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NORGESTIMATE AND ETHINYL ESTRADIOL

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

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

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

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

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

Pregnancy On Oral Contraceptive
103 (11.84%)
Drug Ineffective
62 (7.13%)
Product Quality Issue
48 (5.52%)
Drug Interaction
28 (3.22%)
Off Label Use
22 (2.53%)
Drug Exposure During Pregnancy
18 (2.07%)
Metrorrhagia
18 (2.07%)
Cerebrovascular Accident
16 (1.84%)
Nausea
12 (1.38%)
Anxiety
11 (1.26%)
Headache
11 (1.26%)
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Blood Urine Present
10 (1.15%)
Coagulopathy
10 (1.15%)
Depression
10 (1.15%)
Thrombosis
10 (1.15%)
Vomiting
10 (1.15%)
Abortion Induced
9 (1.03%)
Mood Swings
9 (1.03%)
Abdominal Pain Upper
8 (.92%)
Abortion Spontaneous
8 (.92%)
Contraindication To Medical Treatme...
8 (.92%)
Deep Vein Thrombosis
8 (.92%)
Pain In Extremity
8 (.92%)
Pregnancy
8 (.92%)
Acne
7 (.8%)
Oedema Peripheral
7 (.8%)
Pulmonary Embolism
7 (.8%)
Fatigue
6 (.69%)
Injury
6 (.69%)
Muscle Spasms
6 (.69%)
Therapeutic Response Unexpected Wit...
6 (.69%)
Abdominal Pain
5 (.57%)
Convulsion
5 (.57%)
Dyspnoea
5 (.57%)
Eczema
5 (.57%)
Impaired Work Ability
5 (.57%)
Malaise
5 (.57%)
Migraine
5 (.57%)
Pain
5 (.57%)
Unintended Pregnancy
5 (.57%)
Vaginal Haemorrhage
5 (.57%)
Amenorrhoea
4 (.46%)
Bacterial Infection
4 (.46%)
Dysfunctional Uterine Bleeding
4 (.46%)
Hypoaesthesia
4 (.46%)
Intracranial Venous Sinus Thrombosi...
4 (.46%)
Swelling Face
4 (.46%)
Weight Increased
4 (.46%)
Abortion
3 (.34%)
Anaphylactoid Reaction
3 (.34%)
Anticonvulsant Drug Level Decreased
3 (.34%)
Chest Pain
3 (.34%)
Joint Swelling
3 (.34%)
Live Birth
3 (.34%)
Loss Of Consciousness
3 (.34%)
Menorrhagia
3 (.34%)
Menstruation Irregular
3 (.34%)
Ovarian Cyst
3 (.34%)
Pancreatitis
3 (.34%)
Paraesthesia
3 (.34%)
Polymenorrhoea
3 (.34%)
Pregnancy On Contraceptive
3 (.34%)
Proctocolectomy
3 (.34%)
Swelling
3 (.34%)
Syncope
3 (.34%)
Withdrawal Bleed
3 (.34%)
Abdominal Pain Lower
2 (.23%)
Alcohol Poisoning
2 (.23%)
Arthralgia
2 (.23%)
Back Pain
2 (.23%)
Blindness Unilateral
2 (.23%)
Blood Follicle Stimulating Hormone ...
2 (.23%)
Blood Prolactin Increased
2 (.23%)
Cardiac Arrest
2 (.23%)
Chest Discomfort
2 (.23%)
Cholecystectomy
2 (.23%)
Colitis Ischaemic
2 (.23%)
Colitis Ulcerative
2 (.23%)
Constipation
2 (.23%)
Decreased Appetite
2 (.23%)
Diarrhoea
2 (.23%)
Dizziness
2 (.23%)
Drug Administration Error
2 (.23%)
Drug Dose Omission
2 (.23%)
Dysphagia
2 (.23%)
Economic Problem
2 (.23%)
Embolism
2 (.23%)
Epilepsy
2 (.23%)
Feeling Abnormal
2 (.23%)
Gallbladder Disorder
2 (.23%)
Groin Pain
2 (.23%)
Haematochezia
2 (.23%)
Haematocrit Decreased
2 (.23%)
Haemoglobin Decreased
2 (.23%)
Hormone Level Abnormal
2 (.23%)
Incontinence
2 (.23%)
Intra-uterine Death
2 (.23%)
Irritability
2 (.23%)
Maternal Drugs Affecting Foetus
2 (.23%)
Menstrual Disorder
2 (.23%)
Micturition Disorder
2 (.23%)

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

What are the most common Norgestimate 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 Norgestimate 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 Norgestimate 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 Norgestimate And Ethinyl Estradiol According to Those Reporting Adverse Events

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

Contraception
240
Oral Contraception
38
Product Used For Unknown Indication
29
Drug Use For Unknown Indication
23
Menstruation Irregular
10
Acne
9
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Menorrhagia
7
Menstrual Disorder
5
Dysmenorrhoea
4
Injectable Contraception
3
Menstrual Cycle Management
3
Foetal Exposure During Pregnancy
2
Haemorrhage
1
Prophylaxis
1
Hormone Level Abnormal
1
Hereditary Haemorrhagic Telangiecta...
1
Polycystic Ovaries
1
Muscle Spasms
1
Hormone Replacement Therapy
1
Ill-defined Disorder
1
Mood Swings
1
Ovarian Cyst
1

Drug Labels

LabelLabelerEffective
MononessaWatson Pharmaceuticals07-DEC-10
TrinessaWatson Pharmaceuticals07-DEC-10
Ortho Tri Cyclen LoPhysicians Total Care, Inc.03-FEB-11
Tri-sprintecMedVantx, Inc.03-AUG-11
Tri-sprintecRebel Distributors Corp06-SEP-11
TrinessaRebel Distributors Corp13-SEP-11
Ortho Tri CyclenPhysicians Total Care, Inc.27-FEB-12
Norgestimate And Ethinyl EstradiolGlenmark Generics Inc., USA13-APR-12
Norgestimate And Ethinyl EstradiolGlenmark Generics Inc., USA17-APR-12
Tri-sprintecPhysicians Total Care, Inc.19-APR-12
TrinessaPhysicians Total Care, Inc.23-MAY-12
Tri-lo-sprintecTeva Pharmaceuticals USA Inc03-JUL-12
EstaryllaSandoz Inc05-JUL-12
Tri-estaryllaSandoz Inc06-JUL-12
Mono-linyahNorthstar Rx LLC01-AUG-12
Tri-sprintecBarr Laboratories Inc.07-AUG-12
Tri PrevifemQualitest Pharmaceuticals24-AUG-12
PrevifemQualitest Pharmaceuticals24-AUG-12
Tri-linyahNorthstar Rx LLC01-SEP-12
Ortho Tri Cyclen LoJanssen Pharmaceuticals, Inc.04-MAR-13
Ortho Tri CyclenJanssen Pharmaceuticals, Inc.08-MAR-13
Ortho CyclenJanssen Pharmaceuticals, Inc.08-MAR-13

Norgestimate And Ethinyl Estradiol Case Reports

What Norgestimate 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 Norgestimate 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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