"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
Jadelle Side Effects Center
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
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.
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|
|Long spotting duration or length unclear||8.9||15.1|
|Menorrhagia (increased amount)||1.6||4.5|
|a Excludes women with condition reported at admission, prior to initiation of Jadelle® implants.|
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|
|Headache||Urinary tract symptoms, infection|
|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|
|Benign breast neoplasm||Nonpuerperal lactation|
|Breast fibroadenosis||Ovarian cyst, follicle enlargement|
|Cervical cytology, grade 3 or 4||Perineal pain|
|Constipation, flatulence, or dyspepsia||Purpura|
|Dermatitis||Upper respiratory infectiona|
|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)) »
Additional Jadelle Information
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.
Find out what women really need.