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LEVONORGESTREL AND ETHINYL ESTRADIOL

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Levonorgestrel And Ethinyl Estradiol Adverse Events Reported to the FDA Over Time

How are Levonorgestrel And Ethinyl Estradiol adverse event reports trending over time?

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

Most Common Levonorgestrel And Ethinyl Estradiol Adverse Events Reported to the FDA

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

Drug Ineffective
42 (2.49%)
Pregnancy On Oral Contraceptive
42 (2.49%)
Drug Exposure During Pregnancy
38 (2.25%)
Pulmonary Embolism
38 (2.25%)
Unintended Pregnancy
35 (2.08%)
Nausea
30 (1.78%)
Vomiting
25 (1.48%)
Drug Interaction
23 (1.36%)
Headache
21 (1.25%)
Loss Of Consciousness
21 (1.25%)
Metrorrhagia
17 (1.01%)
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Abortion Spontaneous
16 (.95%)
Alanine Aminotransferase Increased
16 (.95%)
Deep Vein Thrombosis
15 (.89%)
Cerebral Infarction
14 (.83%)
Condition Aggravated
14 (.83%)
Inappropriate Schedule Of Drug Admi...
14 (.83%)
Aspartate Aminotransferase Increase...
13 (.77%)
Chest Pain
13 (.77%)
Dizziness
13 (.77%)
Abdominal Pain
12 (.71%)
Dyspnoea
12 (.71%)
Oedema Peripheral
12 (.71%)
Liver Disorder
11 (.65%)
Thrombosis
11 (.65%)
Abdominal Pain Upper
10 (.59%)
Blood Bilirubin Increased
10 (.59%)
Syncope
10 (.59%)
Abortion Threatened
9 (.53%)
Antepartum Haemorrhage
9 (.53%)
Blood Lactate Dehydrogenase Increas...
9 (.53%)
Cerebrovascular Accident
9 (.53%)
Cholestasis
9 (.53%)
Cytolytic Hepatitis
9 (.53%)
Feeling Hot
9 (.53%)
Hypotension
9 (.53%)
Migraine
9 (.53%)
Premature Baby
9 (.53%)
Vaginal Haemorrhage
9 (.53%)
Abortion Induced
8 (.47%)
Caesarean Section
8 (.47%)
Fatigue
8 (.47%)
Fibrin D Dimer Increased
8 (.47%)
Hepatomegaly
8 (.47%)
Menorrhagia
8 (.47%)
Petit Mal Epilepsy
8 (.47%)
Pulmonary Artery Thrombosis
8 (.47%)
Pulmonary Infarction
8 (.47%)
Anxiety
7 (.42%)
Asthenia
7 (.42%)
Hypoaesthesia
7 (.42%)
Pruritus
7 (.42%)
Subclavian Vein Thrombosis
7 (.42%)
Urinary Tract Infection
7 (.42%)
Vaginal Discharge
7 (.42%)
White Blood Cell Count Increased
7 (.42%)
Amenorrhoea
6 (.36%)
Blood Pressure Decreased
6 (.36%)
Breast Tenderness
6 (.36%)
Cardiac Arrest
6 (.36%)
Diarrhoea
6 (.36%)
Epilepsy
6 (.36%)
Intracranial Venous Sinus Thrombosi...
6 (.36%)
Malaise
6 (.36%)
Pain In Extremity
6 (.36%)
Abortion
5 (.3%)
Acute Myocardial Infarction
5 (.3%)
Angiomyolipoma
5 (.3%)
Antinuclear Antibody Positive
5 (.3%)
Blindness Unilateral
5 (.3%)
Carotid Artery Thrombosis
5 (.3%)
Cough
5 (.3%)
Epigastric Discomfort
5 (.3%)
Haemorrhage
5 (.3%)
Hemiparesis
5 (.3%)
Hepatic Haemorrhage
5 (.3%)
Hepatitis
5 (.3%)
Hepatitis Acute
5 (.3%)
Hyperhidrosis
5 (.3%)
Menstruation Delayed
5 (.3%)
Musculoskeletal Stiffness
5 (.3%)
Myocardial Infarction
5 (.3%)
Optic Atrophy
5 (.3%)
Palpitations
5 (.3%)
Transient Ischaemic Attack
5 (.3%)
Anger
4 (.24%)
Arteriosclerosis Coronary Artery
4 (.24%)
Arthralgia
4 (.24%)
Ascites
4 (.24%)
Cerebral Thrombosis
4 (.24%)
Dehydration
4 (.24%)
Drug Dose Omission
4 (.24%)
Dry Eye
4 (.24%)
Dysmenorrhoea
4 (.24%)
Fluid Retention
4 (.24%)
Gamma-glutamyltransferase Increased
4 (.24%)
Genital Haemorrhage
4 (.24%)
Haemangioma Of Liver
4 (.24%)
Hepatic Function Abnormal
4 (.24%)
Hypertension
4 (.24%)
Jugular Vein Thrombosis
4 (.24%)

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This graph shows the top adverse events submitted to the FDA for Levonorgestrel And Ethinyl 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 Levonorgestrel And Ethinyl 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 Levonorgestrel And Ethinyl Estradiol

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

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

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

Contraception
294
Oral Contraception
167
Menorrhagia
28
Dysmenorrhoea
19
Menstruation Irregular
10
Drug Use For Unknown Indication
9
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Endometriosis
6
Vaginal Haemorrhage
6
Menstrual Cycle Management
6
Off Label Use
6
Prophylaxis
5
Product Used For Unknown Indication
5
Uterine Leiomyoma
5
Ovarian Failure
4
Premenstrual Syndrome
3
Pregnancy
3
Pelvic Pain
3
Epilepsy
3
Metrorrhagia
2
Adenomyosis
2
Polycystic Ovaries
2
Ovarian Disorder
2
Luteinising Hormone Deficiency
1
Acne
1
Hormone Level Abnormal
1
Abdominal Pain
1
Follicle-stimulating Hormone Defici...
1
Osteopenia
1
Hormone Replacement Therapy
1
Hypogonadism Female
1
Muscle Spasms
1
Anaemia
1
Ovarian Cyst
1
Ill-defined Disorder
1
Migraine
1

Drug Labels

LabelLabelerEffective
AvianePhysicians Total Care, Inc.15-SEP-09
QuasenseWatson Pharma, Inc.28-DEC-09
TrivoraWatson Pharma, Inc.15-FEB-10
SeasoniquePhysicians Total Care, Inc.01-JUL-10
AltaveraSandoz Inc07-OCT-10
NordetteTeva Women's Health, Inc.08-OCT-10
LybrelWyeth Pharmaceuticals Company, a subsidiary of Pfizer Inc.12-OCT-10
EnpressePhysicians Total Care, Inc.20-DEC-10
LevonestNovast Laboratories, Ltd.12-JAN-11
EnpresseRebel Distributors Corp26-JAN-11
IntrovaleSandoz Inc29-APR-11
AmethystWatson Pharma, Inc.14-JUN-11
LoseasoniqueTeva Women's Health, Inc.30-JUN-11
AmethiaWatson Pharma, Inc.15-AUG-11
TrivoraPhysicians Total Care, Inc.22-SEP-11
MyzilraQualitest Pharmaceuticals03-OCT-11
OrsythiaQualitest Pharmaceuticals04-OCT-11
Aviane28 DayRebel Distributors Corp04-OCT-11
Levonorgestrel And Ethinyl Estradiol And Ethinyl EstradiolLUPIN PHARMACEUTICALS INC18-OCT-11
AltaveraSandoz Inc16-NOV-11
LoseasoniquePhysicians Total Care, Inc.10-JAN-12
LevoraWatson Pharma, Inc.08-MAR-12
MarlissaGlenmark Generics Inc.,USA09-MAR-12
SronyxWatson Pharma, Inc.09-MAR-12
LevoraPhysicians Total Care, Inc.18-JUN-12
LevoraRebel Distributors Corp10-JUL-12
SeasoniqueTeva Women's Health23-JUL-12
LessinaBarr Laboratories Inc.21-AUG-12
PortiaBarr Laboratories Inc.23-AUG-12
EnpresseBarr Laboratories Inc.28-AUG-12
LevonestNorthstar Rx LLC01-SEP-12
FalminaNorthstar Rx LLC01-SEP-12
CamreseloTeva Pharmaceuticals USA Inc07-SEP-12
Aviane28 DayBarr Laboratories Inc.07-SEP-12
SeasonaleDuramed Pharmaceuticals, Inc.05-OCT-12
JolessaBarr Laboratories Inc.11-OCT-12
KurveloLupin Pharmaceuticals, Inc.17-OCT-12
Levonorgestrel And Ethinyl EstradiolLupin Pharmaceuticals, Inc.24-OCT-12
Chateal Afaxys Inc.16-JAN-13
Levonorgestrel And Ethinyl Estradiol Lupin Pharmaceuticals, Inc.25-JAN-13
CamreseTEVA Pharmaceuticals USA Inc21-FEB-13
Levonorgestrel And Ethinyl Estradiol Mylan Pharmaceuticals Inc.20-MAR-13
OrsythiaQualitest Pharmaceuticals26-APR-13

Levonorgestrel And Ethinyl Estradiol Case Reports

What Levonorgestrel And Ethinyl 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 Levonorgestrel And Ethinyl 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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