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DROSPIRENONE AND ETHINYL ESTRADIOL

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

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

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

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

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

Pain
5211 (12.56%)
Injury
4403 (10.61%)
Anxiety
2221 (5.35%)
Emotional Distress
1988 (4.79%)
Pulmonary Embolism
1988 (4.79%)
Gallbladder Disorder
1940 (4.67%)
Deep Vein Thrombosis
1846 (4.45%)
Cholecystitis Chronic
1797 (4.33%)
Cholelithiasis
1358 (3.27%)
General Physical Health Deteriorati...
1026 (2.47%)
Anhedonia
817 (1.97%)
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Abdominal Pain
656 (1.58%)
Cholecystectomy
649 (1.56%)
Gallbladder Injury
611 (1.47%)
Abdominal Pain Upper
523 (1.26%)
Cerebrovascular Accident
463 (1.12%)
Nausea
452 (1.09%)
Cholecystitis
434 (1.05%)
Thrombosis
429 (1.03%)
Depression
418 (1.01%)
Biliary Dyskinesia
408 (.98%)
Dyspnoea
397 (.96%)
Chest Pain
371 (.89%)
Vomiting
364 (.88%)
Fear
350 (.84%)
Cholecystitis Acute
335 (.81%)
Mental Disorder
310 (.75%)
Pain In Extremity
283 (.68%)
Diarrhoea
276 (.67%)
Myocardial Infarction
230 (.55%)
Dyspepsia
209 (.5%)
Oedema Peripheral
209 (.5%)
Biliary Colic
189 (.46%)
Abdominal Distension
167 (.4%)
Scar
158 (.38%)
Gallbladder Non-functioning
147 (.35%)
Pancreatitis
138 (.33%)
Headache
130 (.31%)
Constipation
121 (.29%)
Back Pain
120 (.29%)
Gallbladder Cholesterolosis
115 (.28%)
Flatulence
106 (.26%)
Pulmonary Infarction
106 (.26%)
Fatigue
102 (.25%)
Dizziness
100 (.24%)
Bile Duct Stone
92 (.22%)
Nervousness
92 (.22%)
Fear Of Death
89 (.21%)
Organ Failure
81 (.2%)
Thrombophlebitis Superficial
81 (.2%)
Deformity
78 (.19%)
Gastrooesophageal Reflux Disease
77 (.19%)
Intracranial Venous Sinus Thrombosi...
69 (.17%)
Migraine
65 (.16%)
Weight Increased
64 (.15%)
Convulsion
63 (.15%)
Gastrointestinal Disorder
62 (.15%)
Procedural Pain
62 (.15%)
Asthenia
59 (.14%)
Hypoaesthesia
59 (.14%)
Nephrolithiasis
58 (.14%)
Muscle Spasms
57 (.14%)
Weight Decreased
57 (.14%)
Palpitations
56 (.13%)
Cholesterosis
54 (.13%)
Gallbladder Pain
52 (.13%)
Stress
52 (.13%)
Transient Ischaemic Attack
51 (.12%)
Discomfort
47 (.11%)
Paraesthesia
46 (.11%)
Cerebral Infarction
45 (.11%)
Abdominal Discomfort
44 (.11%)
Metrorrhagia
44 (.11%)
Post Cholecystectomy Syndrome
44 (.11%)
Musculoskeletal Pain
43 (.1%)
Arthralgia
42 (.1%)
Arrhythmia
38 (.09%)
Emotional Disorder
38 (.09%)
Quality Of Life Decreased
38 (.09%)
Malaise
35 (.08%)
Mobility Decreased
35 (.08%)
Amnesia
34 (.08%)
Hypertension
34 (.08%)
Fear Of Disease
32 (.08%)
Gastric Disorder
32 (.08%)
Jugular Vein Thrombosis
32 (.08%)
Muscular Weakness
32 (.08%)
Insomnia
31 (.07%)
Panic Attack
31 (.07%)
Psychiatric Symptom
31 (.07%)
Visual Impairment
31 (.07%)
Decreased Appetite
30 (.07%)
Superior Sagittal Sinus Thrombosis
30 (.07%)
Hemiparesis
29 (.07%)
Chest Discomfort
28 (.07%)
Gait Disturbance
28 (.07%)
Gastritis
28 (.07%)
Vaginal Haemorrhage
28 (.07%)
Cerebral Thrombosis
27 (.07%)
Menorrhagia
27 (.07%)
Pyrexia
27 (.07%)

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

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

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

Contraception
2020
Acne
1176
Product Used For Unknown Indication
1169
Premenstrual Syndrome
747
Oral Contraception
366
Menstruation Irregular
234
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Menstrual Cycle Management
158
Polycystic Ovaries
122
Menorrhagia
88
Dysmenorrhoea
75
Drug Use For Unknown Indication
55
Menstrual Disorder
45
Ovarian Cyst
37
Endometriosis
30
Hormone Level Abnormal
16
Cyst
13
Vaginal Haemorrhage
9
Unevaluable Event
9
Hormone Therapy
8
Abdominal Pain
8
Migraine
8
Alopecia
7
Hormone Replacement Therapy
7
Hypertrichosis
7
Muscle Spasms
7
Prophylaxis
6
Uterine Leiomyoma
6
Amenorrhoea
6
Metrorrhagia
5
Pain
5
Menopausal Symptoms
5
Menopause
5
Hirsutism
5
Hormone Suppression Therapy
5
Dysfunctional Uterine Bleeding
5
Abdominal Pain Lower
4
Drug Withdrawal Syndrome
4
Hyperandrogenism
3
Fibroma
3
Fertility Increased
2
Progestin Therapy
2
Emotional Disorder
2
Affect Lability
2
Oligomenorrhoea
2
Oestrogen Replacement Therapy
2
Breast Cyst
2
Uterine Haemorrhage
2
Mood Altered
2
Mood Swings
2
Oestrogen Therapy
2
Headache
2

Drug Labels

LabelLabelerEffective
GianviPhysicians Total Care, Inc.11-JUL-10
ZarahWatson Pharma, Inc.09-SEP-10
GianviMedVantx, Inc.03-NOV-10
OcellaPhysicians Total Care, Inc.23-FEB-11
VesturaWatson Pharma, Inc.01-OCT-11
YasminPhysicians Total Care, Inc.15-MAR-12
GianviTeva Pharmaceuticals USA Inc12-APR-12
VesturaWatson Pharma, Inc.01-MAY-12
SyedaSandoz Inc20-JUN-12
YasminBayer HealthCare Pharmaceuticals Inc.27-JUN-12
BeyazBayer HealthCare Pharmaceuticals Inc.28-JUN-12
SafyralBayer HealthCare Pharmaceuticals Inc.28-JUN-12
LorynaSandoz Inc25-SEP-12
Drospirenone And Ethinyl Estradiol Lupin Pharmaceuticals, Inc.03-JAN-13
OcellaBARR LABORATORIES, INC.07-FEB-13

Drospirenone And Ethinyl Estradiol Case Reports

What Drospirenone 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 Drospirenone 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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