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Implanon (Etonogestrel Subcutaneous) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 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 1 11.1%
Emotional Lability 2 2.3%
Weight Increase 2.3%
Headache 1.6%
Acne 1.3%
Depression 3 1.0%

1 Includes "frequent", "heavy", "prolonged", "spotting", and other patterns of bleeding irregularity.
2 Among US subjects (N=330), 6.1% experienced emotional lability that led to discontinuation.
3 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.



REPORTS OF SUSPECTED IMPLANON SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Implanon. The information is not vetted and should not be considered as verified clinical evidence.

Possible Implanon side effects / adverse reactions in 31 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-03

Patient: 31 year old female

Reactions: Application Site Swelling, Swelling, Application Site Erythema, Application Site Pain, Loss of Consciousness, Application Site Irritation, Application Site Pruritus

Suspect drug(s):
Implanon

Other drugs received by patient: Synthroid; Rhinocort



Possible Implanon side effects / adverse reactions in 24 year old female

Reported by a physician from United States on 2011-10-06

Patient: 24 year old female

Reactions: Anxiety, Drug Administered AT Inappropriate Site, Pregnancy With Implant Contraceptive, Abortion Spontaneous

Suspect drug(s):
Implanon



Possible Implanon side effects / adverse reactions in 33 year old female

Reported by a consumer/non-health professional from Chile on 2011-10-06

Patient: 33 year old female weighing 68.0 kg (149.6 pounds)

Reactions: Abortion Threatened, Colitis Ulcerative, Maternal Exposure During Pregnancy, Condition Aggravated, Micturition Urgency, Menstrual Disorder, Weight Increased, Amenorrhoea, Pregnancy With Implant Contraceptive, Abortion Missed, Hypothyroidism

Suspect drug(s):
Implanon



See index of all Implanon side effect reports >>

Drug label data at the top of this Page last updated: 2014-07-14

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