Jinteli

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
(Adverse Reactions)

SIDE EFFECTS

See BOXED WARNING, WARNINGS AND PRECAUTIONS.

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 Ethinyl Estradiol

BODY SYSTEM/ Adverse Event Percent of Patients (%)
Placebo
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
Headache 14.6 15.2 18.2
Back Pain 5.3 5.3 4.7
Viral Infection 7.7 8.6 7.0
DIGESTIVE SYSTEM 24.4 30.5 33.0
Nausea and/or Vomiting 5.3 5.3 7.4
Abdominal Pain 4.5 10.2 8.1
Dyspepsia 2.0 5.3 3.1
Diarrhea 3.6 5.7 3.9
MUSCULOSKELETAL SYSTEM 21.7 20.3 20.4
Arthralgia 6.9 2.9 5.8
Myalgia 8.5 8.6 7.8
PSYCHOBIOLOGIC FUNCTION 8.3 7.9 14.1
Nervousness 1.6 1.6 5.4
Depression 3.6 3.7 5.8
RESPIRATORY SYSTEM 37.2 33.9 35.6
Rhinitis 15.4 12.7 15.1
Sinusitis 9.7 9.4 8.1
UROGENITAL SYSTEM 25.0 31.6 40.8
Breast Pain 5.3 9.0 8.1
Urinary Tract Infection 3.2 3.7 6.2
Vaginitis 4.9 4.5 5.4

The following additional adverse reactions have been reported with estrogen and/or progestin therapy.

Genitourinary System

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.

Breasts

Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.

Cardiovascular

Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.

Gastrointestinal

Nausea, vomiting; cholestatic jaundice; pancreatitis, enlargement of hepatic hemangiomas; bloating, abdominal cramps; increased incidence of gallbladder disease.

Skin

Chloasma or melasma that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; rash, pruritus.

Eyes

Retinal vascular thrombosis, intolerance to contact lenses.

Central Nervous Sys tem

Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia.

Miscellaneous

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) »

A A A

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.


Women's Health

Find out what women really need.


NIH talks about Ebola on WebMD