Prescription medicine
Etonogestrel Brand names: Nexplanon; first approved as Implanon
Etonogestrel (Nexplanon) is a prescription medicine with an FDA approval on record since 2006. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the etonogestrel FDA label on DailyMed (effective May 28, 2026, Organon LLC); the NDA 21529 record on Drugs@FDA; every etonogestrel label on DailyMed.
Highlights of the record
FDA label of May 28, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
RISK OF COMPLICATIONS DUE TO IMPROPER.
INSERTION and REMOVAL Improper insertion of NEXPLANON increases the risk of complications [see Warnings and Precautions (5.1) ]. Proper training prior to first use of NEXPLANON can minimize the risk of improper NEXPLANON insertion [see Warnings and Precautions (5.1) ]. Because of the risk of complications due to improper insertion and removal NEXPLANON is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the NEXPLANON REMS [see Warnings and Precautions (5.2) ]. WARNING: RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION and REMOVAL Improper insertion of NEXPLANON increases the risk of complications [see Warnings and Precautions (5.1) ]. Proper training prior to first use of NEXPLANON can minimize the risk of improper NEXPLANON insertion [see Warnings and Precautions (5.1) ]. NEXPLANON is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the NEXPLANON REMS [see Warnings and Precautions (5.2) ].
Used for
From the label: indications and usageNEXPLANON ® is indicated for prevention of pregnancy in women of reproductive potential for up to 5 years.
Forms and strengths
- 68 mg
Implant.
On the market
- Earliest approval on file
- July 17, 2006 Implanon, Organon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 28, 2030 Implanon implant; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 47,446 through July 30, 2026
What is etonogestrel used for?
From the label: indications and usageNEXPLANON ® 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.
Conditions named in the indications of etonogestrel's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Progestin.
Source: FDA drug label (Nexplanon), Organon LLC, effective May 28, 2026 (SPL set 487f8a62-e142-457c-97cc-2e398fde7594), via openFDA; the full label on DailyMed
Is there a generic for etonogestrel (Nexplanon)?
No generic etonogestrel is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Implanon implant, the last expiring on July 28, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2006 earliest approval on file
- 2030 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the etonogestrel label say about other medicines?
The etonogestrel label names 21 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name etonogestrel. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aprepitant | drug interactions | Some drugs or herbal products that may decrease the effectiveness of HCs include efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. |
| Bosentan | drug interactions | Some drugs or herbal products that may decrease the effectiveness of HCs include efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. |
| Carbamazepine | drug interactions | Some drugs or herbal products that may decrease the effectiveness of HCs include efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. |
| Cyclosporine | drug interactions | Consequently, plasma concentrations may either increase (for example, cyclosporine) or decrease (for example, lamotrigine). |
| Efavirenz | drug interactions | Some drugs or herbal products that may decrease the effectiveness of HCs include efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. |
| Etravirine | drug interactions | … non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nevirapine, efavirenz] or increase [e.g., etravirine]). |
| Felbamate | drug interactions | Some drugs or herbal products that may decrease the effectiveness of HCs include efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. |
| Fluconazole | drug interactions | Substances increasing the plasma concentrations of HCs: Co-administration of certain HCs and strong or moderate CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase the serum concentrations of progestins, including etonogestrel. |
| Griseofulvin | drug interactions | Some drugs or herbal products that may decrease the effectiveness of HCs include efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. |
| Itraconazole | drug interactions | Substances increasing the plasma concentrations of HCs: Co-administration of certain HCs and strong or moderate CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase the serum concentrations of progestins, including etonogestrel. |
| Ketoconazole | drug interactions | Substances increasing the plasma concentrations of HCs: Co-administration of certain HCs and strong or moderate CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase the serum concentrations of progestins, including etonogestrel. |
| Lamotrigine | drug interactions | Consequently, plasma concentrations may either increase (for example, cyclosporine) or decrease (for example, lamotrigine). |
| Nelfinavir | drug interactions | Significant changes (increase or decrease) in the plasma concentrations of progestin have been noted in cases of co-administration with HIV protease inhibitors (decrease [e.g., nelfinavir] or increase [e.g., indinavir, ritonavir and ritonavir-boosted protease inhibitors]) or with non-nucleoside reverse transcriptase … |
| Nevirapine | drug interactions | … ritonavir-boosted protease inhibitors]) or with non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nevirapine, efavirenz] or increase [e.g., etravirine]). |
Every other medicine the etonogestrel label names
| Medicine named | Section | What the label says |
|---|---|---|
| Oxcarbazepine | drug interactions | … phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. |
| Phenytoin | drug interactions | Some drugs or herbal products that may decrease the effectiveness of HCs include efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin … |
| Rifabutin | drug interactions | … bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. |
| Ritonavir | drug interactions | … inhibitors (decrease [e.g., nelfinavir] or increase [e.g., indinavir, ritonavir and ritonavir-boosted protease inhibitors]) or with non-nucleoside reverse transcriptase inhibitors (decrease [e.g. … |
| Rufinamide | drug interactions | … felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. |
| Topiramate | drug interactions | … carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. |
| Voriconazole | drug interactions | … HCs and strong or moderate CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase the serum concentrations of progestins, including … |
Other labels that name etonogestrel
Source: FDA drug label (Nexplanon), Organon LLC, effective May 28, 2026 (SPL set 487f8a62-e142-457c-97cc-2e398fde7594), via openFDA; the full label on DailyMed
What do FAERS reports show for etonogestrel?
The FDA Adverse Event Reporting System holds 47,446 reports that list etonogestrel among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 109 are coded as a death and 1,686 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other progestins
- the pharmacologic class, with prices and generics
- Etonogestrel side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other