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Ortho TRI-Cyclen LO (Norgestimate / Ethinyl Estradiol) - Side Effect Reports to FDA

 
 



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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