ADVERSE REACTIONS
See WARNINGS and PRECAUTIONS for additional important adverse events.
In clinical trials including 942 subjects, bleeding irregularities were the most common adverse event causing discontinuation of IMPLANON™. (see following Table)
Adverse Events Leading to Discontinuation of Treatment in 1% or More of Subjects in Clinical Trials | Adverse Event | All Studies
N=942 |
| Bleeding IrregularitiesIncludes “frequent”, “heavy”, “prolonged”, “spotting”, and other patterns of bleeding irregularity | 11.0% |
| Emotional LabilityAmong U.S. subjects, 6.1% experienced emotional lability that led to discontinuation | 2.3% |
| Weight Increase | 2.3% |
| Headache | 1.6% |
| Acne | 1.3% |
| DepressionAmong U.S. subjects, 2.4% experienced depression that led to discontinuation | 1.0% |
Adverse events that were reported by more than 5% of subjects in clinical trials appear in the following Table.
Adverse Events Reported in More than 5% of Subjects in Clinical TrialsList may include adverse events associated with but unrelated to IMPLANON™ use. | Adverse Event | All Studies
N=942 |
| Headache | 24.9% |
| Vaginitis | 14.5% |
| Weight Increase | 13.7% |
| Acne | 13.5% |
| Breast Pain | 12.8% |
| Upper Respiratory Tract Infection | 12.6% |
| Abdominal Pain | 10.9% |
| Pharyngitis | 10.5% |
| Leukorrhoea | 9.6% |
| Influenza-like symptoms | 7.6% |
| Dizziness | 7.2% |
| Dysmenorrhoea | 7.2% |
| Back Pain | 6.8% |
| Emotional lability | 6.5% |
| Nausea | 6.4% |
| Pain | 5.6% |
| Nervousness | 5.6% |
| Sinusitis | 5.6% |
| Depression | 5.5% |
| Insertion site pain | 5.2% |
Other “Less Common Adverse Events” Reported in Less Than 5% of Subjects in Clinical Trials Include: Allergic Reaction, Alopecia, Anorexia, Anxiety, Appetite Increased, Arthralgia, Asthenia, Asthma, Breast Discharge, Breast Enlargement, Breast Fibroadenosis, Cervical Smear Test Positive, Constipation, Coughing, Crying Abnormal, Diarrhea, Dyspepsia, Dysuria, Edema, Edema Generalized, Fatigue, Fever, Flatulence, Gastritis, Hot Flushes, Hypertension, Hypoasthesia, Injection Site Reaction, Insomnia, Lactation Nonpuerperal, Libido Decreased, Migraine, Myalgia, Otitis Media, Ovarian Cyst, Pelvic Cramping, Premenstrual Tension, Pruritus, Pruritus Genital, Rash, Rhinitis, Sexual Function Abnormal, Skeletal Pain, Somnolence, Vaginal Discomfort, Vein Varicose, Vision Abnormal, Vomiting, and Weight Decrease.
Hypertrichosis has also been reported with use of progestin-only contraceptives.
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 also WARNINGS, COMPLICATONS OF INSERTION AND REMOVAL.
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