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Implanon

Last reviewed on RxList: 9/6/2016
Implanon Side Effects Center

Last reviewed on RxList 8/26/2015

Implanon (etonogestrel) is a contraceptive used to prevent pregnancy. Common side effects of Implanon include

Other side effects of Implanon include

  • pain,
  • bruising,
  • numbness,
  • infection,
  • tingling,
  • minor bleeding, and
  • scarring at the site where the rod is placed.

The medicine in Implanon is contained in a small plastic rod that is implanted into the skin of your upper arm. The medicine dose is released slowly into the body. The rod can remain in place and provide continuous contraception for up to 3 years. Implanon may interact with phenylbutazone, modafinil, St. John's wort, antibiotics, seizure medicines, barbiturates, and HIV medicines. Tell your doctor all medications you are taking. Implanon should not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. A certain serious pregnancy problem (ectopic pregnancy) may be more likely if you become pregnant while using this product. Implanon passes into breast milk in small amounts. Consult your doctor before breast-feeding.

Our Implanon 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.

Implanon Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • warmth, redness, swelling, or oozing where the implant was inserted;
  • sudden numbness or weakness, especially on one side of the body;
  • severe pain or cramping in your pelvic area (may be only on one side);
  • sudden severe headache, confusion, pain behind the eyes, problems with vision, speech, or balance;
  • sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • a breast lump;
  • swelling in your hands, ankles, or feet;
  • jaundice (yellowing of the skin or eyes);
  • symptoms of depression (sleep problems, weakness, tired feeling, mood changes); or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • pain, numbness, or tingling where the implant was inserted;
  • minor bleeding or scarring where the implant was inserted;
  • menstrual cramps, changes in your menstrual periods;
  • mild headache, dizziness, mood changes;
  • vaginal itching or discharge;
  • breast pain;
  • acne;
  • problems with contact lenses;
  • nausea, mild stomach pain;
  • back pain;
  • feeling nervous or depressed;
  • sore throat, flu symptoms; or
  • weight gain.

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.

Read the entire detailed patient monograph for Implanon (Etonogestrel Implant)

Implanon Professional Information

SIDE EFFECTS

The following adverse reactions reported with the use of hormonal contraception are discussed elsewhere in the labeling:

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 including 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 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 IMPLANON

Adverse Reactions All Studies
N = 942
Bleeding Irregularities* 11.1%
Emotional Lability† 2.3%
Weight Increase 2.3%
Headache 1.6%
Acne 1.3%
Depression‡ 1.0%
*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 clinical trials of IMPLANON are listed in Table 4.

Table 4: Common Adverse Reactions Reported by ≥ 5% of Subjects in Clinical Trials with IMPLANON

Adverse Reaction All Studies
N=942
Headache 24.9%
Vaginitis 14.5%
Weight increase 13.7%
Acne 13.5%
Breast pain 12.8%
Abdominal pain 10.9%
Pharyngitis 10.5%
Leukorrhea 9.6%
Influenza-like symptoms 7.6%
Dizziness 7.2%
Dysmenorrhea 7.2%
Back pain 6.8%
Emotional lability 6.5%
Nausea 6.4%
Pain 5.6%
Nervousness 5.6%
Depression 5.5%
Hypersensitivity 5.4%
Insertion site pain 5.2%

Implant site complications were reported by 3.6% of subjects during any of the assessments in clinical trials. Pain was the most frequent implant site complication, reported during and/or after insertion, occurring in 2.9% of subjects. Additionally, hematoma, redness, and swelling were reported by 0.1%, 0.3%, and 0.3% of patients, respectively [see WARNINGS AND PRECAUTIONS].

Postmarketing Experience

The following additional adverse reactions have been identified during post-approval use of 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

Infections and infestations: rhinitis, urinary tract infection.

Investigations: clinically relevant rise in blood pressure, weight decreased.

Metabolism and nutrition disorders: increased appetite.

Musculoskeletal and connective tissue disorders: arthralgia, musculoskeletal pain, myalgia.

Nervous system disorders: convulsions, migraine, somnolence.

Pregnancy, puerperium and perinatal conditions: ectopic pregnancy.

Psychiatric disorders: anxiety, insomnia, libido decreased.

Renal and urinary disorders: dysuria.

Reproductive system and breast disorders: breast discharge, breast enlargement, ovarian cyst, pruritus genital, vulvovaginal discomfort.

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 implant reported include: bruising, slight local irritation, pain or itching, fibrosis at the implant site, paresthesia or paresthesia-like events, scarring and abscess. Expulsion or migration of the implant, have been reported, including to the chest wall. In some cases implants have been found within the vasculature including the pulmonary artery. Some cases of implants found within the pulmonary artery reported chest pain and/or dyspnea; others have been reported as asymptomatic [see WARNINGS AND PRECAUTIONS]. Surgical intervention might be necessary when removing the implant.

Read the entire FDA prescribing information for Implanon (Etonogestrel Implant)

Related Resources for Implanon

Read the Implanon User Reviews »

© Implanon Patient Information is supplied by Cerner Multum, Inc. and Implanon Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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