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Beyaz

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Beyaz

Beyaz

Beyaz Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets) is a combination of female hormones and a form of Vitamin B used as contraception to prevent pregnancy. It is also used to treat moderate acne in women who are at least 14 years old and have started having menstrual periods, and who wish to use birth control pills to prevent pregnancy. Beyaz is also used to treat symptoms of premenstrual dysphoric disorder (PMDD), such as anxiety, depression, irritability, trouble concentrating, lack of energy, sleep or appetite changes, breast tenderness, joint or muscle pain, headache, and weight gain. It will not treat symptoms of premenstrual syndrome (PMS). Common side effects include nausea, vomiting, headache, bloating, breast tenderness, swelling of the ankles/feet (fluid retention), or weight change. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use.

Take one pink Beyaz daily for 24 consecutive days, followed by one light orange tablet daily on Days 25 through 28. Beyaz should be taken in the order directed on the package at the same time each day. Beyaz may interact with bosentan, folic acid or potassium supplements, heparin, St. John's wort, antibiotics, rifampin, heart or blood pressure medication, diuretics, HIV or AIDS medications, antifungals, NSAIDs (non-steroidal anti-inflammatory drugs), phenobarbital and other barbiturates, or seizure medications. Tell your doctor all medications and supplements you use. Beyaz must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, talk with your doctor about birth control, and find out when it is safe to use birth control containing estrogen, such as this medication. This medication passes into breast milk. It may affect milk production and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Our Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets) 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.

Beyaz 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 medicine and call your doctor at once if you have a serious side effect such as:

  • sudden numbness or weakness, confusion, pain behind the eyes, problems with vision, speech, or balance;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • a change in the pattern or severity of migraine headaches;
  • jaundice (yellowing of the skin or eyes); or
  • symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

  • breast pain, tenderness, or swelling;
  • mild headache, feeling tired or irritable;
  • bloating, stomach pain, mild nausea;
  • weight gain, swelling of your hands or feet;
  • problems with contact lenses;
  • loss of interest in sex; or
  • changes in your menstrual periods.

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 Beyaz (Drospirenone/Ethinyl Estradiol/ Levomefolate Calcium Tablets and Levomefolate Calcuim Tablets) »

What is Patient Information Overview?

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

Beyaz Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Precautions section.

Nausea, vomiting, headache, bloating, breast tenderness, swelling of the ankles/feet (fluid retention), or weight change may occur. 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, tell 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 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: pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, sudden shortness of breath, coughing up blood, chest/jaw/left arm pain, unusual sweating, sudden dizziness/fainting, confusion, slurred speech, weakness on one side of the body, sudden vision changes (such as partial/complete blindness), unusual headaches (including headaches with vision changes/lack of coordination, worsening of migraines, sudden/very severe headaches).

Get medical help right away if any of these rare but serious side effects occur: lumps in the breast, stomach/abdominal pain, 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 Beyaz (Drospirenone/Ethinyl Estradiol/ Levomefolate Calcium Tablets and Levomefolate Calcuim Tablets)»

What is Prescribing information?

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

Beyaz 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, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice.

Contraception, Acne and Folate Supplementation Clinical Trials

The data provided reflect the experience with the use of YAZ (3 mg DRSP/0.02 mg EE), in the adequate and well-controlled studies for contraception (N=1,056), for moderate acne vulgaris (N=536) and folate supplementation (N=379).

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. For folate supplementation, the primary efficacy study using Beyaz was a multicenter, double-blind, randomized, active-controlled US trial in 379 healthy women aged 18- 40 who were treated with Beyaz or YAZ for up to 24 weeks.

The adverse reactions seen across the 3 indications overlapped, and are reported using the frequencies from the pooled dataset. The most common adverse reactions ( ≥ 2% of users) were: headache/migraine (5.9%), menstrual irregularities (including vaginal hemorrhage [primarily spotting], metrorrhagia and menorrhagia) (4.1%), nausea/vomiting (3.5%), and breast pain/tenderness (3.2%).

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 OC, Acne and Folate Supplementation 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%) .

Folate Clinical Trial

Of 285 women, 4.6% who used Beyaz or YAZ discontinued from the clinical trials due to an adverse reaction; no reaction leading to discontinuation occurred in ≥ 1% of women.

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

Contraception Clinical Trials: migraine and cervical dysplasia

Acne Clinical Trials: none reported in the clinical trials

Folate Supplementation Clinical Trial: cervix carcinoma stage 0

PMDD Clinical Trials: cervical dysplasia

Postmarketing Experience

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)

Hepatobiliary disorders: Gallbladder disease, liver function disturbances, liver tumors

Immune system disorders: Hypersensitivity (including anaphylactic reaction)

Metabolism and nutrition disorders: Hyperkalemia, hypertriglyceridemia, changes in glucose tolerance or effect on peripheral insulin resistance (including diabetes mellitus)

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

Gastrointestinal disorders: Inflammatory bowel disease

Musculoskeletal and connective tissue disorders: Systemic lupus erythematosus

Read the entire FDA prescribing information for Beyaz (Drospirenone/Ethinyl Estradiol/ Levomefolate Calcium Tablets and Levomefolate Calcuim Tablets) »

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Beyaz - User Reviews

Beyaz 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 Beyaz 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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