What is TAYTULLA?
TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) is a prescription birth control pill used for the prevention of pregnancy. If you are moderately obese, discuss with your healthcare provider whether TAYTULLA is appropriate for you.
IMPORTANT RISK INFORMATION
WARNING TO WOMEN WHO SMOKE
Do not use TAYTULLA if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from 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 TAYTULLA?
Do not use TAYTULLA if you have or have had blood clots, history of heart attack or stroke, high blood pressure that medicine cannot control, breast cancer, liver disease or liver tumors, unexplained bleeding from the vagina, or if you take hepatitis C drugs containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, as this may increase levels of liver enzymes in the blood.
What else should I know about taking TAYTULLA?
Treatment with TAYTULLA should be stopped if you have a blood clot, and at least 4 weeks before and through 2 weeks after major surgery. You should not take TAYTULLA any earlier than 4 weeks after having a baby, or if you are breastfeeding. If you experience yellowing of the skin or eyes due to problems with your liver, you should stop taking TAYTULLA. If you are prediabetic or diabetic, your doctor should monitor you while using TAYTULLA. Your doctor should evaluate you if you have any significant change in headaches or irregular menstrual bleeding. TAYTULLA should not be taken during pregnancy.
What are the most serious risks of taking TAYTULLA?
TAYTULLA increases the risk of serious conditions, including blood clots, stroke, and heart attack. These can be life-threatening or lead to permanent disability.
What are the possible side effects of TAYTULLA?
The most common side effects reported by women taking TAYTULLA in a study were nausea/vomiting, headache, spotting or bleeding between menstrual periods, painful menstruation, weight change, breast tenderness, acne, abdominal pain, anxiety, and depression.
Birth control pills do not protect you against any sexually transmitted disease, including HIV, the virus that causes AIDS.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see the full
Prescribing Information,
Prescribing Information
including Boxed Warning, and Patient Information.
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1. Taytulla prescribing information. North Chicago, IL: AbbVie Inc., 2023.
2. Data on file. Allergan USA, Inc.
3. Birth control patient education pamphlet. Washington, DC: The American College of Obstetricians and Gynecologists; November 2013.
4. Menstruation and the menstrual cycle fact sheet. Womenshealth.gov website. https://www.womenshealth.gov/publications/our-publications/fact-sheet/menstruation.html. Updated October 21, 2009. Accessed June 3, 2022.
5. Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology, 18th ed. New York, NY: Ardent Media; 2004.
REFERENCES
1. Taytulla prescribing information. Madison, NJ: AbbVie Inc., 2022.
2. Data on file. Allergan USA, Inc.
3. Birth control patient education pamphlet. Washington, DC: The American College of Obstetricians and Gynecologists; November 2013.
4. Menstruation and the menstrual cycle fact sheet. Womenshealth.gov website. https://www.womenshealth.gov/publications/our-publications/fact-sheet/menstruation.html. Updated October 21, 2009. Accessed June 3, 2022.
5. Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology, 18th ed. New York, NY: Ardent Media; 2004.
