55/100 · Moderate
Manufactured by Teva Pharmaceuticals USA, Inc.
Common Mild Reactions with Occasional Serious Events for Norethindrone Acetate and Ethinyl Estradiol
4,283 FDA adverse event reports analyzed
Last updated: 2026-05-12
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Teva Pharmaceuticals USA, Inc.. Based on analysis of 4,283 FDA adverse event reports, NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL has a safety score of 55 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL include HEADACHE, NAUSEA, DRUG INEFFECTIVE, FATIGUE, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL.
Norethindrone Acetate And Ethinyl Estradiol has a safety concern score of 55 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 4,283 adverse event reports for this medication, which is primarily manufactured by Teva Pharmaceuticals Usa, Inc..
The most commonly reported adverse events include Headache, Nausea, Drug Ineffective. Of classified reports, 34.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Most common reactions include headache, nausea, and fatigue, which are generally mild.
Serious adverse events, such as pulmonary embolism and pneumonia, are less frequent but still notable. Drug ineffectiveness and product dose omission issues are significant concerns. A wide range of reactions indicates potential for diverse side effects.
Patients taking Norethindrone Acetate And Ethinyl Estradiol should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other drugs, such as anticoagulants, can increase the risk of serious events like pulmonary embolism and pneumonia. Patients should avoid off-label use and follow prescribed dosing schedules. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Norethindrone Acetate And Ethinyl Estradiol received a safety concern score of 55/100 (elevated concern). This is based on a 34.6% serious event ratio across 2,161 classified reports. The score accounts for 4,283 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 2,000, Male: 9, Unknown: 6. The most frequently reported age groups are age 24 (49 reports), age 19 (48 reports), age 20 (48 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 2,161 classified reports for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL:
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 reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Interactions with other drugs, such as anticoagulants, can increase the risk of serious events like pulmonary embolism and pneumonia. Patients should avoid off-label use and follow prescribed dosing schedules.
If you are taking Norethindrone Acetate And Ethinyl Estradiol, here are important things to know. The most commonly reported side effects include headache, nausea, drug ineffective, fatigue, pain. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed dosing schedules to avoid drug ineffectiveness and dose omission issues. Report any serious adverse events to your healthcare provider immediately. 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.
The FDA continues to monitor the safety of Norethindrone Acetate and Ethinyl Estradiol, with ongoing reviews of adverse event reports to ensure patient safety.
The FDA has received approximately 4,283 adverse event reports associated with Norethindrone Acetate And Ethinyl Estradiol. 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.
The most frequently reported adverse events for Norethindrone Acetate And Ethinyl Estradiol include Headache, Nausea, Drug Ineffective, Fatigue, Pain. By volume, the top reported reactions are: Headache (178 reports), Nausea (175 reports), Drug Ineffective (146 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Norethindrone Acetate And Ethinyl Estradiol.
Out of 2,161 classified reports, 747 (34.6%) were classified as serious and 1,414 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.
Adverse event reports for Norethindrone Acetate And Ethinyl Estradiol break down by patient sex as follows: Female: 2,000, Male: 9, Unknown: 6. 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.
The most frequently reported age groups for Norethindrone Acetate And Ethinyl Estradiol adverse events are: age 24: 49 reports, age 19: 48 reports, age 20: 48 reports, age 27: 47 reports, age 23: 45 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Norethindrone Acetate And Ethinyl Estradiol adverse event reports is Teva Pharmaceuticals Usa, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Norethindrone Acetate And Ethinyl Estradiol include: Diarrhoea, Anxiety, Dizziness, Vomiting, Rash. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Norethindrone Acetate And Ethinyl Estradiol 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.
Norethindrone Acetate And Ethinyl Estradiol has a safety concern score of 55 out of 100 (elevated 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. Most common reactions include headache, nausea, and fatigue, which are generally mild.
Key safety signals identified in Norethindrone Acetate And Ethinyl Estradiol's adverse event data include: Pain and dizziness are frequently reported, suggesting potential for discomfort.. Drug ineffectiveness and dose omission issues highlight compliance and efficacy concerns.. Serious events like pulmonary embolism and pneumonia indicate potential for severe complications.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other drugs, such as anticoagulants, can increase the risk of serious events like pulmonary embolism and pneumonia. Patients should avoid off-label use and follow prescribed dosing schedules. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Norethindrone Acetate And Ethinyl Estradiol.
Follow prescribed dosing schedules to avoid drug ineffectiveness and dose omission issues. Report any serious adverse events to your healthcare provider immediately.
Norethindrone Acetate And Ethinyl Estradiol has 4,283 adverse event reports on file with the FDA. Serious adverse events, such as pulmonary embolism and pneumonia, are less frequent but still notable. The volume of reports for Norethindrone Acetate And Ethinyl Estradiol reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Norethindrone Acetate and Ethinyl Estradiol, with ongoing reviews of adverse event reports to ensure patient safety. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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