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THALOMID

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Thalomid Adverse Events Reported to the FDA Over Time

How are Thalomid adverse event reports trending over time?

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

Most Common Thalomid Adverse Events Reported to the FDA

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

Death
3730 (9.93%)
Disease Progression
1903 (5.07%)
Multiple Myeloma
829 (2.21%)
Pneumonia
711 (1.89%)
Blood Human Chorionic Gonadotropin ...
539 (1.43%)
Malignant Neoplasm Progression
478 (1.27%)
Asthenia
459 (1.22%)
Fatigue
454 (1.21%)
Neuropathy Peripheral
445 (1.18%)
Deep Vein Thrombosis
433 (1.15%)
Dyspnoea
420 (1.12%)
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Renal Failure
410 (1.09%)
Sepsis
367 (.98%)
Fall
325 (.87%)
Anaemia
312 (.83%)
Constipation
312 (.83%)
Respiratory Failure
312 (.83%)
Pulmonary Embolism
303 (.81%)
Nausea
286 (.76%)
Pyrexia
278 (.74%)
Cardiac Failure Congestive
273 (.73%)
Oedema Peripheral
257 (.68%)
Dizziness
254 (.68%)
Dehydration
243 (.65%)
Vomiting
218 (.58%)
Diarrhoea
210 (.56%)
Renal Failure Acute
208 (.55%)
Haemoglobin Decreased
200 (.53%)
Hypotension
200 (.53%)
Thrombocytopenia
194 (.52%)
Neutropenia
186 (.5%)
Thrombosis
183 (.49%)
Cardiac Disorder
182 (.48%)
Rash
180 (.48%)
Myocardial Infarction
177 (.47%)
Confusional State
169 (.45%)
Infection
168 (.45%)
Somnolence
165 (.44%)
Cerebrovascular Accident
160 (.43%)
Drug Ineffective
154 (.41%)
Pancytopenia
154 (.41%)
Hypoaesthesia
152 (.4%)
Platelet Count Decreased
151 (.4%)
Pain
150 (.4%)
Convulsion
134 (.36%)
Syncope
133 (.35%)
Hip Fracture
130 (.35%)
Pleural Effusion
130 (.35%)
Atrial Fibrillation
129 (.34%)
Bradycardia
128 (.34%)
Malaise
127 (.34%)
Neoplasm Progression
124 (.33%)
Renal Failure Chronic
121 (.32%)
Chest Pain
118 (.31%)
Paraesthesia
117 (.31%)
Chronic Obstructive Pulmonary Disea...
116 (.31%)
Condition Aggravated
114 (.3%)
Headache
112 (.3%)
Tremor
112 (.3%)
White Blood Cell Count Decreased
111 (.3%)
Febrile Neutropenia
110 (.29%)
Cardiac Arrest
109 (.29%)
Myelodysplastic Syndrome
107 (.28%)
Back Pain
104 (.28%)
Cough
101 (.27%)
Urinary Tract Infection
101 (.27%)
Haemorrhage
99 (.26%)
Hypoxia
97 (.26%)
Acute Myeloid Leukaemia
94 (.25%)
Multi-organ Failure
92 (.24%)
Abdominal Pain
91 (.24%)
Blood Human Chorionic Gonadotropin ...
90 (.24%)
Renal Disorder
87 (.23%)
Muscular Weakness
85 (.23%)
Oedema
85 (.23%)
Gastrointestinal Haemorrhage
83 (.22%)
Pain In Extremity
82 (.22%)
Cardiac Failure
81 (.22%)
Cardio-respiratory Arrest
81 (.22%)
Pregnancy Of Partner
81 (.22%)
Cellulitis
79 (.21%)
Weight Decreased
79 (.21%)
Haematocrit Decreased
78 (.21%)
Hypertension
78 (.21%)
Anorexia
77 (.2%)
Blood Creatinine Increased
77 (.2%)
Blood Human Chorionic Gonadotropin ...
77 (.2%)
Coronary Artery Disease
77 (.2%)
Hypercalcaemia
73 (.19%)
Mental Status Changes
71 (.19%)
Metastases To Central Nervous Syste...
71 (.19%)
Abasia
70 (.19%)
Hyperglycaemia
70 (.19%)
Lethargy
69 (.18%)
Hepatic Failure
68 (.18%)
Pneumonia Aspiration
68 (.18%)
Unevaluable Event
68 (.18%)
Diverticulitis
67 (.18%)
Neoplasm Malignant
66 (.18%)
Staphylococcal Infection
65 (.17%)
Drug Intolerance
64 (.17%)

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

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

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

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

Multiple Myeloma
7351
Drug Use For Unknown Indication
813
Myelodysplastic Syndrome
734
Malignant Melanoma
396
Renal Cell Carcinoma Stage Unspecif...
286
Prostate Cancer
265
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Myelofibrosis
231
Metastatic Malignant Melanoma
164
Brain Neoplasm Malignant
130
Amyloidosis
124
Glioblastoma Multiforme
115
Hepatic Neoplasm Malignant
113
Non-small Cell Lung Cancer
99
Metastases To Central Nervous Syste...
79
Ovarian Cancer
70
Metastatic Renal Cell Carcinoma
55
Colon Cancer
54
Chronic Lymphocytic Leukaemia
52
Lung Neoplasm Malignant
51
Acute Myeloid Leukaemia
49
Renal Cancer Metastatic
48
Pancreatic Carcinoma
47
Lymphoma
39
Plasmacytoma
39
Sarcoma
37
Small Cell Lung Cancer Stage Unspec...
35
Brain Neoplasm
35
Waldenstroms Macroglobulinaemia
34
Metastasis
32
Non-hodgkins Lymphoma
32
Prostate Cancer Metastatic
31
Glioblastoma
30
Systemic Lupus Erythematosus
29
Neoplasm Malignant
28
Metastases To Bone
26
Breast Cancer Female
26
Metastases To Lung
25
Mantle Cell Lymphoma
23
Gammopathy
23
Leukaemia Plasmacytic
21
Neoplasm
20
Chronic Myeloid Leukaemia
20
Behcets Syndrome
19
Malignant Urinary Tract Neoplasm
19
Myeloproliferative Disorder
19
Uterine Cancer
19
Glioma
19
Crohns Disease
18
Colorectal Cancer Metastatic
17
Hypergammaglobulinaemia Benign Mono...
16
Metastases To Liver
16

Drug Labels

LabelLabelerEffective
ThalomidCelgene Corporation18-FEB-13

Thalomid Case Reports

What Thalomid 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 Thalomid. 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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