Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Beyaz
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From May 2010 to May 2025, FDA received 1,431 adverse event reports that name Beyaz. In these reports the drug is a suspect or interacting product.

In the same period, 194 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 0 reports in the 12 months to June 2026 and 3 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Reports for female patients were 99.9% of the reports that name Beyaz and 52.7% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Beyaz is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 0 reports that name Beyaz.
In January to March 2026, FDA received 0.
In April to June 2025, FDA received 3.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 99 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 1,405 of the 1,431 reports (98.2%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 99 terms.

Reaction terms in the reports that name Beyaz, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,431 reports
Pulmonary embolisma blood clot in the lung	307	21.5%
Deep vein thrombosisa blood clot in a deep vein	241	16.8%
Injurya physical injury	232	16.2%
Painpain, site not specified	197	13.8%
Emotional distress	161	11.3%
Anxiety	134	9.4%
No adverse eventno adverse event was reported	94	6.6%
General physical health deteriorationgeneral decline in health	93	6.5%
Drug dose omissiona dose was missed	91	6.4%
Anhedonia	82	5.7%
Metrorrhagia	73	5.1%
Thrombosis	56	3.9%
Dyspnoeashortness of breath	53	3.7%
Nauseafeeling sick	51	3.6%
Off label useused for a purpose or in a way not on the label	47	3.3%
Vaginal haemorrhagevaginal bleeding	46	3.2%
Menstruation delayed	43	3%
Menorrhagiaheavy periods	42	2.9%
Headachehead pain	38	2.7%
Pain in extremitypain in an arm or leg	37	2.6%
Chest pain	35	2.4%
Thrombophlebitis superficial	33	2.3%
Abdominal painstomach or belly pain	31	2.2%
Vomitingbeing sick	30	2.1%
Weight increasedweight gain	30	2.1%
Acne	29	2%
Cerebrovascular accidentstroke	28	2%
Fatiguetiredness	27	1.9%
Pelvic venous thrombosis	27	1.9%
Depressionlow mood	25	1.7%
Hypomenorrhoea	24	1.7%
Inappropriate schedule of drug administrationthe medicine was taken at the wrong times	21	1.5%
Abdominal distensiona bloated abdomen	20	1.4%
Polymenorrhoea	19	1.3%
Cholecystitis chronic	18	1.3%
Product use issuea problem in how the product was used	18	1.3%
Cholelithiasisgallstones	16	1.1%
Malaisegeneral feeling of being unwell	16	1.1%
Mental disorder	16	1.1%
Pulmonary infarction	16	1.1%
Rashskin rash	16	1.1%
Migraine	15	1%
Peripheral swellingswelling of the arms or legs	15	1%
Psychological trauma	15	1%
Abdominal pain upperupper stomach pain	14	1%
Amenorrhoeaperiods stopped	14	1%
Irritability	14	1%
Abdominal pain lower	13	0.9%
Diarrhoealoose or frequent stools	13	0.9%
Hypoaesthesianumbness	13	0.9%

Download all 99 terms of Beyaz (CSV)

The counts add to more than 1,431 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Drospirenone, ethinyl estradiol, levomefolate with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Beyaz (this page)	Brand name	1,431
Safyral	Brand name	213

Sum of the separately reported names: 1,644. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Beyaz, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Other Serious (Important Medical Events)	Not serious
2010	15	0	0	0	0	0	0	15
2011	310	70	3	5	25	1	52	240
2012	363	155	4	6	91	4	79	208
2013	337	235	9	38	173	33	74	102
2014	205	149	2	31	91	21	67	56
2015	101	66	3	6	47	6	35	35
2016	53	17	0	1	9	3	10	36
2017	21	7	0	2	3	1	5	14
2018	9	3	0	1	0	0	3	6
2019	4	0	0	0	0	0	0	4
2020	4	3	0	0	1	0	3	1
2021	4	1	0	0	0	0	1	3
2022	0	0	0	0	0	0	0	0
2023	2	0	0	0	0	0	0	2
2024	0	0	0	0	0	0	0	0
2025	3	0	0	0	0	0	0	3

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Beyaz, by the year in which FDA received them

Show the figures of the chart as a table

Reports that name Beyaz, by the year in which FDA received them
Year	Reports
2010	2
2011	328
2012	450
2013	344
2014	153
2015	60
2016	50
2017	20
2018	7
2019	4
2020	4
2021	4
2023	2
2025	3

Reports that name Beyaz, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Beyaz
Age	Reports	Share
Under 2	1	0.1%
2 to 11	3	0.2%
12 to 17	65	4.5%
18 to 44	671	46.9%
45 to 64	67	4.7%
65 to 74	1	0.1%
75 and over	0	0%
Age not given	623	43.5%

Sex of the patient in the reports that name Beyaz
Sex	Reports	Share
Female	1,429	99.9%
Male	0	0%
Unknown or not given	2	0.1%

Type of reporter in the reports that name Beyaz
Reporter	Reports	Share
Physician	95	6.6%
Pharmacist	16	1.1%
Other health professional	163	11.4%
Lawyer	107	7.5%
Consumer or non-health professional	1,032	72.1%
Not given	18	1.3%

Age and sex are as the report gives them. The reporter is the primary source in the report. 99.8% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Beyaz record
Indication as recorded (MedDRA)	Reports	Share
Contraception	263	18.4%
Acne	54	3.8%
Menstrual cycle management	23	1.6%
Menorrhagia	17	1.2%
Premenstrual syndrome	16	1.1%
Polycystic ovaries	15	1%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,431 reports.

Pages near this one

Safyral same ingredient
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These links are for navigation. No count selected them.

Official pages

DailyMed labels for BeyazThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Beyaz: adverse event reports that FDA received. https://reportedreactions.com/drug/beyaz/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Beyaz as a suspect or interacting product. The 194 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Beyaz was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Beyaz?

No. It is a count of what people reported to FDA: 1,431 reports from May 2010 to May 2025. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Consumer or non-health professional (72.1%), other health professional (11.4%) and lawyer (7.5%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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