspnoea
20 (.86%)
Ovarian Cancer
20 (.86%)
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Progesterone Receptor Assay Positiv...
19 (.81%)
Lymphoedema
16 (.69%)
Myocardial Infarction
16 (.69%)
Pain
15 (.64%)
Cerebrovascular Accident
14 (.6%)
Anxiety
13 (.56%)
Chest Pain
13 (.56%)
Condition Aggravated
12 (.51%)
Fatigue
12 (.51%)
Headache
12 (.51%)
Hot Flush
12 (.51%)
Retinal Haemorrhage
12 (.51%)
Deep Vein Thrombosis
11 (.47%)
Weight Increased
11 (.47%)
Pulmonary Embolism
10 (.43%)
Arthralgia
9 (.39%)
Drug Ineffective
9 (.39%)
Malignant Breast Lump Removal
9 (.39%)
Neuroleptic Malignant Syndrome
9 (.39%)
Breast Cancer Stage Ii
8 (.34%)
Cholecystitis
8 (.34%)
Dizziness
8 (.34%)
Drug Interaction
8 (.34%)
Emotional Distress
8 (.34%)
Fall
8 (.34%)
Heart Rate Increased
8 (.34%)
Major Depression
8 (.34%)
Malaise
8 (.34%)
Pain In Extremity
8 (.34%)
Unevaluable Event
8 (.34%)
Aspiration
7 (.3%)
Asthenia
7 (.3%)
Depression
7 (.3%)
Drug Withdrawal Syndrome
7 (.3%)
Mood Swings
7 (.3%)
Post Procedural Complication
7 (.3%)
Septic Shock
7 (.3%)
Alopecia
6 (.26%)
Breath Sounds Abnormal
6 (.26%)
Cervix Carcinoma
6 (.26%)
Completed Suicide
6 (.26%)
Cyanosis
6 (.26%)
Dehydration
6 (.26%)
Haemorrhage
6 (.26%)
Hepatitis
6 (.26%)
Lymphadenectomy
6 (.26%)
Metastases To Lymph Nodes
6 (.26%)
Renal Failure
6 (.26%)
Scar
6 (.26%)
Self Injurious Behaviour
6 (.26%)
Sleep Disorder
6 (.26%)
Surgery
6 (.26%)
Abnormal Behaviour
5 (.21%)
Blood Pressure Decreased
5 (.21%)
Blood Pressure Increased
5 (.21%)
Breast Cancer Recurrent
5 (.21%)
Breast Cancer Stage Iii
5 (.21%)
Breast Cyst
5 (.21%)
Breast Disorder
5 (.21%)
Electrolyte Imbalance
5 (.21%)
Endometrial Sarcoma
5 (.21%)
General Physical Health Deteriorati...
5 (.21%)
Hypersensitivity
5 (.21%)
Laboratory Test Abnormal
5 (.21%)
Migraine
5 (.21%)
Nausea
5 (.21%)
Overdose
5 (.21%)
Peripheral Coldness
5 (.21%)
Rhabdomyolysis
5 (.21%)
Systemic Lupus Erythematosus
5 (.21%)
Tachycardia
5 (.21%)
Urinary Tract Infection
5 (.21%)
Urticaria
5 (.21%)
Abdominal Distension
4 (.17%)
Aggression
4 (.17%)
Asthma
4 (.17%)
Cardio-respiratory Arrest
4 (.17%)
Confusional State
4 (.17%)
Contusion
4 (.17%)
Cough
4 (.17%)
Crying
4 (.17%)
Hysterectomy
4 (.17%)
Livedo Reticularis
4 (.17%)
Loss Of Consciousness
4 (.17%)
Oedema Peripheral
4 (.17%)
Palpitations
4 (.17%)
Pelvic Pain
4 (.17%)
Pyelonephritis
4 (.17%)
Respiratory Failure
4 (.17%)
Serotonin Syndrome
4 (.17%)

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This graph shows the top adverse events submitted to the FDA for Estrogens, 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 Estrogens 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 Estrogens

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

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This graph shows the top categories of adverse events submitted to the FDA for Estrogens, 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 Estrogens 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 Estrogens According to Those Reporting Adverse Events

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

Hormone Replacement Therapy
2132
Drug Use For Unknown Indication
239
Menopausal Symptoms
101
Menopause
88
Oestrogen Replacement Therapy
66
Hormone Therapy
38
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Hysterectomy
36
Product Used For Unknown Indication
26
Hot Flush
19
Oestrogen Deficiency
14
Ill-defined Disorder
13
Osteoporosis
12
Contraception
8
Prophylaxis
8
Hormone Level Abnormal
7
Vulvovaginal Dryness
7
Endometrial Hyperplasia
6
Postmenopause
6
Osteoporosis Prophylaxis
5
Premature Menopause
4
Endometriosis
4
Prostate Cancer
4
Immunisation
4
Secondary Hypogonadism
3
Atrophic Vulvovaginitis
3
Oestrogen Therapy
3
Insomnia
3
Artificial Menopause
3
Blood Follicle Stimulating Hormone ...
3
Oral Contraception
3
Libido Increased
2
Radical Hysterectomy
2
Uterine Fibrosis
2
Oophorectomy
2
Luteinising Hormone Deficiency
2
Ovarian Failure
2
Supplementation Therapy
2
Body Height Above Normal
2
Osteoarthritis
1
Bone Density Decreased
1
Vaginitis Atrophic
1
Blood Luteinising Hormone Decreased
1
Dementia Alzheimers Type
1
Bone Disorder
1
Blood Prolactin Increased
1
Progestin Replacement Therapy
1
Night Sweats
1
Transgender Hormonal Therapy
1
Suicide Attempt
1
Libido Decreased
1
Nervousness
1

Drug Labels

LabelLabelerEffective
CenestinPhysicians Total Care, Inc.01-SEP-04
CenestinTeva Women's Health Inc.01-SEP-04
EnjuviaPhysicians Total Care, Inc.01-MAR-10
EnjuviaDuramed Pharmaceuticals Inc.01-MAR-10
PremarinState of Florida DOH Central Pharmacy27-MAY-10
Esterified Estrogens And MethyltestosteroneTal Pharma LLC16-SEP-10
PremarinWyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.30-NOV-10
Esterified Estrogens And MethyltestosteroneAmneal Pharmaceuticals07-FEB-11
MenestMonarch Pharmaceuticals, Inc.02-SEP-11
PremarinLake Erie Medical & Surgical Supply DBA Quality Care Products LLC21-MAR-12
PremarinLake Erie Medical & Surgical Supply DBA Quality Care Products LLC22-MAR-12
Esterified Estrogens And MethyltestosteroneANIP Acquisition Company30-MAR-12
Premarin VaginalWyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.10-MAY-12
PremarinCardinal Health22-JUN-12
PremarinvaginalPhysicians Total Care, Inc.22-JUN-12
PremarinAphena Pharma Solutions - Tennessee, Inc.18-JUL-12
PremarinWyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.30-JUL-12
PremphaseWyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.30-SEP-12
PremproWyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.30-SEP-12
PremproPhysicians Total Care, Inc.01-NOV-12
PremphasePhysicians Total Care, Inc.26-NOV-12
PremproDispensing Solutions, Inc.27-FEB-13
EemtCREEKWOOD PHARMACEUTICAL, INC,01-MAR-13
Eemt HsCREEKWOOD PHARMACEUTICAL, INC,01-MAR-13
PremarinCardinal Health17-APR-13
Esterified Estrogens And MethyltestosteroneANIP Acquisition Company29-APR-13
Esterified Estrogens And MethyltestosteroneAmneal Pharmaceuticals, LLC30-APR-13
PremarinCardinal Health30-APR-13

Estrogens Case Reports

What Estrogens 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 Estrogens. 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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