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Jadelle

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Jadelle

Jadelle Side Effects Center

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 of this medication is not available in the U.S., but generic versions may be available. Common side effects include irregular menstrual bleeding, 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.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Jadelle FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE 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)) »

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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.


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