What are the risks of using hormonal contraceptives (including ORTHO TRI-CYCLEN<sup>®</sup> LO)?

    Cigarette smoking increases the risk of serious cardiovascular side effects from hormonal contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use hormonal contraception, including ORTHO TRI-CYCLEN® LO are strongly advised not to smoke.


    • The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:
      • Blood clots in the legs or lungs, heart attacks and stroke (smoking increases the risk of having a heart attack or stroke).
      • Gallbladder disease.
      • Benign but dangerous liver tumors.
      • Breast and cervical cancer.
      • High blood pressure, although blood pressure usually returns to normal when ORTHO TRI-CYCLEN® LO is stopped.

      Call your doctor immediately if you experience any of these side effects while you are using ORTHO TRI-CYCLEN® LO:
      • Sharp chest pain, coughing of blood, or sudden shortness of breath (indicating a possible clot in the lung)
      • Pain in the calf (indicating a possible clot in the leg)
      • Crushing chest pain or heaviness in the chest (indicating a possible heart attack)
      • Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (indicating a possible stroke)
      • Sudden partial or complete loss of vision (indicating a possible clot in the eye)
      • Breast lumps (indicating possible breast cancer or fibrocystic disease of the breast; ask your healthcare professional to show you how to examine your breasts)
      • Severe pain or tenderness in the stomach area (indicating a possibly ruptured liver tumor)
      • Difficulty in sleeping, weakness, lack of energy, fatigue, or change in mood (possibly indicating severe depression)
      • Jaundice or a yellowing of the skin or eyeballs, accompanied frequently by fever, fatigue, loss of appetite, dark colored urine, or light colored bowel movements (indicating possible liver problems)