How are Norethindrone Acetate adverse event reports trending over time?
This graph shows volume of adverse events submitted to the FDA by quarter for Norethindrone Acetate, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Norethindrone Acetate is flagged as the suspect drug causing the adverse event.
What are the most common Norethindrone Acetate adverse events reported to the FDA?
Breast Cancer | 405 (4.72%) |
Breast Cancer Female | 273 (3.18%) |
Vaginal Haemorrhage | 121 (1.41%) |
Pain | 99 (1.15%) |
Headache | 94 (1.09%) |
Depression | 90 (1.05%) |
Anxiety | 79 (.92%) |
Rash Maculo-papular | 78 (.91%) |
Nausea | 77 (.9%) |
Purpura | 77 (.9%) |
Haemoglobin Decreased | 76 (.89%) |
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This graph shows the top adverse events submitted to the FDA for Norethindrone Acetate, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Norethindrone Acetate is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.
What are the most common Norethindrone Acetate adverse events reported to the FDA?
Breast Neoplasms Malignant And Unsp... | 746 (8.69%) |
Epidermal And Dermal Conditions | 332 (3.87%) |
Anxiety Disorders | 311 (3.62%) |
Sleep Disorders | 243 (2.83%) |
Mood Disorders | 218 (2.54%) |
Gastrointestinal Signs | 199 (2.32%) |
Neurological | 197 (2.29%) |
Joint | 171 (1.99%) |
Mental Impairment | 171 (1.99%) |
Vulvovaginal Disorders | 168 (1.96%) |
Menstrual Cycle And Uterine Bleedin... | 157 (1.83%) |
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This graph shows the top categories of adverse events submitted to the FDA for Norethindrone Acetate, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Norethindrone Acetate is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.
Why are people taking Norethindrone Acetate, according to those reporting adverse events to the FDA?
Hormone Replacement Therapy | 1121 |
Menopausal Symptoms | 193 |
Menopause | 174 |
Product Used For Unknown Indication | 150 |
Contraception | 113 |
Drug Use For Unknown Indication | 52 |
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Label | Labeler | Effective |
---|---|---|
Femhrt | Physicians Total Care, Inc. | 02-OCT-08 |
Tilia Fe | Watson Pharma, Inc. | 01-JUN-09 |
Estrostep Fe | Warner Chilcott (US), LLC | 07-JUL-09 |
Norethindrone Acetate | Glenmark Generics Inc., USA | 23-JUL-10 |
Tilia Fe | Physicians Total Care, Inc. | 07-DEC-10 |
Jevantique | Watson Pharma, Inc. | 23-MAR-11 |
Tilia Fe | Watson Pharma, Inc. | 13-MAY-11 |
Estradiol / Norethindrone Acetate | Breckenridge Pharmaceutical, Inc. | 10-JUN-11 |
Femhrt | Warner Chilcott (US), LLC | 21-JUN-11 |
Tilia Fe | Rebel Distributors Corp | 29-JUL-11 |
Gildess Fe 1.5/30 | Qualitest Pharmaceuticals | 07-OCT-11 |
Gildess Fe 1/20 | Qualitest Pharmaceuticals | 13-OCT-11 |
Junel Fe 1.5/30 | Physicians Total Care, Inc. | 16-APR-12 |
Junel Fe 1/20 | Physicians Total Care, Inc. | 16-APR-12 |
Junel 1.5/30 | Physicians Total Care, Inc. | 16-APR-12 |
Microgestin Fe | Physicians Total Care, Inc. | 26-APR-12 |
Microgestin | Physicians Total Care, Inc. | 26-APR-12 |
Junel Fe 1.5/30 | Rebel Distributors Corp | 13-JUN-12 |
Gildess 1.5/30 | Qualitest Pharmaceuticals | 28-JUN-12 |
Gildess 1/20 | Qualitest Pharmaceuticals | 28-JUN-12 |
Lo Loestrin Fe | Warner Chilcott (US), LLC | 28-JUN-12 |
Microgestin | Watson Pharma, Inc. | 19-JUL-12 |
Microgestin Fe | Watson Pharma, Inc. | 19-JUL-12 |
Mimvey | Teva Pharmaceuticals USA Inc | 20-JUL-12 |
Aygestin | Teva Women's Health, Inc. | 10-AUG-12 |
Norethindrone Acetate | Barr Laboratories Inc. | 17-AUG-12 |
Tri-legest Fe28 Day | Barr Laboratories Inc. | 17-AUG-12 |
Estradiol / Norethindrone Acetate | Physicians Total Care, Inc. | 29-AUG-12 |
Junel 1.5/30 | Barr Laboratories Inc. | 13-SEP-12 |
Junel Fe 1.5/30 | Barr Laboratories Inc. | 13-SEP-12 |
Junel 1/20 | Barr Laboratories Inc. | 13-SEP-12 |
Junel Fe 1/20 | Barr Laboratories Inc. | 13-SEP-12 |
Norethindrone Acetate | Amneal Pharmaceuticals | 07-NOV-12 |
Loestrin 1.5/3021 Day | Teva Women's Health, Inc | 03-DEC-12 |
Loestrin 1/2021 Day | Teva Women's Health, Inc | 03-DEC-12 |
Loestrin Fe 1.5/3028 Day | Teva Women's Health, Inc | 03-DEC-12 |
Loestrin Fe 1/2028 Day | Teva Women's Health, Inc | 03-DEC-12 |
What Norethindrone Acetate safety concerns are being reported by doctors and researchers in the medical literature?
This report contains aggregated drug side effects and adverse events for Norethindrone Acetate. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.
DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.
DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.
Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.
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