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Overview: Annovera (segesterone/ethinyl estradiol) is a form of birth control that is used to prevent pregnancy for up to one year. It works by slowly releasing hormones into the body through a reusable ring that is inserted into the vagina. Common side effects include headache, nausea or vomiting, vaginal itching or discharge, breast tenderness, and changes in menstrual bleeding. Serious side effects are rare but can include blood clots and an increase in blood pressure.

Uses

What is Annovera used for?

Annovera (segesterone/ethinyl estradiol) is a form of hormonal birth control and is commonly used to prevent pregnancy for up to one year.  

Annovera may also be used for other conditions as determined by your health care provider.

How does Annovera work (mechanism of action)?

Annovera contains two types of hormones, segesterone (a progestin) and ethinyl estradiol (an estrogen).

Annovera works by slowly releasing these hormones into the body through a reusable ring that is inserted into the vagina. It prevents pregnancy by stopping the release of an egg from the ovaries (ovulation).

How is Annovera supplied (dosage forms)?

Brands and other names

  • Annovera

Dosage forms and strengths

  • 0.15 mg/0.013 mg per day vaginal system (vaginal ring)

How should I store Annovera?

Annovera should be stored in the supplied storage case at room temperature, between 68 F to 77 F (20 C to 25 C). Protect it from direct sunlight or excessive heat. Do not store it in the refrigerator or freezer. 

Side Effects

What are the most common side effects of Annovera?

The most common side effects of Annovera are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Headache or migraine (see below)
  • Nausea, vomiting, or diarrhea
  • Vaginal itching or discharge
  • Vaginal yeast infection
  • Stomach or pelvic pain
  • Painful periods
  • Kidney or bladder infection
  • Breast tenderness, pain, or discomfort
  • Changes in menstrual bleeding (see below)

There may be other side effects of Annovera that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Annovera?

While less common, the most serious side effects of Annovera are described below, along with what to do if they happen.

Severe Allergic Reactions. Annovera may cause allergic reactions, which can be serious. Stop using Annovera and get emergency help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Blood Clots. Annovera may cause a blood clot in your arteries or veins and could cause a stroke, heart attack, or venous thromboembolism (VTE), including a blood clot in the lungs (pulmonary embolism), in the back of your eye (retinal vein occlusion), or in your legs or arms (deep venous thrombosis). Stop using Annovera and get emergency help if you have any of the following signs of a blood clot.

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness
  • Sudden weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech
  • Pain, swelling, or tenderness in your arm or leg
  • Vision loss
  • Bulging eyes
  • Double vision

Changes in Menstrual Bleeding. Annovera can cause irregular bleeding, spotting, or light bleeding between periods, especially during the first month of using it. For some people, periods will stop. Call your health care provider right away if you continue to have spotting or breakthrough bleeding between periods, or if you have spotting after having regular cycles while using Annovera. 

Increased Blood Pressure (Hypertension). Annovera may increase your blood pressure or make it worse if you have a history of high blood pressure. Call your health care provider if your blood pressure increases while using this medicine.

If you measure your blood pressure and the top number (systolic) is 180 or higher or the bottom number (diastolic) is 120 or higher, get medical attention right away. Increases in blood pressure may not be noticeable, but look out for and tell your health care provider right away if you have any of the following symptoms of severely high blood pressure.

  • Sudden severe headache
  • Chest pain
  • Dizziness or confusion
  • Trouble breathing
  • Nausea or vomiting
  • Blurry or other changes to vision
  • Anxiety
  • Buzzing in the ears
  • Nosebleed
  • Feeling of skipped heartbeats

Toxic Shock Syndrome. Annovera may cause toxic shock syndrome (TSS), which is a sudden, potentially deadly condition caused when an overgrowth of bacteria releases toxins into your bloodstream. Stop using Annovera and get emergency care right away if you have any of the following symptoms of TSS.

  • Sudden high fever
  • Vomiting or diarrhea
  • Dizziness or fainting
  • A sunburn-like rash, especially on the palms of the hands and bottoms of the feet
  • Muscle aches
  • Low blood pressure (hypotension)
  • Red eyes, mouth, and throat
  • Confusion
  • Seizures

Gallbladder Problems. Using Annovera may increase the risk of gallbladder problems, including cholecystitis and cholelithiasis (also known as gallstones). Call your health care provider right away if you have any of the following symptoms.

  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
  • Fever
  • Pain in your upper stomach area
  • Stool (poop) that is clay-colored

Headache or Migraine. Annovera may cause headaches or migraine. Call your health care provider right away if you develop new headaches or migraine attacks that keep coming back, do not go away, or cause you a lot of pain.

Depression. Annovera may cause changes in mood, including depression. Call your health care provider right away if you have new or increased depression or other unusual changes in mood or behavior. 

Liver Problems. Annovera may cause changes to your liver function, including an increase in your liver enzymes or liver tumors. Call your health care provider if you have any of the following symptoms of liver problems.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Warnings & Precautions

Who should not use Annovera?

Allergies to Ingredients. People who are allergic to any of the following should not use Annovera.

  • Annovera
  • Segesterone
  • Ethinyl estradiol
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Annovera.

Smoking. Annovera should not be used if you smoke and are over age 35, as this can increase your chances of having a heart attack, stroke, or blood clots.

Blood Clots. Annovera should not be used if you have or have had blood clots, including a blood clot in the lungs (pulmonary embolism) or deep vein thrombosis (DVT). Annovera should also not be used if you have a condition that makes your blood more prone to getting blood clots (thrombophilia). Annovera can increase the risk of developing a blood clot that could be dangerous or even deadly.

Heart Attack or Stroke. Annovera should not be used if you have had a stroke or heart attack. Annovera can increase the risk of having a heart attack or stroke that could be dangerous or even deadly.

Blood Vessel Problems. Annovera should not be used if you have or have had a history of plaque buildup in your blood vessels (coronary artery disease) or if you have or have had a condition that affects blood flow to your brain (cerebrovascular disease). Annovera could increase your chances of having a heart attack, stroke, or blood clots. 

Heart Problems. Annovera should not be used if you have heart rhythm problems (such as atrial fibrillation), heart valve problems, or infection in the lining of your heart (endocarditis), as this may increase your chances of having a blood clot.

Increased Blood Pressure (Hypertension). Annovera should not be used if you have high blood pressure that is not managed or high blood pressure with a condition that affects your blood vessels (vascular disease). Annovera could increase your chances of having a heart attack, stroke, or blood clots.

Diabetes. Annovera should not be used if you have diabetes and are over age 35, have high blood pressure, or have kidney, eye, nerve, or blood vessel damage. Annovera should also not be used if you have had diabetes for more than 20 years. This can increase your chance of having a heart attack, stroke, or blood clots.

Headaches or Migraine. Annovera should not be used if you have migraine with vision or hearing changes, muscle weakness, tingling, or trouble speaking (known as migraine with aura) or certain other types of headaches. This can increase your risk of having a stroke. Annovera should also not be used if you are over age 35 and have any type of migraine headaches (with or without aura).

Certain Cancers. Annovera should not be used if you have or have had breast cancer or any cancer that is sensitive to hormones, which could get worse if you use Annovera.

Liver Problems. Annovera should not be used if you have certain problems with your liver, including hepatitis, cirrhosis, or a liver tumor. 

Unusual Vaginal Bleeding. Annovera should not be used if you have bleeding from the uterus or vagina that is not part of your menstrual cycle or is abnormal. 

Drug Interactions. Annovera should not be used while you are using certain other medicines. Before using Annovera, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.  See the Interactions section for more details.

What should I know about Annovera before using it?

Do not use Annovera unless it has been prescribed to you by a health care provider. Use it as prescribed.

Do not share Annovera with other people, even if they have the same condition as you. It may harm them.

Keep Annovera out of the reach of children.

Annovera does not protect you from HIV, AIDS, or other sexually transmitted diseases (STDs). 

Expect to start Annovera during a specific time of your menstrual period. The timing will determine whether and for how long you need to use backup birth control (such as condoms or spermicide) after starting Annovera. Ask your health care provider if you are not sure how or when to start Annovera.

Follow the “Instructions for Use” that come with Annovera. One Annovera ring should be placed in the vagina and left in place for 21 days (three weeks) straight. It should then be removed for seven days to allow for a week-free interval. The ring can be reused for up to 13 cycles (one year). Each cycle is 28 days. Talk to your pharmacist or other health care provider about how to store and clean Annovera during the weeks the ring is not inside the vagina. 

Consider using a calendar or app to mark the day you insert Annovera, when you remove it, and when to reinsert the ring. Accidentally leaving Annovera out too long or using it for more than 13 cycles can increase your risk of pregnancy.

You do not have to take Annovera out during sex. Annovera could accidentally come out when removing a tampon, having sex, or straining during a bowel movement. Take care to avoid accidentally removing the ring. If Annovera comes out, clean the ring with warm water and mild soap, rinse and pat it dry with a clean cloth or paper towel, and reinsert it as soon as possible. 

Check with your pharmacist or other health care provider before using other products that are placed inside the vagina, such as suppositories, creams, lubricants, or condoms. Some products could cause problems with Annovera. 

Annovera may affect your blood sugar or cholesterol levels. Make sure to keep all follow-up appointments, including for blood work and blood pressure checks, with your health care provider. 

Throw away Annovera after 13 cycles of use. Put Annovera into its storage case, then take it to a drug take-back program. If one is not available, throw it away in a trash can that is out of the reach of children and pets. Do not flush Annovera down the toilet.

Annovera may affect the results of some laboratory tests. Tell all of your health care providers about all the medicines you take, and talk with your health care provider if you have any concerns.  

Annovera is a combination birth control vaginal ring that contains two hormones. Certain cancers, including breast cancer and cervical cancer, are types of cancers that may be sensitive to hormones. Make sure you keep all appointments with your health care provider.

What should I tell my health care provider before using Annovera?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Annovera is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Diabetes
  • High blood pressure
  • High cholesterol or triglycerides
  • Headaches or migraine
  • Gallbladder, kidney, or liver problems
  • Personal or family history of heart disease, blood clots, or stroke
  • Depression 
  • Seizures
  • A condition called hereditary angioedema
  • Recently had a baby, miscarriage, or abortion
  • Breast problems, including cysts or nodules or a family history of breast cancer
  • Any condition that makes your vagina become irritated easily
  • History of toxic shock syndrome 

Smoking. Smoking can increase your risk of getting heart disease, which increases your risk of having a heart attack, stroke, or blood clots. Tell your health care provider if you smoke before starting Annovera. 

Upcoming Surgery or Bed Rest. You may be at higher risk for some side effects of Annovera if you do not move around normally for an extended period of time. Tell your health care provider if you have any upcoming surgeries or need to be on bed rest. Your health care provider can tell you if or when you need to stop using Annovera.

Skin Issues. Tell your health care provider if you have had dark patches on your cheeks, forehead, upper lip, and chin, especially during pregnancy. This is sometimes called a “pregnancy mask” (chloasma). If you have had this in the past, you should use sunscreen and avoid spending a long time in the sun or in tanning booths.

Pregnancy. Annovera should not be used during pregnancy. Tell your health care provider if you are or plan to become pregnant. If you become pregnant, stop using Annovera right away and contact your health care provider.

Breastfeeding. Annovera can pass into breast milk and may reduce milk production. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will advise you if you should stop breastfeeding or stop Annovera.

How can I get more information about Annovera?

For more information about Annovera, you can visit the manufacturer’s website at www.annovera.com or call them at 844-825-8500.

Interactions

Does Annovera interact with foods or drinks?

Eating grapefruit or drinking grapefruit juice while using Annovera can increase levels of the medicine in your body and increase the risk of side effects. Talk to your health care provider if you eat grapefruit or drink grapefruit juice. 

There are no known interactions between Annovera and alcohol.

Does Annovera interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using Annovera.

  • Aprepitant, which is a medicine used to prevent nausea and vomiting caused by chemotherapy 
  • A barbiturate, such as butalbital, phenobarbital, or primidone, which is a medicine that may be used to treat insomnia, migraine, or seizures
  • Bosentan, which is a medicine used to treat a condition called pulmonary arterial hypertension (PAH)
  • Any medicine that may be used to treat seizures, such as carbamazepine (Carbatrol, Tegretol, and others), felbamate, lamotrigine, oxcarbazepine (Oxtellar XR, Trileptal), phenytoin (Dilantin, Phenytek, and others), or topiramate (Qudexy XR, Topamax, Trokendi XR)
  • Fluconazole (Diflucan), griseofulvin, itraconazole (Sporanox, Tolsura), ketoconazole, or voriconazole (Vfend), which are used for fungal infections
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis, or rifabutin (Mycobutin), which is a medicine used to prevent mycobacterium avium complex infection
  • St. John’s wort, which is a supplement that may be used for depression
  • A medicine for HIV, AIDS, or hepatitis C 
  • Cyclosporine (Gengraf, Neoral, Sandimmune, and others), which is a medicine that suppresses your immune system
  • A statin, such as atorvastatin (Lipitor and others) or rosuvastatin (Crestor), which is a medicine to lower cholesterol
  • A thyroid medicine, such as levothyroxine, which is used to raise thyroid hormone levels 
  • A corticosteroid, such as dexamethasone, methylprednisolone, prednisolone, or prednisone, which is a medicine for certain inflammatory conditions
  • Acetaminophen (Tylenol), which is a medicine used for pain or fever
  • Morphine, which is a medicine used for certain types of pain
  • A vitamin C supplement  
  • Temazepam, which is a medicine used for anxiety
  • Theophylline (Elixophyllin, Theo-24), which is a medicine for asthma or certain other breathing problems
  • Tizanidine (Zanaflex), which is a muscle relaxant

Many other medicines may alter the blood levels of Annovera and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Annovera. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Annovera?

If you or someone else has used too much Annovera, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Annovera?

Annovera may not prevent pregnancy if you take it out too soon or forget to reinsert it after the week-free interval. It may also not prevent pregnancy if the ring is out of the vagina for more than two hours (either at one time or different times adding up to two hours) during the 21 days when it should be in the vagina. In these cases, avoid sexual intercourse or use backup birth control (such as condoms or spermicide) until Annovera has been in the vagina for seven days in a row. Ask your health care provider if you are not sure what to do.