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TEMODAL

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Temodal Adverse Events Reported to the FDA Over Time

How are Temodal adverse event reports trending over time?

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

Most Common Temodal Adverse Events Reported to the FDA

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

Thrombocytopenia
289 (2.33%)
Pneumonia
234 (1.89%)
Disease Progression
210 (1.69%)
Platelet Count Decreased
204 (1.64%)
Pancytopenia
201 (1.62%)
General Physical Health Deteriorati...
164 (1.32%)
White Blood Cell Count Decreased
156 (1.26%)
Pyrexia
150 (1.21%)
Alanine Aminotransferase Increased
144 (1.16%)
Bone Marrow Failure
143 (1.15%)
Neoplasm Progression
137 (1.1%)
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Lymphocyte Count Decreased
125 (1.01%)
Sepsis
120 (.97%)
Pulmonary Embolism
117 (.94%)
Anaemia
115 (.93%)
Aspartate Aminotransferase Increase...
115 (.93%)
Hepatic Function Abnormal
114 (.92%)
Nausea
110 (.89%)
Vomiting
110 (.89%)
Neutropenia
108 (.87%)
Convulsion
106 (.85%)
Malignant Neoplasm Progression
102 (.82%)
Leukopenia
97 (.78%)
Pneumocystis Jiroveci Pneumonia
93 (.75%)
Febrile Neutropenia
88 (.71%)
Gamma-glutamyltransferase Increased
82 (.66%)
Glioblastoma Multiforme
76 (.61%)
Septic Shock
75 (.6%)
Condition Aggravated
73 (.59%)
Neutrophil Count Decreased
73 (.59%)
C-reactive Protein Increased
72 (.58%)
Respiratory Failure
72 (.58%)
Haemoglobin Decreased
71 (.57%)
Brain Oedema
70 (.56%)
Disseminated Intravascular Coagulat...
70 (.56%)
Deep Vein Thrombosis
63 (.51%)
Death
59 (.48%)
Febrile Bone Marrow Aplasia
59 (.48%)
Interstitial Lung Disease
58 (.47%)
Asthenia
57 (.46%)
Infection
57 (.46%)
Altered State Of Consciousness
53 (.43%)
Multi-organ Failure
52 (.42%)
Pneumonia Aspiration
52 (.42%)
Dehydration
50 (.4%)
Dyspnoea
50 (.4%)
Depressed Level Of Consciousness
49 (.4%)
Glioblastoma
49 (.4%)
Blood Lactate Dehydrogenase Increas...
48 (.39%)
Fatigue
48 (.39%)
Headache
48 (.39%)
Lymphopenia
48 (.39%)
Urinary Tract Infection
48 (.39%)
Decreased Appetite
47 (.38%)
Petechiae
46 (.37%)
Cerebral Haemorrhage
45 (.36%)
Cholestasis
43 (.35%)
Fall
43 (.35%)
Cytolytic Hepatitis
42 (.34%)
Diarrhoea
42 (.34%)
Rash
42 (.34%)
Oedema Peripheral
41 (.33%)
Pleural Effusion
41 (.33%)
Tumour Haemorrhage
41 (.33%)
Anaplastic Astrocytoma
39 (.31%)
Coma
39 (.31%)
Hydrocephalus
39 (.31%)
Aplasia
38 (.31%)
Cardiac Failure
38 (.31%)
Dysphagia
38 (.31%)
Hemiparesis
38 (.31%)
Drug Interaction
37 (.3%)
Haemorrhage
37 (.3%)
Jaundice
36 (.29%)
Shock
36 (.29%)
Loss Of Consciousness
35 (.28%)
Anorexia
34 (.27%)
Blood Alkaline Phosphatase Increase...
34 (.27%)
Intracranial Tumour Haemorrhage
34 (.27%)
Hemiplegia
33 (.27%)
Renal Failure
32 (.26%)
Somnolence
32 (.26%)
Acute Respiratory Distress Syndrome
31 (.25%)
Aphasia
31 (.25%)
Confusional State
31 (.25%)
Epistaxis
31 (.25%)
Liver Disorder
31 (.25%)
Chills
30 (.24%)
Haematotoxicity
30 (.24%)
Neoplasm Recurrence
30 (.24%)
Stevens-johnson Syndrome
30 (.24%)
Brain Neoplasm
29 (.23%)
Lung Disorder
29 (.23%)
Constipation
28 (.23%)
Epilepsy
28 (.23%)
Hepatotoxicity
27 (.22%)
Toxic Skin Eruption
27 (.22%)
Abdominal Pain
26 (.21%)
Blood Bilirubin Increased
26 (.21%)
Blood Pressure Decreased
26 (.21%)
Hepatic Enzyme Increased
26 (.21%)

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

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

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

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

Glioblastoma Multiforme
778
Glioblastoma
729
Anaplastic Astrocytoma
242
Glioma
144
Oligodendroglioma
131
Drug Use For Unknown Indication
128
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Brain Neoplasm
115
Astrocytoma
82
Product Used For Unknown Indication
72
Metastases To Central Nervous Syste...
68
Metastatic Malignant Melanoma
64
Malignant Glioma
60
Malignant Melanoma
52
Recurrent Cancer
37
Neoplasm Recurrence
34
Lymphoma
27
Neoplasm
20
Central Nervous System Lymphoma
19
Chemotherapy
18
Brain Neoplasm Malignant
17
Gliosarcoma
16
Brain Stem Glioma
15
Medulloblastoma Recurrent
15
Malignant Oligodendroglioma
14
Mixed Oligo-astrocytoma
14
Disease Recurrence
13
Ependymoma Malignant
12
Non-small Cell Lung Cancer
8
Metastasis
7
Neoplasm Malignant
7
Neuroblastoma
6
Ependymoma
6
Lung Cancer Metastatic
5
Astrocytoma Malignant
5
Gliomatosis Cerebri
5
Breast Cancer Metastatic
4
Neuroendocrine Tumour
4
Non-hodgkins Lymphoma
4
Pancreatic Neoplasm
4
Non-small Cell Lung Cancer Metastat...
4
Neuroblastoma Recurrent
4
Gastrointestinal Carcinoma
4
Radiotherapy
4
Sarcoma
4
Central Nervous System Neoplasm
3
Breast Cancer
3
Phaeochromocytoma
3
Myelodysplastic Syndrome
3
Acute Myeloid Leukaemia
3
Ovarian Cancer
2
Peritoneal Carcinoma
2

Temodal Case Reports

What Temodal 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 Temodal. 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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