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DACARBAZINE

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Dacarbazine Adverse Events Reported to the FDA Over Time

How are Dacarbazine adverse event reports trending over time?

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

Most Common Dacarbazine Adverse Events Reported to the FDA

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

Pulmonary Toxicity
111 (2.74%)
Pyrexia
79 (1.95%)
Dyspnoea
66 (1.63%)
Febrile Neutropenia
66 (1.63%)
Neutropenia
58 (1.43%)
Disease Progression
52 (1.28%)
Vomiting
49 (1.21%)
Pulmonary Embolism
47 (1.16%)
Dehydration
46 (1.14%)
Thrombocytopenia
46 (1.14%)
Anaemia
43 (1.06%)
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Fatigue
42 (1.04%)
Nausea
38 (.94%)
Acute Myeloid Leukaemia
37 (.91%)
Malignant Neoplasm Progression
35 (.86%)
Metastatic Malignant Melanoma
34 (.84%)
Pancytopenia
34 (.84%)
Pneumonia
34 (.84%)
Platelet Count Decreased
31 (.77%)
Haemoglobin Decreased
30 (.74%)
Abdominal Pain
29 (.72%)
Hypotension
29 (.72%)
Hypothyroidism
29 (.72%)
Interstitial Lung Disease
29 (.72%)
Pleural Effusion
28 (.69%)
Asthenia
26 (.64%)
Drug Toxicity
26 (.64%)
Alanine Aminotransferase Increased
25 (.62%)
Diarrhoea
25 (.62%)
Renal Failure
25 (.62%)
Aspartate Aminotransferase Increase...
23 (.57%)
Hypertension
21 (.52%)
Sepsis
21 (.52%)
White Blood Cell Count Decreased
21 (.52%)
Atrial Fibrillation
20 (.49%)
Chills
19 (.47%)
Myelodysplastic Syndrome
19 (.47%)
Death
18 (.44%)
Blood Bilirubin Increased
17 (.42%)
Loss Of Consciousness
17 (.42%)
Renal Failure Acute
17 (.42%)
Tumour Lysis Syndrome
17 (.42%)
Hypoxia
16 (.39%)
Infection
16 (.39%)
Lung Infiltration
16 (.39%)
Pericardial Effusion
16 (.39%)
Tachycardia
16 (.39%)
Cough
15 (.37%)
Mucosal Inflammation
15 (.37%)
Back Pain
14 (.35%)
Cellulitis
14 (.35%)
Cerebral Haemorrhage
14 (.35%)
Constipation
14 (.35%)
Liver Function Test Abnormal
14 (.35%)
Malignant Melanoma
14 (.35%)
Metastases To Central Nervous Syste...
14 (.35%)
Oedema Peripheral
14 (.35%)
Confusional State
13 (.32%)
Deep Vein Thrombosis
13 (.32%)
Hyponatraemia
13 (.32%)
Metastases To Lung
13 (.32%)
Staphylococcal Infection
13 (.32%)
Syncope
13 (.32%)
Acute Lymphocytic Leukaemia
12 (.3%)
Hypocalcaemia
12 (.3%)
Lethargy
12 (.3%)
Lower Respiratory Tract Infection
12 (.3%)
Neutrophil Count Decreased
12 (.3%)
Pneumothorax
12 (.3%)
Sinus Tachycardia
12 (.3%)
Thrombosis
12 (.3%)
White Blood Cell Count Increased
12 (.3%)
Anorexia
11 (.27%)
Ascites
11 (.27%)
Chest Pain
11 (.27%)
Diverticulitis
11 (.27%)
Drug Exposure During Pregnancy
11 (.27%)
General Physical Health Deteriorati...
11 (.27%)
Headache
11 (.27%)
Lung Disorder
11 (.27%)
Malaise
11 (.27%)
Myocardial Infarction
11 (.27%)
Orthostatic Hypotension
11 (.27%)
Treatment Related Secondary Maligna...
11 (.27%)
Gamma-glutamyltransferase Increased
10 (.25%)
Gastrointestinal Haemorrhage
10 (.25%)
Lymphocyte Count Decreased
10 (.25%)
Neoplasm Malignant
10 (.25%)
Nephrolithiasis
10 (.25%)
Neuropathy Peripheral
10 (.25%)
Pancreatitis
10 (.25%)
Rash
10 (.25%)
Ureteric Obstruction
10 (.25%)
Urinary Tract Infection
10 (.25%)
Abdominal Pain Upper
9 (.22%)
Blood Lactate Dehydrogenase Increas...
9 (.22%)
Chest Discomfort
9 (.22%)
Cytolytic Hepatitis
9 (.22%)
Ileus
9 (.22%)
Intracardiac Thrombus
9 (.22%)
Lipase Increased
9 (.22%)

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

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

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

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

Hodgkins Disease
506
Metastatic Malignant Melanoma
272
Malignant Melanoma
232
Malignant Melanoma Stage Iv
43
Sarcoma
31
Non-hodgkins Lymphoma
14
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Lymphoma
14
Multiple Myeloma
13
Neuroblastoma
11
Drug Use For Unknown Indication
10
Hodgkins Disease Nodular Sclerosis ...
8
Chemotherapy
7
Pseudolymphoma
7
Rhabdomyosarcoma
7
Metastases To Lung
7
Hodgkins Disease Stage Iii
7
Product Used For Unknown Indication
6
Neoplasm Malignant
5
Leiomyosarcoma
5
Mesothelioma
4
Hodgkins Disease Stage Iv
4
Metastases To Liver
4
Hodgkins Disease Stage Ii
3
Drug Exposure During Pregnancy
3
Carcinoid Tumour Of The Small Bowel
3
Thyroid Cancer
3
Adenomatous Polyposis Coli
3
Synovial Sarcoma
3
Non-hodgkins Lymphoma Stage Iv
3
Haematological Malignancy
2
Lymphoma Aids Related
2
Sarcoma Metastatic
2
Ganglioneuroblastoma
2
Ovarian Cancer Recurrent
2
Brain Neoplasm
2
Hodgkins Disease Mixed Cellularity ...
2
Foetal Exposure During Pregnancy
2
Accidental Exposure
1
Peritoneal Sarcoma
1
Metastasis
1
Depression
1
Metastases To Skin
1
Retroperitoneal Cancer
1
Malignant Soft Tissue Neoplasm
1
Intraocular Melanoma
1
Bone Sarcoma
1
Melanoma Recurrent
1
Pancreatic Neuroendocrine Tumour
1
Renal Mass
1
Chemotherapy Multiple Agents System...
1
Retroperitoneal Neoplasm
1

Drug Labels

LabelLabelerEffective
DacarbazineTeva Parenteral Medicines, Inc09-OCT-09
DacarbazineBedford Laboratories05-MAY-10
DacarbazineBedford Laboratories05-MAY-10
DacarbazineHospira Worldwide, Inc.27-SEP-11
DacarbazineAPP Pharmaceuticals, LLC04-SEP-12

Dacarbazine Case Reports

What Dacarbazine 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 Dacarbazine. 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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