NORETHINDRONE ACETATE

Norethindrone Acetate Adverse Events Reported to the FDA Over Time

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.

Most Common Norethindrone Acetate Adverse Events Reported to the FDA

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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Insomnia	76 (.89%)
Rectal Haemorrhage	76 (.89%)
Rash Erythematous	73 (.85%)
Fatigue	72 (.84%)
Hot Flush	71 (.83%)
Melaena	67 (.78%)
Back Pain	66 (.77%)
Drug Ineffective	66 (.77%)
Dyspnoea	66 (.77%)
Weight Increased	62 (.72%)
Arthralgia	61 (.71%)
Haemorrhage	55 (.64%)
Menorrhagia	55 (.64%)
Malaise	54 (.63%)
Abortion Spontaneous	52 (.61%)
Weight Decreased	52 (.61%)
Diarrhoea	51 (.59%)
Heart Rate Increased	50 (.58%)
Blood Pressure Increased	49 (.57%)
Irritability	49 (.57%)
Sleep Disorder	49 (.57%)
Agitation	48 (.56%)
Chest Pain	48 (.56%)
Convulsion	48 (.56%)
Nervousness	48 (.56%)
Thrombosis	47 (.55%)
Abdominal Pain Upper	46 (.54%)
Arthritis	46 (.54%)
Blood Glucose Increased	46 (.54%)
Emotional Disorder	46 (.54%)
Feeling Abnormal	46 (.54%)
Hormone Level Abnormal	46 (.54%)
Viral Infection	46 (.54%)
Alopecia	45 (.52%)
Amnesia	45 (.52%)
Bronchitis	45 (.52%)
Memory Impairment	44 (.51%)
Muscle Tightness	44 (.51%)
Visual Impairment	44 (.51%)
Withdrawal Syndrome	44 (.51%)
Fibromyalgia	43 (.5%)
Increased Appetite	43 (.5%)
Panic Attack	43 (.5%)
Somnolence	43 (.5%)
Stress	43 (.5%)
Anger	42 (.49%)
Feeling Cold	42 (.49%)
General Physical Health Deteriorati...	42 (.49%)
Menstrual Disorder	42 (.49%)
Urinary Tract Infection	42 (.49%)
Hallucination	41 (.48%)
Menopause	41 (.48%)
Mood Altered	41 (.48%)
Tension	41 (.48%)
Arthropathy	40 (.47%)
Disturbance In Attention	40 (.47%)
Enuresis	40 (.47%)
Influenza Like Illness	40 (.47%)
Mental Impairment	40 (.47%)
Pyrexia	40 (.47%)
Abnormal Behaviour	39 (.45%)
Abnormal Dreams	39 (.45%)
Bed Rest	39 (.45%)
Blood Cholesterol Decreased	39 (.45%)
Blood Glucose Decreased	39 (.45%)
Frustration	39 (.45%)
Hallucination, Auditory	39 (.45%)
Hypersomnia	39 (.45%)
Ill-defined Disorder	39 (.45%)
Polydipsia	39 (.45%)
Sleep Talking	39 (.45%)
Somnambulism	39 (.45%)
Tobacco User	39 (.45%)
Vulvovaginal Burning Sensation	39 (.45%)
Dysarthria	37 (.43%)
Lice Infestation	37 (.43%)
Dry Mouth	36 (.42%)
Parosmia	35 (.41%)
Activities Of Daily Living Impaired	34 (.4%)
Hypersensitivity	34 (.4%)
Medication Error	34 (.4%)
Pain In Extremity	34 (.4%)
Euphoric Mood	33 (.38%)
Breast Mass	32 (.37%)
Breast Cancer In Situ	31 (.36%)
Dry Throat	31 (.36%)
Paraesthesia	31 (.36%)
Hypertension	30 (.35%)
Dizziness	29 (.34%)
Gait Disturbance	29 (.34%)

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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.

Adverse Event Categories for Norethindrone Acetate

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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Therapeutic And Nontherapeutic Effe...	156 (1.82%)
Gastrointestinal Hemorrhages	149 (1.74%)
Musculoskeletal And Connective Tiss...	149 (1.74%)
Infections - Pathogen Unspecified	142 (1.65%)
Respiratory	141 (1.64%)
Breast	131 (1.53%)
Muscle	118 (1.37%)
Hematology Investigations	117 (1.36%)
Physical Examination Topics	117 (1.36%)
Cardiac And Vascular Investigations	115 (1.34%)
Headaches	113 (1.32%)
Injuries	113 (1.32%)
Metabolic, Nutritional And Blood Ga...	110 (1.28%)
Lifestyle Issues	103 (1.2%)
Depressed Mood Disorders	100 (1.16%)
Therapeutic Procedures And Supporti...	99 (1.15%)
Endocrine Investigations	88 (1.03%)
Gastrointestinal Motility And Defec...	87 (1.01%)
Vascular	86 (1%)
Psychiatric	85 (.99%)
Disturbances In Thinking	83 (.97%)
Skin Appendage Conditions	83 (.97%)
Skin Vascular Abnormalities	77 (.9%)
Embolism And Thrombosis	75 (.87%)
Administration Site Reactions	68 (.79%)
Reproductive Organ And Breast Inves...	66 (.77%)
Urinary Tract Signs	65 (.76%)
Medication Errors	60 (.7%)
Seizures	60 (.7%)
Viral Infectious	59 (.69%)
Vision	59 (.69%)
Breast Therapeutic Procedures	58 (.68%)
Abortions And Stillbirth	55 (.64%)
Vascular Hemorrhagic	55 (.64%)
Central Nervous System Vascular	54 (.63%)
Lipid Analyses	53 (.62%)
Appetite And General Nutritional	51 (.59%)
Electrolyte And Fluid Balance Condi...	49 (.57%)
Cardiac Arrhythmias	45 (.52%)
Hepatobiliary	44 (.51%)
Reproductive Neoplasms Female Malig...	42 (.49%)
Age Related Factors	41 (.48%)
Bone Disorders	41 (.48%)
Allergic Conditions	40 (.47%)
Body Temperature Conditions	40 (.47%)
Investigations, Imaging And Histopa...	39 (.45%)
Psychiatric And Behavioural Symptom...	39 (.45%)
Sleep Disturbances	39 (.45%)
Cranial Nerve Disorders	37 (.43%)
Ectoparasitic	37 (.43%)
Hepatic And Hepatobiliary	37 (.43%)
Vascular Hypertensive	37 (.43%)
Salivary Gland Conditions	36 (.42%)
Menopause And Related Conditions	32 (.37%)
Uterine, Pelvic And Broad Ligament	30 (.35%)
Product Quality Issues	29 (.34%)
Pulmonary Vascular	29 (.34%)
Pregnancy, Labour, Delivery And Pos...	27 (.31%)
Injuries By Physical Agents	25 (.29%)
Decreased And Nonspecific Blood Pre...	24 (.28%)
Manic And Bipolar Mood Disorders	24 (.28%)
Neurological, Special Senses And Ps...	23 (.27%)
Personality Disorders	19 (.22%)
Chemical Injury And Poisoning	16 (.19%)
Enzyme	16 (.19%)
Cardiac Disorder Signs	15 (.17%)
Lipid Metabolism	15 (.17%)
Bile Duct	14 (.16%)
Head And Neck Therapeutic Procedure...	14 (.16%)
Bronchial Disorders	13 (.15%)
Deliria	13 (.15%)
Gastrointestinal	13 (.15%)
Miscellaneous And Site Unspecified ...	13 (.15%)
Procedural And Device Related Injur...	13 (.15%)
Upper Respiratory Tract Disorders	13 (.15%)
Bone And Joint Therapeutic Procedur...	12 (.14%)
Coronary Artery	12 (.14%)
Hematological And Lymphoid Tissue T...	12 (.14%)
Movement Disorders	12 (.14%)
Bacterial Infectious	11 (.13%)
Cutaneous Neoplasms Benign	11 (.13%)
Family Issues	11 (.13%)
Ocular Infections, Irritations And ...	11 (.13%)
Spleen, Lymphatic And Reticulendoth...	11 (.13%)
Bone And Joint Injuries	10 (.12%)
Dental And Gingival Conditions	10 (.12%)
Fungal Infectious	10 (.12%)
Gallbladder	10 (.12%)
Inner Ear And Viiith Cranial Nerve	10 (.12%)
Musculoskeletal And Soft Tissue Inv...	10 (.12%)

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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.