Medical Editor: John P. Cunha, DO, FACOEP
Jadelle (levonorgestrel) Implants is a form of a female hormone used to prevent pregnancy and are a long-term (up to 5 years) reversible method of contraception. The brand name Jadelle is not available in the U.S., but generic versions may be available. Common side effects of Jadelle (levonorgestrel) Implants include:
- irregular menstrual bleeding (heavy bleeding, extremely light bleeding, absence of menstrual periods, infrequent periods, spotting, shortened cycles),
- premenstrual syndrome,
- application site reactions,
- dizziness,
- headache,
- vaginal discharge,
- breast pain,
- nausea,
- pelvic pain,
- urinary tract symptoms,
- vaginitis, and
- weight gain.
Jadelle implants are a set of two flexible cylindrical implants, each containing 75 mg of the progestin levonorgestrel. The total administered (implanted) dose is 150 mg. Jadelle may interact with phenytoin, phenobarbital, carbamazepine, oxcarbazepine, rifampicin, or St. John's Wort. Tell your doctor all medications and supplements you use. Jadelle is not recommended for use during pregnancy. Hormonal contraceptives are not considered the contraceptives of first choice for breastfeeding women. Consult your doctor before breastfeeding.
Our Jadelle (levonorgestrel) Implants 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.
QUESTION
Which of the following are methods for contraception? See AnswerSIDE EFFECTS
Jadelle® (levonorgestrel implants (unavailable in us)) implants were used by 1393 subjects during clinical trials. The adverse medical events reported by subjects during these trials are given below.
Menstrual Complaints
Various menstrual complaints reported by more than 1.0% of subjects during the first year of Jadelle® (levonorgestrel implants (unavailable in us)) use are listed below.
| Menstrual Condition | Year 1 | Years 1-5 |
| % | % | |
| Menorrhagia (increased duration) | 13.4 | 25.9 |
| Amenorrhea | 9.8 | 13.9 |
| Menometrorrhagia | 9.6 | 20.5 |
| Oligomenorrhea | 9.5 | 12.8 |
| Long spotting duration or length unclear | 8.9 | 15.1 |
| Dysmenorrhea | 3.5a | 8.0a |
| Polymenorrhea | 2.7 | 5.0 |
| Premenstrual syndrome | 1.8a | 5.8a |
| Menorrhagia (increased amount) | 1.6 | 4.5 |
| Hypomenorrhea | 1.5 | 2.9 |
| a Excludes women with condition reported at admission, prior to initiation of Jadelle® implants. | ||
Dysmenorrhea and premenstrual syndrome were reported at admission into the studies by 7.8% and 4.9% of the subjects, respectively.
Insertion and Removal Difficulties
Removal complications or difficulties, including damage to the implants, were reported in 7.5% of the more than 1,100 Jadelle® (levonorgestrel implants (unavailable in us)) removals. Complications of insertion or removal included deep placement, multiple or long incisions, bruising, displacement, pain, prolonged removal, incomplete removal requiring an additional visit or visits, broken implants, and fibrous pericapsular tissue. See also Warnings Based On Experience With Levonorgestrel-Containing Implants.
Other Adverse Events
Adverse reactions that were reported by 10% or more of the subjects during 5 years of Jadelle® (levonorgestrel implants (unavailable in us)) use in clinical trials are listed below.
| Application site reaction, pain, etc. | Nausea |
| Dizziness | Pelvic pain |
| Headache | Urinary tract symptoms, infection |
| Leukorrhea | Vaginitisa |
| Mastalgia | Weight increase |
| a) includes also genital pruritus, infections and vaginal problems not else where classified. | |
Adverse reactions that were reported by 1.0-9.9% of the subjects during 5 years of Jadelle® (levonorgestrel implants (unavailable in us)) use in clinical trials are listed below.
| Abdominal pain | Flu-like symptoms |
| Abnormal vision | Folliculitis |
| Acne | Hypertension |
| Alopecia | Hypertrichosis |
| Anorexia | Hypoesthesia |
| Anxiety | Insomnia |
| Appetite increase | Injury |
| Asthenia | Libido decreased |
| Asthma | Migraine |
| Back Pain | Nervousness |
| Benign breast neoplasm | Nonpuerperal lactation |
| Breast fibroadenosis | Ovarian cyst, follicle enlargement |
| Bronchitis | Pain |
| Cervical lesion | Palpitation |
| Cervical cytology, grade 3 or 4 | Perineal pain |
| Cervicitis | Pruritus |
| Constipation, flatulence, or dyspepsia | Purpura |
| Chest pain | Rash |
| Contact dermatitis | Somnolence |
| Depression | Syncope |
| Dermatitis | Upper respiratory infectiona |
| Dyspnea | Uterine enlargement |
| Dyspareunia | Varicose veins |
| Emotional liability | Vomiting |
| Fatigue | Vulvar disorderb |
| Weight decrease | |
| a) includes rhinitis, pharyngitis and sinusitis as well as
undefined upper respiratory infection b) includes genital ulceration, herpes simplex and papilloma virus and other vulvar disorders |
|
Read the entire FDA prescribing information for Jadelle (Levonorgestrel Implants (Unavailable in US))
