Ortho Tri-Cyclen is the brand name for a prescription birth-control pill.Its generic name is based on the hormones it's made of, ethinyl estradiol and norgestimate.The combination of female hormones in this contraceptive drug prevents ovulation, which is the release of an egg from the ovary.Ortho Tri-Cyclen Lo is another form of the drug that has a lower dose of the ethinyl estradiol part of the drug.When taken on schedule and without missing any pills, oral contraceptives that combine two hormones are highly effective, with only 1 in 1,000 women getting pregnant ("failing") in a year, according to the Food and Drug Administration (FDA).But pregnancy rates are typically higher with birth-control pills, because many people take don't them correctly. When studying large numbers of women taking pills that combine two hormones, the typical failure rate is closer to 3 percent a year, according to the FDA.On the company website for Ortho Tri-Cyclen Lo, it says failure rates are about 5 percent per year.Ortho Tri-Cyclen was approved by the FDA for birth-control in 1992 (and for acne in 1997). Ortho Tri-Cyclen Lo was approved by the FDA in 2002.Ortho Tri-Cyclen is manufactured by Janssen Pharmaceuticals. The drug also comes in several generic forms.In 2013, the FDA required companies to include additional warnings for birth-control products that use a combination of hormones, including Ortho Tri-Cyclen. (See Warnings section.)Acne and Ortho Tri-CyclenIn 1997, the FDA approved the use of Ortho Tri-Cyclen for acne in women ages 15 and older. It is thought to work by balancing hormones, so the body doesn't produce as much oil and sweat.In a study of more than 400 women, those who took Ortho Tri-Cyclen had a 42 percent decrease in number of pimples, compared with a 27 percent decrease in people who took a placebo.However, some people actually report worse acne with oral contraceptives. You should talk to your doctor about this possibility and weigh the risks against the benefits.Weight Gain and Ortho Tri-CyclenOrtho Tri-Cyclen may cause weight gain. Much of the weight gain women experience is due to fluid retention (not fat).To combat this unwanted effect, you should avoid caffeine, alcohol, and salt (sodium).Also, a healthy diet and exercise program can minimize weight gain.Warnings for Ortho Tri-CyclenIn 2013, the FDA added a black-box warning for Ortho Tri-Cyclen and other birth-control pills that use a combination of hormones.A black-box warning against smoking was added. You shouldn't use Ortho Tri-Cyclen if you smoke and are over age 35 because it can increase the risk of blood clots, stroke, or heart attack.The FDA also added a warning that if you have high blood pressure, or you develop high blood pressure when taking Ortho Tri-Cyclen, you should work with your doctor to get your blood pressure under control and monitor it closely, or you should use a non-hormonal type of contraception.If your blood pressure is already often above 160 (systolic) or above 100 (diastolic), you should stop taking Ortho Tri-Cyclen and other birth-control pills.Ortho Tri-Cyclen may increase your blood pressure. If you have diseases related to high blood pressure or kidney disease, you also should not use a contraceptive pill.Before using Ortho Tri-Cyclen, you should tell your doctor if you have or have ever had:A blood-clotting disorderHigh blood pressureA heart valve disorderChest painA heart attack, stroke, or blood clotHigh cholesterol or triglyceride levelsAny other type of heart or blood-circulation conditions (cardiovascular illnesses)Kidney diseasePre-diabetic glucose levelsDiabetes or diabetes complications of the eyes or kidneysLiver disease or liver cancerJaundice caused by birth control pills or pregnancySevere migrainesBreast or uterine cancerUnusual vaginal bleedingA history of depressionGallbladder diseaseSeizures or epilepsyA history of irregular menstrual cyclesBreast lumps, nodules, or an abnormal mammogramYou might need to use a backup birth-control method when you first start on Ortho Tri-Cyclen or if you miss a dose. You should follow your doctor's instructions carefully.You may experience breakthrough bleeding, especially during the first three months you use Ortho Tri-Cyclen.Every doctor or surgeon who treats you should know you are taking this medication. You may need to stop using Ortho Tri-Cyclen for a period of time if you need surgery or other medical procedures that require you to be on bed rest.After stopping Tri-Cyclen, your increased risk of developing breast cancer and heart disease may continue for a number of years.Pregnancy and Ortho Tri-CyclenYou shouldn't use Ortho Tri-Cyclen if you are pregnant. This medication can cause birth defects.Tell your doctor immediately if you become pregnant or miss two menstrual periods in a row while taking Ortho Tri-Cyclen.If you've recently had a baby, you should wait at least four weeks before taking this medicine.The hormones in Ortho Tri-Cyclen can pass into breast milk and may harm a breastfeeding baby. You shouldn't breastfeed while taking this medicine.