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What is the most important information I should know about ORTHO TRI-CYCLEN® Lo? Do not use ORTHO TRI-CYCLEN® Lo if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from hormonal birth control pills, including death from heart attack, blood clots, or stroke. This risk increases with age and the number of cigarettes you smoke.
Who should not take ORTHO TRI-CYCLEN® Lo?

Do not take ORTHO TRI-CYCLEN® Lo if you:

smoke and are over 35 years of age
had blood clots in your arms, legs, lungs, or eyes
had a problem with your blood that makes it clot more than normal
have certain heart valve problems or irregular heart beat that increases your risk of having blood clots
had a stroke
had a heart attack
have high blood pressure that cannot be controlled by medicine
have diabetes with kidney, eye, nerve, or blood vessel damage
have certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or any migraine headaches if you are over 35 years of age
have liver problems, including liver tumors
have any unexplained vaginal bleeding
are pregnant
had breast cancer or any cancer that is sensitive to female hormones

If any of these conditions happen while you are taking ORTHO TRI-CYCLEN® Lo, stop taking ORTHO TRI-CYCLEN® Lo right away and talk to your healthcare professional. Use nonhormonal contraception when you stop taking ORTHO TRI-CYCLEN® Lo. What are the possible serious side effects of ORTHO TRI-CYCLEN® Lo?

Like pregnancy, ORTHO TRI-CYCLEN® Lo may cause serious side effects, including blood clots in your lungs, heart attack, or a stroke that may lead to death. Some other examples of serious blood clots include blood clots in the legs or eyes.

Serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age. Serious blood clots are more likely to happen when you:

first start taking birth control pills
restart the same or different birth control pills after not using them for a month or more

Call your healthcare professional or go to a hospital emergency room right away if you have:

leg pain that will not go away
sudden severe shortness of breath
sudden change in vision or blindness
chest pain
a sudden, severe headache unlike your usual headaches
weakness or numbness in your arm or leg
trouble speaking

Other serious side effects include:

Liver problems, including:
rare liver tumors
jaundice (cholestasis), especially if you previously had cholestasis of pregnancy. Call your healthcare professional if you have yellowing of your skin or eyes
High blood pressure. You should see your healthcare professional for a yearly check of your blood pressure.
Gallbladder problems
Changes in the sugar and fat (cholesterol and triglycerides) levels in your blood
New or worsening headaches including migraine headaches
Irregular or unusual vaginal bleeding and spotting between your menstrual periods, especially during the first 3 months of taking ORTHO TRI-CYCLEN® Lo.
Depression
Possible cancer in your breast and cervix
Swelling of your skin especially around your mouth, eyes, and in your throat (angioedema). Call your healthcare professional if you have a swollen face, lips, mouth, tongue or throat, which may lead to difficulty swallowing or breathing. Your chance of having angioedema is higher if you have a history of angioedema.
Dark patches of skin around your forehead, nose, cheeks, and around your mouth, especially during pregnancy (chloasma). Women who tend to get chloasma should avoid spending a long time in sunlight, tanning booths, and under sun lamps while taking ORTHO TRI-CYCLEN® Lo. Use sunscreen if you have to be in the sunlight.

What are the most common side effects of ORTHO TRI-CYCLEN® Lo?

headache (including migraine)
nausea and vomiting
breast problems
tenderness, pain, and discomfort
enlargement and swelling
discharge
nipple pain
stomach pain
pain with your periods (menstrual cycle)
mood changes, including depression
acne
vaginal infections
bloating
weight gain
fatigue

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