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Femara Adverse Events Reported to the FDA Over Time

How are Femara adverse event reports trending over time?

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

Most Common Femara Adverse Events Reported to the FDA

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

Arthralgia
451 (2.35%)
Death
296 (1.54%)
Fatigue
266 (1.39%)
Myalgia
192 (1%)
Fall
187 (.97%)
Pain
187 (.97%)
Headache
185 (.96%)
Bone Pain
180 (.94%)
Hot Flush
177 (.92%)
Dyspnoea
174 (.91%)
Nausea
158 (.82%)
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Pain In Extremity
151 (.79%)
Asthenia
141 (.73%)
Oedema Peripheral
140 (.73%)
Depression
139 (.72%)
Dizziness
139 (.72%)
Malignant Neoplasm Progression
132 (.69%)
Neoplasm Malignant
126 (.66%)
Alopecia
125 (.65%)
Back Pain
118 (.61%)
Weight Increased
114 (.59%)
Hypoaesthesia
112 (.58%)
Malaise
106 (.55%)
Arthritis
95 (.49%)
Cough
95 (.49%)
Pyrexia
95 (.49%)
Visual Acuity Reduced
94 (.49%)
Insomnia
91 (.47%)
Vomiting
87 (.45%)
Chest Pain
84 (.44%)
Gait Disturbance
84 (.44%)
Paraesthesia
84 (.44%)
Drug Ineffective
83 (.43%)
Hyperhidrosis
81 (.42%)
Metastases To Bone
79 (.41%)
Diarrhoea
78 (.41%)
Hypertension
77 (.4%)
Osteoporosis
76 (.4%)
Cataract
75 (.39%)
Aspartate Aminotransferase Increase...
71 (.37%)
Palpitations
70 (.36%)
Pneumonia
69 (.36%)
Alanine Aminotransferase Increased
67 (.35%)
Constipation
67 (.35%)
Feeling Abnormal
67 (.35%)
Anxiety
66 (.34%)
Vision Blurred
66 (.34%)
Amnesia
65 (.34%)
Rash
65 (.34%)
Bone Disorder
62 (.32%)
Blood Cholesterol Increased
61 (.32%)
Osteonecrosis
60 (.31%)
Anaemia
59 (.31%)
Blood Pressure Increased
59 (.31%)
General Physical Health Deteriorati...
59 (.31%)
Swelling
59 (.31%)
Weight Decreased
59 (.31%)
Surgery
56 (.29%)
Bone Density Decreased
55 (.29%)
Dysphagia
54 (.28%)
Cerebrovascular Accident
53 (.28%)
Condition Aggravated
53 (.28%)
Metastases To Lung
53 (.28%)
Visual Impairment
53 (.28%)
Osteoarthritis
52 (.27%)
Musculoskeletal Pain
51 (.27%)
Atrial Fibrillation
50 (.26%)
Muscular Weakness
50 (.26%)
Night Sweats
50 (.26%)
Blood Lactate Dehydrogenase Increas...
49 (.26%)
Joint Swelling
49 (.26%)
Syncope
49 (.26%)
Abdominal Pain
48 (.25%)
Cardiac Failure
48 (.25%)
Confusional State
48 (.25%)
Drug Exposure Before Pregnancy
48 (.25%)
Haemoglobin Decreased
48 (.25%)
Macular Degeneration
48 (.25%)
Memory Impairment
48 (.25%)
Musculoskeletal Stiffness
48 (.25%)
Urinary Tract Infection
48 (.25%)
Cardiac Disorder
47 (.24%)
Lung Disorder
47 (.24%)
Pruritus
47 (.24%)
Erythema
45 (.23%)
Muscle Spasms
45 (.23%)
Myocardial Infarction
45 (.23%)
Loss Of Consciousness
44 (.23%)
Thrombocytopenia
44 (.23%)
Breast Cancer
43 (.22%)
Carpal Tunnel Syndrome
43 (.22%)
Gamma-glutamyltransferase Increased
43 (.22%)
Metastases To Liver
43 (.22%)
Pulmonary Embolism
43 (.22%)
Blood Glucose Increased
42 (.22%)
Decreased Appetite
42 (.22%)
Joint Stiffness
42 (.22%)
Neuropathy Peripheral
42 (.22%)
Pleural Effusion
42 (.22%)
Balance Disorder
41 (.21%)
Abdominal Pain Upper
40 (.21%)

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

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

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

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

Breast Cancer
2544
Breast Cancer Metastatic
252
Neoplasm Malignant
152
Breast Cancer Female
124
Drug Use For Unknown Indication
62
Breast Cancer Recurrent
52
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Product Used For Unknown Indication
42
Metastases To Bone
34
Ovulation Induction
27
Breast Cancer Stage Iv
23
Breast Neoplasm
15
Bone Neoplasm Malignant
13
Body Height Below Normal
11
Breast Cancer Stage Iii
11
Infertility
11
Breast Cancer Stage Ii
11
Breast Mass
10
Hormone Replacement Therapy
9
Ovarian Cancer
8
Prophylaxis
8
Hormone Therapy
8
Breast Cancer In Situ
8
Postoperative Care
7
Growth Retardation
7
Chemotherapy
7
Antioestrogen Therapy
6
Metastases To Liver
6
Endometrial Sarcoma
4
Endometriosis
4
Breast Cancer Stage I
4
Breast Disorder
3
Malignant Neoplasm Progression
3
Lymphoma
3
Neoplasm Prophylaxis
3
Metastases To Skin
3
Delayed Puberty
3
Metastases To Lung
3
Endometrial Cancer
3
Metastasis
3
Mastectomy
3
Breast Cancer Male
2
Lung Neoplasm
2
Drug Dispensing Error
2
Epiphyses Delayed Fusion
2
Aromatase Inhibition Therapy
2
Assisted Fertilisation
2
Hormone Suppression Therapy
2
Bone Disorder
2
Benign Breast Neoplasm
2
Pleural Disorder
2
Drug Therapy
2

Drug Labels

LabelLabelerEffective
FemaraNovartis Pharmaceuticals Corporation25-DEC-11
FemaraPhysicians Total Care, Inc.09-JAN-12

Femara Case Reports

What Femara 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 Femara. 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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