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THIOTEPA

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Thiotepa Adverse Events Reported to the FDA Over Time

How are Thiotepa adverse event reports trending over time?

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

Most Common Thiotepa Adverse Events Reported to the FDA

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

Mucosal Inflammation
86 (2.63%)
Sepsis
83 (2.54%)
Neutropenia
57 (1.74%)
Pyrexia
55 (1.68%)
Diarrhoea
48 (1.47%)
Febrile Neutropenia
48 (1.47%)
Drug Toxicity
38 (1.16%)
Stem Cell Transplant
38 (1.16%)
Venoocclusive Disease
36 (1.1%)
Multi-organ Failure
34 (1.04%)
Respiratory Failure
34 (1.04%)
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Venoocclusive Liver Disease
33 (1.01%)
Graft Versus Host Disease
31 (.95%)
Leukoencephalopathy
30 (.92%)
Renal Failure
30 (.92%)
Infection
28 (.86%)
Acute Respiratory Distress Syndrome
27 (.83%)
Hypotension
27 (.83%)
Encephalopathy
25 (.76%)
General Physical Health Deteriorati...
25 (.76%)
Haematotoxicity
25 (.76%)
Gastrointestinal Toxicity
24 (.73%)
Hypertension
24 (.73%)
Dermatitis
23 (.7%)
Ascites
22 (.67%)
Hyperbilirubinaemia
22 (.67%)
Pneumonitis
22 (.67%)
Vomiting
22 (.67%)
Hypoxia
20 (.61%)
Thrombocytopenia
20 (.61%)
Bone Marrow Failure
19 (.58%)
Stomatitis
19 (.58%)
Bone Sarcoma
18 (.55%)
Hepatotoxicity
18 (.55%)
Pleural Effusion
18 (.55%)
Convulsion
17 (.52%)
Blood Bilirubin Increased
16 (.49%)
Acute Graft Versus Host Disease
15 (.46%)
Mental Status Changes
15 (.46%)
Metaplasia
15 (.46%)
Myelopathy
15 (.46%)
Pericardial Effusion
15 (.46%)
Pneumonia
15 (.46%)
Disease Progression
14 (.43%)
Respiratory Distress
14 (.43%)
Abdominal Pain
13 (.4%)
Cardiac Arrest
13 (.4%)
Neuropathy Peripheral
13 (.4%)
Neurotoxicity
13 (.4%)
Thrombotic Microangiopathy
13 (.4%)
Bone Marrow Transplant
12 (.37%)
Haematuria
12 (.37%)
Hepatic Function Abnormal
12 (.37%)
Malignant Neoplasm Progression
12 (.37%)
Neoplasm Malignant
12 (.37%)
Adenovirus Infection
11 (.34%)
Alanine Aminotransferase Increased
11 (.34%)
Cytomegalovirus Infection
11 (.34%)
Death
11 (.34%)
Epistaxis
11 (.34%)
Gastrointestinal Haemorrhage
11 (.34%)
Nausea
11 (.34%)
Pulmonary Oedema
11 (.34%)
Renal Failure Acute
11 (.34%)
Skin Toxicity
11 (.34%)
Stevens-johnson Syndrome
11 (.34%)
Anaemia
10 (.31%)
Aspartate Aminotransferase Increase...
10 (.31%)
Aspergillosis
10 (.31%)
Blood Culture Positive
10 (.31%)
Cystitis Haemorrhagic
10 (.31%)
Dyspnoea
10 (.31%)
Pancytopenia
10 (.31%)
Weight Increased
10 (.31%)
Abdominal Distension
9 (.28%)
Bk Virus Infection
9 (.28%)
Blood Lactate Dehydrogenase Increas...
9 (.28%)
Cardiac Failure
9 (.28%)
Central Nervous System Lymphoma
9 (.28%)
Chronic Graft Versus Host Disease
9 (.28%)
Confusional State
9 (.28%)
Device Related Infection
9 (.28%)
Epstein-barr Virus Infection
9 (.28%)
Myelitis Transverse
9 (.28%)
Nephropathy Toxic
9 (.28%)
Oedema
9 (.28%)
Platelet Count Decreased
9 (.28%)
Pneumothorax
9 (.28%)
Tachypnoea
9 (.28%)
Acute Leukaemia
8 (.24%)
Deafness
8 (.24%)
Dehydration
8 (.24%)
Erythema
8 (.24%)
Fungaemia
8 (.24%)
Haematemesis
8 (.24%)
Herpes Zoster
8 (.24%)
Pulmonary Veno-occlusive Disease
8 (.24%)
Tachycardia
8 (.24%)
Thrombosis
8 (.24%)
Anxiety
7 (.21%)
Asthenia
7 (.21%)

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

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

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

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

Stem Cell Transplant
112
Bone Marrow Conditioning Regimen
59
Acute Lymphocytic Leukaemia
57
Medulloblastoma
49
Acute Myeloid Leukaemia
31
Acute Leukaemia
24
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Central Nervous System Lymphoma
24
Bone Marrow Transplant
21
Primitive Neuroectodermal Tumour
16
Brain Neoplasm Malignant
15
Non-hodgkins Lymphoma
14
Chemotherapy
13
Haematological Malignancy
12
Neoplasm
10
Allogenic Bone Marrow Transplantati...
10
Product Used For Unknown Indication
9
Myelodysplastic Syndrome
7
Ewings Sarcoma
7
Acute Promyelocytic Leukaemia
7
Hodgkins Disease
6
Germ Cell Cancer
6
Lymphoma
6
B-cell Lymphoma
6
Burkitts Lymphoma
6
Breast Cancer
5
Rhabdomyosarcoma
5
Cord Blood Transplant Therapy
5
Lung Neoplasm
5
Breast Cancer Metastatic
5
Diffuse Large B-cell Lymphoma
4
Nephroblastoma
4
Pinealoblastoma
4
Autologous Bone Marrow Transplantat...
4
Diffuse Large B-cell Lymphoma Stage...
3
Glioma
3
Chronic Myeloid Leukaemia
3
Retinoblastoma Bilateral
3
Leukaemia
3
Neuroblastoma
3
Nephritic Syndrome
2
Retinoblastoma
2
Prophylaxis Against Transplant Reje...
2
Testis Cancer
2
Bone Neoplasm Malignant
2
Acute Biphenotypic Leukaemia
2
Therapeutic Procedure
2
Anaplastic Astrocytoma
2
Transplant
2
Neoplasm Malignant
2
Drug Use For Unknown Indication
2
Acute Lymphocytic Leukaemia Recurre...
2

Drug Labels

LabelLabelerEffective
ThiotepaBedford Laboratories02-APR-10

Thiotepa Case Reports

What Thiotepa 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 Thiotepa. 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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