Black Box Warning

BOXED WARNING: Cigarette smoking increases risk of serious cardiovascular events (stroke, MI, VTE). Women who are ≥35 years and smoke should NOT use combined hormonal contraceptives.

What this means:A black box warning is the FDA's strongest required safety notice. It signals a serious or life-threatening risk. Patients should review this with their prescriber before starting, continuing, or switching Yaz.

Other warnings & precautions

VTE risk: COCs increase VTE risk 3–4 fold. Drospirenone-containing pills may have slightly higher VTE risk than levonorgestrel-containing pills. Discontinue at least 4 weeks before and 2 weeks after major surgery or prolonged immobilization.
Hyperkalemia: Drospirenone has aldosterone-antagonist effect — retains potassium. Check potassium at baseline and monthly for the first 3 months in patients on ACE inhibitors, ARBs, NSAIDs, potassium-sparing diuretics, heparin, or with renal/adrenal/hepatic impairment.
Contraindicated in: pregnancy; breastfeeding (first 6 weeks postpartum); uncontrolled hypertension; history of VTE or arterial thrombosis; migraine with aura; diabetes with vascular complications; liver tumors; undiagnosed vaginal bleeding; breast or uterine cancer.
Contraceptive effectiveness: 91% typical use (9% failure due to inconsistent use), >99% perfect use. Does not protect against STIs/HIV.
Bone density: Long-term COC use may affect bone mineral density in adolescents; ensure adequate calcium and vitamin D intake.

Black Box Warning

BOXED WARNING: Cigarette smoking increases risk of serious cardiovascular events (stroke, MI, VTE). Women who are ≥35 years and smoke should NOT use combined hormonal contraceptives.

Other warnings & precautions

VTE risk: COCs increase VTE risk 3–4 fold. Drospirenone-containing pills may have slightly higher VTE risk than levonorgestrel-containing pills. Discontinue at least 4 weeks before and 2 weeks after major surgery or prolonged immobilization.
Hyperkalemia: Drospirenone has aldosterone-antagonist effect — retains potassium. Check potassium at baseline and monthly for the first 3 months in patients on ACE inhibitors, ARBs, NSAIDs, potassium-sparing diuretics, heparin, or with renal/adrenal/hepatic impairment.
Contraindicated in: pregnancy; breastfeeding (first 6 weeks postpartum); uncontrolled hypertension; history of VTE or arterial thrombosis; migraine with aura; diabetes with vascular complications; liver tumors; undiagnosed vaginal bleeding; breast or uterine cancer.
Contraceptive effectiveness: 91% typical use (9% failure due to inconsistent use), >99% perfect use. Does not protect against STIs/HIV.
Bone density: Long-term COC use may affect bone mineral density in adolescents; ensure adequate calcium and vitamin D intake.

Yaz Black Box Warning

Black Box Warning

Other warnings & precautions

Yaz Black Box Warning

Black Box Warning

Other warnings & precautions