This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Ortho TRI-Cyclen LO (Norgestimate / Ethinyl Estradiol) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (36)
Death (3)
Life Threatening Events (5)
Disability (4)
Reports by Reaction Type
Pulmonary Embolism (5),
Inappropriate Schedule of Drug Administration (5),
Off Label Use (4),
Metrorrhagia (4),
Paget-Schroetter Syndrome (3),
Pregnancy ON Oral Contraceptive (3),
Maternal Exposure During Pregnancy (3),
Convulsion (3),
Syncope (3),
Cardiac Arrest (3),
Haemorrhage (2),
Fall (2)
Below are a few examples of reports where side effects / adverse reactions may be related to Ortho TRI-Cyclen LO (Norgestimate / Ethinyl Estradiol). For a complete list or a specific selection of reports, please use the links above.
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: female, weighing 98.4 kg (216.5 pounds)
Reactions: Abdominal Pain, Nausea, Hypotension, Bundle Branch Block Right, Pulmonary Embolism, Convulsion, Syncope, Abdominal Distension, Cardiac Arrest, Oxygen Saturation Decreased
Adverse event resulted in: death, life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Cinryze
Start date: 2012-07-09
End date: 2012-07-09
Cinryze
Start date: 2011-11-07
End date: 2011-11-07
Cinryze
Start date: 2012-07-09
End date: 2012-07-09
Cinryze
Start date: 2010-11-27
End date: 2010-11-27
Cinryze
Start date: 2010-11-27
End date: 2010-11-27
Cinryze
Start date: 2012-02-06
End date: 2012-02-06
Cinryze
Start date: 2011-08-24
End date: 2011-08-24
Cinryze
Start date: 2012-02-06
End date: 2012-02-06
Cinryze
Start date: 2011-11-07
End date: 2011-11-07
Cinryze
Start date: 2012-06-28
End date: 2012-06-28
Cinryze
Start date: 2012-02-13
End date: 2012-02-13
Cinryze
Start date: 2011-08-24
End date: 2011-08-24
Cinryze
Start date: 2012-02-13
End date: 2012-02-13
Cinryze
Start date: 2009-10-01
End date: 2009-10-01
Cinryze
Start date: 2012-06-28
End date: 2012-06-28
Cinryze
Start date: 2010-11-27
End date: 2010-11-27
Cinryze
Indication: Hereditary Angioedema
Start date: 2012-07-09
End date: 2012-07-09
Cinryze
Indication: Abdominal Distension
Start date: 2012-02-06
End date: 2012-02-06
Cinryze
Indication: Nausea
Start date: 2010-11-27
End date: 2010-11-27
Cinryze
Start date: 2012-06-28
End date: 2012-06-28
Cinryze
Start date: 2011-08-24
End date: 2011-08-24
Cinryze
Start date: 2012-02-06
End date: 2012-02-06
Cinryze
Start date: 2009-10-01
End date: 2009-10-01
Cinryze
Start date: 2012-02-13
End date: 2012-02-13
Cinryze
Start date: 2011-11-07
End date: 2011-11-07
Cinryze
Start date: 2012-02-13
End date: 2012-02-13
Cinryze
Start date: 2012-07-09
End date: 2012-07-09
Cinryze
Start date: 2009-10-01
End date: 2009-10-01
Cinryze
Start date: 2011-08-24
End date: 2011-08-24
Cinryze
Indication: Pain
Start date: 2009-10-01
End date: 2009-10-01
Cinryze
Start date: 2011-11-07
End date: 2011-11-07
Cinryze
Start date: 2012-06-28
End date: 2012-06-28
Nuvaring
Indication: Contraception
Start date: 2011-08-27
End date: 2011-09-24
Ortho TRI-Cyclen LO
Administration route: Oral
Indication: Contraception
Start date: 2012-06-21
Other drugs received by patient: Melatonin; Epipen; Fexofenadine; Fexofenadine; Metoprolol Tartrate; Nortriptyline; Clonazepam; Prilosec; Citalopram Hydrobromide; Remeron
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a individual with unspecified qualification from United States on 2012-08-21
Patient: female, weighing 98.5 kg (216.7 pounds)
Reactions: Off Label Use, Syncope, Acute Sinusitis, Cerebral Infarction, Hereditary Angioedema, Pulmonary Embolism, Depression, Cardiac Arrest, Convulsion
Adverse event resulted in: death, life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Cinryze
Start date: 2011-11-07
End date: 2011-11-07
Cinryze
Indication: Hereditary Angioedema
Start date: 2009-10-01
End date: 2009-10-01
Cinryze
Start date: 2012-07-09
Cinryze
Start date: 2011-08-24
End date: 2011-08-24
Cinryze
Start date: 2012-02-06
End date: 2012-02-06
Cinryze
Start date: 2012-02-13
End date: 2012-02-13
Cinryze
Start date: 2012-06-28
End date: 2012-06-28
Cinryze
Start date: 2010-11-27
End date: 2010-11-27
Nuvaring
Indication: Contraception
Start date: 2011-09-03
End date: 2011-09-24
Ortho TRI-Cyclen LO
Indication: Contraception
Other drugs received by patient: Citalopram Hydrobromide; Epipen; Metoprolol Tartrate; Melatonin; Clonazepam; Fexofenadine; Remeron; Nortriptyline; Prilosec
Possible Ortho TRI-Cyclen LO side effects in 28 year old female
Reported by a individual with unspecified qualification from United States on 2012-08-15
Patient: 28 year old female, weighing 70.3 kg (154.7 pounds)
Reactions: Thrombosis, Blindness Unilateral, Cerebrovascular Accident
Adverse event resulted in: life threatening event, disablity
Drug(s) suspected as cause:
Ortho TRI-Cyclen LO
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a physician from United States on 2012-07-30
Patient: female
Reactions: Off Label Use, Syncope, Pulmonary Embolism, Hereditary Angioedema, Cerebrovascular Accident, Cardiac Arrest, Convulsion
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Cinryze
Indication: Hereditary Angioedema
Start date: 2009-10-01
Ortho TRI-Cyclen LO
Dosage: unknown
Indication: Contraception
Other drugs received by patient: Metoprolol Tartrate; Nortriptyline HCL; Omeprazole; Fexofenadine; Klonopin; Celexa
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a pharmacist from United States on 2012-07-17
Patient: female
Reactions: Coeliac Disease
Drug(s) suspected as cause:
Ortho TRI-Cyclen LO
Possible Ortho TRI-Cyclen LO side effects in
Reported by a individual with unspecified qualification from United States on 2012-07-17
Patient:
Reactions: Medication Error, Wrong Drug Administered, Drug Dispensing Error
Drug(s) suspected as cause:
Ortho TRI-Cyclen
Ortho TRI-Cyclen LO
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-26
Patient: female, weighing 72.6 kg (159.7 pounds)
Reactions: Maternal Exposure During Pregnancy, Pregnancy ON Oral Contraceptive, Abortion Spontaneous
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ortho TRI-Cyclen LO
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-15
Patient: female, weighing 90.7 kg (199.6 pounds)
Reactions: Colitis Ulcerative, Incorrect Dose Administered
Drug(s) suspected as cause:
Ortho TRI-Cyclen LO
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-13
Patient: female, weighing 68.0 kg (149.7 pounds)
Reactions: Asthma, Inappropriate Schedule of Drug Administration
Drug(s) suspected as cause:
Ortho TRI-Cyclen LO
Administration route: Oral
Indication: Contraception
Ortho TRI-Cyclen LO
Administration route: Oral
Indication: Menstruation Irregular
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-08
Patient: female
Reactions: Papilloma Viral Infection
Drug(s) suspected as cause:
Ortho TRI-Cyclen LO
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-29
Patient: female, weighing 81.7 kg (179.6 pounds)
Reactions: Viral Infection, Hypothyroidism
Drug(s) suspected as cause:
Ortho TRI-Cyclen LO
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-23
Patient: female, weighing 67.1 kg (147.7 pounds)
Reactions: Irritability, Drug Dose Omission, Anxiety, Swelling, Ovarian Cyst, Depression, Metrorrhagia
Drug(s) suspected as cause:
Ortho TRI-Cyclen
Administration route: Oral
Indication: Contraception
Start date: 2011-01-01
End date: 2012-01-01
Ortho TRI-Cyclen LO
Administration route: Oral
Indication: Contraception
End date: 2011-01-01
Ortho TRI-Cyclen LO
Administration route: Oral
Start date: 2012-01-01
Other drugs received by patient: Synthroid
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-23
Patient: female, weighing 90.7 kg (199.6 pounds)
Reactions: Nausea, Urinary Tract Infection, Menstruation Delayed, Secretion Discharge
Drug(s) suspected as cause:
Ortho TRI-Cyclen LO
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-11
Patient: female, weighing 81.7 kg (179.6 pounds)
Reactions: Back Pain, Pain in Extremity, Gait Disturbance, Fall, Crying
Drug(s) suspected as cause:
Ortho Evra
Indication: Contraception
Start date: 2011-09-01
End date: 2011-09-01
Ortho TRI-Cyclen LO
Administration route: Oral
Indication: Contraception
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-04
Patient: female, weighing 112.0 kg (246.5 pounds)
Reactions: Off Label Use, Inappropriate Schedule of Drug Administration, Haemorrhage, Ovarian Enlargement, Uterine Enlargement
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ortho TRI-Cyclen LO
Administration route: Oral
Indication: Menstruation Irregular
Start date: 2002-06-02
End date: 2002-06-01
Ortho TRI-Cyclen LO
Administration route: Oral
Start date: 2002-06-01
End date: 2002-06-10
Other drugs received by patient: Metformin HCL
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-04
Patient: female, weighing 61.2 kg (134.7 pounds)
Reactions: Product Quality Issue, Maternal Exposure During Pregnancy, Adverse Event, Unintended Pregnancy, Pregnancy ON Oral Contraceptive
Drug(s) suspected as cause:
Ortho TRI-Cyclen
Indication: Contraception
End date: 2005-01-01
Ortho TRI-Cyclen LO
Administration route: Oral
Indication: Contraception
End date: 2005-01-01
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a lawyer from United States on 2012-04-20
Patient: female, weighing 59.0 kg (129.7 pounds)
Reactions: Paget-Schroetter Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ortho TRI-Cyclen LO
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-30
Patient: female, weighing 59.0 kg (129.7 pounds)
Reactions: Paget-Schroetter Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ortho TRI-Cyclen LO
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-30
Patient: female, weighing 54.4 kg (119.7 pounds)
Reactions: Inappropriate Schedule of Drug Administration, Maternal Exposure During Pregnancy, Foetal Death, Pregnancy ON Oral Contraceptive
Drug(s) suspected as cause:
Ortho TRI-Cyclen LO
Administration route: Oral
Start date: 2011-01-01
End date: 2011-01-01
Ortho TRI-Cyclen LO
Administration route: Oral
Indication: Contraception
Start date: 2010-01-01
End date: 2010-11-01
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-12
Patient: female, weighing 52.2 kg (114.8 pounds)
Reactions: Coeliac Disease, Stress Fracture, Bone Density Decreased
Drug(s) suspected as cause:
Ortho TRI-Cyclen LO
Administration route: Oral
Indication: Contraception
Start date: 2006-01-01
Ortho TRI-Cyclen LO
Administration route: Oral
Indication: Menstruation Irregular
Start date: 2006-01-01
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-12
Patient: female, weighing 46.3 kg (101.8 pounds)
Reactions: Narcolepsy
Drug(s) suspected as cause:
Ortho TRI-Cyclen LO
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-02
Patient: female, weighing 49.9 kg (109.8 pounds)
Reactions: Gastrointestinal Disorder, Vulvovaginal Dryness, Hormone Level Abnormal, Loss of Libido, Cervix Carcinoma
Drug(s) suspected as cause:
Ortho TRI-Cyclen LO
Possible Ortho TRI-Cyclen LO side effects in 23 year old female
Reported by a consumer/non-health professional from United States on 2012-02-28
Patient: 23 year old female, weighing 59.4 kg (130.7 pounds)
Reactions: Product Substitution Issue, Haemorrhage, Urinary Tract Infection, Abdominal Distension, Muscle Spasms, Metrorrhagia
Drug(s) suspected as cause:
Ortho TRI-Cyclen LO
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-23
Patient: female, weighing 59.0 kg (129.7 pounds)
Reactions: Paget-Schroetter Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ortho TRI-Cyclen LO
Possible Ortho TRI-Cyclen LO side effects in 27 year old female
Reported by a consumer/non-health professional from United States on 2012-02-03
Patient: 27 year old female, weighing 71.7 kg (157.7 pounds)
Reactions: Pulmonary Embolism
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Ortho TRI-Cyclen LO
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-25
Patient: female
Reactions: Salpingectomy
Drug(s) suspected as cause:
Ortho Cyclen-28
Indication: Product Used FOR Unknown Indication
Ortho Evra
Indication: Contraception
Ortho TRI-Cyclen
Indication: Product Used FOR Unknown Indication
Ortho TRI-Cyclen
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Ortho TRI-Cyclen LO
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a consumer/non-health professional from United States on 2012-01-18
Patient: female, weighing 58.1 kg (127.7 pounds)
Reactions: Inappropriate Schedule of Drug Administration, Wrong Technique in Drug Usage Process, Adverse Event, Drug Prescribing Error, Disability
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Ortho TRI-Cyclen LO
Administration route: Oral
Ortho TRI-Cyclen LO
Administration route: Oral
Indication: Contraception
Start date: 2012-01-01
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a consumer/non-health professional from United States on 2012-01-17
Patient: female, weighing 81.7 kg (179.6 pounds)
Reactions: Abnormal Dreams, Road Traffic Accident, Central Nervous System Lesion, Optic Neuritis, Multiple Sclerosis, Metrorrhagia, Vaginal Haemorrhage
Drug(s) suspected as cause:
Ortho TRI-Cyclen LO
Administration route: Oral
Start date: 2007-01-01
Ortho TRI-Cyclen LO
Administration route: Oral
Start date: 2011-10-01
Ortho TRI-Cyclen LO
Administration route: Oral
Indication: Contraception
End date: 2006-01-01
Other drugs received by patient: Anti-Asthma Inhaler
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a consumer/non-health professional from United States on 2012-01-10
Patient: female, weighing 81.7 kg (179.6 pounds)
Reactions: Pain in Extremity, Fall
Drug(s) suspected as cause:
Ortho Evra
Indication: Contraception
Start date: 2011-09-01
End date: 2011-09-01
Ortho TRI-Cyclen LO
Administration route: Oral
Indication: Contraception
Possible Ortho TRI-Cyclen LO side effects in female
Reported by a consumer/non-health professional from United States on 2012-01-03
Patient: female, weighing 72.6 kg (159.7 pounds)
Reactions: Vomiting, Diarrhoea, Dehydration, Metrorrhagia
Drug(s) suspected as cause:
Ortho TRI-Cyclen LO
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