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Index of reports
> Cases with Off Label Use (4)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Ortho TRI-Cyclen LO (Norgestimate / Ethinyl Estradiol) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.
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
Nuvaring
Indication: Contraception
Start date: 2011-09-03
End date: 2011-09-24
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
Ortho TRI-Cyclen LO
Indication: Contraception
Cinryze
Start date: 2010-11-27
End date: 2010-11-27
Other drugs received by patient: Citalopram Hydrobromide; Epipen; Metoprolol Tartrate; Melatonin; Clonazepam; Fexofenadine; Remeron; Nortriptyline; Prilosec
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 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 2011-11-03
Patient: female, weighing 61.2 kg (134.7 pounds)
Reactions: Drug Dose Omission, Off Label Use, Attention Deficit / Hyperactivity Disorder
Drug(s) suspected as cause:
Ortho TRI-Cyclen LO
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