"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
Nexplanon Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
Nexplanon (etonogestrel implant) is indicated for use by women to prevent pregnancy. Nexplanon is a radiopaque, progestin-only, soft, flexible implant preloaded in a sterile, disposable applicator for subdermal use. This drug is available as generic named Implanon. Nexplanon is effective for up to three years. Some known side effects of Nexplanon can include changes in menstrual bleeding patterns, ectopic pregnancies, liver disease, minor weight gain, and fluid retention.
Nexplanon (etonogestrel implant) is available in a sterile disposable container that has non-biodegradable polymer, 4 cm long by 2 mm wide, containing 68 mg of etonogestrel. A single Nexplanon implant is inserted, using sterile technique, subdermally in the upper arm by individuals trained to do this technique. As with all progestin-only contraceptive products, be alert to the possibility of an ectopic pregnancy among women using Nexplanon who become pregnant or complain of lower abdominal pain. Although ectopic pregnancies are uncommon among women using Nexplanon, a pregnancy that occurs in a woman using Nexplanon may be more likely to be ectopic than a pregnancy occurring in a woman using no contraception. Women with a history of depressed mood should be carefully observed. Serious side effects include blood clot formation, liver disease, ectopic pregnancy and serious depression; the side effects may warrant the removal of the implant. Nexplanon may be used during breastfeeding after the fourth postpartum week. There is no evidence that the risk associated with etonogestrel is different from that of combination oral contraceptives. Nexplanon should be removed if a person becomes pregnant and is interested in maintaining the pregnancy, but it is imperative to rule out pregnancy before inserting the implant. The implant should be removed at the end of three years; another can be inserted if the patient still wants pregnancy prevention. This implant has not been studied in female patients under age 18.
Our Nexplanon (etonogestrel implant) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Nexplanon FDA Prescribing Information: Side Effects
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]
- Ectopic Pregnancies [see WARNINGS AND PRECAUTIONS]
- Thrombotic and Other Vascular Events [see WARNINGS AND PRECAUTIONS]
- Liver Disease [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, 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.
In clinical trials 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.
Table 3: Adverse Reactions Leading to Discontinuation
of Treatment in 1% or More of Subjects in Clinical Trials of the Non-Radiopaque
Etonogestrel Implant (IMPLANON)
|Adverse Reactions||All Studies
N = 942
|* Includes “frequent”, “heavy”,
“prolonged”, “spotting”, and other patterns of bleeding irregularity.
†Among US subjects (N=330), 6.1% experienced emotional lability that led to discontinuation.
‡Among US subjects (N=330), 2.4% experienced depression that led to discontinuation.
Other adverse reactions that were reported by at least 5% of subjects in the non-radiopaque etonogestrel implant clinical trials are listed in Table 4.
Table 4: Common Adverse Reactions Reported by
≥ 5% of Subjects in Clinical Trials With the Non-Radiopaque Etonogestrel
|Adverse Reactions||All Studies
N = 942
|Insertion site pain||5.2%|
In a clinical trial of NEXPLANON, in which investigators were asked to examine the implant site after insertion, implant site reactions were reported in 8.6% of women. Erythema was the most frequent implant site complication, reported during and/or shortly after insertion, occurring in 3.3% of subjects. Additionally, hematoma (3.0%), bruising (2.0%), pain (1.0%), and swelling (0.7%) were reported.
The following additional adverse reactions have been identified during post-approval use of the non-radiopaque etonogestrel implant (IMPLANON). Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal disorders: constipation, diarrhea, flatulence, vomiting.
General disorders and administration site conditions: edema, fatigue, implant site reaction, pyrexia.
Immune system disorders: anaphylactic reactions.
Investigations: clinically relevant rise in blood pressure, weight decreased.
Metabolism and nutrition disorders: increased appetite.
Pregnancy, puerperium and perinatal conditions: ectopic pregnancy.
Psychiatric disorders: anxiety, insomnia, libido decreased.
Renal and urinary disorders: dysuria.
Skin and subcutaneous tissue disorders: angioedema, aggravation of angioedema and/or aggravation of hereditary angioedema, alopecia, chloasma, hypertrichosis, pruritus, rash, seborrhea, urticaria. Vascular disorders: hot flush.
Complications related to insertion or removal of the non-radiopaque etonogestrel implant reported include: bruising, slight local irritation, pain or itching, fibrosis at the implant site, paresthesia or paresthesia-like events, scarring and abscess.
Read the entire FDA prescribing information for Nexplanon (Etonogestrel Implant) »
Additional Nexplanon Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.