Implanon® (etonogestrel implant) 68 mg

Risks and side effects

Possible risks

Complications of insertion and removal. Rarely, removal of IMPLANON is difficult or even impossible because IMPLANON is not where it should be. If IMPLANON cannot be removed, then the effects of IMPLANON will continue for a longer period of time.

Rarely, IMPLANON is not inserted at all due to a failed insertion, or the implant has fallen out of the needle, and then you may become pregnant. After insertion, and with direction from your healthcare provider, you should be able to feel IMPLANON under your skin. If you can’t feel IMPLANON, tell your healthcare provider.

Some other problems related to insertion and removal are: pain, irritation, swelling, or bruising; scarring, including a thick scar called a keloid; infection; IMPLANON breaks making it difficult to remove IMPLANON; thick scar tissue forming around IMPLANON making removal difficult; rarely, expulsion of the implant; rarely, need for surgery in the hospital for removal of IMPLANON; removals of deeply inserted implants can lead to scarring or complications such as damage to nerves or blood vessels.

Ectopic pregnancy. If you become pregnant while using IMPLANON, you have a slightly higher chance that the pregnancy will be ectopic (occurring outside the womb) than do women who are not using birth control. Ectopic pregnancies can cause serious internal bleeding and even death.

Interaction with other medicines. Certain medicines may make IMPLANON less effective and you may need to use back-up non-hormone birth control. Tell your healthcare provider about any medicines you are taking, or intend to take, including over-the-counter medicines and prescription medicines such as: barbiturates, griseofulvin, rifampin, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate and modafinil. Herbal remedies such as St. John’s Wort may also reduce the effectiveness of contraceptive drug products. This is not a complete list of drugs that may interact with IMPLANON.

When you are using IMPLANON, tell all of your healthcare providers that you have IMPLANON.

Ovarian cysts. Cysts on the ovaries usually go away without treatment. Sometimes surgery is needed.

Breast cancer. It is not known whether IMPLANON changes a woman’s risk for breast cancer. If you have breast cancer now, or have had it in the past, do not use IMPLANON because some breast cancers are sensitive to hormones.

Blood clots (thrombosis). It is not known whether IMPLANON changes a woman’s risk for serious blood clots called thrombosis. Thrombosis is a side effect of birth control pills and pregnancy. Because IMPLANON contains one of the two hormones that are in birth control pills, thrombosis may be a side effect of IMPLANON. There have been post-marketing reports of thrombosis among IMPLANON users.

Some examples of thrombosis are: legs (deep vein thrombosis); lung (pulmonary embolism); brain (stroke); heart (heart attack); eyes (blindness). The risk of thrombosis is increased in women who smoke. If you smoke, you should quit. Your healthcare provider may be able to help.

Tell your healthcare provider at least four weeks before if you are going to have surgery or will need to be on bed rest. You have an increased chance of getting thrombosis during surgery or bed rest.

Other risks. A few women who use birth control that contains hormones may get high blood pressure, gallbladder problems or rare cancerous or noncancerous liver tumors.

Most common side effects

The most common side effect of IMPLANON is change in your menstrual period. In studies, about one out of 10 women stopped using IMPLANON because of bleeding problems. You should expect your menstrual periods to be irregular and unpredictable throughout the time you are using IMPLANON. You may have more, less or no bleeding. The time between periods also may vary, and in between periods you may have spotting. Talk with your healthcare provider if you think you may be pregnant or your vaginal bleeding is heavy and prolonged

Besides irregular bleeding, the most frequent side effects that caused women to stop using IMPLANON in clinical studies were mood swings, weight gain, headache, acne and depression.

The most common side effects reported in women using IMPLANON during clinical trials include irregular bleeding; headaches; vaginitis; weight gain; acne; breast pain; viral infections such as colds, sore throats, sinus infections or flu-like symptoms; stomach pain; painful periods; mood swings; nervousness or depression; back pain; nausea; dizziness; pain; and pain at the site of insertion.

Rare side effects that have been reported include: extra hair on your face and body, trouble using contact lenses, and spotty darkening of the skin, especially of the face. This is not a complete list of possible side effects. Talk to your healthcare provider if you experience any side effect that concern you.

IMPLANON is for the prevention of pregnancy in women.

IMPORTANT SAFETY INFORMATION

  • IMPLANON does not protect against HIV (AIDS) or other sexually transmitted diseases.
  • IMPLANON must be removed by the end of the third year and may be replaced by a new IMPLANON at the time of removal, if continued contraceptive protection is desired. Failure to remove IMPLANON may result in infertility, ectopic pregnancy, or inability to stop a drug-related adverse event.
  • After you receive IMPLANON, check that it is in place by pressing your fingertips over the skin of your arm where IMPLANON was placed. You should be able to feel the IMPLANON rod. If IMPLANON is not placed properly, it may not prevent pregnancy or it may be difficult or impossible to remove.
  • Serious consequences may be associated with the insertion and removal of IMPLANON. This may result in the need for a surgical procedure in an operating room in order to remove IMPLANON. Difficult removals may cause pain and scarring, and may result in damage to nerves and blood vessels. In clinical trials, 9 out of 942 (1.0%) patients had complications at implant insertion and 15 out of 942 (1.7%) had complications at implant removal.
  • You should not use IMPLANON if you are pregnant or think you may be pregnant, have or have had blood clots, have unexplained vaginal bleeding, have liver disease, have or have had breast cancer, or if you are allergic to anything in IMPLANON.
  • The use of IMPLANON and other progestin-only hormonal contraceptives have been associated with ectopic pregnancy, bleeding irregularities, and ovarian cysts. The use of hormonal contraceptives is associated with increased risks of several serious side effects including blood clots which may lead to stroke or heart attack. Blood clots are a side effect of birth control pills and pregnancy. It is unknown if the risk of blood clots with IMPLANON is different than with birth control pills. Some examples of blood clots are deep vein thrombosis (legs), pulmonary embolism (lungs), retinal thrombosis (eyes), stroke (head), and heart attack (heart). There have been reports of blood clots, including pulmonary emboli and strokes, in patients using IMPLANON. Tell your doctor at least 4 weeks before if you are going to have surgery or will need to be on bed rest, because you have an increased chance of experiencing blood clots during surgery or bed rest.
  • Cigarette smoking increases the risk of serious cardiovascular side effects from the use of hormonal contraceptives. The risk increases with age (women > 35), and with heavy smoking. Women who use hormonal contraceptives are strongly advised not to smoke.
  • The most common side effect of IMPLANON is a change in your menstrual periods. In studies, about 1 in 10 women stopped using IMPLANON because of bleeding problems. Expect your menstrual periods to be irregular and unpredictable throughout the time you are using IMPLANON. You may have more bleeding, less bleeding, or no bleeding. The time between periods may vary, and in between periods you may have spotting. Other common side effects reported in women using IMPLANON during clinical trials include: headache; vaginitis; weight gain; acne; breast pain; viral infections such as colds, sore throats, sinus infections, or flu-like symptoms; stomach pain; painful periods; mood swings; nervousness or depression; back pain; nausea; dizziness; pain; and pain at the site of insertion.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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