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OCELLA

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Ocella Adverse Events Reported to the FDA Over Time

How are Ocella adverse event reports trending over time?

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

Most Common Ocella Adverse Events Reported to the FDA

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

Pain
1151 (8.05%)
Injury
853 (5.97%)
Gallbladder Disorder
719 (5.03%)
Cholelithiasis
666 (4.66%)
Pulmonary Embolism
598 (4.18%)
Cholecystitis Chronic
546 (3.82%)
Deep Vein Thrombosis
516 (3.61%)
Abdominal Pain Upper
443 (3.1%)
Cholecystectomy
424 (2.97%)
Nausea
413 (2.89%)
Abdominal Pain
348 (2.43%)
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Vomiting
311 (2.18%)
Emotional Distress
306 (2.14%)
Anxiety
296 (2.07%)
Gallbladder Injury
209 (1.46%)
Cholecystitis
181 (1.27%)
Biliary Dyskinesia
172 (1.2%)
Chest Pain
168 (1.18%)
Diarrhoea
157 (1.1%)
Dyspnoea
157 (1.1%)
Cerebrovascular Accident
137 (.96%)
Gallbladder Cholesterolosis
129 (.9%)
Thrombosis
119 (.83%)
Pain In Extremity
113 (.79%)
Myocardial Infarction
103 (.72%)
Biliary Colic
99 (.69%)
Back Pain
94 (.66%)
Depression
88 (.62%)
Abdominal Distension
82 (.57%)
Headache
82 (.57%)
General Physical Health Deteriorati...
79 (.55%)
Oedema Peripheral
79 (.55%)
Multiple Injuries
75 (.52%)
Cholecystitis Acute
74 (.52%)
Mental Disorder
70 (.49%)
Dizziness
64 (.45%)
Cholesterosis
57 (.4%)
Fatigue
56 (.39%)
Pancreatitis
55 (.38%)
Dyspepsia
53 (.37%)
Anhedonia
51 (.36%)
Gastrooesophageal Reflux Disease
51 (.36%)
Hypertension
47 (.33%)
Pyrexia
46 (.32%)
Fear
44 (.31%)
Abdominal Discomfort
41 (.29%)
Abdominal Tenderness
41 (.29%)
Thrombophlebitis
41 (.29%)
Metrorrhagia
40 (.28%)
Constipation
39 (.27%)
Palpitations
38 (.27%)
Hypoaesthesia
37 (.26%)
Cerebral Thrombosis
36 (.25%)
Gastritis
35 (.24%)
Cerebral Haemorrhage
34 (.24%)
Hepatic Adenoma
34 (.24%)
Benign Hepatic Neoplasm
33 (.23%)
Muscle Spasms
33 (.23%)
Migraine
32 (.22%)
Weight Increased
32 (.22%)
Abdominal Pain Lower
30 (.21%)
Arrhythmia
30 (.21%)
Gallbladder Non-functioning
30 (.21%)
Nephrolithiasis
29 (.2%)
Paraesthesia
28 (.2%)
Chest Discomfort
27 (.19%)
Vaginal Haemorrhage
27 (.19%)
Musculoskeletal Pain
26 (.18%)
Weight Decreased
26 (.18%)
Bile Duct Stone
25 (.17%)
Flank Pain
25 (.17%)
Procedural Pain
25 (.17%)
Scar
25 (.17%)
Gastrointestinal Disorder
24 (.17%)
Menorrhagia
24 (.17%)
Mood Altered
24 (.17%)
Thrombophlebitis Superficial
24 (.17%)
Pulmonary Infarction
23 (.16%)
Alopecia
21 (.15%)
Decreased Appetite
21 (.15%)
Mood Swings
21 (.15%)
Organ Failure
21 (.15%)
Acne
20 (.14%)
Chills
20 (.14%)
Intracranial Venous Sinus Thrombosi...
20 (.14%)
Nervousness
20 (.14%)
No Adverse Event
20 (.14%)
Crying
19 (.13%)
Discomfort
19 (.13%)
Pleuritic Pain
19 (.13%)
Syncope
19 (.13%)
Transient Ischaemic Attack
19 (.13%)
Convulsion
18 (.13%)
Blood Pressure Increased
17 (.12%)
Cerebral Infarction
17 (.12%)
Flatulence
17 (.12%)
Malaise
17 (.12%)
Tachycardia
17 (.12%)
Asthenia
16 (.11%)
Erythema
16 (.11%)
Jaundice
16 (.11%)

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

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

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

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

Product Used For Unknown Indication
1273
Acne
505
Contraception
495
Drug Use For Unknown Indication
483
Oral Contraception
233
Premenstrual Syndrome
167
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Menstruation Irregular
72
Menstrual Cycle Management
58
Polycystic Ovaries
36
Dysmenorrhoea
24
Ovarian Cyst
21
Menorrhagia
21
Endometriosis
15
Menstrual Disorder
11
Vaginal Haemorrhage
6
Migraine
5
Amenorrhoea
5
Oligomenorrhoea
5
Cyst
4
Hormone Replacement Therapy
4
Pelvic Pain
3
Prophylaxis
3
Emotional Disorder
3
Hormone Level Abnormal
2
Abdominal Pain
2
Deep Vein Thrombosis
2
Hormone Therapy
2
Uterine Leiomyoma
2
Menometrorrhagia
2
Pain
2
Eczema
2
Genital Haemorrhage
2
Dysfunctional Uterine Bleeding
2
Metrorrhagia
2
Ovulation Pain
2
Abdominal Pain Lower
2
Menstrual Discomfort
1
Adnexa Uteri Pain
1
Uterine Disorder
1
Dyspnoea
1
Hypertrichosis
1
Night Sweats
1
Hypomenorrhoea
1
Vomiting
1
Uterine Haemorrhage
1
Cholecystitis Chronic
1
Cholecystitis Acute
1
Anaemia
1
Menopause
1
Off Label Use
1
Menopausal Symptoms
1

Drug Labels

LabelLabelerEffective
OcellaPhysicians Total Care, Inc.23-FEB-11
OcellaBARR LABORATORIES, INC.07-FEB-13

Ocella Case Reports

What Ocella 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 Ocella. 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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