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FEMHRT

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Femhrt Adverse Events Reported to the FDA Over Time

How are Femhrt adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Femhrt, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Femhrt is flagged as the suspect drug causing the adverse event.

Most Common Femhrt Adverse Events Reported to the FDA

What are the most common Femhrt adverse events reported to the FDA?

Breast Cancer
257 (4.25%)
Breast Cancer Female
139 (2.3%)
Vaginal Haemorrhage
86 (1.42%)
Rash Maculo-papular
78 (1.29%)
Purpura
77 (1.27%)
Haemoglobin Decreased
76 (1.26%)
Rash Erythematous
73 (1.21%)
Rectal Haemorrhage
73 (1.21%)
Melaena
67 (1.11%)
Headache
59 (.98%)
Nausea
56 (.93%)
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Depression
54 (.89%)
Pain
53 (.88%)
Drug Ineffective
52 (.86%)
Weight Increased
52 (.86%)
Abortion Spontaneous
51 (.84%)
Dyspnoea
51 (.84%)
Back Pain
50 (.83%)
Fatigue
50 (.83%)
Anxiety
49 (.81%)
Insomnia
48 (.79%)
Convulsion
47 (.78%)
Irritability
46 (.76%)
Arthralgia
45 (.74%)
Haemorrhage
45 (.74%)
Thrombosis
45 (.74%)
Menorrhagia
44 (.73%)
Abdominal Pain Upper
43 (.71%)
Blood Glucose Increased
43 (.71%)
Increased Appetite
43 (.71%)
Malaise
43 (.71%)
Panic Attack
43 (.71%)
Visual Impairment
43 (.71%)
Alopecia
42 (.7%)
Amnesia
42 (.7%)
Anger
42 (.7%)
Blood Pressure Increased
42 (.7%)
Diarrhoea
42 (.7%)
Feeling Abnormal
42 (.7%)
Heart Rate Increased
42 (.7%)
Memory Impairment
42 (.7%)
Menstrual Disorder
42 (.7%)
Sleep Disorder
42 (.7%)
Somnolence
42 (.7%)
Urinary Tract Infection
42 (.7%)
Weight Decreased
42 (.7%)
Feeling Cold
41 (.68%)
Hallucination
41 (.68%)
Muscle Tightness
41 (.68%)
Nervousness
41 (.68%)
Agitation
40 (.66%)
Arthropathy
40 (.66%)
Disturbance In Attention
40 (.66%)
Fibromyalgia
40 (.66%)
General Physical Health Deteriorati...
40 (.66%)
Influenza Like Illness
40 (.66%)
Mental Impairment
40 (.66%)
Mood Altered
40 (.66%)
Pyrexia
40 (.66%)
Viral Infection
40 (.66%)
Abnormal Behaviour
39 (.65%)
Abnormal Dreams
39 (.65%)
Arthritis
39 (.65%)
Bed Rest
39 (.65%)
Blood Cholesterol Decreased
39 (.65%)
Blood Glucose Decreased
39 (.65%)
Enuresis
39 (.65%)
Frustration
39 (.65%)
Hallucination, Auditory
39 (.65%)
Hypersomnia
39 (.65%)
Ill-defined Disorder
39 (.65%)
Menopause
39 (.65%)
Polydipsia
39 (.65%)
Sleep Talking
39 (.65%)
Somnambulism
39 (.65%)
Stress
39 (.65%)
Tension
39 (.65%)
Tobacco User
39 (.65%)
Vulvovaginal Burning Sensation
39 (.65%)
Withdrawal Syndrome
39 (.65%)
Dysarthria
37 (.61%)
Hormone Level Abnormal
37 (.61%)
Lice Infestation
37 (.61%)
Chest Pain
36 (.6%)
Dry Mouth
36 (.6%)
Emotional Disorder
36 (.6%)
Parosmia
35 (.58%)
Activities Of Daily Living Impaired
34 (.56%)
Euphoric Mood
33 (.55%)
Medication Error
32 (.53%)
Dry Throat
31 (.51%)
Hypersensitivity
31 (.51%)
Bronchitis
30 (.5%)
Pain In Extremity
25 (.41%)
Pulmonary Embolism
25 (.41%)
Gait Disturbance
24 (.4%)
Paraesthesia
24 (.4%)
Adverse Event
22 (.36%)
Road Traffic Accident
22 (.36%)
Transient Ischaemic Attack
22 (.36%)
Adverse Reaction
21 (.35%)

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This graph shows the top adverse events submitted to the FDA for Femhrt, 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 Femhrt 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 Femhrt

What are the most common Femhrt adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Femhrt, 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 Femhrt 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 Femhrt According to Those Reporting Adverse Events

Why are people taking Femhrt, according to those reporting adverse events to the FDA?

Hormone Replacement Therapy
637
Product Used For Unknown Indication
140
Contraception
113
Menopausal Symptoms
108
Menopause
63
Menstrual Disorder
40
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Drug Use For Unknown Indication
35
Endometriosis
34
Hormone Therapy
21
Menorrhagia
15
Oral Contraception
15
Hot Flush
15
Prophylaxis
14
Hormone Level Abnormal
9
Osteoporosis
7
Vaginal Haemorrhage
6
Polycystic Ovaries
5
Menstruation Irregular
5
Uterine Leiomyoma
4
Menstrual Cycle Management
4
Haemorrhage
4
Metrorrhagia
4
Drug Therapy
3
Supplementation Therapy
3
Adverse Drug Reaction
3
Back Disorder
3
Postmenopause
3
Drug Exposure During Pregnancy
3
Uterine Haemorrhage
3
Ovarian Failure
3
Oestrogen Therapy
3
Night Sweats
3
Hysterectomy
2
Gastrooesophageal Reflux Prophylaxi...
2
Exposure During Breast Feeding
2
Bone Density Decreased
2
Acne
2
Autoimmune Thrombocytopenia
2
Dysmenorrhoea
2
Ill-defined Disorder
2
Osteopenia
1
Gastric Disorder
1
Vaginal Pain
1
Bone Disorder
1
Progestin Therapy
1
Oligomenorrhoea
1
Hirsutism
1
Migraine
1
Wrong Drug Administered
1
Progesterone Abnormal
1
Progestin Replacement Therapy
1

Drug Labels

LabelLabelerEffective
FemhrtPhysicians Total Care, Inc.02-OCT-08
FemhrtWarner Chilcott (US), LLC21-JUN-11

Femhrt Case Reports

What Femhrt 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 Femhrt. 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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