We highly recommend enabling Javascript while using the BlackBoxRX site.

Estradiol Valerate/Dienogest

Cigarette Smoking and Serious Cardiovascular Events

  • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.
  • This risk increases with age, particularly in women over the age of 35 yrs, and with the number of cigarettes smoked.
  • For this reason, COCs should not be used in women who are over 35 years of age and smoke. [See Contraindications]

FDA and Industry Communications

Index to FDA Drug Safety Information

Patient Counseling Information

Package Inserts


Updated January 2018