Ethinyl Estradiol / Segesterone Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 7, 2024.

Applies to ethinyl estradiol / segesterone: vaginal insert extended release.

Serious side effects

Along with its needed effects, ethinyl estradiol/segesterone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ethinyl estradiol / segesterone:

Other side effects

Some side effects of ethinyl estradiol / segesterone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to ethinyl estradiol / segesterone: vaginal ring.

General adverse events

The more commonly reported adverse reactions have included headache/migraine, nausea/vomiting, vulvovaginal mycotic infection/candidiasis, upper and lower abdominal pain, dysmenorrhea, and vaginal discharge; 25% of women reported at least 1 complete expulsion of vaginal system during use.^[Ref]

Cardiovascular

Combination Hormonal Contraceptives (CHC):

• Uncommon (0.1% to 1%): Venous thrombotic event (VTE) rate
• Frequency not reported: Increased blood pressure

Segesterone and Ethinyl Estradiol Vaginal System:

• Frequency not reported: Venous thrombotic events (VTEs)

Serious adverse reactions occurred in 2% or more of subjects in clinical trials and included VTEs (deep vein thrombosis, cerebral vein thrombosis, and pulmonary embolism). At about 50% enrollment, females with BMI greater than 29 kg/m2 were excluded from participation due to the occurrence of 2 VTEs in this subgroup.

The rate of VTE in females using CHC has been estimated at 3 to 12 cases per 10,000 women. The risk of VTE for females who are not pregnant and do not use CHC is estimated to be between 1 and 5 for 10,000 women. For pregnant women, the risk is estimated to be 5 to 20 per 10,000 women and for those through 12 weeks postpartum, 40 to 65 per 10,000 women.

Local

• Very common (10% or more): Vaginal system expulsion

One complete vaginal system expulsion was experienced by 25% of women during clinical trials; 1.4% of patients discontinued use due to vaginal system expulsions.

Hypersensitivity

• Frequency not reported: Hypersensitivity reactions

Serious adverse reactions occurred in 2% or more of subjects in clinical trials and included drug hypersensitivity. Hypersensitivity reactions included throat constriction, facial edema, urticaria, hives, and wheezing.

Nervous system

• Very common (10% or more): Headache, including migraine (38.6%)

Hepatic

Combination Hormonal Contraceptives (CHC):

• Very rare (less than 0.01%): Hepatic adenomas

Segesterone and Ethinyl Estradiol Vaginal System:

• Frequency not reported: Liver enzyme elevations (with concomitant hepatitis C treatment)

An estimate of the attributable risk of hepatic adenomas associated with CHC use is 3.3 cases per 100,000 CHC users.

Gastrointestinal

• Frequency not reported: Gallbladder disease (new onset or worsening)

Segesterone and Ethinyl Estradiol Vaginal System:

• Very common (10% or more): Nausea/vomiting (25%), Abdominal pain/lower/upper (13.3%)
• Common (1% to 10%): Diarrhea

Combination Hormonal Contraceptives (CHC)

Genitourinary

• Very common (10% or more): Vulvovaginal mycotic infection/vaginal candidiasis (14.5%), dysmenorrhea (12.5%), vaginal discharge (11.8%)
• Common (1% to 10%): Unscheduled (breakthrough) bleeding, amenorrhea, UTI/cystitis/pyelonephritis/genitourinary tract infection, metorrhagia/menstrual disorder, genital pruritus
• Frequency not reported: Metrorrhagia, menorrhagia, abnormal withdrawal bleeding

Endocrine

• Common (1% to 10%): Breast pain/discomfort
• Frequency not reported: Spontaneous abortions

Serious adverse reactions occurred in 2% or more of subjects in clinical trials and included spontaneous abortions.

Psychiatric

• Frequency not reported: Psychiatric events

Serious adverse reactions occurred in 2% or more of subjects in clinical trials and included psychiatric events. These events were not further defined.

Oncologic

• Very rare (less than 0.01%): Hepatocellular carcinoma

The risk of long-term CHC users developing hepatocellular carcinomas is less than 1 case per million users. Long-term use is greater than 8 years.

Combination Hormonal Contraceptives (CHC)

Frequently asked questions

• How do you use Annovera for birth control?

Further information

Ethinyl estradiol/segesterone side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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