65/100 · Elevated
Manufactured by Teva Pharmaceuticals USA, Inc.
Safety Profile for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
4,509 FDA adverse event reports analyzed
Last updated: 2026-05-12
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Teva Pharmaceuticals USA, Inc.. Based on analysis of 4,509 FDA adverse event reports, NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE has a safety score of 65 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 AND FERROUS FUMARATE include NAUSEA, HEADACHE, 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 AND FERROUS FUMARATE.
Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 4,509 adverse event reports for this medication, which is primarily manufactured by Teva Pharmaceuticals Usa, Inc..
The most commonly reported adverse events include Nausea, Headache, Drug Ineffective. Of classified reports, 37.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common adverse reactions include nausea, headache, and fatigue, with a significant number of reports involving serious conditions like pulmonary embolism and deep vein thrombosis.
A diverse range of reactions were reported, indicating potential for multiple side effects. The majority of reports were non-serious, but the serious condition reports were concerning, particularly for cardiovascular issues. The drug is primarily used in females, with the majority of reports coming from young adults.
Patients taking Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Drug interactions and warnings include the potential for serious cardiovascular events, and patients should be monitored for signs of pulmonary embolism and deep vein thrombosis. Injection site reactions and pain are also common and should be managed This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate received a safety concern score of 65/100 (elevated concern). This is based on a 37.6% serious event ratio across 2,456 classified reports. The score accounts for 4,509 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: 2,302, Unknown: 8, Male: 7. The most frequently reported age groups are age 24 (66 reports), age 30 (64 reports), age 28 (57 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 2,456 classified reports for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE:
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.
Drug interactions and warnings include the potential for serious cardiovascular events, and patients should be monitored for signs of pulmonary embolism and deep vein thrombosis. Injection site reactions and pain are also common and should be managed
If you are taking Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate, here are important things to know. The most commonly reported side effects include nausea, headache, 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. Monitor for signs of serious cardiovascular events such as pulmonary embolism and deep vein thrombosis. Report any injection site reactions or pain to your healthcare provider. 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 this drug, and healthcare providers should report any serious adverse events to the FDA's MedWatch program. Patients should be informed about the potential for serious side effects and should follow prescrib
The FDA has received approximately 4,509 adverse event reports associated with Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate. 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 And Ferrous Fumarate include Nausea, Headache, Drug Ineffective, Fatigue, Pain. By volume, the top reported reactions are: Nausea (205 reports), Headache (173 reports), Drug Ineffective (150 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 And Ferrous Fumarate.
Out of 2,456 classified reports, 923 (37.6%) were classified as serious and 1,533 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 And Ferrous Fumarate break down by patient sex as follows: Female: 2,302, Unknown: 8, Male: 7. 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 And Ferrous Fumarate adverse events are: age 24: 66 reports, age 30: 64 reports, age 28: 57 reports, age 19: 56 reports, age 21: 55 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 And Ferrous Fumarate 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 And Ferrous Fumarate include: Vomiting, Anxiety, Diarrhoea, Dizziness, 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 And Ferrous Fumarate 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 And Ferrous Fumarate has a safety concern score of 65 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. The most common adverse reactions include nausea, headache, and fatigue, with a significant number of reports involving serious conditions like pulmonary embolism and deep vein thrombosis.
Key safety signals identified in Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate's adverse event data include: Pulmonary embolism and deep vein thrombosis were reported as serious conditions.. A significant number of reports involved drug dose omission issues.. There were multiple reports of injection site reactions and pain.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Drug interactions and warnings include the potential for serious cardiovascular events, and patients should be monitored for signs of pulmonary embolism and deep vein thrombosis. Injection site reactions and pain are also common and should be managed Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate.
Monitor for signs of serious cardiovascular events such as pulmonary embolism and deep vein thrombosis. Report any injection site reactions or pain to your healthcare provider.
Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate has 4,509 adverse event reports on file with the FDA. A diverse range of reactions were reported, indicating potential for multiple side effects. The volume of reports for Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of this drug, and healthcare providers should report any serious adverse events to the FDA's MedWatch program. Patients should be informed about the potential for serious side effects and should follow prescrib For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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