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Ortho TRI-Cyclen (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 (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

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 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 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 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 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 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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