TRETINOIN

Tretinoin Adverse Events Reported to the FDA Over Time

How are Tretinoin adverse event reports trending over time?

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

Most Common Tretinoin Adverse Events Reported to the FDA

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

Acute Myeloid Leukaemia	56 (3.41%)
Drug Interaction	35 (2.13%)
Pyrexia	35 (2.13%)
Sepsis	35 (2.13%)
Retinoic Acid Syndrome	34 (2.07%)
Haemorrhage Intracranial	30 (1.83%)
Dyspnoea	24 (1.46%)
Myelodysplastic Syndrome	24 (1.46%)
Febrile Neutropenia	21 (1.28%)
Cytogenetic Abnormality	20 (1.22%)
Multi-organ Failure	20 (1.22%)
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Pneumonia	20 (1.22%)
Pulmonary Haemorrhage	19 (1.16%)
Off Label Use	17 (1.04%)
Bacterial Sepsis	16 (.98%)
Diarrhoea	16 (.98%)
Renal Failure Acute	15 (.91%)
Thrombocytopenia	15 (.91%)
Neuropathy Peripheral	14 (.85%)
Neutropenia	14 (.85%)
Headache	13 (.79%)
Malignant Neoplasm Progression	13 (.79%)
Haemorrhage	12 (.73%)
Hepatotoxicity	12 (.73%)
Septic Shock	12 (.73%)
Drug Exposure During Pregnancy	11 (.67%)
Nausea	11 (.67%)
Chronic Myelomonocytic Leukaemia	10 (.61%)
Necrotising Fasciitis	10 (.61%)
Platelet Count Decreased	10 (.61%)
Pleural Effusion	10 (.61%)
Treatment Related Secondary Maligna...	10 (.61%)
Gastrointestinal Toxicity	9 (.55%)
Infection	9 (.55%)
Abdominal Pain	8 (.49%)
Chloroma	8 (.49%)
Haemoglobin Decreased	8 (.49%)
Hyperbilirubinaemia	8 (.49%)
Hypotension	8 (.49%)
Renal Failure	8 (.49%)
Weight Increased	8 (.49%)
Abdominal Distension	7 (.43%)
Cardiac Tamponade	7 (.43%)
Condition Aggravated	7 (.43%)
Disseminated Intravascular Coagulat...	7 (.43%)
Hepatic Function Abnormal	7 (.43%)
Hypoxia	7 (.43%)
Metabolic Acidosis	7 (.43%)
Neutrophil Count Decreased	7 (.43%)
Oesophageal Mass	7 (.43%)
Pain	7 (.43%)
Respiratory Distress	7 (.43%)
Tachycardia	7 (.43%)
Venoocclusive Liver Disease	7 (.43%)
Vomiting	7 (.43%)
Acute Promyelocytic Leukaemia	6 (.37%)
Alveolar Proteinosis	6 (.37%)
Blood Alkaline Phosphatase Increase...	6 (.37%)
Bone Marrow Necrosis	6 (.37%)
Cerebral Haemorrhage	6 (.37%)
Death	6 (.37%)
Fatigue	6 (.37%)
Fungal Infection	6 (.37%)
Gene Mutation	6 (.37%)
Pancytopenia	6 (.37%)
Pericarditis	6 (.37%)
Pulmonary Embolism	6 (.37%)
Acute Febrile Neutrophilic Dermatos...	5 (.3%)
Asthenia	5 (.3%)
Blood Bilirubin Increased	5 (.3%)
Bone Pain	5 (.3%)
Cardiac Arrest	5 (.3%)
Chest Pain	5 (.3%)
Disease Progression	5 (.3%)
Dizziness	5 (.3%)
Erythema	5 (.3%)
Genital Ulceration	5 (.3%)
Haemodialysis	5 (.3%)
Hypercalcaemia	5 (.3%)
Leukopenia	5 (.3%)
Oxygen Saturation Decreased	5 (.3%)
Phlebitis	5 (.3%)
Pulmonary Mycosis	5 (.3%)
Skin Exfoliation	5 (.3%)
Tachypnoea	5 (.3%)
White Blood Cell Count Decreased	5 (.3%)
Acute Myelomonocytic Leukaemia	4 (.24%)
Acute Myocardial Infarction	4 (.24%)
Acute Promyelocytic Leukaemia Diffe...	4 (.24%)
Anaemia	4 (.24%)
Benign Intracranial Hypertension	4 (.24%)
Bilirubin Conjugated Increased	4 (.24%)
Blood Lactate Dehydrogenase Increas...	4 (.24%)
Chills	4 (.24%)
Drug Hypersensitivity	4 (.24%)
Gastrointestinal Haemorrhage	4 (.24%)
Hepatitis Toxic	4 (.24%)
Hepatomegaly	4 (.24%)
Ileal Perforation	4 (.24%)
Leukocytosis	4 (.24%)
Liver Function Test Abnormal	4 (.24%)

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

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

Infections - Pathogen Unspecified	132 (8.05%)
Leukemias	119 (7.26%)
Respiratory	114 (6.95%)
Therapeutic And Nontherapeutic Effe...	51 (3.11%)
Hepatic And Hepatobiliary	50 (3.05%)
Hematology Investigations	49 (2.99%)
White Blood Cell	46 (2.8%)
Central Nervous System Vascular	41 (2.5%)
Gastrointestinal Signs	39 (2.38%)
Body Temperature Conditions	35 (2.13%)
Epidermal And Dermal Conditions	34 (2.07%)
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Bacterial Infectious	29 (1.77%)
Renal Disorders	29 (1.77%)
Cardiac And Vascular Investigations	27 (1.65%)
Cardiac Arrhythmias	27 (1.65%)
Chromosomal Abnormalities And Abnor...	26 (1.59%)
Fungal Infectious	21 (1.28%)
Gastrointestinal Motility And Defec...	21 (1.28%)
Hepatobiliary	21 (1.28%)
Neurological	20 (1.22%)
Lower Respiratory Tract Disorders	19 (1.16%)
Miscellaneous And Site Unspecified ...	17 (1.04%)
Peripheral Neuropathies	17 (1.04%)
Therapeutic Procedures And Supporti...	17 (1.04%)
Gastrointestinal Inflammatory Condi...	15 (.91%)
Pericardial	15 (.91%)
Platelet	15 (.91%)
Chemical Injury And Poisoning	14 (.85%)
Vascular Hemorrhagic	14 (.85%)
Anemias Nonhemolytic And Marrow Dep...	13 (.79%)
Headaches	13 (.79%)
Administration Site Reactions	12 (.73%)
Hematological And Lymphoid Tissue T...	12 (.73%)
Coagulopathies And Bleeding Diathes...	11 (.67%)
Coronary Artery	11 (.67%)
Enzyme	11 (.67%)
Pleural	11 (.67%)
Urinary Tract Signs	11 (.67%)
Gastrointestinal Conditions	10 (.61%)
Injuries	10 (.61%)
Neoplasm Related Morbidities	10 (.61%)
Renal And Urinary Tract Investigati...	10 (.61%)
Hematological	9 (.55%)
Physical Examination Topics	9 (.55%)
Decreased And Nonspecific Blood Pre...	8 (.49%)
Gastrointestinal Neoplasms Malignan...	8 (.49%)
Musculoskeletal And Connective Tiss...	8 (.49%)
Viral Infectious	8 (.49%)
Acid-base	7 (.43%)
Bone Disorders	7 (.43%)
Electrolyte And Fluid Balance Condi...	7 (.43%)
Microbiology And Serology	7 (.43%)
Oral Soft Tissue Conditions	7 (.43%)
Pulmonary Vascular	7 (.43%)
Allergic Conditions	6 (.37%)
Bone, Calcium, Magnesium And Phosph...	6 (.37%)
Cardiac Valve	6 (.37%)
Embolism And Thrombosis	6 (.37%)
Fatal Outcomes	6 (.37%)
Gastrointestinal Ulceration And Per...	6 (.37%)
Increased Intracranial Pressure And...	6 (.37%)
Metabolic, Nutritional And Blood Ga...	6 (.37%)
Muscle	6 (.37%)
Penile And Scrotal Disorders	6 (.37%)
Angiedema And Urticaria	5 (.3%)
Gastrointestinal Hemorrhages	5 (.3%)
Gastrointestinal Stenosis And Obstr...	5 (.3%)
Glucose Metabolism Disorders	5 (.3%)
Hematopoietic Neoplasms	5 (.3%)
Myocardial	5 (.3%)
Renal And Urinary Tract Neoplasms M...	5 (.3%)
Reproductive Tract	5 (.3%)
Skin Neoplasms Malignant And Unspec...	5 (.3%)
Vascular Inflammations	5 (.3%)
Appetite And General Nutritional	4 (.24%)
Deliria	4 (.24%)
Depressed Mood Disorders	4 (.24%)
Exocrine Pancreas Conditions	4 (.24%)
Injuries By Physical Agents	4 (.24%)
Lifestyle Issues	4 (.24%)
Metastases	4 (.24%)
Movement Disorders	4 (.24%)
Musculoskeletal And Connective Tiss...	4 (.24%)
Product Quality Issues	4 (.24%)
Toxicology And Therapeutic Drug Mon...	4 (.24%)
Encephalopathies	3 (.18%)
Joint	3 (.18%)
Peritoneal And Retroperitoneal Cond...	3 (.18%)
Procedural And Device Related Injur...	3 (.18%)
Reproductive Neoplasms Female Malig...	3 (.18%)
Skin Vascular Abnormalities	3 (.18%)
Soft Tissue Sarcomas	3 (.18%)
Spleen, Lymphatic And Reticulendoth...	3 (.18%)
Anal And Rectal Conditions	2 (.12%)
Aural	2 (.12%)
Bronchial Disorders	2 (.12%)
Malabsorption Conditions	2 (.12%)
Medication Errors	2 (.12%)
Mental Impairment	2 (.12%)
Metabolism	2 (.12%)
Nephropathies	2 (.12%)

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