Natazia
Plan B One-Step Emergency Contraceptive Approved for 15 and Older »
"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
Read the Plan B One-Step Emergency Contraceptive Approved for 15 and Older article »
Natazia
Natazia Side Effects Center
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; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication 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 severe headache, confusion, problems with vision, speech, or balance;
- sudden cough, wheezing, rapid breathing, coughing up blood;
- pain, swelling, warmth, or redness in one or both legs;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- jaundice (yellowing of the skin or eyes);
- a change in the pattern or severity of migraine headaches;
- swelling in your hands, ankles, or feet;
- a breast lump; or
- symptoms of depression (sleep problems, weakness, mood changes).
Less serious side effects may include:
- mild nausea or vomiting, appetite or weight changes;
- breast swelling or tenderness;
- headache, nervousness, dizziness;
- problems with contact lenses;
- freckles or darkening of facial skin, loss of scalp hair; or
- vaginal itching or discharge.
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
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:
- Serious cardiovascular events and stroke [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
- Vascular events [see WARNINGS AND PRECAUTIONS]
- Liver disease [see WARNINGS AND PRECAUTIONS]
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 Studies
Two multicenter phase 3 clinical trials evaluated the safety and efficacy of Natazia for pregnancy prevention. Both were non-comparative, open-labeled, single-arm studies with a treatment duration up to 28 cycles. A total of 1,867 women aged 18-50 were enrolled and took at least one dose of Natazia. [See Clinical Studies.]
Adverse Reactions Leading to Study Discontinuation: 11.5% of the women discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reactions leading to discontinuation were metrorrhagia and irregular menstruation (1.9%), acne (1.2%), headache and migraine (1.0%), and weight increase (0.7 %).
Common Adverse Reactions ( ≥ 2%): headache (including migraines) (13.2%), metrorrhagia and irregular menstruation (8.0%), breast pain, discomfort or tenderness (6.6%), nausea or vomiting (6.5%), acne (3.9%) and increased weight (2.8%).
Serious Adverse Reactions: deep vein thrombosis, myocardial infarction, focal nodular hyperplasia of the liver, uterine leiomyoma, and ruptured ovarian cyst.
Read the entire FDA prescribing information for Natazia (Estradiol Valerate and Estradiol Valerate Dienogest Tablets) »
Additional Natazia Information
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.
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.
Updated & New
