Etonogestrel

The contraceptive effect of NEXPLANON is achieved by suppression of ovulation, increased viscosity of the cervical mucus, and alterations in the endometrium.

• NEXPLANON ® is indicated for prevention of pregnancy in women of reproductive potential for up to 5 years. NEXPLANON is a progestin indicated for prevention of pregnancy in women of reproductive potential for up to 5 years.ICD-10: Z30.9

• NEXPLANON should not be used in women who have Known or suspected pregnancy Current or past history of thrombosis or thromboembolic disorders Liver tumors, benign or malignant, or active liver disease Undiagnosed abnormal uterine bleeding Known or suspected breast cancer, personal history of breast cancer, or other progestin-sensitive cancer, now or in the past Allergic reaction to any of the components of NEXPLANON [see Adverse Reactions (6) ] Known or suspected pregnancy. ( 4 ) Current or past history of thrombosis or thromboembolic disorders.contraindicated

The efficacy of NEXPLANON does not depend on daily, weekly, or monthly administration. All healthcare professionals should receive instruction and training prior to performing insertion and/or removal of NEXPLANON. A single NEXPLANON implant is inserted subdermally just under the skin at the inner side of the non-dominant upper arm. The insertion site is overlying the triceps muscle about 8-10 cm (3-4 inches) from the medial epicondyle of the humerus and 3-5 cm (1.25-2 inches) posterior to (below) the sulcus (groove) between the biceps and triceps muscles. This location is intended to avoid the large blood vessels and nerves lying within and surrounding the sulcus (see Figures 2a , 2b and 2c ). Inserting an implant more deeply than subdermally (a deep insertion) may preclude palpation and localization, making removal difficult or impossible [see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ] . NEXPLANON must be inserted by the expiration date stated on the packaging. NEXPLANON is a long-acting (up to 5 years), reversible, hormonal contraceptive method. The implant must be removed by the end of the fifth year and may be replaced by a new implant at the time of removal, if continued contraceptive protection is desired. Insert one NEXPLANON subdermally just under the skin at the inner side of the non-dominant upper arm. NEXPLANON must be removed no later than by the end of the fifth year. ( 2 ) 2.1 Initiating Contraception with NEXPLANON IMPORTANT: Rule out pregnancy before inserting the implant.

The following information is based on experience with the etonogestrel implants (IMPLANON and/or NEXPLANON), other progestin-only contraceptives, or experience with combination (estrogen plus progestin) oral contraceptives. Insertion and removal complications: Pain, paresthesia, bleeding, hematoma, scarring, infection, or migration to vasculature, including pulmonary vessels, may occur. Symptoms associated with implants in pulmonary vessels include chest pain, dyspnea, cough, or hemoptysis. Surgical interventions may be necessary to remove implants. ( 5.1 ) Menstrual bleeding pattern: Counsel women regarding changes in bleeding frequency, intensity, or duration. ( 5.3 ) Ectopic pregnancies: Be alert to the possibility of an ectopic pregnancy in women using NEXPLANON who become pregnant or complain of lower abdominal pain. ( 5.4 ) Thrombotic and other vascular events: The NEXPLANON implant should be removed in the event of a thrombosis. ( 5.5 ) Liver disease: Remove the NEXPLANON implant if jaundice occurs. ( 5.8 ) Elevated blood pressure: The NEXPLANON implant should be removed if blood pressure rises significantly and becomes uncontrolled. ( 5.10 ) Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women using NEXPLANON. ( 5.12 ) 5.1 Risk of Complications Due to Improper Insertion and Removal Complications of Insertion and Removal NEXPLANON should be inserted subdermally so that it will be palpable after insertion, and this should be confirmed by palpation immediately after insertion.

The following adverse reactions reported with the use of hormonal contraception are discussed elsewhere in the labeling: Changes in Menstrual Bleeding Patterns [see Warnings and Precautions (5.3) ] Ectopic Pregnancies [see Warnings and Precautions (5.4) ] Thrombotic and Other Vascular Events [see Warnings and Precautions (5.5) ] Liver Disease [see Warnings and Precautions (5.8) ] Most common (≥10%) adverse reactions reported in clinical trials were change in menstrual bleeding pattern, headache, vaginitis, weight increase, acne, breast pain, abdominal pain, and pharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon USA LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice, because clinical trials are conducted under widely varying conditions. In clinical trials of three years duration involving 942 women who were evaluated for safety, change in menstrual bleeding patterns (irregular menses) was the most common adverse reaction causing discontinuation of use of the non-radiopaque etonogestrel implant (IMPLANON) (11.1% of women). Adverse reactions that resulted in a rate of discontinuation of ≥1% are shown in Table 3 .

Pregnancy: Discontinue if maintaining a pregnancy. ( 8.1 ) 8.1 Pregnancy Risk Summary NEXPLANON is contraindicated during pregnancy because there is no need for pregnancy prevention in a woman who is already pregnant [see Contraindications (4) ] . Epidemiologic studies and meta-analyses have not shown an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following maternal exposure to low dose CHCs prior to conception or during early pregnancy. No adverse development outcomes were observed in pregnant rats and rabbits with the administration of etonogestrel during organogenesis at doses of 315 or 781 times the anticipated human dose (60 µg/day) (see Data ). NEXPLANON should be removed if maintaining a pregnancy. Data Animal Data Teratology studies have been performed in rats and rabbits using oral administration up to 315 and 781 times the human etonogestrel dose (based upon body surface) and revealed no evidence of fetal harm due to etonogestrel exposure. 8.2 Lactation Risk Summary Small amounts of contraceptive steroids and/or metabolites, including etonogestrel are present in human milk. No significant adverse effects have been observed in the production or quality of breast milk, or on the physical and psychomotor development of breastfed infants (see Data ).

Metabolism

Absorption After subdermal insertion of the etonogestrel implant, etonogestrel is released into the circulation and is approximately 100% bioavailable. Maximum serum concentrations were reached within the first two weeks after insertion and gradually decreased over time.

Overdosage may result if more than one implant is inserted. In case of suspected overdose, the implant should be removed.

• Oct 3, 2001NDANDA021187Organon Usa Organon
• Jul 17, 2006NDANDA021529Organon
• Dec 11, 2019ANDAANDA210830Amneal
• Jan 13, 2021ANDAANDA204305Teva Pharms Usa Inc
• Jun 29, 2023ANDAANDA211157Xiromed

1. 1No Adverse Event11,49817%
2. 2Product Quality Issue6,1568.9%
3. 3Device Breakage5,3317.7%
4. 4Complication Associated With Device5,3197.7%
5. 5Device Difficult To Use4,6636.7%
6. 6Unintended Pregnancy4,4836.5%
7. 7Pulmonary Embolism4,0645.9%
8. 8Incorrect Product Administration Duration3,8595.6%
9. 9Device Expulsion3,5455.1%
10. 10Device Deployment Issue3,3824.9%
11. 11Complication Of Device Removal3,3144.8%
12. 12Complication Of Device Insertion3,2774.7%
13. 13Pregnancy With Implant Contraceptive3,2514.7%
14. 14Menorrhagia3,0694.4%
15. 15Vaginal Haemorrhage2,8634.1%

The 10 most recently updated of 142 ClinicalTrials.gov registrations naming Etonogestrel as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Effects of the Contraceptive Implant in Women With Sickle Cell Disease
  Active not recruiting · Phase 4 · Interventional · 22 enrolled · University of Pennsylvania
  NCT05730205updated 2026-06-12
• Immediate vs Delayed Postpartum Implanon-NXT
  Not yet recruiting · Observational · 90 enrolled · Assiut University
  NCT07626502updated 2026-06-04
• Etonogestrel (ENG) Implant Insertion for Emergency Contraception With Oral Levonorgestrel (LNG) vs Placebo
  Recruiting · Phase 4 · Interventional · 790 enrolled · Lori Gawron
  NCT06162611updated 2026-06-02
• Long Term Evaluation of Scapular-inserted Contraceptive Implants
  Recruiting · Phase 2 · Interventional · 62 enrolled · Yale University
  NCT07201402updated 2026-05-12
• Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV
  Not yet recruiting · Observational · 105 enrolled · University of Alabama at Birmingham
  NCT07516548updated 2026-05-08
• Hormonal Influences on Inflammatory Bowel Diseases
  Completed · Observational · 50 enrolled · University of Utah
  NCT05610527updated 2026-04-17
• Kuwa Free! - Live Free!
  Recruiting · Interventional · 700 enrolled · University of Alabama at Birmingham
  NCT05044962updated 2026-04-13
• An Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Etonogestrel-releasing Medicated Intrauterine Systems (Study P06060)
  Completed · Phase 2 · Interventional · 84 enrolled · Organon and Co
  NCT00967746updated 2026-04-08
• Casea S Contraceptive Implants (Casea S) Trial
  Active not recruiting · Phase 1 · Interventional · 20 enrolled · FHI 360
  NCT05174884updated 2026-04-08
• A Trial to Investigate the Effectiveness and Safety of Org 3236 (Etonogestrel) Tablets in Men With Urinary Complaints Suggestive of a Benign Enlargement of the Prostate (304001)(P05806)
  Terminated · Phase 2 · Interventional · 16 enrolled · Organon and Co
  NCT00651807updated 2026-04-08

Frequently asked questions

How does Etonogestrel work?

The contraceptive effect of NEXPLANON is achieved by suppression of ovulation, increased viscosity of the cervical mucus, and alterations in the endometrium.

What is Etonogestrel used for?

According to FDA labeling, Etonogestrel carries indications including: NEXPLANON ® is indicated for prevention of pregnancy in women of reproductive potential for up to 5 years. NEXPLANON is a progestin indicated for prevention of pregnancy in women of reproductive potential for up to 5 years.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Etonogestrel?

Etonogestrel is classified as Progestogens, Progestin, Progestational Hormone Receptor Agonists, Decreased Embryonic Implantation, Inhibit Ovulation.

What are the brand names for Etonogestrel?

Etonogestrel is marketed under brand names including EluRyng, Enilloring, Haloette, Nexplanon, NuvaRing.

What are the contraindications for Etonogestrel?

Etonogestrel labeling lists contraindications including: NEXPLANON should not be used in women who have Known or suspected pregnancy Current or past history of thrombosis or thromboembolic disorders Liver tumors, benign or malignant, or active liver disease Undiagnosed abnormal uterine bleeding Known or suspected breast cancer, personal history of breast cancer, or other progestin-sensitive cancer, now or in the past Allergic reaction to any of the components of NEXPLANON [see Adverse Reactions (6) ] Known or suspected pregnancy. ( 4 ) Current or past history of thrombosis or thromboembolic disorders.. Always consult the full prescribing information and a clinician.