"The U.S. Food and Drug Administration today approved Beyaz tablets, an estrogen/progestin combined oral contraceptive that also contains a folate (levomefolate calcium 0.451 mg).
Levomefolate calcium is a metabolite of folic acid, a wat"...
Yaz Side Effects Center
Yaz (drospirenone and ethinyl estradiol) is an oral contraceptive. A generic version is available. Yaz is used for preventing pregnancy, treating premenstrual dysphoric disorder (PMDD), and treating moderate acne in females at least 14 years of age. Common side effects of Yaz include headache, menstrual irregularities, nausea, vomiting, breast pain, fatigue, irritability, decreased libido, weight gain, and mood changes. Yaz may increase the risk of blood clots, stroke, and heart attack. It can also increase blood potassium levels.
The usual dose of Yaz is one tablet daily. Nonsteroidal anti-inflammatory drugs or NSAIDs (for example, Motrin), spironolactone, potassium supplements, ACE inhibitors, and angiotensin-II receptor antagonists (ARBs) may contribute to increased potassium levels when combined with Yaz. Drugs that increase or decrease drug metabolism may decrease or increase blood levels of Yaz, respectively. There is little or no increased risk of birth defects in women who inadvertently use oral contraceptives during early pregnancy. Small amounts of the hormones in Yaz are excreted in breast-milk.
Our Yaz 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.
Yaz 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 birth control pills 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 tenderness or swelling, nipple discharge;
- freckles or darkening of facial skin, increased hair growth, loss of scalp hair;
- changes in weight or appetite;
- problems with contact lenses;
- vaginal itching or discharge; or
- changes in your menstrual periods, decreased sex drive.
Read the entire detailed patient monograph for Yaz (Drospirenone and Ethinyl Estradiol) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Yaz 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 right away if any of these serious side effects occur: unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding, missed periods), symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat).
This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, pulmonary embolism, stroke, heart attack). Talk to your doctor about the risks and benefits of this birth control pill. Get medical help right away if you experience: sudden shortness of breath, chest/jaw/left arm pain, unusual sweating, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, unusual headaches (including headaches with vision changes/lack of coordination, worsening of migraines, sudden/very severe headaches), slurred speech, weakness on one side of the body, sudden vision changes (such as partial/complete blindness).
Get medical help right away if any of these rare but serious side effects occur: lumps in the breast, severe stomach/abdominal pain, dark urine, yellowing eyes/skin, mental/mood changes (such as new/worsening depression, suicidal thoughts).
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 Yaz (Drospirenone and Ethinyl Estradiol)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Yaz FDA Prescribing Information: 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:
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 Acne Clinical Trials
The data provided reflect the experience with the use of Yaz in the adequate and well-controlled studies for contraception (N= 1,056) and for moderate acne vulgaris (N=536).
For contraception, a Phase 3, multicenter, multinational, open-label study was conducted to evaluate safety and efficacy up to one year in 1,027 women aged 17 - 36 who took at least one dose of Yaz. A second Phase 3 study was a single center, open-label, active-controlled study to evaluate the effect of 7 28-day cycles of Yaz on carbohydrate metabolism, lipids and hemostasis in 29 women aged 18-35. For acne, two multicenter, double-blind, randomized, placebo-controlled studies, in 536 women aged 14-45 with moderate acne vulgaris who took at least one dose of Yaz, evaluated the safety and efficacy during up to 6 cycles.
The adverse reactions seen across the 2 indications overlapped, and are reported using the frequencies from the pooled dataset. The most common adverse reactions (≥ 2% of users) were: headache/migraine (6.7%), menstrual irregularities (including vaginal hemorrhage [primarily spotting] and metrorrhagia (4.7%), nausea/vomiting (4.2%), breast pain/tenderness (4%) and mood changes (mood swings, depression, depressed mood and affect lability) (2.2%).
PMDD Clinical Trials
Safety data from trials for the indication of PMDD are reported separately due to differences in study design and setting in the Contraception and Acne studies as compared to the PMDD clinical program.
Two (one parallel and one crossover designed) multicenter, double-blind, randomized, placebo-controlled trials for the secondary indication of treating the symptoms of PMDD evaluated safety and efficacy of Yaz during up to 3 cycles among 285 women aged 18-42, diagnosed with PMDD and who took at least one dose of Yaz.
Common adverse reactions (≥ 2% of users) were: menstrual irregularities (including vaginal hemorrhage [primarily spotting] and metrorrhagia) (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and affect lability (2.1%).
Adverse Reactions (≥1%) Leading to Study Discontinuation
Contraception Clinical Trials
Of 1,056 women, 6.6% discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reactions leading to discontinuation were headache/migraine (1.6%) and nausea/vomiting (1.0%).
Acne Clinical Trials
Of 536 women, 5.4% discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reaction leading to discontinuation was menstrual irregularities (including menometrorrhagia, menorrhagia, metrorrhagia and vaginal hemorrhage) (2.2%).
PMDD Clinical Trials
Of 285 women, 11.6% discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reactions leading to discontinuation were: nausea/vomiting (4.6%), menstrual irregularity (including vaginal hemorrhage, menorrhagia, menstrual disorder, menstruation irregular and metrorrhagia) (4.2%), fatigue (1.8%), breast tenderness (1.4%), depression (1.4%), headache (1.1%), and irritability (1.1%).
Serious Adverse Reactions
Acne Clinical Trials: none reported in the clinical trials
PMDD Clinical Trials: cervical dysplasia
The following adverse reactions have been identified during post approval use of Yaz. 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.
Adverse reactions are grouped into System Organ Classes, and ordered by frequency.
Vascular disorders: Venous and arterial thromboembolic events (including pulmonary emboli, deep vein thrombosis, cerebral thrombosis, retinal thrombosis, myocardial infarction and stroke), hypertension (including hypertensive crisis)
Immune system disorders: Hypersensitivity (including anaphylactic reaction)
Gastrointestinal disorders: Inflammatory bowel disease
Musculoskeletal and connective tissue disorders: Systemic lupus erythematosus
Read the entire FDA prescribing information for Yaz (Drospirenone and Ethinyl Estradiol) »
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