CLADRIBINE

Cladribine Adverse Events Reported to the FDA Over Time

How are Cladribine adverse event reports trending over time?

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

Most Common Cladribine Adverse Events Reported to the FDA

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

Pyrexia	42 (3.22%)
Pancytopenia	39 (2.99%)
Lymphopenia	34 (2.61%)
Myelodysplastic Syndrome	33 (2.53%)
Neutropenia	30 (2.3%)
Sepsis	29 (2.23%)
Anaemia Haemolytic Autoimmune	22 (1.69%)
Bone Marrow Failure	20 (1.53%)
Thrombocytopenia	19 (1.46%)
Pneumonia	17 (1.3%)
Type Iv Hypersensitivity Reaction	17 (1.3%)
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Autoimmune Thrombocytopenia	16 (1.23%)
Febrile Neutropenia	15 (1.15%)
Rash Maculo-papular	13 (1%)
Aspergillosis	11 (.84%)
Respiratory Failure	10 (.77%)
Bronchopulmonary Aspergillosis	9 (.69%)
Chronic Lymphocytic Leukaemia Trans...	9 (.69%)
Dermatitis	9 (.69%)
Drug Ineffective	9 (.69%)
Malignant Neoplasm Progression	9 (.69%)
Metastases To Liver	9 (.69%)
Off Label Use	9 (.69%)
Pulmonary Haemorrhage	9 (.69%)
Squamous Cell Carcinoma	9 (.69%)
Thyroiditis	9 (.69%)
Hairy Cell Leukaemia	8 (.61%)
Hypotension	8 (.61%)
Infection	8 (.61%)
Neuropathy Peripheral	8 (.61%)
Progressive Multifocal Leukoencepha...	8 (.61%)
Renal Failure	8 (.61%)
Disease Recurrence	7 (.54%)
Drug Eruption	7 (.54%)
Dyspnoea	7 (.54%)
Nausea	7 (.54%)
Neutrophil Count Decreased	7 (.54%)
Non-small Cell Lung Cancer	7 (.54%)
Rash	7 (.54%)
Acute Myeloid Leukaemia	6 (.46%)
Anaemia	6 (.46%)
Death	6 (.46%)
Epstein-barr Virus Infection	6 (.46%)
Hypoalbuminaemia	6 (.46%)
Hypoxia	6 (.46%)
Lymphadenopathy	6 (.46%)
Multi-organ Failure	6 (.46%)
Oesophageal Carcinoma	6 (.46%)
Refractory Anaemia	6 (.46%)
Renal Impairment	6 (.46%)
Skin Disorder	6 (.46%)
Vomiting	6 (.46%)
Arrhythmia	5 (.38%)
Cardiac Disorder	5 (.38%)
Cd4/cd8 Ratio Decreased	5 (.38%)
Disseminated Intravascular Coagulat...	5 (.38%)
Embolism	5 (.38%)
Grand Mal Convulsion	5 (.38%)
Incorrect Route Of Drug Administrat...	5 (.38%)
Leukaemia Recurrent	5 (.38%)
Lung Disorder	5 (.38%)
Neuroendocrine Carcinoma Of The Ski...	5 (.38%)
Pain	5 (.38%)
Pulmonary Embolism	5 (.38%)
Stem Cell Transplant	5 (.38%)
Acute Febrile Neutrophilic Dermatos...	4 (.31%)
Anaphylactic Reaction	4 (.31%)
B-cell Lymphoma	4 (.31%)
Cd4 Lymphocytes Decreased	4 (.31%)
Decreased Appetite	4 (.31%)
Deep Vein Thrombosis	4 (.31%)
Disseminated Cytomegaloviral Infect...	4 (.31%)
Eye Infection Toxoplasmal	4 (.31%)
Gastric Cancer	4 (.31%)
Haematotoxicity	4 (.31%)
Haemorrhage	4 (.31%)
Hepatic Enzyme Increased	4 (.31%)
Hepatotoxicity	4 (.31%)
Herpes Zoster	4 (.31%)
Hyperbilirubinaemia	4 (.31%)
Hypothyroidism	4 (.31%)
Liver Function Test Abnormal	4 (.31%)
Lung Neoplasm Malignant	4 (.31%)
Lymphoproliferative Disorder	4 (.31%)
Metastases To Bone	4 (.31%)
Mucosal Inflammation	4 (.31%)
Neoplasm Malignant	4 (.31%)
Neurotoxicity	4 (.31%)
No Therapeutic Response	4 (.31%)
Papilloedema	4 (.31%)
Pneumatosis Intestinalis	4 (.31%)
Respiratory Distress	4 (.31%)
Sinusitis Fungal	4 (.31%)
Splenomegaly	4 (.31%)
Systemic Mastocytosis	4 (.31%)
Therapeutic Response Decreased	4 (.31%)
Urine Output Decreased	4 (.31%)
Varicella	4 (.31%)
Acute Monocytic Leukaemia	3 (.23%)
Agranulocytosis	3 (.23%)
Aplasia Pure Red Cell	3 (.23%)

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

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

White Blood Cell	86 (6.6%)
Leukemias	74 (5.68%)
Infections - Pathogen Unspecified	72 (5.53%)
Anemias Nonhemolytic And Marrow Dep...	71 (5.45%)
Epidermal And Dermal Conditions	68 (5.22%)
Respiratory	51 (3.91%)
Body Temperature Conditions	42 (3.22%)
Viral Infectious	39 (2.99%)
Fungal Infectious	37 (2.84%)
Platelet	35 (2.69%)
Miscellaneous And Site Unspecified ...	27 (2.07%)
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Bacterial Infectious	26 (2%)
Allergic Conditions	25 (1.92%)
Hematology Investigations	25 (1.92%)
Therapeutic And Nontherapeutic Effe...	24 (1.84%)
Hemolyses And Related Conditions	22 (1.69%)
Hepatic And Hepatobiliary	20 (1.53%)
Renal Disorders	20 (1.53%)
Gastrointestinal Signs	18 (1.38%)
Hepatobiliary	16 (1.23%)
Gastrointestinal Neoplasms Malignan...	15 (1.15%)
Decreased And Nonspecific Blood Pre...	14 (1.07%)
Metastases	14 (1.07%)
Therapeutic Procedures And Supporti...	14 (1.07%)
Cardiac Arrhythmias	13 (1%)
Lower Respiratory Tract Disorders	13 (1%)
Respiratory And Mediastinal Neoplas...	13 (1%)
Thyroid Gland	13 (1%)
Lymphomas Non-hodgkins B-cell	12 (.92%)
Spleen, Lymphatic And Reticulendoth...	11 (.84%)
Embolism And Thrombosis	10 (.77%)
Hematological And Lymphoid Tissue T...	10 (.77%)
Neurological	10 (.77%)
Hematological	9 (.69%)
Peripheral Neuropathies	9 (.69%)
Electrolyte And Fluid Balance Condi...	8 (.61%)
Gastrointestinal Motility And Defec...	8 (.61%)
Medication Errors	8 (.61%)
Mycobacterial Infectious	8 (.61%)
Seizures	8 (.61%)
Cardiac Disorder Signs	7 (.54%)
Fatal Outcomes	7 (.54%)
Gastrointestinal Hemorrhages	7 (.54%)
Skin Neoplasms Malignant And Unspec...	7 (.54%)
Heart Failures	6 (.46%)
Hematopoietic Neoplasms	6 (.46%)
Immune	6 (.46%)
Protein And Amino Acid Metabolism	6 (.46%)
Pulmonary Vascular	6 (.46%)
Renal And Urinary Tract Investigati...	6 (.46%)
Appetite And General Nutritional	5 (.38%)
Central Nervous System Vascular	5 (.38%)
Chemical Injury And Poisoning	5 (.38%)
Coagulopathies And Bleeding Diathes...	5 (.38%)
Coronary Artery	5 (.38%)
Deliria	5 (.38%)
Gastrointestinal Inflammatory Condi...	5 (.38%)
Skin And Subcutaneous Tissue	5 (.38%)
Lymphomas Non-hodgkins T-cell	4 (.31%)
Microbiology And Serology	4 (.31%)
Myocardial	4 (.31%)
Ocular Structural Change, Deposit A...	4 (.31%)
Oral Soft Tissue Conditions	4 (.31%)
Protozoal Infectious	4 (.31%)
Skin Vascular Abnormalities	4 (.31%)
Vascular Hemorrhagic	4 (.31%)
Administration Site Reactions	3 (.23%)
Cardiac And Vascular Investigations	3 (.23%)
Enzyme	3 (.23%)
Metabolic, Nutritional And Blood Ga...	3 (.23%)
Muscle	3 (.23%)
Neoplasm Related Morbidities	3 (.23%)
Peritoneal And Retroperitoneal Cond...	3 (.23%)
Physical Examination Topics	3 (.23%)
Pleural	3 (.23%)
Vision	3 (.23%)
Adrenal Gland	2 (.15%)
Bronchial Disorders	2 (.15%)
Central Nervous System Infections A...	2 (.15%)
Changes In Physical Activity	2 (.15%)
Cutaneous Neoplasms Benign	2 (.15%)
Dental And Gingival Conditions	2 (.15%)
Encephalopathies	2 (.15%)
Gastrointestinal	2 (.15%)
Gastrointestinal Stenosis And Obstr...	2 (.15%)
Gastrointestinal Therapeutic Proced...	2 (.15%)
Glucose Metabolism Disorders	2 (.15%)
Headaches	2 (.15%)
Hepatobiliary Neoplasms Malignant A...	2 (.15%)
Lymphomas	2 (.15%)
Menstrual Cycle And Uterine Bleedin...	2 (.15%)
Mental Impairment	2 (.15%)
Nephropathies	2 (.15%)
Neuromuscular	2 (.15%)
Ocular Infections, Irritations And ...	2 (.15%)
Prostatic Disorders	2 (.15%)
Protein And Chemistry Analyses	2 (.15%)
Respiratory Disorders Congenital	2 (.15%)
Skin Appendage Conditions	2 (.15%)
Soft Tissue Neoplasms Benign	2 (.15%)
Vascular Inflammations	2 (.15%)

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This graph shows the top categories of adverse events submitted to the FDA for Cladribine, 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 Cladribine 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.