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ORTHO TRI CYCLEN LO

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Ortho Tri Cyclen Lo Adverse Events Reported to the FDA Over Time

How are Ortho Tri Cyclen Lo adverse event reports trending over time?

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

Most Common Ortho Tri Cyclen Lo Adverse Events Reported to the FDA

What are the most common Ortho Tri Cyclen Lo adverse events reported to the FDA?

Drug Exposure During Pregnancy
297 (13.87%)
Pregnancy On Oral Contraceptive
291 (13.59%)
Metrorrhagia
108 (5.04%)
Nausea
41 (1.91%)
Pulmonary Embolism
32 (1.49%)
Headache
30 (1.4%)
Drug Dose Omission
29 (1.35%)
Off Label Use
25 (1.17%)
Inappropriate Schedule Of Drug Admi...
22 (1.03%)
Acne
21 (.98%)
Deep Vein Thrombosis
19 (.89%)
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Weight Increased
18 (.84%)
Menstruation Irregular
17 (.79%)
Vomiting
17 (.79%)
Abdominal Pain
16 (.75%)
Amenorrhoea
16 (.75%)
Depression
16 (.75%)
Unintended Pregnancy
16 (.75%)
Vaginal Haemorrhage
16 (.75%)
Menorrhagia
15 (.7%)
Drug Interaction
14 (.65%)
Breast Tenderness
13 (.61%)
Convulsion
13 (.61%)
Dyspnoea
13 (.61%)
Thrombosis
13 (.61%)
Treatment Noncompliance
13 (.61%)
Abortion Spontaneous
12 (.56%)
Coeliac Disease
11 (.51%)
Anxiety
10 (.47%)
Feeling Abnormal
10 (.47%)
Medication Error
10 (.47%)
Chest Pain
9 (.42%)
Pain
9 (.42%)
Pruritus
9 (.42%)
Rubella Antibody Positive
9 (.42%)
Urinary Tract Infection
9 (.42%)
Abdominal Distension
8 (.37%)
Cerebrovascular Accident
8 (.37%)
Dizziness
8 (.37%)
Fatigue
8 (.37%)
Loss Of Consciousness
8 (.37%)
Oedema Peripheral
8 (.37%)
Ovarian Cyst
8 (.37%)
Pyrexia
8 (.37%)
Asthma
7 (.33%)
Cardiac Arrest
7 (.33%)
Diarrhoea
7 (.33%)
Dysmenorrhoea
7 (.33%)
Heart Rate Increased
7 (.33%)
Malaise
7 (.33%)
Rash
7 (.33%)
Adverse Event
6 (.28%)
Amniocentesis Abnormal
6 (.28%)
Anorexia
6 (.28%)
Chills
6 (.28%)
Crying
6 (.28%)
Cystitis
6 (.28%)
Fall
6 (.28%)
Oligomenorrhoea
6 (.28%)
Oropharyngeal Pain
6 (.28%)
Premature Labour
6 (.28%)
Syncope
6 (.28%)
Uterine Spasm
6 (.28%)
Abdominal Discomfort
5 (.23%)
Abdominal Pain Upper
5 (.23%)
Alanine Aminotransferase Increased
5 (.23%)
Alopecia
5 (.23%)
Aspartate Aminotransferase Increase...
5 (.23%)
Asthenia
5 (.23%)
Cerebral Artery Occlusion
5 (.23%)
Colitis
5 (.23%)
Drug Administration Error
5 (.23%)
Emotional Disorder
5 (.23%)
Haemorrhage
5 (.23%)
Menstrual Disorder
5 (.23%)
Product Substitution Issue
5 (.23%)
Self-medication
5 (.23%)
Stress
5 (.23%)
Abortion
4 (.19%)
Aphagia
4 (.19%)
Arthralgia
4 (.19%)
Chest Discomfort
4 (.19%)
Cholelithiasis
4 (.19%)
Dehydration
4 (.19%)
Dysfunctional Uterine Bleeding
4 (.19%)
Fungal Infection
4 (.19%)
Hepatic Enzyme Increased
4 (.19%)
Hypocoagulable State
4 (.19%)
Hypothyroidism
4 (.19%)
Infectious Mononucleosis
4 (.19%)
Influenza
4 (.19%)
Insomnia
4 (.19%)
Intentional Overdose
4 (.19%)
Irritability
4 (.19%)
Joint Swelling
4 (.19%)
Loss Of Libido
4 (.19%)
Menstruation Delayed
4 (.19%)
Migraine
4 (.19%)
Multiple Sclerosis
4 (.19%)
Paranasal Sinus Hypersecretion
4 (.19%)
Pelvic Pain
4 (.19%)

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This graph shows the top adverse events submitted to the FDA for Ortho Tri Cyclen Lo, 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 Ortho Tri Cyclen Lo 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 Ortho Tri Cyclen Lo

What are the most common Ortho Tri Cyclen Lo adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Ortho Tri Cyclen Lo, 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 Ortho Tri Cyclen Lo 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 Ortho Tri Cyclen Lo According to Those Reporting Adverse Events

Why are people taking Ortho Tri Cyclen Lo, according to those reporting adverse events to the FDA?

Contraception
735
Drug Use For Unknown Indication
81
Oral Contraception
36
Menstruation Irregular
27
Acne
23
Product Used For Unknown Indication
16
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Menstrual Disorder
12
Menorrhagia
9
Dysmenorrhoea
7
Muscle Spasms
4
Ovarian Cyst
4
Polycystic Ovaries
4
Menstrual Cycle Management
4
Dysfunctional Uterine Bleeding
2
Abdominal Pain
2
Pregnancy
2
Endometriosis
2
Prophylaxis
2
Drug Exposure During Pregnancy
2
Drug Exposure Via Breast Milk
2
Maternal Drugs Affecting Foetus
2
Uterine Spasm
2
Metrorrhagia
2
Uterine Leiomyoma
1
Skin Disorder
1
Ovarian Disorder
1
Off Label Use
1
Pelvic Pain
1
Ill-defined Disorder
1
Dehydroepiandrosterone Increased
1
Rosacea
1
Abdominal Pain Upper
1
Mood Swings
1
Cyst
1

Drug Labels

LabelLabelerEffective
Ortho Tri Cyclen LoPhysicians Total Care, Inc.03-FEB-11
Ortho Tri Cyclen LoJanssen Pharmaceuticals, Inc.04-MAR-13

Ortho Tri Cyclen Lo Case Reports

What Ortho Tri Cyclen Lo 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 Ortho Tri Cyclen Lo. 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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