Slideshows Images Quizzes

Natazia

Last reviewed on RxList: 6/5/2017
Natazia Side Effects Center

Last reviewed on RxList 02/14/2017

Natazia (estradiol valerate and estradiol valerate/dienogest) is an oral contraceptive used to prevent pregnancy. Common side effects of Natazia include:

  • irregular or light menstrual periods,
  • nausea (especially when you first start taking Natazia),
  • vomiting,
  • breast pain/tenderness/enlargement,
  • stomach cramping or bloating,
  • freckles or darkening of facial skin,
  • weight gain,
  • problems with contact lenses,
  • vaginal itching or discharge,
  • decreased sex drive, or
  • headache.

Acne may improve or get worse. Tell your doctor if you have serious side effects of Natazia including:

  • a lump in your breast,
  • unusual changes in vaginal bleeding,
  • mental/mood changes (such as new or worsening depression),
  • dark urine,
  • yellowing eyes or skin,
  • severe stomach/abdominal/pelvic pain, or
  • unusual tiredness.

Natazia must be taken exactly as directed. Take one tablet by mouth at the same time every day. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or intake delayed by more than 12 hours. Natazia may interact with bosentan, antibiotics, tuberculosis medications, drugs to treat hepatitis C or HIV/AIDS, phenobarbital and other barbiturates, St. John's wort, seizure medications, dantrolene, tizanidine, or tranexamic acid. Tell your doctor all medications and supplements you use. Do not use Natazia if you are pregnant; it can cause birth defects. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking Natazia. The hormones in Natazia can pass into breast milk and may harm a nursing baby. Natazia may also slow breast milk production. Breastfeeding while using Natazia is not recommended.

Our Natazia (estradiol valerate and estradiol valerate/dienogest) 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.

Natazia Consumer Information

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

Stop using dienogest and estradiol and call your doctor at once if you have a serious side effect such as:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden and severe headache, confusion, problems with vision, speech, or balance;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • a change in the pattern or severity of migraine headaches;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • swelling in your hands, ankles, or feet;
  • a breast lump; or
  • symptoms of depression (sleep problems, weakness, tired feeling, mood changes).

Less serious side effects may include:

  • mild nausea (especially when you first start taking this medicine), vomiting, bloating, stomach cramps;
  • breast pain or tenderness;
  • freckles or darkening of facial skin, acne;
  • weight gain;
  • problems with contact lenses;
  • vaginal itching or discharge, very light menstrual periods; or
  • decreased sex drive.

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 Natazia (Estradiol Valerate and Estradiol Valerate Dienogest Tablets)

Natazia Professional Information

SIDE EFFECTS

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:

Adverse reactions commonly reported by COC users are:

  • Irregular uterine bleeding
  • Nausea
  • Breast tenderness
  • Headache

Clinical Trials Experience

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.

Contraception and Heavy Menstrual Bleeding Studies

A total of 2,131 women, 18 to 54 years of age, who took at least one dose of Natazia were enrolled in four clinical phase 3 trials. A total of 1,867 subjects were included in two clinical phase 3 studies with a treatment duration up to 28 cycles with Natazia as an oral contraceptive and 264 subjects in the two phase 3 clinical trials with a treatment duration of 7 cycles evaluating Natazia in the treatment of heavy, prolonged, and/or frequent menstrual bleeding in women without organic pathology. [See Clinical Studies]

Adverse Reactions Leading to Study Discontinuation: 11.4% of the women discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reactions leading to discontinuation were menstrual disorder (metrorrhagia, menorrhagia, menstruation irregular, genital hemorrhage, vaginal hemorrhage, dysfunctional uterine bleeding) (2.3%); mood changes (depression, mood swings, mood altered, depressed mood, dysthymic disorder, crying) (1.2%); acne (1.1%), headache (including migraines) (1.1%), and weight increased (0.7 %).

Common Adverse Reactions ( ≥ 2%): headache (including migraines) (12.7%), breast pain, discomfort or tenderness (7.0%), menstrual disorders (metrorrhagia, menstruation irregular, menorrhagia, vaginal hemorrhage, dysfunctional uterine bleeding, genital hemorrhage, abnormal withdrawal bleeding, uterine hemorrhage) (6.9%), nausea or vomiting (6.0%), acne (3.9%), mood changes (depression, mood swings, depressed mood, mood altered, affect lability, dysthymic disorder, crying) (3.0%) and increased weight (2.9%).

Serious Adverse Reactions: myocardial infarction (2 cases), ruptured ovarian cyst (2 cases), deep vein thrombosis, focal nodular hyperplasia of the liver, uterine leiomyoma, acute cholecystitis, and chronic acalculous cholecystitis.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Natazia. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Vascular disorders: Venous and arterial thromboembolic events (including pulmonary emboli, deep vein thrombosis, cerebral thrombosis, myocardial infarction and stroke), hypertension

Hepatobiliary disorders: Gallbladder disease, hepatitis

Immune system disorders: Hypersensitivity

Metabolism and nutrition disorders: Fluid retention, hypertriglyceridemia

Nervous system disorders: Dizziness

Skin and subcutaneous tissue disorders: Chloasma, angioedema, erythema nodosum, erythema multiforme

Gastrointestinal disorders: Gastrointestinal symptoms (for example, abdominal pain)

Infections and infestations: Vulvovaginal candidiasis

Read the entire FDA prescribing information for Natazia (Estradiol Valerate and Estradiol Valerate Dienogest Tablets)

Related Resources for Natazia

Read the Natazia User Reviews »

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

Health Solutions From Our Sponsors