Natazia Side Effects

Generic name: dienogest / estradiol

Medically reviewed by Drugs.com. Last updated on Aug 4, 2024.

Note: This document provides detailed information about Natazia Side Effects associated with dienogest / estradiol. Some dosage forms listed on this page may not apply specifically to the brand name Natazia.

Applies to dienogest / estradiol: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. These visits will usually be every 12 months, but some doctors require them more often.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you suspect that you may be pregnant, stop using this medicine immediately and check with your doctor.

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier.

• If this should occur, continue with your regular dosing schedule.
• The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week.
• If bleeding continues after you have been taking hormonal contraceptives on schedule and for more than 3 months, check with your doctor.

Check with your doctor right away if you miss a menstrual period. Missed periods may occur if you skip one or more tablets and have not taken your pills exactly as directed. If you miss two periods in a row, talk to your doctor. You might need a pregnancy test.

Do not use this medicine if you smoke cigarettes or if you are over 35 years old. If you smoke while using birth control pills, you increase your risk of having a heart attack, stroke, or blood clot. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Stop using this medicine and check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, unexplained shortness of breath, a sudden loss of coordination, or vision changes while using this medicine.

Check with your doctor immediately if you have problems wearing contact lenses or if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your eyes need to be checked by an ophthalmologist (eye doctor).

Stop using this medicine and check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may not work as well in women who are overweight. If you gain a lot of weight after you start taking this medicine, ask your doctor if you should change to another type of birth control pill.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or certain medical tests.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

Serious side effects of Natazia

Along with its needed effects, dienogest / estradiol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking dienogest / estradiol:

Other side effects of Natazia

Some side effects of dienogest / estradiol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to dienogest / estradiol: oral tablet.

General adverse events

The most common adverse events were irregular uterine bleeding, nausea, breast tenderness, and headache.^[Ref]

Hepatic

• Common (1% to 10%): Liver enzymes increased (including alanine aminotransferase increased, aspartate aminotransferase increased, and gamma-glutamyltransferase increased)
• Uncommon (0.1% to 1%): Cholecystitis chronic
• Rare (less than 0.1%): Focal nodular hyperplasia of the liver, chronic acalculous cholecystitis
• Frequency not reported: Acute cholecystitis
• Postmarketing reports: Gallbladder disease, hepatitis^[Ref]

Genitourinary

• Common (1% to 10%): Amenorrhea, breast pain/discomfort/tenderness (including nipple disorder and nipple pain), dysmenorrhea, intracyclic bleeding (metrorrhagia), menstrual disorders (menstruation irregular, menorrhagia, vaginal hemorrhage, dysfunctional uterine bleeding, genital hemorrhage, abnormal withdrawal bleeding, uterine hemorrhage), genital discharge
• Uncommon (0.1% to 1%): Urinary tract pain, breast discharge, breast enlargement, breast mass, cervical dysplasia, dyspareunia, cervical polyp, cervix erythema, fibrocystic breast disease, ovarian cyst, pelvic pain, premenstrual syndrome, vulvovaginal dryness, smear cervix abnormal, fibrocystic breast disease, uterine spasm, uterine/vaginal bleeding including spotting, vaginal discharge, vulvovaginal dryness
• Rare (less than 0.1%): Breast cyst, coital bleeding, galactorrhea, hypomenorrhea, menstruation delayed, ovarian cyst ruptured, vaginal odor, vulvovaginal burning sensation, vulvovaginal discomfort^[Ref]

Gastrointestinal

• Common (1% to 10%): Nausea or vomiting, abdominal pain (including abdominal distension)
• Uncommon (0.1% to 1%): Diarrhea, constipation, dry mouth
• Rare (less than 0.1%): Dyspepsia, gastroesophageal reflux disease
• Postmarketing reports: Gastrointestinal symptoms^[Ref]

Nervous system

• Common (1% to 10%): Tension headaches
• Uncommon (0.1% to 1%): Dizziness, migraine (including migraine with and without aura)
• Rare (less than 0.1%): Disturbance in attention, paresthesia, vertigo^[Ref]

Nervous Very common (10% or more): Headache (12.7%)

Dermatologic

• Common (1% to 10%): Acne
• Uncommon (0.1% to 1%): Alopecia, pruritus (including pruritus generalized and rash pruritic), rash (including rash macular), hirsutism, hyperhidrosis, rash
• Rare (less than 0.1%): Chloasma, dermatitis, neurodermatitis, pigmentation disorder, seborrhea, skin disorder (including skin tightness)
• Postmarketing reports: Chloasma, angioedema, erythema nodosum, erythema multiforme^[Ref]

Cardiovascular

• Common (1% to 10%): Blood pressure changes (including blood pressure increased and blood pressure decreased)
• Uncommon (0.1% to 1%): Hypertension, myocardial infarction, palpitations, phlebitis superficialis, vein pain
• Rare (less than 0.1%): Hypotension, bleeding varicose vein, venous thromboembolism (VTE), arterial thromboembolism (ATE)
• Frequency not reported: Deep vein thrombosis
• Postmarketing reports: Venous and arterial thromboembolic events (including pulmonary emboli, deep vein thrombosis, cerebral thrombosis, myocardial infarction, and stroke)^[Ref]

Hematologic

• Rare (less than 0.1%): Lymphadenopathy^[Ref]

Hypersensitivity

• Rare (less than 0.1%): Allergic skin reaction (including dermatitis allergic and urticaria)
• Postmarketing reports: Hypersensitivity^[Ref]

Immunologic

• Common (1% to 10%): Vulvovaginal mycotic infection (including vaginal candidiasis)
• Uncommon (0.1% to 1%): Fungal infection, vaginal infection
• Rare (less than 0.1%): Candidiasis, herpes simplex, presumed ocular histoplasmosis syndrome, tinea versicolor, urinary tract infection, vaginitis bacterial, vulvovaginal mycotic infection, pelvic inflammatory disease^[Ref]

Metabolic

• Uncommon (0.1% to 1%): Increased appetite, fluid retention
• Rare (less than 0.1%): Hypertriglyceridemia^[Ref]

Musculoskeletal

• Uncommon (0.1% to 1%): Muscle spasms, pain in jaw
• Rare (less than 0.1%): Back pain^[Ref]

Ocular

• Uncommon (0.1% to 1%): Dry eye, eye swelling
• Rare (less than 0.1%): Contact lens intolerance^[Ref]

Oncologic

• Uncommon (0.1% to 1%): Breast cancer in situ, uterine leiomyoma
• Rare (less than 0.1%): Benign breast neoplasm^[Ref]

Other

• Common (1% to 10%): Increased weight, fatigue
• Uncommon (0.1% to 1%): Edema, weight decreased, peripheral edema, pyrexia
• Rare (less than 0.1%): Hot flush, sensation of heaviness, malaise, chest pain
• Postmarketing reports: Vulvovaginal candidiasis^[Ref]

Psychiatric

• Common (1% to 10%): Mood changes (depression, mood swings, depressed mood, mood altered, affect lability, dysthymic disorder, crying), emotional disorder, insomnia, libido decreased
• Uncommon (0.1% to 1%): Libido increased, nervousness, restlessness, sleep disorder, stress, irritability, nightmare
• Rare (less than 0.1%): Aggression^[Ref]

Respiratory

• Uncommon (0.1% to 1%): Asthma, dyspnea, epistaxis^[Ref]

See also:

Further information

Natazia side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer