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 SUSPECTED ORTHO TRI-CYCLEN LO SIDE EFFECTS / ADVERSE REACTIONS

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

Reported by a consumer/non-health professional from United States on 2011-12-01

Patient: 26 year old female weighing 91.6 kg (201.6 pounds)

Reactions: Pulmonary Embolism

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Ortho TRI-Cyclen LO

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

Reported by a consumer/non-health professional from United States on 2012-02-03

Patient: 27 year old female weighing 71.7 kg (157.7 pounds)

Reactions: Pulmonary Embolism

Adverse event resulted in: life threatening event

Suspect drug(s):
Ortho TRI-Cyclen LO

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

Reported by a consumer/non-health professional from United States on 2012-02-28

Patient: 23 year old female weighing 59.4 kg (130.7 pounds)

Reactions: Product Substitution Issue, Haemorrhage, Urinary Tract Infection, Abdominal Distension, Muscle Spasms, Metrorrhagia

Suspect drug(s):
Ortho TRI-Cyclen LO