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Faslodex Adverse Events Reported to the FDA Over Time

How are Faslodex adverse event reports trending over time?

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

Most Common Faslodex Adverse Events Reported to the FDA

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

Nausea
111 (2.47%)
Dyspnoea
91 (2.02%)
Fatigue
77 (1.71%)
Injection Site Pain
66 (1.47%)
Arthralgia
64 (1.42%)
Asthenia
62 (1.38%)
Pulmonary Embolism
58 (1.29%)
Dizziness
56 (1.25%)
Headache
54 (1.2%)
Pain
54 (1.2%)
Back Pain
51 (1.13%)
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Disease Progression
49 (1.09%)
Hot Flush
43 (.96%)
Death
41 (.91%)
Vomiting
38 (.85%)
Bone Pain
37 (.82%)
Tumour Marker Increased
36 (.8%)
Weight Decreased
34 (.76%)
Cough
33 (.73%)
Decreased Appetite
32 (.71%)
Diarrhoea
31 (.69%)
Pain In Extremity
31 (.69%)
Pleural Effusion
31 (.69%)
Abdominal Pain
30 (.67%)
Alopecia
30 (.67%)
Dehydration
29 (.64%)
Cerebrovascular Accident
28 (.62%)
Myalgia
27 (.6%)
Hypertension
26 (.58%)
Blood Pressure Increased
24 (.53%)
Malaise
24 (.53%)
Pyrexia
24 (.53%)
Rash
23 (.51%)
Oedema Peripheral
22 (.49%)
Coma
21 (.47%)
Deep Vein Thrombosis
21 (.47%)
Drug Ineffective
21 (.47%)
Metastases To Bone
21 (.47%)
Platelet Count Decreased
21 (.47%)
Chest Pain
20 (.44%)
Constipation
19 (.42%)
Fall
19 (.42%)
Gait Disturbance
19 (.42%)
Hypoaesthesia
19 (.42%)
Cardiac Failure
18 (.4%)
Thrombocytopenia
18 (.4%)
Urine Odour Abnormal
18 (.4%)
Anxiety
17 (.38%)
Breast Cancer
17 (.38%)
Chills
17 (.38%)
Depression
17 (.38%)
Injection Site Swelling
17 (.38%)
Metastases To Liver
17 (.38%)
Renal Failure Acute
17 (.38%)
Dysgeusia
16 (.36%)
Insomnia
16 (.36%)
Pruritus
16 (.36%)
Abdominal Pain Upper
15 (.33%)
Ascites
15 (.33%)
Muscular Weakness
15 (.33%)
Pneumonia
15 (.33%)
Breast Cancer Metastatic
14 (.31%)
Injection Site Erythema
14 (.31%)
Injection Site Pruritus
14 (.31%)
Joint Swelling
14 (.31%)
Muscle Spasms
14 (.31%)
Paraesthesia
14 (.31%)
Feeling Abnormal
13 (.29%)
Flushing
13 (.29%)
Hepatic Enzyme Increased
13 (.29%)
Hyperhidrosis
13 (.29%)
Hypotension
13 (.29%)
Injection Site Reaction
13 (.29%)
Neoplasm Malignant
13 (.29%)
Neuropathy Peripheral
13 (.29%)
Oropharyngeal Pain
13 (.29%)
Tremor
13 (.29%)
Weight Increased
13 (.29%)
Balance Disorder
12 (.27%)
Breast Cancer Recurrent
12 (.27%)
Confusional State
12 (.27%)
Incorrect Dose Administered
12 (.27%)
Incorrect Route Of Drug Administrat...
12 (.27%)
Influenza Like Illness
12 (.27%)
Musculoskeletal Pain
12 (.27%)
Optic Neuritis
12 (.27%)
Palpitations
12 (.27%)
Renal Failure
12 (.27%)
Transaminases Increased
12 (.27%)
Anaemia
11 (.24%)
Hip Fracture
11 (.24%)
Injection Site Irritation
11 (.24%)
Myocardial Infarction
11 (.24%)
Rash Generalised
11 (.24%)
Somnolence
11 (.24%)
Stomatitis
11 (.24%)
Swollen Tongue
11 (.24%)
Throat Tightness
11 (.24%)
Thrombosis
11 (.24%)
Urticaria
11 (.24%)
Arthritis
10 (.22%)

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

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

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

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

Breast Cancer
611
Breast Cancer Metastatic
322
Breast Cancer Female
55
Breast Cancer Stage Iv
23
Breast Cancer Recurrent
22
Lung Neoplasm Malignant
21
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Metastases To Bone
17
Non-small Cell Lung Cancer
17
Neoplasm Malignant
12
Drug Use For Unknown Indication
11
Metastases To Lung
8
Oestrogen Receptor Assay Positive
5
Product Used For Unknown Indication
5
Metastatic Neoplasm
5
Uterine Cancer
3
Endometrial Cancer
2
Inflammatory Carcinoma Of Breast St...
2
Metastasis
2
Hepatic Neoplasm Malignant
2
Metastases To Liver
2
Hormone Therapy
2
Disease Progression
2
Chemotherapy
2
Recurrent Cancer
2
Bone Lesion
2
Endometrial Cancer Metastatic
2
Metastases To Central Nervous Syste...
2
Non-small Cell Lung Cancer Stage Ii...
1
Premedication
1
Lung Disorder
1
Chronic Obstructive Airways Disease...
1
Inflammatory Carcinoma Of The Breas...
1
Breast Cancer In Situ
1
Breast Cancer Stage Iii
1
Metastases To Chest Wall
1
Blood Oestrogen Decreased
1
Breast Cancer Stage I
1
Metastases To Pleura
1
Sarcoma Uterus
1
Neoplasm Prophylaxis
1
Bone Neoplasm Malignant
1
Endometrial Cancer Recurrent
1
Colon Cancer
1
Bone Disorder
1
Ovarian Cancer
1
Metastases To Bone Marrow
1
Breast Cancer Male
1
Prophylaxis
1
Breast Neoplasm
1

Drug Labels

LabelLabelerEffective
FaslodexAstraZeneca Pharmaceuticals LP09-NOV-12

Faslodex Case Reports

What Faslodex 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 Faslodex. 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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