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ESTRADIOL

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Estradiol Adverse Events Reported to the FDA Over Time

How are Estradiol adverse event reports trending over time?

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

Most Common Estradiol Adverse Events Reported to the FDA

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

Pain
5349 (9.19%)
Injury
4450 (7.64%)
Anxiety
2309 (3.97%)
Pulmonary Embolism
2235 (3.84%)
Gallbladder Disorder
2028 (3.48%)
Emotional Distress
2001 (3.44%)
Deep Vein Thrombosis
1983 (3.41%)
Cholecystitis Chronic
1813 (3.11%)
Breast Cancer Female
1490 (2.56%)
Cholelithiasis
1399 (2.4%)
General Physical Health Deteriorati...
1034 (1.78%)
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Anhedonia
819 (1.41%)
Abdominal Pain
767 (1.32%)
Cholecystectomy
688 (1.18%)
Nausea
657 (1.13%)
Gallbladder Injury
631 (1.08%)
Abdominal Pain Upper
593 (1.02%)
Cerebrovascular Accident
552 (.95%)
Vomiting
527 (.91%)
Depression
524 (.9%)
Thrombosis
503 (.86%)
Dyspnoea
492 (.85%)
Chest Pain
458 (.79%)
Breast Cancer
448 (.77%)
Cholecystitis
440 (.76%)
Biliary Dyskinesia
414 (.71%)
Drug Ineffective
382 (.66%)
Pain In Extremity
369 (.63%)
Diarrhoea
355 (.61%)
Fear
351 (.6%)
Headache
344 (.59%)
Cholecystitis Acute
338 (.58%)
Mental Disorder
319 (.55%)
Oedema Peripheral
290 (.5%)
Myocardial Infarction
262 (.45%)
Pregnancy On Oral Contraceptive
248 (.43%)
Product Quality Issue
245 (.42%)
Dyspepsia
232 (.4%)
Metrorrhagia
218 (.37%)
Abdominal Distension
212 (.36%)
Fatigue
207 (.36%)
Dizziness
197 (.34%)
Biliary Colic
193 (.33%)
Unintended Pregnancy
186 (.32%)
Back Pain
185 (.32%)
Scar
170 (.29%)
Application Site Erythema
163 (.28%)
Migraine
155 (.27%)
Gallbladder Non-functioning
152 (.26%)
Pancreatitis
151 (.26%)
Constipation
150 (.26%)
Application Site Pruritus
140 (.24%)
Vaginal Haemorrhage
138 (.24%)
Weight Increased
136 (.23%)
Drug Interaction
125 (.21%)
Pulmonary Infarction
122 (.21%)
Gallbladder Cholesterolosis
121 (.21%)
Nervousness
121 (.21%)
Asthenia
120 (.21%)
Flatulence
120 (.21%)
Hot Flush
120 (.21%)
Muscle Spasms
118 (.2%)
Malaise
117 (.2%)
Hypoaesthesia
114 (.2%)
Drug Exposure During Pregnancy
103 (.18%)
Menorrhagia
100 (.17%)
Loss Of Consciousness
98 (.17%)
Insomnia
97 (.17%)
Bile Duct Stone
96 (.16%)
Abortion Spontaneous
95 (.16%)
Palpitations
94 (.16%)
Gastrooesophageal Reflux Disease
93 (.16%)
Fear Of Death
92 (.16%)
Weight Decreased
92 (.16%)
Application Site Rash
91 (.16%)
Convulsion
89 (.15%)
Intracranial Venous Sinus Thrombosi...
89 (.15%)
Pruritus
89 (.15%)
Arthralgia
84 (.14%)
Thrombophlebitis Superficial
83 (.14%)
Paraesthesia
82 (.14%)
Deformity
81 (.14%)
Hypertension
81 (.14%)
Organ Failure
81 (.14%)
Transient Ischaemic Attack
77 (.13%)
Alopecia
69 (.12%)
Gastrointestinal Disorder
69 (.12%)
Stress
69 (.12%)
Cerebral Infarction
68 (.12%)
Fall
68 (.12%)
Nephrolithiasis
68 (.12%)
Procedural Pain
67 (.12%)
Abdominal Discomfort
66 (.11%)
Musculoskeletal Pain
66 (.11%)
Condition Aggravated
62 (.11%)
Discomfort
61 (.1%)
Inappropriate Schedule Of Drug Admi...
61 (.1%)
Mood Swings
61 (.1%)
Rash
61 (.1%)
Application Site Irritation
60 (.1%)
Hypersensitivity
58 (.1%)

ExportShare/Embed GraphExport Export Data

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

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

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ExportShare/Embed Graph Export Export Data

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

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

Hormone Replacement Therapy
3395
Contraception
3384
Product Used For Unknown Indication
1802
Acne
1195
Premenstrual Syndrome
754
Oral Contraception
691
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Drug Use For Unknown Indication
464
Menopause
346
Menopausal Symptoms
331
Menstruation Irregular
285
Menstrual Cycle Management
187
Menorrhagia
171
Polycystic Ovaries
143
Dysmenorrhoea
125
Hysterectomy
120
Vulvovaginal Dryness
117
Hormone Therapy
117
Hot Flush
105
Oestrogen Replacement Therapy
76
Atrophic Vulvovaginitis
76
Menstrual Disorder
61
Endometriosis
54
Ovarian Cyst
53
Off Label Use
51
Postmenopause
49
Hormone Level Abnormal
45
Ill-defined Disorder
43
Prostate Cancer
35
Osteoporosis
32
Prostate Cancer Stage Iv
22
Migraine
20
Vaginal Haemorrhage
20
Prophylaxis
20
Uterine Leiomyoma
17
Metrorrhagia
17
Oestrogen Deficiency
15
Transgender Hormonal Therapy
15
Oestrogen Therapy
15
Blood Oestrogen
14
Ovarian Failure
14
Cyst
14
Amenorrhoea
12
Unevaluable Event
12
Premature Menopause
10
Mood Swings
10
In Vitro Fertilisation
9
Blood Oestrogen Decreased
9
Blood Luteinising Hormone Decreased
9
Artificial Menopause
9
Abdominal Pain
9
Muscle Spasms
9

Drug Labels

LabelLabelerEffective
Tri-norinylWatson Pharma, Inc.01-MAY-07
FemhrtPhysicians Total Care, Inc.02-OCT-08
Femcon FePhysicians Total Care, Inc.01-APR-09
Femcon FeWarner Chilcott (US), LLC01-APR-09
Ovcon 35Warner Chilcott (US), LLC01-APR-09
Ovcon 50Warner Chilcott (US), LLC01-APR-09
AngeliqPhysicians Total Care, Inc.29-MAY-09
Tilia FeWatson Pharma, Inc.01-JUN-09
ClimaraBayer HealthCare Pharmaceuticals Inc.03-JUN-09
Estrostep FeWarner Chilcott (US), LLC07-JUL-09
DivigelPhysicians Total Care, Inc.31-AUG-09
EstradiolHeritage Pharmaceuticals Inc31-AUG-09
EstracePhysicians Total Care, Inc.01-SEP-09
AvianePhysicians Total Care, Inc.15-SEP-09
EstringPharmacia and Upjohn Company01-OCT-09
EstringPhysicians Total Care, Inc.01-OCT-09
EstradiolStat Rx USA27-OCT-09
EstradiolPD-Rx Pharmaceuticals, Inc.09-DEC-09
EstradiolMylan Pharmaceuticals Inc.09-DEC-09
EstradiolMylan Pharmaceuticals Inc.09-DEC-09
EstradiolPD-Rx Pharmaceuticals, Inc.09-DEC-09
FemtraceWarner Chilcott (US), LLC17-DEC-09
QuasenseWatson Pharma, Inc.28-DEC-09
EstradiolPhysicians Total Care, Inc.18-JAN-10
Estradiol ValeratePaddock Laboratories, Inc.27-JAN-10
TrivoraWatson Pharma, Inc.15-FEB-10
Depo-estradiolPharmacia and Upjohn Company02-MAR-10
Depo-estradiolPhysicians Total Care, Inc.02-MAR-10
EstradiolPhysicians Total Care, Inc.09-JUN-10
SeasoniquePhysicians Total Care, Inc.01-JUL-10
Guna-beta-estradiol Guna spa09-JUL-10
GianviPhysicians Total Care, Inc.11-JUL-10
ZenchentWatson Pharma, Inc.13-AUG-10
ZenchentPhysicians Total Care, Inc.13-AUG-10
EvamistPhysicians Total Care, Inc.24-AUG-10
ZarahWatson Pharma, Inc.09-SEP-10
NataziaPhysicians Total Care, Inc.05-OCT-10
AltaveraSandoz Inc07-OCT-10
NordetteTeva Women's Health, Inc.08-OCT-10
LybrelWyeth Pharmaceuticals Company, a subsidiary of Pfizer Inc.12-OCT-10
EstradiolKAISER FOUNDATION HOSPITALS29-OCT-10
GianviMedVantx, Inc.03-NOV-10
LeenaWatson Pharma, Inc.12-NOV-10
TrinessaWatson Pharmaceuticals07-DEC-10
Tilia FePhysicians Total Care, Inc.07-DEC-10
MononessaWatson Pharmaceuticals07-DEC-10
Necon 777Watson Pharma Inc15-DEC-10
EnpressePhysicians Total Care, Inc.20-DEC-10
LevonestNovast Laboratories, Ltd.12-JAN-11
KarivaPhysicians Total Care, Inc.16-JAN-11
CrysellePhysicians Total Care, Inc.20-JAN-11
ApriPhysicians Total Care, Inc.24-JAN-11
Kelnor 1/35 Physicians Total Care, Inc.24-JAN-11
EstradiolRebel Distributors Corp26-JAN-11
EnpresseRebel Distributors Corp26-JAN-11
SoliaPrasco Laboratories02-FEB-11
Ortho Tri Cyclen LoPhysicians Total Care, Inc.03-FEB-11
JinteliPhysicians Total Care, Inc.15-FEB-11
OcellaPhysicians Total Care, Inc.23-FEB-11
NeconRebel Distributors Corp15-MAR-11
Necon 1/35Physicians Total Care, Inc.15-MAR-11
JevantiqueWatson Pharma, Inc.23-MAR-11
IntrovaleSandoz Inc29-APR-11
Tilia FeWatson Pharma, Inc.13-MAY-11
BriellynGlenmark Generics Inc., USA31-MAY-11
Estradiol / Norethindrone AcetateBreckenridge Pharmaceutical, Inc.10-JUN-11
AmethystWatson Pharma, Inc.14-JUN-11
FemhrtWarner Chilcott (US), LLC21-JUN-11
LoseasoniqueTeva Women's Health, Inc.30-JUN-11
Tilia FeRebel Distributors Corp29-JUL-11
Tri-sprintecMedVantx, Inc.03-AUG-11
AmethiaWatson Pharma, Inc.15-AUG-11
Tri-sprintecRebel Distributors Corp06-SEP-11
TrinessaRebel Distributors Corp13-SEP-11
TrivoraPhysicians Total Care, Inc.22-SEP-11
VesturaWatson Pharma, Inc.01-OCT-11
MyzilraQualitest Pharmaceuticals03-OCT-11
Aviane28 DayRebel Distributors Corp04-OCT-11
Norethindrone And Ethinyl Estradiol And Ferrous FumarateLupin Pharmaceuticals, Inc.04-OCT-11
OrsythiaQualitest Pharmaceuticals04-OCT-11
Necon 777777Dispensing Solutions, Inc.06-OCT-11
Gildess Fe 1.5/30Qualitest Pharmaceuticals07-OCT-11
Gildess Fe 1/20Qualitest Pharmaceuticals13-OCT-11
Estradiol ValerateSandoz Inc13-OCT-11
Levonorgestrel And Ethinyl Estradiol And Ethinyl EstradiolLUPIN PHARMACEUTICALS INC18-OCT-11
Cyclafem 7/7/7Qualitest Pharmaceuticals18-OCT-11
Cyclafem 1/35Qualitest Pharmaceuticals21-OCT-11
AltaveraSandoz Inc16-NOV-11
EvamistTher-Rx Corporation09-DEC-11
Estradiol Transdermal SystemAlvogen, Inc.19-DEC-11
EstraceWarner Chilcott (US), LLC27-DEC-11
LoseasoniquePhysicians Total Care, Inc.10-JAN-12
EstringU.S. Pharmaceuticals12-JAN-12
NuvaringPhysicians Total Care, Inc.09-FEB-12
EstradiolPreferred Pharmaceuticals, Inc13-FEB-12
DelestrogenJHP Pharmaceuticals LLC22-FEB-12
EstrasorbMedicis Pharmaceutical Corp24-FEB-12
Ortho Tri CyclenPhysicians Total Care, Inc.27-FEB-12
AngeliqBayer HealthCare Pharmaceuticals Inc.29-FEB-12
Norgestrel/ethinyl EstradiolAkrimax Pharmaceuticals, LLC29-FEB-12
Necon 10/11Watson Pharma, Inc.07-MAR-12
Necon 1/35Watson Pharma, Inc.07-MAR-12
Necon 0.5/35Watson Pharma, Inc.07-MAR-12
Low-ogestrelWatson Pharma, Inc.08-MAR-12
Ogestrel 0.5/50Watson Pharma, Inc.08-MAR-12
LevoraWatson Pharma, Inc.08-MAR-12
Alyacen 7/7/7Glenmark Generics Inc., USA09-MAR-12
MarlissaGlenmark Generics Inc.,USA09-MAR-12
SronyxWatson Pharma, Inc.09-MAR-12
Alyacen 1/35Glenmark Generics Inc.,USA09-MAR-12
YasminPhysicians Total Care, Inc.15-MAR-12
VagifemPhysicians Total Care, Inc.15-MAR-12
EstradiolLake Erie Medical & Surgical Supply DBA Quality Care Products LLC15-MAR-12
Generess FeWatson Pharma, Inc.30-MAR-12
Estradiol ValerateJHP Pharmaceuticals, LLC09-APR-12
FemringWarner Chilcott (US), LLC10-APR-12
GianviTeva Pharmaceuticals USA Inc12-APR-12
Zovia 1/50e-28Physicians Total Care, Inc.13-APR-12
Zovia 1/35e-28Physicians Total Care, Inc.13-APR-12
Norgestimate And Ethinyl EstradiolGlenmark Generics Inc., USA13-APR-12
Junel Fe 1.5/30Physicians Total Care, Inc.16-APR-12
Junel 1.5/30Physicians Total Care, Inc.16-APR-12
Junel Fe 1/20Physicians Total Care, Inc.16-APR-12
VioreleGlenmark Generics Inc., USA17-APR-12
Norgestimate And Ethinyl EstradiolGlenmark Generics Inc., USA17-APR-12
Tri-sprintecPhysicians Total Care, Inc.19-APR-12
Microgestin FePhysicians Total Care, Inc.26-APR-12
MicrogestinPhysicians Total Care, Inc.26-APR-12
VesturaWatson Pharma, Inc.01-MAY-12
Velivettriphasic RegimenPhysicians Total Care, Inc.16-MAY-12
TrinessaPhysicians Total Care, Inc.23-MAY-12
NuvaringOrganon Pharmaceuticals USA31-MAY-12
Nortrel 7/7/7(28 Day Regimen)Physicians Total Care, Inc.01-JUN-12
DivigelUpsher-Smith Laboratories, Inc.12-JUN-12
Junel Fe 1.5/30Rebel Distributors Corp13-JUN-12
LevoraPhysicians Total Care, Inc.18-JUN-12
SyedaSandoz Inc20-JUN-12
NataziaBayer HealthCare Pharmaceuticals Inc.27-JUN-12
YasminBayer HealthCare Pharmaceuticals Inc.27-JUN-12
Gildess 1.5/30Qualitest Pharmaceuticals28-JUN-12
Gildess 1/20Qualitest Pharmaceuticals28-JUN-12
Lo Loestrin FeWarner Chilcott (US), LLC28-JUN-12
SafyralBayer HealthCare Pharmaceuticals Inc.28-JUN-12
BeyazBayer HealthCare Pharmaceuticals Inc.28-JUN-12
ElestrinJazz Pharmaceuticals Commercial Corp.29-JUN-12
ElestrinJazz Pharmaceuticals Commercial Corp.29-JUN-12
Tri-lo-sprintecTeva Pharmaceuticals USA Inc03-JUL-12
EstaryllaSandoz Inc05-JUL-12
Tri-estaryllaSandoz Inc06-JUL-12
LevoraRebel Distributors Corp10-JUL-12
EstradiolPD-Rx Pharmaceuticals, Inc.16-JUL-12
EstradiolWatson Laboratories, Inc.16-JUL-12
EstradiolPD-Rx Pharmaceuticals, Inc.16-JUL-12
Microgestin FeWatson Pharma, Inc.19-JUL-12
MicrogestinWatson Pharma, Inc.19-JUL-12
Zovia 1/35e-28Watson Pharma, Inc.19-JUL-12
Zovia 1/50e-28Watson Pharma, Inc.19-JUL-12
MimveyTeva Pharmaceuticals USA Inc20-JUL-12
SeasoniqueTeva Women's Health23-JUL-12
Philith Northstar Rx LLC01-AUG-12
Mono-linyahNorthstar Rx LLC01-AUG-12
Nortrel(28 Day Regimen)Barr Laboratories Inc.03-AUG-12
Nortrel(21 Day Regimen)Barr Laboratories Inc.03-AUG-12
ApriBarr Laboratories Inc.06-AUG-12
Nortrel 7/7/7(28 Day Regimen)Barr Laboratories Inc.07-AUG-12
Tri-sprintecBarr Laboratories Inc.07-AUG-12
ZeosaTeva Pharmaceuticals USA Inc13-AUG-12
CyclessaOrganon Pharmaceuticals USA16-AUG-12
AranelleBarr Laboratories Inc.16-AUG-12
CryselleBarr Laboratories Inc.16-AUG-12
EmoquetteQualitest Pharmaceuticals16-AUG-12
Tri-legest Fe28 DayBarr Laboratories Inc.17-AUG-12
Velivettriphasic RegimenBarr Laboratories Inc.17-AUG-12
LessinaBarr Laboratories Inc.21-AUG-12
EstradiolBarr Laboratories Inc.21-AUG-12
PortiaBarr Laboratories Inc.23-AUG-12
PrevifemQualitest Pharmaceuticals24-AUG-12
Tri PrevifemQualitest Pharmaceuticals24-AUG-12
BalzivaBarr Laboratories Inc.27-AUG-12
EnpresseBarr Laboratories Inc.28-AUG-12
Estradiol / Norethindrone AcetatePhysicians Total Care, Inc.29-AUG-12
LevonestNorthstar Rx LLC01-SEP-12
Dasetta 1/35Northstar Rx LLC01-SEP-12
FalminaNorthstar Rx LLC01-SEP-12
Tri-linyahNorthstar Rx LLC01-SEP-12
ElinestNorthstar Rx LLC01-SEP-12
WeraNorthstar Rx LLC01-SEP-12
EstradiolSTAT Rx USA LLC04-SEP-12
Necon 0.5/35Rebel Distributors Corp05-SEP-12
CamreseloTeva Pharmaceuticals USA Inc07-SEP-12
Aviane28 DayBarr Laboratories Inc.07-SEP-12
KarivaBarr Laboratories Inc.11-SEP-12
Junel Fe 1/20Barr Laboratories Inc.13-SEP-12
Junel Fe 1.5/30Barr Laboratories Inc.13-SEP-12
Junel 1/20Barr Laboratories Inc.13-SEP-12
Junel 1.5/30Barr Laboratories Inc.13-SEP-12
Kelnor 1/35Barr Laboratories Inc.14-SEP-12
EstradiolKAISER FOUNDATION HOSPITALS19-SEP-12
LorynaSandoz Inc25-SEP-12
Dasetta 7/7/7Northstar Rx LLC01-OCT-12
SeasonaleDuramed Pharmaceuticals, Inc.05-OCT-12
JolessaBarr Laboratories Inc.11-OCT-12
KurveloLupin Pharmaceuticals, Inc.17-OCT-12
Ortho EvraJanssen Pharmaceutical, Inc.23-OCT-12
Levonorgestrel And Ethinyl EstradiolLupin Pharmaceuticals, Inc.24-OCT-12
EstradiolMylan Pharmaceuticals Inc.29-OCT-12
MircetteTeva Women's Health, Inc.14-NOV-12
EstradiolCardinal Health16-NOV-12
GildagiaQualitest Pharmaceuticals27-NOV-12
Loestrin Fe 1.5/3028 DayTeva Women's Health, Inc03-DEC-12
Loestrin 1/2021 DayTeva Women's Health, Inc03-DEC-12
Loestrin Fe 1/2028 DayTeva Women's Health, Inc03-DEC-12
Loestrin 1.5/3021 DayTeva Women's Health, Inc03-DEC-12
ReclipsenWatson Pharma, Inc.10-DEC-12
JinteliTeva Pharmaceuticals USA Inc17-DEC-12
Wymzya FeLupin Pharmaceuticals, Inc.19-DEC-12
PrefestTeva Women's Health, Inc.20-DEC-12
Drospirenone And Ethinyl Estradiol Lupin Pharmaceuticals, Inc.03-JAN-13
AloraWatson Pharma, Inc.03-JAN-13
MinivelleNoven Therapeutics, LLC03-JAN-13
EstraceWarner Chilcott (US), LLC09-JAN-13
EstrogelASCEND Therapeutics, Inc.10-JAN-13
Chateal Afaxys Inc.16-JAN-13
EstradiolBryant Ranch Prepack17-JAN-13
EstradiolBryant Ranch Prepack18-JAN-13
EstradiolBryant Ranch Prepack18-JAN-13
Levonorgestrel And Ethinyl Estradiol Lupin Pharmaceuticals, Inc.25-JAN-13
OcellaBARR LABORATORIES, INC.07-FEB-13
CamreseTEVA Pharmaceuticals USA Inc21-FEB-13
Ortho CeptJanssen Pharmaceuticals, Inc.27-FEB-13
Ortho Tri Cyclen LoJanssen Pharmaceuticals, Inc.04-MAR-13
Ortho Tri CyclenJanssen Pharmaceuticals, Inc.08-MAR-13
Ortho CyclenJanssen Pharmaceuticals, Inc.08-MAR-13
Levonorgestrel And Ethinyl Estradiol Mylan Pharmaceuticals Inc.20-MAR-13
Ortho-novum 777Janssen Pharmaceuticals, Inc.29-MAR-13
ModiconJanssen Pharmaceuticals, Inc.29-MAR-13
Ortho Novum 135Janssen Pharmaceuticals, Inc.29-MAR-13
NorinylWatson Pharma, Inc.03-APR-13
BreviconWatson Pharma, Inc.03-APR-13
Estradiol ValerateJHP Pharmaceuticals, LLC04-APR-13
VagifemNovo Nordisk11-APR-13
Nortrel 7/7/7(28 Day Regimen)Barr Laboratories Inc.22-APR-13
OrsythiaQualitest Pharmaceuticals26-APR-13

Estradiol Case Reports

What Estradiol 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 Estradiol. 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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