Ortho TRI-Cyclen (Norgestimate / Ethinyl Estradiol) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS Section).

• Thrombophlebitis and venous thrombosis with or without embolism
• Arterial thromboembolism
• Pulmonary embolism
• Myocardial infarction
• Cerebral hemorrhage
• Cerebral thrombosis
• Hypertension
• Gallbladder disease
• Hepatic adenomas or benign liver tumors

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:

• Nausea
• Vomiting
• Gastrointestinal symptoms (such as abdominal cramps and bloating)
• Breakthrough bleeding
• Spotting
• Change in menstrual flow
• Amenorrhea
• Temporary infertility after discontinuation of treatment
• Edema
• Melasma which may persist
• Breast changes: tenderness, enlargement, secretion
• Change in weight (increase or decrease)
• Change in cervical erosion and secretion
• Diminution in lactation when given immediately postpartum
• Cholestatic jaundice
• Migraine
• Rash (allergic)
• Mental depression
• Reduced tolerance to carbohydrates
• Vaginal candidiasis
• Change in corneal curvature (steepening)
• Intolerance to contact lenses

The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:

• Pre-menstrual syndrome
• Cataracts
• Changes in appetite
• Cystitis-like syndrome
• Headache
• Nervousness
• Dizziness
• Hirsutism
• Loss of scalp hair
• Erythema multiforme
• Erythema nodosum
• Hemorrhagic eruption
• Vaginitis
• Porphyria
• Impaired renal function
• Hemolytic uremic syndrome
• Acne
• Changes in libido
• Colitis
• Budd-Chiari Syndrome

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO ORTHO TRI-CYCLEN

Possible Ortho TRI-Cyclen side effects / adverse reactions in 26 year old female

Reported by a consumer/non-health professional from United States on 2007-02-01

Patient: 26 year old female weighing 52.0 kg (114.4 pounds)

Reactions: Hot Flush, Amenorrhoea, Acne, Alopecia, Intra-Uterine Contraceptive Device Expelled, Vaginal Infection, Ectopic Pregnancy

Suspect drug(s):
Mirena
    Dosage: 20 ug/day, cont, intra-uterine
    Indication: Contraception
    Start date: 2002-08-01

Ortho TRI-Cyclen
    Dosage: 1 tab(s), 1x/day, oral
    Administration route: Oral

Other drugs received by patient: Lexapro

Possible Ortho TRI-Cyclen side effects / adverse reactions in 23 year old female

Reported by a physician from United States on 2007-02-21

Patient: 23 year old female weighing 74.8 kg (164.7 pounds)

Reactions: Cerebral Infarction

Suspect drug(s):
Ortho TRI-Cyclen

Possible Ortho TRI-Cyclen side effects / adverse reactions in 17 year old female

Reported by a pharmacist from United States on 2007-02-27

Patient: 17 year old female weighing 62.6 kg (137.7 pounds)

Reactions: Dehydration, Sinus Headache, Superior Sagittal Sinus Thrombosis, Lethargy

Adverse event resulted in: hospitalization

Suspect drug(s):
Ortho TRI-Cyclen