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Natazia

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Natazia

Natazia Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Natazia (estradiol valerate and estradiol valerate/dienogest) is an oral contraceptive used to prevent pregnancy. Common side effects include irregular menstrual periods, nausea, breast tenderness/enlargement, stomach cramping/bloating, or headache. Acne may improve or get worse.

Natazia must be taken exactly as directed. The dose of Natazia is one tablet taken by mouth the same time every day. Tablets must be taken in the order directed on the blister pack. Natazia may interact with antifungal medications, antibiotics, antidepressants, St. John's wort, HIV medications, seizure medications, isoniazid, rifabutin, rifampin, rifapentine, thyroid replacement, phenobarbital or other barbiturates, heart or blood pressure medications. Tell your doctor all medications and supplements you use. Natazia must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor. The risk of a serious blood clot is higher if you have just given birth or had a pregnancy loss/abortion after the first 3 months. Talk with your doctor about birth control. This medication passes into breast milk. This may affect milk production and may have harmful effects on a nursing infant. Breastfeeding is not recommended while using Natazia.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Natazia in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Natazia Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, headache, stomach cramping/bloating, or breast tenderness/enlargement may occur. Acne may improve or get worse. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use. If any of these effects persist or worsen, notify your doctor promptly. If you miss 2 periods in a row (or 1 period if the pill has not been used properly), contact your doctor for a pregnancy test.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding, missed periods), problem wearing contact lenses, dark patches on the skin (melasma), unwanted facial/body hair, swelling of the ankles/feet, weight changes (gain or loss).

This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as pulmonary embolism, stroke, heart attack). Get medical help right away if you experience: chest/jaw/left arm pain, shortness of breath, unusual sweating, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, headaches that are different from those you have experienced before (such as headaches with other symptoms such as vision changes/lack of coordination, existing migraines becoming worse, sudden/very severe headaches), slurred speech, weakness on one side of the body, vision problems/changes (such as blindness, double vision).

Tell your doctor immediately if any of these rare but serious side effects occur: lumps in the breast, severe stomach/abdominal/pelvic pain, mental/mood changes (such as depression, suicidal thoughts, persistent trouble sleeping), unusual tiredness, dark urine, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Natazia (Estradiol Valerate and Estradiol Valerate Dienogest Tablets)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Natazia FDA Prescribing Information: Side Effects
(Adverse Reactions)

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:

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 tendernes s (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 s wings, 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 uncerta in 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, er ythema 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) »

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Natazia - User Reviews

Natazia User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Natazia sorted by most helpful. Patient Discussions FAQs

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.


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