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NOLVADEX

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Nolvadex Adverse Events Reported to the FDA Over Time

How are Nolvadex adverse event reports trending over time?

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

Most Common Nolvadex Adverse Events Reported to the FDA

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

Arthralgia
117 (1.27%)
Hot Flush
109 (1.18%)
Uterine Polyp
89 (.97%)
Fatigue
78 (.85%)
Pain In Extremity
74 (.8%)
Pulmonary Embolism
73 (.79%)
Breast Cancer
72 (.78%)
Nausea
71 (.77%)
Dyspnoea
68 (.74%)
Weight Increased
67 (.73%)
Fall
65 (.7%)
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Dizziness
60 (.65%)
Back Pain
58 (.63%)
Depression
58 (.63%)
Headache
58 (.63%)
Endometrial Hyperplasia
56 (.61%)
Hepatic Steatosis
56 (.61%)
Deep Vein Thrombosis
55 (.6%)
Malaise
53 (.57%)
Insomnia
52 (.56%)
Thrombosis
51 (.55%)
Pyrexia
50 (.54%)
Breast Cancer Recurrent
49 (.53%)
Weight Decreased
49 (.53%)
Endometrial Hypertrophy
48 (.52%)
Oedema Peripheral
47 (.51%)
Drug Interaction
46 (.5%)
Metastases To Bone
46 (.5%)
Vaginal Haemorrhage
46 (.5%)
Myalgia
45 (.49%)
Cerebrovascular Accident
44 (.48%)
Alopecia
43 (.47%)
Death
43 (.47%)
Asthenia
42 (.46%)
Drug Ineffective
42 (.46%)
Pain
42 (.46%)
Visual Acuity Reduced
41 (.44%)
Disease Progression
40 (.43%)
Uterine Leiomyoma
40 (.43%)
Endometrial Cancer
39 (.42%)
Ovarian Cyst
39 (.42%)
Acute Myeloid Leukaemia
38 (.41%)
Cerebral Infarction
38 (.41%)
Hepatic Failure
38 (.41%)
Diarrhoea
37 (.4%)
Anaemia
34 (.37%)
Drug Exposure During Pregnancy
34 (.37%)
Vomiting
34 (.37%)
Uterine Cancer
33 (.36%)
Muscle Spasms
32 (.35%)
Cataract
31 (.34%)
Osteoporosis
31 (.34%)
Rash
31 (.34%)
Condition Aggravated
30 (.33%)
Hypoaesthesia
30 (.33%)
Aplastic Anaemia
29 (.31%)
Hysterectomy
29 (.31%)
Osteonecrosis
29 (.31%)
Transient Ischaemic Attack
29 (.31%)
Neoplasm Malignant
28 (.3%)
Blood Pressure Increased
26 (.28%)
Hepatic Cirrhosis
26 (.28%)
Musculoskeletal Stiffness
26 (.28%)
Chest Pain
25 (.27%)
Metrorrhagia
25 (.27%)
Suicidal Ideation
25 (.27%)
Abdominal Pain
24 (.26%)
Blood Cholesterol Increased
24 (.26%)
Cervical Polyp
24 (.26%)
Hysteroscopy
24 (.26%)
Interstitial Lung Disease
24 (.26%)
Paraesthesia
24 (.26%)
Pneumonia
24 (.26%)
Vision Blurred
24 (.26%)
Organising Pneumonia
23 (.25%)
Bone Pain
22 (.24%)
Endometrial Disorder
22 (.24%)
Hypertension
22 (.24%)
Maculopathy
22 (.24%)
Myocardial Infarction
22 (.24%)
Pruritus
22 (.24%)
Deafness
21 (.23%)
Osteoarthritis
21 (.23%)
Constipation
20 (.22%)
Cough
20 (.22%)
Electrocardiogram Qt Prolonged
20 (.22%)
Feeling Abnormal
20 (.22%)
Anxiety
19 (.21%)
Blood Triglycerides Increased
19 (.21%)
Breast Cancer Female
19 (.21%)
Gait Disturbance
19 (.21%)
Hypothyroidism
19 (.21%)
Metastases To Liver
19 (.21%)
Pancytopenia
19 (.21%)
Pleural Effusion
19 (.21%)
Urinary Tract Infection
19 (.21%)
Vaginal Discharge
19 (.21%)
White Blood Cell Count Decreased
19 (.21%)
Acute Promyelocytic Leukaemia
18 (.2%)
Anorexia
18 (.2%)
Arthritis
18 (.2%)

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

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

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

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

Breast Cancer
3232
Drug Use For Unknown Indication
162
Breast Cancer Female
152
Product Used For Unknown Indication
94
Breast Cancer Metastatic
88
Neoplasm Malignant
57
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Breast Cancer In Situ
54
Prophylaxis
31
Breast Cancer Stage Ii
23
Hormone Therapy
22
Gynaecomastia
22
Metastases To Bone
18
Breast Cancer Recurrent
17
Menopause
16
Breast Cancer Stage I
15
Ovarian Cancer
12
Breast Cancer Stage Iii
12
Prostate Cancer
11
Metastases To Lymph Nodes
10
Breast Neoplasm
10
Ill-defined Disorder
9
Malignant Melanoma
9
Breast Cancer Male
8
Desmoid Tumour
7
Neoplasm Prophylaxis
7
Malignant Melanoma Stage Iv
7
Rheumatoid Arthritis
7
Chemotherapy
7
Neoplasm
6
Body Height Below Normal
6
Hormone Suppression Therapy
5
Hormone Replacement Therapy
5
Breast Hyperplasia
5
Glioblastoma Multiforme
5
Endometrial Sarcoma
4
Lung Neoplasm Malignant
4
Breast Mass
4
Mastectomy
4
Sclerosing Encapsulating Peritoniti...
4
Ovarian Epithelial Cancer
4
Hepatic Neoplasm Malignant
4
Antioestrogen Therapy
4
Breast Disorder
3
Malignant Breast Lump Removal
3
Familial Risk Factor
3
Metastases To Liver
3
Adenomatous Polyposis Coli
3
Prophylactic Chemotherapy
3
Endometrial Cancer
3
Astrocytoma
3
Breast Cancer Stage Iv
3

Nolvadex Case Reports

What Nolvadex 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 Nolvadex. 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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