Ethinyl Estradiol / Segesterone Side Effects

Medically reviewed by Drugs.com. Last updated on May 5, 2024.

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

Precautions

It is very important that your doctor check your progress at regular annual visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects. Your doctor may also want to check your blood pressure while using this medicine.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away. You may start using this medicine 4 weeks after giving birth and if you are not breastfeeding.

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first month of use. This is sometimes called spotting when lighter, or breakthrough bleeding when heavier.

• If this should occur, continue using Annovera™.
• The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week.
• If the bleeding continues after you have been taking hormonal contraceptives on schedule, check with your doctor.

Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).

Do not use this medicine if you smoke cigarettes or if you are over 35 years of age If you smoke while using Annovera™, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Using this medicine may increase your risk of having blood clotting problems. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, unexplained shortness of breath, a sudden loss of coordination, or vision changes while using this medicine.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor (ophthalmologist) to check your eyes.

Check with your doctor right away if you have pain or tenderness in the upper stomach, dark urine, pale stools, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

This medicine may increase your risk of having gallbladder disease. Check with your doctor if you start to have stomach pains, nausea, and vomiting.

Using this medicine may increase your risk of cervical cancer. Talk with your doctor about this risk. Check with your doctor immediately if you experience abnormal vaginal bleeding.

This medicine may cause skin discoloration. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Toxic shock syndrome (TSS) may occur while using this medicine. Call your doctor right away if you have any of the following symptoms: sudden high fever, diarrhea, dizziness, fainting, vomiting, muscle aches, or a sunburn-like rash.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.

Make sure any doctor or dentist who treats you knows that you are using this medicine. The results of some medical tests may be affected by this medicine. You may also need to stop using this medicine at least 4 weeks before and 2 weeks after having major surgery.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

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)

See also:

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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