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Lysodren Adverse Events Reported to the FDA Over Time

How are Lysodren adverse event reports trending over time?

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

Most Common Lysodren Adverse Events Reported to the FDA

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

Drug Level Above Therapeutic
22 (2.99%)
Gamma-glutamyltransferase Increased
18 (2.45%)
Cytolytic Hepatitis
17 (2.31%)
Weight Decreased
16 (2.18%)
Vomiting
15 (2.04%)
Asthenia
14 (1.9%)
Dizziness
13 (1.77%)
Fatigue
13 (1.77%)
Malignant Neoplasm Progression
13 (1.77%)
Rash
13 (1.77%)
Somnolence
13 (1.77%)
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Adrenal Insufficiency
12 (1.63%)
Alanine Aminotransferase Increased
12 (1.63%)
Condition Aggravated
12 (1.63%)
Nausea
12 (1.63%)
Aspartate Aminotransferase Increase...
11 (1.5%)
Anaemia
10 (1.36%)
Death
10 (1.36%)
Diarrhoea
10 (1.36%)
Hepatitis Acute
10 (1.36%)
Overdose
9 (1.22%)
Hepatic Enzyme Increased
8 (1.09%)
Hepatitis
8 (1.09%)
Anorexia
7 (.95%)
Blood Alkaline Phosphatase Increase...
7 (.95%)
Hypokalaemia
7 (.95%)
Tremor
7 (.95%)
Accidental Exposure
6 (.82%)
Blood Lactate Dehydrogenase Increas...
6 (.82%)
Cholestasis
6 (.82%)
Disturbance In Attention
6 (.82%)
Hypercholesterolaemia
6 (.82%)
Hypothyroidism
6 (.82%)
Memory Impairment
6 (.82%)
Neoplasm Progression
6 (.82%)
Psychomotor Hyperactivity
6 (.82%)
Sleep Disorder
6 (.82%)
White Blood Cell Count Decreased
6 (.82%)
Altered State Of Consciousness
5 (.68%)
Aplasia Pure Red Cell
5 (.68%)
Drug Level Below Therapeutic
5 (.68%)
Drug Level Increased
5 (.68%)
Gastrointestinal Disorder
5 (.68%)
Leukopenia
5 (.68%)
Neutropenia
5 (.68%)
Neutrophil Count Decreased
5 (.68%)
Red Blood Cell Count Decreased
5 (.68%)
Speech Disorder
5 (.68%)
Adverse Event
4 (.54%)
Dysphagia
4 (.54%)
Gait Disturbance
4 (.54%)
Liver Disorder
4 (.54%)
Myalgia
4 (.54%)
Renal Failure
4 (.54%)
Abdominal Pain
3 (.41%)
Adrenocortical Carcinoma
3 (.41%)
Aggression
3 (.41%)
Cardiac Arrest
3 (.41%)
Coma
3 (.41%)
Confusional State
3 (.41%)
Decreased Appetite
3 (.41%)
Dehydration
3 (.41%)
Depressed Level Of Consciousness
3 (.41%)
Depression
3 (.41%)
Diplopia
3 (.41%)
Disease Progression
3 (.41%)
Dyspepsia
3 (.41%)
Eosinophil Count Increased
3 (.41%)
Febrile Neutropenia
3 (.41%)
Hyponatraemia
3 (.41%)
Lethargy
3 (.41%)
Liver Function Test Abnormal
3 (.41%)
Neurological Symptom
3 (.41%)
Off Label Use
3 (.41%)
Pelvic Pain
3 (.41%)
Proteinuria
3 (.41%)
Pyrexia
3 (.41%)
Renal Failure Acute
3 (.41%)
Renal Impairment
3 (.41%)
Respiratory Distress
3 (.41%)
Sepsis
3 (.41%)
Septic Shock
3 (.41%)
Thrombocytopenia
3 (.41%)
Transaminases Increased
3 (.41%)
Vertigo
3 (.41%)
Vision Blurred
3 (.41%)
Amnesia
2 (.27%)
Ataxia
2 (.27%)
Blood Count Abnormal
2 (.27%)
Blood Potassium Decreased
2 (.27%)
Cerebral Thrombosis
2 (.27%)
Chills
2 (.27%)
Disorientation
2 (.27%)
Drug Administration Error
2 (.27%)
Dysarthria
2 (.27%)
Epistaxis
2 (.27%)
Feeling Drunk
2 (.27%)
Gastrointestinal Haemorrhage
2 (.27%)
Hepatic Failure
2 (.27%)
Hepatitis Toxic
2 (.27%)
Hypertension
2 (.27%)

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

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

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

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

Adrenocortical Carcinoma
93
Adrenal Carcinoma
38
Hyperadrenocorticism
8
Cushings Syndrome
7
Adrenal Gland Cancer Metastatic
5
Pituitary-dependent Cushings Syndro...
4
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Drug Use For Unknown Indication
3
Ill-defined Disorder
2
Product Used For Unknown Indication
1
Metastases To Liver
1
Recurrent Cancer
1
Accidental Exposure
1
Acth-producing Pituitary Tumour
1
Chemotherapy
1

Drug Labels

LabelLabelerEffective
LysodrenE.R. Squibb & Sons, L.L.C.11-NOV-11

Lysodren Case Reports

What Lysodren 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 Lysodren. 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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