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Doxil Adverse Events Reported to the FDA Over Time

How are Doxil adverse event reports trending over time?

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

Most Common Doxil Adverse Events Reported to the FDA

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

Interstitial Lung Disease
157 (1.55%)
Nausea
155 (1.53%)
Vomiting
151 (1.49%)
Pyrexia
145 (1.43%)
Palmar-plantar Erythrodysaesthesia ...
138 (1.36%)
Pneumonia
136 (1.34%)
Asthenia
118 (1.16%)
Diarrhoea
112 (1.1%)
Pancytopenia
112 (1.1%)
Dyspnoea
110 (1.08%)
Dehydration
107 (1.05%)
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Renal Failure Acute
100 (.99%)
Neutropenia
97 (.96%)
Fatigue
91 (.9%)
Thrombocytopenia
91 (.9%)
Death
89 (.88%)
White Blood Cell Count Decreased
86 (.85%)
Febrile Neutropenia
84 (.83%)
Infusion Related Reaction
83 (.82%)
Platelet Count Decreased
83 (.82%)
Hypotension
81 (.8%)
Anaemia
76 (.75%)
Ovarian Cancer
75 (.74%)
Pulmonary Embolism
74 (.73%)
Rash
74 (.73%)
Respiratory Failure
72 (.71%)
Haemoglobin Decreased
70 (.69%)
Pleural Effusion
69 (.68%)
Oedema Peripheral
68 (.67%)
Abdominal Pain
65 (.64%)
Malaise
65 (.64%)
Pain
63 (.62%)
Malignant Neoplasm Progression
61 (.6%)
Multiple Myeloma
59 (.58%)
Renal Failure
58 (.57%)
Stomatitis
56 (.55%)
Aspartate Aminotransferase Increase...
55 (.54%)
Cardiac Failure Congestive
55 (.54%)
Disease Progression
55 (.54%)
Sepsis
55 (.54%)
Off Label Use
54 (.53%)
Constipation
53 (.52%)
Atrial Fibrillation
51 (.5%)
Decreased Appetite
50 (.49%)
Myocardial Infarction
48 (.47%)
Confusional State
47 (.46%)
Deep Vein Thrombosis
47 (.46%)
Urinary Tract Infection
46 (.45%)
Bone Marrow Failure
45 (.44%)
Hepatic Function Abnormal
44 (.43%)
Infection
44 (.43%)
Neuropathy Peripheral
43 (.42%)
Hypertension
41 (.4%)
Alanine Aminotransferase Increased
40 (.39%)
Chest Pain
40 (.39%)
Disseminated Intravascular Coagulat...
39 (.38%)
Leukopenia
39 (.38%)
Dizziness
38 (.37%)
Fall
38 (.37%)
Hypoxia
38 (.37%)
Erythema
37 (.36%)
Mental Status Changes
37 (.36%)
Anorexia
36 (.35%)
Blister
36 (.35%)
Cellulitis
36 (.35%)
Tachycardia
36 (.35%)
Cardiac Failure
35 (.35%)
Chills
35 (.35%)
Hyponatraemia
35 (.35%)
Pain In Extremity
35 (.35%)
International Normalised Ratio Incr...
34 (.34%)
Multi-organ Failure
34 (.34%)
Blood Creatinine Increased
33 (.33%)
Blood Sodium Decreased
33 (.33%)
Neutrophil Count Decreased
33 (.33%)
Syncope
33 (.33%)
Staphylococcal Infection
31 (.31%)
Blood Pressure Decreased
30 (.3%)
Flushing
30 (.3%)
General Physical Health Deteriorati...
30 (.3%)
Headache
30 (.3%)
Hypersensitivity
30 (.3%)
Back Pain
29 (.29%)
Hypokalaemia
29 (.29%)
Tumour Lysis Syndrome
29 (.29%)
Abdominal Distension
28 (.28%)
Ileus
28 (.28%)
Pulmonary Oedema
28 (.28%)
Cough
27 (.27%)
Failure To Thrive
27 (.27%)
Neutropenic Sepsis
27 (.27%)
Pulmonary Hypertension
27 (.27%)
Weight Decreased
27 (.27%)
Acute Respiratory Distress Syndrome
26 (.26%)
Blood Alkaline Phosphatase Increase...
26 (.26%)
Haematocrit Decreased
26 (.26%)
Intestinal Obstruction
26 (.26%)
Rhabdomyolysis
26 (.26%)
Blood Pressure Increased
25 (.25%)
Carbohydrate Antigen 125 Increased
25 (.25%)
Acute Myeloid Leukaemia
24 (.24%)

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

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

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

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

Multiple Myeloma
708
Ovarian Cancer
415
Ovarian Cancer Recurrent
186
Breast Cancer
88
Drug Use For Unknown Indication
77
Product Used For Unknown Indication
53
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Breast Cancer Metastatic
47
T-cell Lymphoma
39
Prostate Cancer
38
Kaposis Sarcoma
35
Endometrial Cancer
31
Uterine Cancer
30
Ovarian Cancer Metastatic
29
Diffuse Large B-cell Lymphoma
23
Non-hodgkins Lymphoma
20
Ovarian Epithelial Cancer Recurrent
19
Neoplasm Malignant
17
Sarcoma
17
Acute Lymphocytic Leukaemia
17
Ovarian Epithelial Cancer
15
B-cell Lymphoma
14
Burkitts Lymphoma
13
Lymphoma
12
Malignant Peritoneal Neoplasm
12
Mycosis Fungoides
9
Hepatic Neoplasm Malignant
9
Fallopian Tube Cancer
8
Cervix Carcinoma
7
Endometrial Cancer Recurrent
7
Peritoneal Carcinoma
7
Recurrent Cancer
6
Uterine Leiomyosarcoma
6
Chemotherapy
6
Breast Cancer Female
6
Hodgkins Disease
6
Lung Neoplasm Malignant
5
Kaposis Sarcoma Aids Related
5
Mantle Cell Lymphoma
5
Peripheral T-cell Lymphoma Unspecif...
5
Neoplasm Recurrence
4
Angiosarcoma
4
Malignant Ascites
4
Bladder Cancer
3
Squamous Cell Carcinoma Of Skin
3
Genital Neoplasm Malignant Female
3
Liposarcoma Recurrent
3
Hepatic Neoplasm
3
Non-small Cell Lung Cancer
3
Renal Cancer Metastatic
3
Lung Cancer Metastatic
3
Leukaemia
3

Drug Labels

LabelLabelerEffective
DoxilJanssen Products, LP19-SEP-12
DoxilJanssen Products, LP12-MAR-13

Doxil Case Reports

What Doxil 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 Doxil. 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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