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DROSPIRENONE

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Drospirenone Adverse Events Reported to the FDA Over Time

How are Drospirenone adverse event reports trending over time?

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

Most Common Drospirenone Adverse Events Reported to the FDA

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

Pain
5236 (12.32%)
Injury
4419 (10.39%)
Anxiety
2227 (5.24%)
Pulmonary Embolism
2051 (4.82%)
Gallbladder Disorder
2019 (4.75%)
Emotional Distress
1992 (4.69%)
Deep Vein Thrombosis
1890 (4.45%)
Cholecystitis Chronic
1811 (4.26%)
Cholelithiasis
1386 (3.26%)
General Physical Health Deteriorati...
1026 (2.41%)
Anhedonia
817 (1.92%)
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Abdominal Pain
683 (1.61%)
Cholecystectomy
679 (1.6%)
Gallbladder Injury
640 (1.51%)
Abdominal Pain Upper
541 (1.27%)
Cerebrovascular Accident
478 (1.12%)
Nausea
476 (1.12%)
Thrombosis
440 (1.04%)
Cholecystitis
435 (1.02%)
Depression
427 (1%)
Dyspnoea
415 (.98%)
Biliary Dyskinesia
413 (.97%)
Vomiting
385 (.91%)
Chest Pain
383 (.9%)
Fear
350 (.82%)
Cholecystitis Acute
337 (.79%)
Mental Disorder
311 (.73%)
Pain In Extremity
291 (.68%)
Diarrhoea
288 (.68%)
Myocardial Infarction
239 (.56%)
Oedema Peripheral
218 (.51%)
Dyspepsia
214 (.5%)
Biliary Colic
193 (.45%)
Abdominal Distension
173 (.41%)
Scar
159 (.37%)
Gallbladder Non-functioning
152 (.36%)
Headache
143 (.34%)
Pancreatitis
141 (.33%)
Back Pain
124 (.29%)
Constipation
122 (.29%)
Gallbladder Cholesterolosis
121 (.28%)
Pulmonary Infarction
109 (.26%)
Dizziness
108 (.25%)
Flatulence
107 (.25%)
Fatigue
105 (.25%)
Bile Duct Stone
96 (.23%)
Nervousness
95 (.22%)
Fear Of Death
92 (.22%)
Thrombophlebitis Superficial
82 (.19%)
Organ Failure
81 (.19%)
Deformity
78 (.18%)
Gastrooesophageal Reflux Disease
78 (.18%)
Intracranial Venous Sinus Thrombosi...
71 (.17%)
Weight Increased
68 (.16%)
Migraine
67 (.16%)
Convulsion
65 (.15%)
Gastrointestinal Disorder
65 (.15%)
Weight Decreased
64 (.15%)
Asthenia
63 (.15%)
Procedural Pain
63 (.15%)
Palpitations
61 (.14%)
Hypoaesthesia
60 (.14%)
Nephrolithiasis
60 (.14%)
Muscle Spasms
57 (.13%)
Transient Ischaemic Attack
57 (.13%)
Cholesterosis
54 (.13%)
Gallbladder Pain
52 (.12%)
Stress
52 (.12%)
Abdominal Discomfort
49 (.12%)
Metrorrhagia
49 (.12%)
Cerebral Infarction
47 (.11%)
Discomfort
47 (.11%)
Paraesthesia
47 (.11%)
Post Cholecystectomy Syndrome
45 (.11%)
Musculoskeletal Pain
43 (.1%)
Arthralgia
42 (.1%)
Arrhythmia
41 (.1%)
Malaise
39 (.09%)
Emotional Disorder
38 (.09%)
Quality Of Life Decreased
38 (.09%)
Hypertension
37 (.09%)
Amnesia
35 (.08%)
Mobility Decreased
35 (.08%)
Gastric Disorder
34 (.08%)
Muscular Weakness
33 (.08%)
Chest Discomfort
32 (.08%)
Fear Of Disease
32 (.08%)
Jugular Vein Thrombosis
32 (.08%)
Insomnia
31 (.07%)
Menorrhagia
31 (.07%)
Panic Attack
31 (.07%)
Psychiatric Symptom
31 (.07%)
Visual Impairment
31 (.07%)
Decreased Appetite
30 (.07%)
Gastritis
30 (.07%)
Hemiparesis
30 (.07%)
Superior Sagittal Sinus Thrombosis
30 (.07%)
Pyrexia
29 (.07%)
Syncope
29 (.07%)
Vaginal Haemorrhage
29 (.07%)
Abdominal Pain Lower
28 (.07%)

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

What are the most common Drospirenone 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, 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 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 According to Those Reporting Adverse Events

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

Contraception
2076
Product Used For Unknown Indication
1315
Acne
1185
Premenstrual Syndrome
751
Oral Contraception
432
Menstruation Irregular
236
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Menstrual Cycle Management
160
Polycystic Ovaries
124
Drug Use For Unknown Indication
101
Menorrhagia
89
Dysmenorrhoea
75
Menstrual Disorder
45
Ovarian Cyst
39
Endometriosis
33
Hormone Level Abnormal
16
Cyst
13
Unevaluable Event
9
Hormone Replacement Therapy
9
Vaginal Haemorrhage
9
Hormone Therapy
9
Migraine
8
Alopecia
8
Menopause
8
Abdominal Pain
8
Muscle Spasms
8
Hypertrichosis
7
Amenorrhoea
7
Uterine Leiomyoma
6
Prophylaxis
6
Dysfunctional Uterine Bleeding
5
Metrorrhagia
5
Hormone Suppression Therapy
5
Hirsutism
5
Menopausal Symptoms
5
Pain
5
Drug Withdrawal Syndrome
4
Abdominal Pain Lower
4
Hysterectomy
3
Fibroma
3
Hyperandrogenism
3
Oedema
2
Foetal Exposure During Pregnancy
2
Drug Exposure During Pregnancy
2
Headache
2
Oestrogen Therapy
2
Mood Swings
2
Mood Altered
2
Uterine Haemorrhage
2
Breast Cyst
2
Oestrogen Replacement Therapy
2
Oligomenorrhoea
2

Drug Labels

LabelLabelerEffective
AngeliqPhysicians Total Care, Inc.29-MAY-09
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
AngeliqBayer HealthCare Pharmaceuticals Inc.29-FEB-12
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
SafyralBayer HealthCare Pharmaceuticals Inc.28-JUN-12
BeyazBayer 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 Case Reports

What Drospirenone 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. 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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