Jinteli Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Jinteli (northindrone acetate and ethinyl estradiol) is a continuous dosage regimen of a progestin-estrogen combination used to treat moderate to severe vasomotor symptoms associated with menopause and to prevent postmenopausal osteoporosis. Common side effects include nausea, vomiting, headache, bloating, breast tenderness, swelling of the ankles/feet (fluid retention), or weight change. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use.
Jinteli therapy consists of a single tablet taken once daily. Jinteli may interact with cyclosporine, prednisolone, theophylline, other drugs containing estrogen such as birth control pills, acetaminophen, temazapam, salicylic acid, morphine, and clofibric acid. Tell your doctor all medications and supplements you use. Jinteli is not recommended for use during pregnancy. It may cause birth defects. This drug passes into breast milk and may affect the quality and quantity of milk produced. Consult your doctor before breastfeeding.
Our Jinteli (northindrone acetate and ethinyl estradiol) 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.
Jinteli FDA Prescribing Information: Side Effects
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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Adverse events reported in controlled clinical studies of norethindrone acetate and ethinyl estradiol are shown in Table 6 below.
Table 6: All Treatment-Emergent Adverse Events
Reported at a Frequency of ≥ 5% of Patients with Norethindrone Acetate and
|BODY SYSTEM/ Adverse Event||Percent of Patients (%)|
N = 247
|Norethindrone Acetate and Ethinyl Estradiol, 0.5/2.5
N = 244
|Norethindrone Acetate and Ethinyl Estradiol, 1/5
N = 258
|BODY AS A WHOLE||40.1||38.5||39.5|
|Nausea and/or Vomiting||5.3||5.3||7.4|
|Urinary Tract Infection||3.2||3.7||6.2|
Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; increase in size of uterine leiomyomata, vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer.
Retinal vascular thrombosis, intolerance to contact lenses.
Central Nervous Sys tem
Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthalgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.
Read the entire FDA prescribing information for Jinteli (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP) »
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