Last reviewed 2026-05-15 · How we verify

levonorgestrel and ethinyl estradiol

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• WARNING: 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 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Iclevia, are contraindicated in women who are over 35 years of age and smoke [see Contraindications (4) and Warnings and Precautions (5.1) ]. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. Iclevia is contraindicated in women over 35 years old who smoke. ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 5.1 )

Common side effects

• Nausea, vomiting and gastrointestinal symptoms
• Breast tenderness, pain, enlargement, secretion
• Change in menstrual flow
• Change in weight or appetite
• Headache
• Edema/fluid retention
• Melasma/chloasma
• Mood changes, including depression
• Bleeding irregularities and amenorrhea
• Vaginitis, including candidiasis
• Change in cervical erosion and secretion
• Rash (allergic)

Serious adverse events

• Serious cardiovascular adverse events
• Vascular events
• Mesenteric thrombosis
• Liver disease
• Cholestatic jaundice
• Gallbladder disease
• Hypertension
• Anaphylactic/anaphylactoid reactions
• Budd-Chiari syndrome
• Hemolytic uremic syndrome

Key clinical trials

• A Research Study Looking Into the Effect of NNC0519-0130 on Blood Levels of a Birth Control Pill and Emptying of the Stomach in Women After Menopause (PHASE1)
• 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)
• Oral Contraceptive Pills Versus Levonorgestrel-Releasing Intrauterine System for Niche-Related Abnormal Uterine Bleeding (NA)
• 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)

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:

• levonorgestrel and ethinyl estradiol CI brief — competitive landscape report
• levonorgestrel and ethinyl estradiol updates RSS · CI watch RSS
• Agile Therapeutics portfolio CI