Ortho Tri-Cyclen Lo (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

There is evidence of an association between the following conditions and the use of oral contraceptives:

• Mesenteric thrombosis
• Retinal thrombosis

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
• Allergic reaction, including rash, urticaria and angioedema
• 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 LO

Possible Ortho TRI-Cyclen LO side effects / adverse reactions in 33 year old female

Reported by a consumer/non-health professional from United States on 2009-09-02

Patient: 33 year old female weighing 72.7 kg (159.9 pounds)

Reactions: NO Adverse Event

Adverse event resulted in: death

Suspect drug(s):
Ortho TRI-Cyclen LO

Possible Ortho TRI-Cyclen LO side effects / adverse reactions in 27 year old female

Reported by a individual with unspecified qualification from United States on 2009-09-24

Patient: 27 year old female weighing 59.0 kg (129.7 pounds)

Reactions: Pneumonia, Pulmonary Embolism

Adverse event resulted in: hospitalization

Suspect drug(s):
Ortho TRI-Cyclen LO

Possible Ortho TRI-Cyclen LO side effects / adverse reactions in 47 year old female

Reported by a consumer/non-health professional from United States on 2009-09-29

Patient: 47 year old female weighing 72.6 kg (159.7 pounds)

Reactions: Pleurisy, Pulmonary Embolism

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Ortho TRI-Cyclen LO