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

 
 



Index of reports > All Cases (36)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Ortho TRI-Cyclen LO (Norgestimate / Ethinyl Estradiol) all cases. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 36   Next >>

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 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 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 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 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 2012-03-30

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 2012-03-12

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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