Jinteli

Last updated on RxList: 6/12/2018
Jinteli Side Effects Center

Last reviewed on RxList 6/12/2018

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 of Jinteli include nausea, vomiting, stomach pain or upset, headache, bloating, breast tenderness or swelling, swelling of the ankles/feet (fluid retention), weight changes, changes in appetite, freckles or darkening of facial skin, increased hair growth, loss of scalp hair, problems with contact lenses, runny nose, vaginal itching or discharge, decreased sex drive, dizziness, or sleep problems. Vaginal bleeding between periods (spotting) or missed/irregular menstrual periods may occur, especially during the first few months of Jinteli 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.

SLIDESHOW

What Is Osteoporosis? Treatment, Symptoms, Medication See Slideshow
Jinteli Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed;
  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
  • swelling or tenderness in your stomach;
  • jaundice (yellowing of the skin or eyes);
  • unusual vaginal bleeding, pelvic pain;
  • a breast lump;
  • memory problems, confusion, unusual behavior; or
  • high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects may include:

  • stomach pain;
  • bloating, swelling, weight gain;
  • breast pain;
  • light vaginal bleeding or spotting;
  • thinning scalp hair; or
  • headache.

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.

Read the entire detailed patient monograph for Jinteli (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP)

QUESTION

If menopause occurs in a woman younger than ___ years, it is considered to be premature. See Answer
Jinteli Professional Information

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)

© Jinteli Patient Information is supplied by Cerner Multum, Inc. and Jinteli Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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