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TEMODAR

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Temodar Adverse Events Reported to the FDA Over Time

How are Temodar adverse event reports trending over time?

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

Most Common Temodar Adverse Events Reported to the FDA

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

Pancytopenia
164 (1.96%)
Death
160 (1.91%)
Platelet Count Decreased
136 (1.62%)
Vomiting
134 (1.6%)
Thrombocytopenia
133 (1.59%)
Disease Progression
132 (1.58%)
Nausea
131 (1.57%)
Asthenia
120 (1.43%)
Pyrexia
118 (1.41%)
Convulsion
115 (1.37%)
Dehydration
108 (1.29%)
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Pneumonia
101 (1.21%)
Fatigue
97 (1.16%)
Confusional State
95 (1.14%)
Pulmonary Embolism
95 (1.14%)
Deep Vein Thrombosis
83 (.99%)
Headache
82 (.98%)
White Blood Cell Count Decreased
80 (.96%)
Febrile Neutropenia
79 (.94%)
Neutropenia
77 (.92%)
Diarrhoea
74 (.88%)
Haemoglobin Decreased
74 (.88%)
Fall
71 (.85%)
Dyspnoea
70 (.84%)
Hypotension
64 (.76%)
Aplastic Anaemia
62 (.74%)
Mental Status Changes
62 (.74%)
Hyperglycaemia
60 (.72%)
Sepsis
55 (.66%)
Hyponatraemia
53 (.63%)
Malignant Neoplasm Progression
53 (.63%)
Renal Failure Acute
51 (.61%)
Bone Marrow Failure
49 (.59%)
Anaemia
48 (.57%)
Rash
48 (.57%)
Neoplasm Progression
46 (.55%)
Leukopenia
40 (.48%)
Urinary Tract Infection
39 (.47%)
Lymphopenia
38 (.45%)
Constipation
36 (.43%)
Abdominal Pain
35 (.42%)
Hypokalaemia
35 (.42%)
Atrial Fibrillation
34 (.41%)
Muscular Weakness
34 (.41%)
Chills
33 (.39%)
Anorexia
31 (.37%)
Glioblastoma Multiforme
31 (.37%)
Neutrophil Count Decreased
31 (.37%)
Tachycardia
30 (.36%)
Weight Decreased
30 (.36%)
Alanine Aminotransferase Increased
29 (.35%)
Malaise
29 (.35%)
Somnolence
29 (.35%)
Brain Oedema
28 (.33%)
Dizziness
28 (.33%)
Lethargy
28 (.33%)
Pain
28 (.33%)
Aspartate Aminotransferase Increase...
27 (.32%)
Gait Disturbance
27 (.32%)
Infection
27 (.32%)
Oedema Peripheral
27 (.32%)
Syncope
27 (.32%)
Haematocrit Decreased
25 (.3%)
Pneumonitis
25 (.3%)
Haemorrhage
24 (.29%)
Hypoxia
24 (.29%)
Cerebral Haemorrhage
23 (.27%)
Depressed Level Of Consciousness
23 (.27%)
Thrombosis
23 (.27%)
Condition Aggravated
22 (.26%)
Decreased Appetite
22 (.26%)
General Physical Health Deteriorati...
22 (.26%)
Hemiparesis
22 (.26%)
Renal Failure
22 (.26%)
Urinary Incontinence
22 (.26%)
Atelectasis
21 (.25%)
Blood Glucose Increased
20 (.24%)
Chest Pain
20 (.24%)
Grand Mal Convulsion
20 (.24%)
Tremor
20 (.24%)
Agitation
19 (.23%)
Drug Ineffective
19 (.23%)
Dysphagia
19 (.23%)
Pneumocystis Jiroveci Pneumonia
19 (.23%)
Abasia
18 (.22%)
Back Pain
18 (.22%)
Balance Disorder
18 (.22%)
Cough
18 (.22%)
Hypophosphataemia
18 (.22%)
Petechiae
18 (.22%)
Respiratory Failure
18 (.22%)
Unresponsive To Stimuli
18 (.22%)
Aphasia
17 (.2%)
Colitis
17 (.2%)
Contusion
17 (.2%)
Encephalopathy
17 (.2%)
Oedema
17 (.2%)
Pleural Effusion
17 (.2%)
Acute Respiratory Distress Syndrome
16 (.19%)
Blood Alkaline Phosphatase Increase...
16 (.19%)
Cerebrovascular Accident
16 (.19%)

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

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

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

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

Glioblastoma Multiforme
658
Brain Neoplasm
151
Glioblastoma
118
Drug Use For Unknown Indication
114
Malignant Melanoma
98
Product Used For Unknown Indication
58
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Brain Neoplasm Malignant
51
Metastatic Malignant Melanoma
49
Oligodendroglioma
44
Astrocytoma
41
Anaplastic Astrocytoma
37
Glioma
31
Metastases To Central Nervous Syste...
29
Acute Myeloid Leukaemia
24
Malignant Glioma
18
Neoplasm Malignant
17
Non-small Cell Lung Cancer
15
Astrocytoma, Low Grade
13
Chemotherapy
11
Breast Cancer Metastatic
8
Neuroendocrine Tumour
7
Central Nervous System Lymphoma
6
Hepatic Neoplasm Malignant
6
Nervous System Disorder
5
Metastasis
5
Neoplasm
5
Neuroblastoma
5
Malignant Melanoma Stage Iv
4
Malignant Oligodendroglioma
4
Neuroendocrine Carcinoma
4
Disease Recurrence
3
Gliosarcoma
3
Connective Tissue Disorder
3
Lung Adenocarcinoma
3
Metastatic Neoplasm
3
Ependymoma
3
Gliomatosis Cerebri
3
Metastases To Meninges
3
Sarcoma
2
Lung Neoplasm Malignant
2
Metastases To Liver
2
Lymphoma
2
Mixed Oligo-astrocytoma
2
Small Cell Lung Cancer Stage Unspec...
2
Haemangiopericytoma
2
Lung Cancer Metastatic
2
Lung Squamous Cell Carcinoma Stage ...
2
Tongue Cancer Metastatic
2
Off Label Use
2
Prostate Cancer
2
Meningeal Disorder
2

Drug Labels

LabelLabelerEffective
TemodarPhysicians Total Care, Inc.09-FEB-11
TemodarMerck Sharp & Dohme Corp.08-JAN-13

Temodar Case Reports

What Temodar 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 Temodar. 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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