ESTROGENS, CONJUGATED

82/100 · Critical

Manufactured by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

High Safety Concerns with Estrogens, Conjugated: Breast Cancer and Cardiovascular Risks

102,186 FDA adverse event reports analyzed

Last updated: 2026-05-12

About ESTROGENS, CONJUGATED

ESTROGENS, CONJUGATED is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.. Based on analysis of 102,186 FDA adverse event reports, ESTROGENS, CONJUGATED has a safety score of 82 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for ESTROGENS, CONJUGATED include BREAST CANCER, BREAST CANCER FEMALE, DRUG INEFFECTIVE, NAUSEA, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ESTROGENS, CONJUGATED.

AI Safety Analysis

Estrogens, Conjugated has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 102,186 adverse event reports for this medication, which is primarily manufactured by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc..

The most commonly reported adverse events include Breast Cancer, Breast Cancer Female, Drug Ineffective. Of classified reports, 71.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious adverse events, particularly breast cancer and cardiovascular issues, are prevalent.

A significant number of reports involve drug ineffectiveness and off-label use. Common non-serious reactions include nausea, headache, and fatigue.

Patients taking Estrogens, Conjugated should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Caution is advised with concomitant use of other drugs that may increase the risk of thrombosis or cardiovascular events. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.

Safety Score: 82/100

Estrogens, Conjugated received a safety concern score of 82/100 (high concern). This is based on a 71.1% serious event ratio across 58,742 classified reports. The score accounts for 102,186 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.

Top Adverse Reactions

BREAST CANCER9,639 reports
BREAST CANCER FEMALE8,870 reports
DRUG INEFFECTIVE3,402 reports
NAUSEA2,385 reports
HEADACHE2,341 reports
PAIN2,278 reports
FATIGUE2,253 reports
OFF LABEL USE2,201 reports
BREAST CANCER METASTATIC1,682 reports
DIZZINESS1,662 reports
DYSPNOEA1,642 reports
MALAISE1,603 reports
DIARRHOEA1,550 reports
ARTHRALGIA1,474 reports
ANXIETY1,439 reports
DEPRESSION1,430 reports
INSOMNIA1,329 reports
FALL1,293 reports
PAIN IN EXTREMITY1,289 reports
ASTHENIA1,244 reports
HYPERTENSION1,238 reports
CEREBROVASCULAR ACCIDENT1,207 reports
FEELING ABNORMAL1,200 reports
VOMITING1,151 reports
HOT FLUSH1,126 reports
CHEST PAIN1,050 reports
PRURITUS1,048 reports
URINARY TRACT INFECTION1,021 reports
WEIGHT INCREASED1,019 reports
BACK PAIN1,013 reports
WEIGHT DECREASED971 reports
RASH958 reports
CONDITION AGGRAVATED946 reports
MYOCARDIAL INFARCTION911 reports
ALOPECIA890 reports
COUGH852 reports
PNEUMONIA823 reports
DRUG HYPERSENSITIVITY813 reports
MUSCLE SPASMS782 reports
BLOOD PRESSURE INCREASED738 reports
ABDOMINAL PAIN730 reports
HYPERSENSITIVITY694 reports
OESTROGEN RECEPTOR ASSAY POSITIVE693 reports
GAIT DISTURBANCE690 reports
PYREXIA673 reports
HYPERHIDROSIS657 reports
CONSTIPATION656 reports
OEDEMA PERIPHERAL653 reports
MEMORY IMPAIRMENT645 reports
SINUSITIS636 reports
ABDOMINAL PAIN UPPER627 reports
PRODUCT USE ISSUE619 reports
OVARIAN CANCER612 reports
PROGESTERONE RECEPTOR ASSAY POSITIVE600 reports
GASTROOESOPHAGEAL REFLUX DISEASE596 reports
THROMBOSIS594 reports
MIGRAINE582 reports
NASOPHARYNGITIS575 reports
ARTHRITIS572 reports
JOINT SWELLING561 reports
MYALGIA554 reports
TREMOR554 reports
PALPITATIONS553 reports
INTENTIONAL PRODUCT MISUSE547 reports
PARAESTHESIA538 reports
OSTEOARTHRITIS534 reports
DEEP VEIN THROMBOSIS530 reports
SOMNOLENCE529 reports
PULMONARY EMBOLISM522 reports
HYPOAESTHESIA521 reports
CHRONIC KIDNEY DISEASE517 reports
BRONCHITIS507 reports
RENAL FAILURE495 reports
BREAST CANCER IN SITU494 reports
ANAEMIA486 reports
DIABETES MELLITUS478 reports
URTICARIA467 reports
DRUG INTERACTION466 reports
PRODUCT QUALITY ISSUE465 reports
CONFUSIONAL STATE464 reports
VISION BLURRED463 reports
BLOOD CHOLESTEROL INCREASED460 reports
ABDOMINAL DISTENSION444 reports
DECREASED APPETITE443 reports
ASTHMA442 reports
VULVOVAGINAL BURNING SENSATION441 reports
OSTEOPOROSIS432 reports
ABDOMINAL DISCOMFORT428 reports
CONTUSION428 reports
INJECTION SITE PAIN428 reports
RHEUMATOID ARTHRITIS426 reports
CATARACT423 reports
DYSPEPSIA422 reports
DEHYDRATION419 reports
CARDIAC DISORDER417 reports
BURNING SENSATION413 reports
DEATH404 reports
ERYTHEMA404 reports
CARDIAC FAILURE CONGESTIVE402 reports
PRODUCT USE IN UNAPPROVED INDICATION398 reports

Key Safety Signals

  • High incidence of breast cancer and its metastatic forms.
  • Multiple cardiovascular events, including myocardial infarction and deep vein thrombosis.
  • Significant reports of drug ineffectiveness and off-label use.

Patient Demographics

Adverse event reports by sex: Female: 56,218, Male: 205, Unknown: 101. The most frequently reported age groups are age 59 (1,138 reports), age 57 (1,119 reports), age 62 (1,102 reports). These demographics reflect reporting patterns and may not represent the full patient population.

Report Outcomes

Out of 58,742 classified reports for ESTROGENS, CONJUGATED:

  • Serious: 41,779 reports (71.1%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 16,963 reports (28.9%)
Serious 71.1%Non-Serious 28.9%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female56,218 (99.5%)
Male205 (0.4%)
Unknown101 (0.2%)

Reports by Age

Age 591,138 reports
Age 571,119 reports
Age 621,102 reports
Age 611,068 reports
Age 581,057 reports
Age 641,045 reports
Age 601,040 reports
Age 631,031 reports
Age 561,019 reports
Age 65978 reports
Age 55941 reports
Age 66874 reports
Age 54870 reports
Age 68861 reports
Age 67841 reports
Age 53825 reports
Age 69808 reports
Age 70752 reports
Age 52749 reports
Age 72716 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Drug Interactions & Warnings

Caution is advised with concomitant use of other drugs that may increase the risk of thrombosis or cardiovascular events.

What You Should Know

If you are taking Estrogens, Conjugated, here are important things to know. The most commonly reported side effects include breast cancer, breast cancer female, drug ineffective, nausea, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Discuss any concerns about the effectiveness of the medication with your healthcare provider. Be aware of potential side effects and report any unusual symptoms promptly. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.

Regulatory Context

Regulatory oversight is ongoing, with a focus on monitoring and managing risks associated with breast cancer and cardiovascular outcomes.

Frequently Asked Questions

How many adverse event reports has the FDA received for Estrogens, Conjugated?

The FDA has received approximately 102,186 adverse event reports associated with Estrogens, Conjugated. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.

What are the most commonly reported side effects of Estrogens, Conjugated?

The most frequently reported adverse events for Estrogens, Conjugated include Breast Cancer, Breast Cancer Female, Drug Ineffective, Nausea, Headache. By volume, the top reported reactions are: Breast Cancer (9,639 reports), Breast Cancer Female (8,870 reports), Drug Ineffective (3,402 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Estrogens, Conjugated.

What percentage of Estrogens, Conjugated adverse event reports are serious?

Out of 58,742 classified reports, 41,779 (71.1%) were classified as serious and 16,963 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.

Who reports adverse events for Estrogens, Conjugated (by sex)?

Adverse event reports for Estrogens, Conjugated break down by patient sex as follows: Female: 56,218, Male: 205, Unknown: 101. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.

What age groups report the most side effects for Estrogens, Conjugated?

The most frequently reported age groups for Estrogens, Conjugated adverse events are: age 59: 1,138 reports, age 57: 1,119 reports, age 62: 1,102 reports, age 61: 1,068 reports, age 58: 1,057 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.

Who manufactures Estrogens, Conjugated?

The primary manufacturer associated with Estrogens, Conjugated adverse event reports is Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.

What other side effects have been reported for Estrogens, Conjugated?

Beyond the most common reactions, other reported adverse events for Estrogens, Conjugated include: Pain, Fatigue, Off Label Use, Breast Cancer Metastatic, Dizziness. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.

How do I report a side effect from Estrogens, Conjugated?

You can report adverse events from Estrogens, Conjugated to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.

What is Estrogens, Conjugated's safety score and what does it mean?

Estrogens, Conjugated has a safety concern score of 82 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Serious adverse events, particularly breast cancer and cardiovascular issues, are prevalent.

What are the key safety signals for Estrogens, Conjugated?

Key safety signals identified in Estrogens, Conjugated's adverse event data include: High incidence of breast cancer and its metastatic forms.. Multiple cardiovascular events, including myocardial infarction and deep vein thrombosis.. Significant reports of drug ineffectiveness and off-label use.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.

Does Estrogens, Conjugated interact with other drugs?

Caution is advised with concomitant use of other drugs that may increase the risk of thrombosis or cardiovascular events. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Estrogens, Conjugated.

What should patients know before taking Estrogens, Conjugated?

Discuss any concerns about the effectiveness of the medication with your healthcare provider. Be aware of potential side effects and report any unusual symptoms promptly.

Are Estrogens, Conjugated side effects well-documented?

Estrogens, Conjugated has 102,186 adverse event reports on file with the FDA. A significant number of reports involve drug ineffectiveness and off-label use. The volume of reports for Estrogens, Conjugated reflects both the drug's usage level and the vigilance of the reporting community.

What is the FDA's position on Estrogens, Conjugated?

Regulatory oversight is ongoing, with a focus on monitoring and managing risks associated with breast cancer and cardiovascular outcomes. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.

Related Drugs

Drugs related to ESTROGENS, CONJUGATED based on therapeutic use, drug class, or shared indications:

WarfarinAspirinDabigatran
Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.