Cardiovascular and Other Risks Associated with Diane-35

Common Side Effects

The American Academy of Dermatology notes that Diane-35 has significant cardiovascular effects, including edema, varicose vein aggravation, increased risk of arterial thromboembolism, cerebral thrombosis, hypertension, and myocardial infarction 1, 2
Central nervous system effects, such as depression, migraine, headaches, mood changes, and nervousness, have been reported with the use of Diane-35 1, 2
Skin effects, including chloasma, melasma, allergic rash, and erythema nodosum, are associated with Diane-35 use 1, 2
Endocrine effects, such as amenorrhea, breakthrough bleeding, breast pain/tenderness, breast changes, fluid retention, and infertility, have been observed with Diane-35 1, 2
Gastrointestinal effects, including abdominal bloating, abdominal cramps, nausea, weight changes, vomiting, and appetite changes, are common with Diane-35 use 1, 2
Genitourinary effects, such as cervical ectropion, cervical secretion changes, vaginal candidiasis, and vaginitis, have been reported with Diane-35 1, 2

Hepatic effects, including cholestatic jaundice and liver dysfunction, are potential risks of Diane-35 1, 2
Blood effects, such as decreased folate levels and exacerbation of porphyria, have been associated with Diane-35 use 1
Anaphylaxis and exacerbation of systemic lupus erythematosus are rare but serious side effects of Diane-35 1, 2

The American Academy of Dermatology recommends that Diane-35 is contraindicated in patients with active or history of arterial thromboembolic disease, breast cancer, cerebrovascular disease, coronary artery disease, deep vein thrombosis, thromboembolic disease, pulmonary embolism, headaches with focal neurologic symptoms, hepatic dysfunction, hepatic tumors, hypercoagulopathies, uncontrolled hypertension, pregnancy, smoking if ≥35 years of age, undiagnosed uterine bleeding, and thrombogenic valvular or rhythm diseases 2
Pregnancy is a contraindication for Diane-35 use, as it is classified as Pregnancy category X 1, 2

Many antibiotics, anticonvulsants, HIV protease inhibitors, herbal supplements, and other medications may interact with Diane-35 1

Baseline monitoring should include pregnancy status and blood pressure, while ongoing monitoring should include blood pressure and general health status changes 1, 2