Last reviewed 2026-04-20 · How we verify

Aviane

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

Common side effects

• Nausea
• Breast changes: tenderness, pain, enlargement, secretion
• Edema/fluid retention
• Vomiting
• Gastrointestinal symptoms (such as abdominal pain, cramps, and bloating)
• Menstrual flow, change in
• Spotting
• Unscheduled bleeding
• Mood changes, including depression
• Headache
• Dizziness
• Acne

Serious adverse events

• Myocardial infarction
• Cerebral hemorrhage
• Cerebral thrombosis
• Pulmonary embolism
• Venous thrombosis
• Thrombophlebitis
• Carcinoma of the reproductive organs and breasts
• Hepatic neoplasia (including hepatic adenomas or benign liver tumors)
• Optic neuritis, which may lead to partial or complete loss of vision
• Budd-Chiari syndrome

Key clinical trials

• A Study to Investigate the Effect of AZD6234, AZD9550, and a Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity (PHASE1)
• Effects of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Participants (PHASE1)
• Phase 2b, Open Label, Multisite, Randomized Crossover Study of DPP Versus 2PR (PHASE2)
• A Study of ABBV-295 Subcutaneous Injections to Assess Pharmacokinetics and Adverse Events in Healthy Adult Women Participants With Overweight or Obesity Taking Oral Contraceptives (PHASE1)
• A Study of Elenestinib in Healthy Adult Female Participants (PHASE1)
• A Study to Investigate the Impact of Multiple Doses of Itraconazole on AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants (PHASE1)
• Validating and Assessing Reliability
• Role of Estrogen on Skeletal Outcomes in FHA (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Aviane CI brief — competitive landscape report
• Aviane updates RSS · CI watch RSS
• Oregon Health and Science University portfolio CI