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COSMEGEN

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Cosmegen Adverse Events Reported to the FDA Over Time

How are Cosmegen adverse event reports trending over time?

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

Most Common Cosmegen Adverse Events Reported to the FDA

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

Venoocclusive Liver Disease
30 (3.19%)
Liver Disorder
29 (3.09%)
Venoocclusive Disease
25 (2.66%)
Ascites
24 (2.56%)
Hepatotoxicity
22 (2.34%)
Aspartate Aminotransferase Increase...
16 (1.7%)
Pyrexia
16 (1.7%)
Alanine Aminotransferase Increased
15 (1.6%)
Blood Bilirubin Increased
15 (1.6%)
Decreased Appetite
15 (1.6%)
Disseminated Intravascular Coagulat...
15 (1.6%)
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Bone Marrow Failure
13 (1.38%)
Malnutrition
13 (1.38%)
Respiratory Failure
13 (1.38%)
Sepsis
13 (1.38%)
Febrile Neutropenia
12 (1.28%)
Drug Toxicity
11 (1.17%)
Vomiting
11 (1.17%)
Neutropenia
10 (1.06%)
Therapeutic Agent Toxicity
10 (1.06%)
Neutropenic Sepsis
9 (.96%)
Hepatic Failure
8 (.85%)
Malignant Neoplasm Progression
8 (.85%)
Nausea
8 (.85%)
Platelet Count Decreased
8 (.85%)
Thrombocytopenia
8 (.85%)
Leukopenia
7 (.75%)
Medication Error
7 (.75%)
Metastases To Lung
7 (.75%)
Nephroblastoma
7 (.75%)
Rhabdomyolysis
7 (.75%)
Accidental Overdose
6 (.64%)
Death
6 (.64%)
Gastrointestinal Disorder
6 (.64%)
General Physical Health Deteriorati...
6 (.64%)
Metastases To Bone
6 (.64%)
Metastases To Liver
6 (.64%)
Mucosal Inflammation
6 (.64%)
Multi-organ Failure
6 (.64%)
Bacterial Infection
5 (.53%)
Blood Creatinine Increased
5 (.53%)
Convulsion
5 (.53%)
Depressed Level Of Consciousness
5 (.53%)
Hepatomegaly
5 (.53%)
Pulmonary Haemorrhage
5 (.53%)
Altered State Of Consciousness
4 (.43%)
Anaemia
4 (.43%)
Anorexia
4 (.43%)
Anuria
4 (.43%)
Blood Lactate Dehydrogenase Increas...
4 (.43%)
Dermatitis Exfoliative
4 (.43%)
Dyspnoea
4 (.43%)
Fasciotomy
4 (.43%)
Gastrointestinal Mucosal Necrosis
4 (.43%)
Haematotoxicity
4 (.43%)
Haemoglobin Decreased
4 (.43%)
Inappropriate Antidiuretic Hormone ...
4 (.43%)
Liver Function Test Abnormal
4 (.43%)
Neoplasm Recurrence
4 (.43%)
Ototoxicity
4 (.43%)
Pneumonia
4 (.43%)
Renal Failure Acute
4 (.43%)
Renal Impairment
4 (.43%)
Treatment Related Secondary Maligna...
4 (.43%)
Tumour Lysis Syndrome
4 (.43%)
Urine Output Decreased
4 (.43%)
White Blood Cell Count Decreased
4 (.43%)
Activated Partial Thromboplastin Ti...
3 (.32%)
Acute Hepatic Failure
3 (.32%)
Bedridden
3 (.32%)
Blood Lactic Acid Increased
3 (.32%)
Blood Pressure Decreased
3 (.32%)
Blood Urea Increased
3 (.32%)
C-reactive Protein Increased
3 (.32%)
Caesarean Section
3 (.32%)
Cardiac Arrest
3 (.32%)
Choriocarcinoma
3 (.32%)
Continuous Haemodiafiltration
3 (.32%)
Dialysis
3 (.32%)
Diarrhoea
3 (.32%)
Disease Progression
3 (.32%)
Dizziness
3 (.32%)
Drug Exposure During Pregnancy
3 (.32%)
Dyslalia
3 (.32%)
Eyelid Oedema
3 (.32%)
Gait Disturbance
3 (.32%)
Gastrointestinal Haemorrhage
3 (.32%)
Haemorrhage
3 (.32%)
Hepatic Encephalopathy
3 (.32%)
Hypoglycaemia
3 (.32%)
Interstitial Lung Disease
3 (.32%)
Leukaemia
3 (.32%)
Lung Disorder
3 (.32%)
Microangiopathy
3 (.32%)
Myelodysplastic Syndrome
3 (.32%)
Nephropathy Toxic
3 (.32%)
No Therapeutic Response
3 (.32%)
Pancytopenia
3 (.32%)
Prothrombin Time Prolonged
3 (.32%)
Pulmonary Fibrosis
3 (.32%)
Pulmonary Oedema
3 (.32%)

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

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

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

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

Rhabdomyosarcoma
90
Nephroblastoma
40
Gestational Trophoblastic Tumour
27
Ewings Sarcoma
17
Renal Neoplasm
16
Choriocarcinoma
15
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Product Used For Unknown Indication
9
Malignant Melanoma
8
Neuroblastoma
6
Fibrosarcoma
6
Teratoma
5
Hodgkins Disease
4
Drug Use For Unknown Indication
3
Germ Cell Cancer
3
Testicular Germ Cell Tumour Mixed S...
3
Aesthesioneuroblastoma
3
Metastases To Lung
3
Herpes Zoster
3
Ewings Sarcoma Metastatic
3
Testicular Mass
3
Chondrosarcoma
2
Leiomyosarcoma
2
Neoplasm Malignant
2
Chemotherapy
2
Metastases To Liver
2
Renal Cancer
2
Testis Cancer
2
Congenital Fibrosarcoma
2
Fibromatosis
2
Carcinoma In Situ
2
Arthritis
2
Undifferentiated Sarcoma
2
Malignant Soft Tissue Neoplasm
1
Drug Therapy
1
Primitive Neuroectodermal Tumour
1
Lung Neoplasm
1
Ovarian Germ Cell Cancer
1
Benign Hydatidiform Mole
1
Metastasis
1
Testicular Germ Cell Cancer
1
Malignant Mesenchymoma
1
Bone Sarcoma
1
Sarcoma
1

Drug Labels

LabelLabelerEffective
CosmegenLundbeck LLC22-MAR-12

Cosmegen Case Reports

What Cosmegen 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 Cosmegen. 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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