This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Ortho TRI-Cyclen (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 (40)
Death (1)
Life Threatening Events (2)
Disability (2)
Reports by Reaction Type
Pregnancy ON Oral Contraceptive (8),
Maternal Exposure During Pregnancy (8),
Pulmonary Embolism (5),
Thrombosis (3),
Abortion Spontaneous (3),
Adverse Event (3),
Nausea (3),
Metrorrhagia (3),
Deep Vein Thrombosis (3),
Drug Dose Omission (2),
Drug Ineffective FOR Unapproved Indication (2),
Abdominal Pain Upper (2)
Below are a few examples of reports where side effects / adverse reactions may be related to Ortho TRI-Cyclen (Norgestimate / Ethinyl Estradiol). For a complete list or a specific selection of reports, please use the links above.
Possible Ortho TRI-Cyclen side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: female
Reactions: Drug Dose Omission, Maternal Exposure During Pregnancy, Pregnancy ON Oral Contraceptive, Abortion Spontaneous, Fluid Retention
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ortho TRI-Cyclen
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-05-01
End date: 2011-11-01
Ortho TRI-Cyclen
Administration route: Oral
Start date: 2012-06-01
Possible Ortho TRI-Cyclen side effects in 24 year old female
Reported by a physician from United States on 2012-07-27
Patient: 24 year old female, weighing 103.4 kg (227.5 pounds)
Reactions: Vomiting, Nausea, Drug Hypersensitivity, Headache
Drug(s) suspected as cause:
Norgestimate and Ethinyl Estradiol
Dosage: 0.18mg/35mcg 1 poqd x 7 day po
Administration route: Oral
Indication: Contraception
Start date: 2012-01-01
End date: 2012-01-28
Ortho TRI-Cyclen
Dosage: 0.215mg/35mcg, 0.25mg/35mcg 1 poqd x 7 day po
Administration route: Oral
Indication: Contraception
Possible Ortho TRI-Cyclen 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 side effects in 21 year old female
Reported by a consumer/non-health professional from United States on 2012-06-11
Patient: 21 year old female, weighing 68.0 kg (149.7 pounds)
Reactions: Brain Death, Pulmonary Thrombosis, Myocardial Infarction, Loss of Consciousness, Convulsion
Adverse event resulted in: death, life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Ortho TRI-Cyclen
Possible Ortho TRI-Cyclen side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-05
Patient: female, weighing 63.5 kg (139.7 pounds)
Reactions: Pulmonary Embolism, Deep Vein Thrombosis
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Ortho TRI-Cyclen
Dosage: daily po
Administration route: Oral
Indication: Contraception
Reclipsen
Dosage: daily po
Administration route: Oral
Indication: Contraception
Possible Ortho TRI-Cyclen side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-05
Patient: female
Reactions: Maternal Exposure During Pregnancy, Abortion, Pregnancy ON Oral Contraceptive
Drug(s) suspected as cause:
Ortho TRI-Cyclen
Possible Ortho TRI-Cyclen side effects in 33 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-30
Patient: 33 year old female
Reactions: Abdominal Mass
Drug(s) suspected as cause:
Ortho Cyclen-28
Administration route: Oral
Indication: Contraception
Start date: 2012-03-01
Ortho TRI-Cyclen
Administration route: Oral
Indication: Contraception
Start date: 2012-03-01
Possible Ortho TRI-Cyclen 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 LO
Administration route: Oral
Indication: Contraception
End date: 2011-01-01
Ortho TRI-Cyclen LO
Administration route: Oral
Start date: 2012-01-01
Ortho TRI-Cyclen
Administration route: Oral
Indication: Contraception
Start date: 2011-01-01
End date: 2012-01-01
Other drugs received by patient: Synthroid
Possible Ortho TRI-Cyclen side effects in female
Reported by a individual with unspecified qualification from United States on 2012-05-18
Patient: female, weighing 85.3 kg (187.6 pounds)
Reactions: Thrombosis, Dyspnoea
Drug(s) suspected as cause:
Ortho TRI-Cyclen
Ortho Evra
Possible Ortho TRI-Cyclen 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 side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-25
Patient: female, weighing 68.0 kg (149.6 pounds)
Reactions: Inhibitory Drug Interaction, Metrorrhagia
Drug(s) suspected as cause:
Provigil
Dosage: 400 milligram;
Administration route: Oral
Indication: Circadian Rhythm Sleep Disorder
Start date: 2006-05-04
Ortho TRI-Cyclen
Administration route: Oral
Indication: Contraception
Possible Ortho TRI-Cyclen side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-04
Patient: female, weighing 68.0 kg (149.7 pounds)
Reactions: Drug Ineffective FOR Unapproved Indication, Adverse Event, Cartilage Injury
Drug(s) suspected as cause:
Ortho TRI-Cyclen
Possible Ortho TRI-Cyclen side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-03
Patient: female, weighing 68.0 kg (149.7 pounds)
Reactions: Drug Ineffective FOR Unapproved Indication, Adverse Event, Cartilage Injury
Drug(s) suspected as cause:
Ortho TRI-Cyclen
Possible Ortho TRI-Cyclen side effects in 26 year old female
Reported by a consumer/non-health professional from United States on 2012-03-23
Patient: 26 year old female, weighing 54.4 kg (119.7 pounds)
Reactions: Metrorrhagia
Drug(s) suspected as cause:
Ortho TRI-Cyclen
Possible Ortho TRI-Cyclen side effects in 17 year old female
Reported by a physician from United States on 2012-03-20
Patient: 17 year old female, weighing 611.4 kg (1345.2 pounds)
Reactions: Menstrual Disorder
Drug(s) suspected as cause:
Ortho TRI-Cyclen
Possible Ortho TRI-Cyclen side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-19
Patient: female
Reactions: Product Quality Issue, Menorrhagia
Drug(s) suspected as cause:
Ortho TRI-Cyclen
Ogestrel 0.5 / 50-21
LO / Ovral-28
LO / Ovral-28
Possible Ortho TRI-Cyclen side effects in female
Reported by a pharmacist from United States on 2012-03-16
Patient: female, weighing 854.6 kg (1880.0 pounds)
Reactions: Pulmonary Embolism
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ortho TRI-Cyclen
Possible Ortho TRI-Cyclen side effects in 39 year old female
Reported by a physician from United States on 2012-03-16
Patient: 39 year old female
Reactions: Thrombosis
Drug(s) suspected as cause:
Yasmin
Administration route: Oral
Indication: Product Used FOR Unknown Indication
YAZ
Indication: Product Used FOR Unknown Indication
Beyaz
Indication: Product Used FOR Unknown Indication
Ortho TRI-Cyclen
Dosage: unk
Indication: Product Used FOR Unknown Indication
Possible Ortho TRI-Cyclen side effects in female
Reported by a consumer/non-health professional from Canada on 2012-03-12
Patient: female
Reactions: Maternal Exposure During Pregnancy, Drug Interaction, Abortion Induced, Pregnancy ON Oral Contraceptive
Drug(s) suspected as cause:
Ortho TRI-Cyclen
Other drugs received by patient possibly interacting with the suspect drug: Zoplicone
Indication: Product Used FOR Unknown Indication
Start date: 2009-01-01
Docusate Sodium
Indication: Product Used FOR Unknown Indication
Start date: 2009-01-01
Lamotrigine
Indication: Product Used FOR Unknown Indication
Start date: 2009-01-01
Trimebutine
Indication: Product Used FOR Unknown Indication
Start date: 2009-01-01
Omeprazole
Indication: Product Used FOR Unknown Indication
Start date: 2009-01-01
Acetaminophen
Indication: Product Used FOR Unknown Indication
Acetaminophen
Amoxicillin
Indication: Pharyngitis
Start date: 2011-12-15
Vitamin
Indication: Product Used FOR Unknown Indication
Start date: 2009-01-01
Possible Ortho TRI-Cyclen side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-21
Patient: female
Reactions: Menorrhagia
Drug(s) suspected as cause:
LO / Ovral-28
Ortho TRI-Cyclen
LO / Ovral-28
Ogestrel 0.5 / 50-21
Possible Ortho TRI-Cyclen side effects in 31 year old female
Reported by a consumer/non-health professional from United States on 2012-02-18
Patient: 31 year old female
Reactions: Facial Paresis
Drug(s) suspected as cause:
Ortho TRI-Cyclen
Dosage: 1 df, qd
Administration route: Oral
Indication: Contraception
Start date: 2011-03-01
Botox Cosmetic
Dosage: unk
Indication: Skin Wrinkling
Start date: 2011-04-26
End date: 2011-04-26
Other drugs received by patient: Levothyroxine Sodium
Possible Ortho TRI-Cyclen side effects in 23 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-17
Patient: 23 year old female, weighing 59.0 kg (129.8 pounds)
Reactions: Blood Bilirubin Increased, White Blood Cell Count Decreased, Blood Alkaline Phosphatase Increased, Pruritus, Gamma-Glutamyltransferase Increased, Cholecystitis, Neutrophil Count Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Etoposide
Indication: B Precursor Type Acute Leukaemia
Start date: 2010-05-28
Mercaptopurine
Dosage: last diose on 24jan12 held on 25jan2012
Administration route: Oral
Indication: B Precursor Type Acute Leukaemia
Start date: 2010-05-28
Methotrexate
Dosage: last dose on 18jan12 held on 25jan12
Administration route: Oral
Indication: B Precursor Type Acute Leukaemia
Start date: 2010-05-28
Prednisone TAB
Dosage: last dose on 01/01/2012 held on 1/25/2012
Administration route: Oral
Indication: B Precursor Type Acute Leukaemia
Start date: 2010-05-28
Cyclophosphamide
Indication: B Precursor Type Acute Leukaemia
Start date: 2010-05-28
Vincristine Sulfate
Dosage: last dose on 28dec2011 held on 25jan12
Indication: B Precursor Type Acute Leukaemia
Start date: 2010-05-28
Dexamethasone
Administration route: Oral
Indication: B Precursor Type Acute Leukaemia
Start date: 2010-05-28
Neurontin
Daunorubicin HCL
Indication: B Precursor Type Acute Leukaemia
Start date: 2010-05-28
Elspar
Indication: B Precursor Type Acute Leukaemia
Start date: 2010-05-28
Ortho TRI-Cyclen
Cytarabine
Indication: B Precursor Type Acute Leukaemia
Start date: 2010-05-28
Ifosfamide
Indication: B Precursor Type Acute Leukaemia
Start date: 2010-05-28
Oncaspar
Indication: B Precursor Type Acute Leukaemia
Start date: 2010-05-28
Sprycel
Dosage: last dose on 10jan2012 held on 25jan2012
Administration route: Oral
Indication: B Precursor Type Acute Leukaemia
Start date: 2010-05-28
Hydrocortisone
Indication: B Precursor Type Acute Leukaemia
Start date: 2010-05-28
Possible Ortho TRI-Cyclen side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-02
Patient: female
Reactions: Haematochezia
Drug(s) suspected as cause:
Ortho TRI-Cyclen
Indication: Contraception
Plan B ONE-Step
Dosage: 1.5 milligram;
Administration route: Oral
Indication: Post Coital Contraception
Possible Ortho TRI-Cyclen 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 TRI-Cyclen LO
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Ortho TRI-Cyclen
Indication: Product Used FOR Unknown Indication
Ortho TRI-Cyclen
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Ortho Evra
Indication: Contraception
Ortho Cyclen-28
Indication: Product Used FOR Unknown Indication
Possible Ortho TRI-Cyclen side effects in female
Reported by a physician from United States on 2011-12-16
Patient: female
Reactions: Maternal Exposure During Pregnancy, Pregnancy ON Oral Contraceptive, Abortion Spontaneous
Drug(s) suspected as cause:
Ortho TRI-Cyclen
Administration route: Oral
Indication: Contraception
Paxil
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Simponi; Vicoprofen
Possible Ortho TRI-Cyclen side effects in female
Reported by a pharmacist from United States on 2011-11-30
Patient: female, weighing 59.3 kg (130.5 pounds)
Reactions: Pain in Extremity, Oedema Peripheral, Deep Vein Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ortho TRI-Cyclen
Possible Ortho TRI-Cyclen side effects in female
Reported by a pharmacist from United States on 2011-11-30
Patient: female, weighing 61.6 kg (135.5 pounds)
Reactions: Echocardiogram Abnormal, Thrombosis, Renal Atrophy, Renal Hypertrophy, Deep Vein Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ortho TRI-Cyclen
Administration route: Oral
Indication: Pain
Ortho TRI-Cyclen
Administration route: Oral
Indication: Haemorrhage
Ortho TRI-Cyclen
Administration route: Oral
Indication: Affective Disorder
Possible Ortho TRI-Cyclen side effects in female
Reported by a pharmacist from United States on 2011-11-30
Patient: female, weighing 41.6 kg (91.5 pounds)
Reactions: Post Procedural Pneumonia, Ileostomy, Postoperative Wound Infection, Malnutrition, Pulmonary Embolism
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ortho TRI-Cyclen
Possible Ortho TRI-Cyclen side effects in female
Reported by a pharmacist from United States on 2011-11-30
Patient: female, weighing 62.4 kg (137.3 pounds)
Reactions: Cerebral Venous Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ortho TRI-Cyclen
Possible Ortho TRI-Cyclen side effects in female
Reported by a pharmacist from United States on 2011-11-30
Patient: female, weighing 106.0 kg (233.2 pounds)
Reactions: Pneumonia, Dyspnoea, Musculoskeletal Pain, International Normalised Ratio Decreased, Atrial Thrombosis, Pulmonary Embolism, Bronchitis, Cough
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ortho TRI-Cyclen
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