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NORETHINDRONE ACETATE

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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?

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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.

Common Uses of Norethindrone Acetate According to Those Reporting Adverse Events

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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Endometriosis
49
Menstrual Disorder
41
Hot Flush
34
Hormone Therapy
32
Menorrhagia
24
Prophylaxis
18
Oral Contraception
15
Osteoporosis
14
Hormone Level Abnormal
12
Vaginal Haemorrhage
10
Postmenopause
7
Menstrual Cycle Management
7
Amenorrhoea
6
Uterine Haemorrhage
6
Menstruation Irregular
6
Uterine Leiomyoma
6
Night Sweats
5
Metrorrhagia
5
Polycystic Ovaries
5
Haemorrhage
5
Back Disorder
4
Hypogonadism
4
Adverse Drug Reaction
3
Drug Therapy
3
Premature Menopause
3
Supplementation Therapy
3
Drug Exposure During Pregnancy
3
Ovarian Failure
3
Oestrogen Therapy
3
Hysterectomy
2
Dysmenorrhoea
2
Acne
2
Oestrogen Replacement Therapy
2
Exposure During Breast Feeding
2
Autoimmune Thrombocytopenia
2
Gastrooesophageal Reflux Prophylaxi...
2
Sleep Disorder
2
Bone Density Decreased
2
Affective Disorder
2
Ill-defined Disorder
2
Osteopenia
1
Gastric Disorder
1
Vasculitis
1
Vaginal Pain
1
Dysfunctional Uterine Bleeding
1

Drug Labels

LabelLabelerEffective
FemhrtPhysicians Total Care, Inc.02-OCT-08
Tilia FeWatson Pharma, Inc.01-JUN-09
Estrostep FeWarner Chilcott (US), LLC07-JUL-09
Norethindrone AcetateGlenmark Generics Inc., USA23-JUL-10
Tilia FePhysicians Total Care, Inc.07-DEC-10
JevantiqueWatson Pharma, Inc.23-MAR-11
Tilia FeWatson Pharma, Inc.13-MAY-11
Estradiol / Norethindrone AcetateBreckenridge Pharmaceutical, Inc.10-JUN-11
FemhrtWarner Chilcott (US), LLC21-JUN-11
Tilia FeRebel Distributors Corp29-JUL-11
Gildess Fe 1.5/30Qualitest Pharmaceuticals07-OCT-11
Gildess Fe 1/20Qualitest Pharmaceuticals13-OCT-11
Junel Fe 1.5/30Physicians Total Care, Inc.16-APR-12
Junel Fe 1/20Physicians Total Care, Inc.16-APR-12
Junel 1.5/30Physicians Total Care, Inc.16-APR-12
Microgestin FePhysicians Total Care, Inc.26-APR-12
MicrogestinPhysicians Total Care, Inc.26-APR-12
Junel Fe 1.5/30Rebel Distributors Corp13-JUN-12
Gildess 1.5/30Qualitest Pharmaceuticals28-JUN-12
Gildess 1/20Qualitest Pharmaceuticals28-JUN-12
Lo Loestrin FeWarner Chilcott (US), LLC28-JUN-12
MicrogestinWatson Pharma, Inc.19-JUL-12
Microgestin FeWatson Pharma, Inc.19-JUL-12
MimveyTeva Pharmaceuticals USA Inc20-JUL-12
AygestinTeva Women's Health, Inc.10-AUG-12
Norethindrone AcetateBarr Laboratories Inc.17-AUG-12
Tri-legest Fe28 DayBarr Laboratories Inc.17-AUG-12
Estradiol / Norethindrone AcetatePhysicians Total Care, Inc.29-AUG-12
Junel 1.5/30Barr Laboratories Inc.13-SEP-12
Junel Fe 1.5/30Barr Laboratories Inc.13-SEP-12
Junel 1/20Barr Laboratories Inc.13-SEP-12
Junel Fe 1/20Barr Laboratories Inc.13-SEP-12
Norethindrone AcetateAmneal Pharmaceuticals07-NOV-12
Loestrin 1.5/3021 DayTeva Women's Health, Inc03-DEC-12
Loestrin 1/2021 DayTeva Women's Health, Inc03-DEC-12
Loestrin Fe 1.5/3028 DayTeva Women's Health, Inc03-DEC-12
Loestrin Fe 1/2028 DayTeva Women's Health, Inc03-DEC-12

Norethindrone Acetate Case Reports

What Norethindrone Acetate safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

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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