TICE BCG

Tice Bcg Adverse Events Reported to the FDA Over Time

How are Tice Bcg adverse event reports trending over time?

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

Most Common Tice Bcg Adverse Events Reported to the FDA

What are the most common Tice Bcg adverse events reported to the FDA?

Pyrexia	48 (3.9%)
Bovine Tuberculosis	41 (3.33%)
Cystitis	27 (2.19%)
Immune Reconstitution Syndrome	27 (2.19%)
Lymphadenopathy	21 (1.7%)
Haematuria	20 (1.62%)
Sepsis	16 (1.3%)
Injection Site Ulcer	15 (1.22%)
Bladder Cancer Recurrent	14 (1.14%)
Injection Site Erythema	14 (1.14%)
Tuberculosis	14 (1.14%)
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Chills	13 (1.06%)
Injection Site Abscess	13 (1.06%)
Injection Site Pain	13 (1.06%)
Wrong Drug Administered	13 (1.06%)
Incorrect Route Of Drug Administrat...	12 (.97%)
Malaise	12 (.97%)
Arthralgia	11 (.89%)
Myalgia	11 (.89%)
Urinary Tract Infection	11 (.89%)
Disseminated Tuberculosis	10 (.81%)
Influenza Like Illness	10 (.81%)
Cough	9 (.73%)
Haemorrhage	9 (.73%)
Injection Site Vesicles	9 (.73%)
Lymphadenitis	9 (.73%)
Dyspnoea	8 (.65%)
Liver Function Test Abnormal	8 (.65%)
Nausea	8 (.65%)
Atrial Fibrillation	7 (.57%)
Contracted Bladder	7 (.57%)
Drug Ineffective	7 (.57%)
Lethargy	7 (.57%)
Arthritis	6 (.49%)
Blister	6 (.49%)
Condition Aggravated	6 (.49%)
Cyanosis	6 (.49%)
Dysuria	6 (.49%)
Haemorrhage Urinary Tract	6 (.49%)
Hepatosplenomegaly	6 (.49%)
Multi-organ Failure	6 (.49%)
Night Sweats	6 (.49%)
Pneumonia	6 (.49%)
Premature Baby	6 (.49%)
Rash	6 (.49%)
Weight Decreased	6 (.49%)
Aortic Aneurysm	5 (.41%)
Blood Bilirubin Increased	5 (.41%)
Confusional State	5 (.41%)
Dizziness	5 (.41%)
Drug Hypersensitivity	5 (.41%)
Granuloma	5 (.41%)
Headache	5 (.41%)
Hypotension	5 (.41%)
Pseudomonas Infection	5 (.41%)
Skin Reaction	5 (.41%)
Vomiting	5 (.41%)
Wheezing	5 (.41%)
White Blood Cell Count Increased	5 (.41%)
Abscess	4 (.32%)
Atelectasis	4 (.32%)
Bone Marrow Failure	4 (.32%)
Cardiac Arrest	4 (.32%)
Cardio-respiratory Arrest	4 (.32%)
Cardiomegaly	4 (.32%)
Cerebrovascular Accident	4 (.32%)
Diverticulum	4 (.32%)
Emphysema	4 (.32%)
Granulomatous Liver Disease	4 (.32%)
Haemoglobin Decreased	4 (.32%)
Hepatorenal Failure	4 (.32%)
Hepatotoxicity	4 (.32%)
Herpes Simplex	4 (.32%)
Hypersensitivity	4 (.32%)
Hypoxia	4 (.32%)
Infection	4 (.32%)
Jaundice	4 (.32%)
Joint Swelling	4 (.32%)
Mycotic Aneurysm	4 (.32%)
Pancreatitis	4 (.32%)
Pancytopenia	4 (.32%)
Pleural Effusion	4 (.32%)
Pollakiuria	4 (.32%)
Pulmonary Congestion	4 (.32%)
Renal Failure	4 (.32%)
Respiratory Failure	4 (.32%)
Rheumatoid Arthritis	4 (.32%)
Tubulointerstitial Nephritis	4 (.32%)
Urine Flow Decreased	4 (.32%)
Vaccination Failure	4 (.32%)
Accidental Exposure	3 (.24%)
Acute Hepatic Failure	3 (.24%)
Acute Respiratory Distress Syndrome	3 (.24%)
Alanine Aminotransferase Increased	3 (.24%)
Anaemia	3 (.24%)
Ascites	3 (.24%)
Asthenia	3 (.24%)
Bacterial Sepsis	3 (.24%)
Blood Creatinine Increased	3 (.24%)
Blood Lactate Dehydrogenase Increas...	3 (.24%)
Blood Pressure Decreased	3 (.24%)

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

What are the most common Tice Bcg adverse events reported to the FDA?

Infections - Pathogen Unspecified	105 (8.52%)
Mycobacterial Infectious	78 (6.33%)
Urinary Tract Signs	55 (4.46%)
Administration Site Reactions	53 (4.3%)
Body Temperature Conditions	48 (3.9%)
Respiratory	44 (3.57%)
Hepatic And Hepatobiliary	36 (2.92%)
Spleen, Lymphatic And Reticulendoth...	33 (2.68%)
Medication Errors	31 (2.52%)
Joint	28 (2.27%)
Neurological	28 (2.27%)
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Immunodeficiency Syndromes	27 (2.19%)
Hematology Investigations	24 (1.95%)
Lower Respiratory Tract Disorders	23 (1.87%)
Epidermal And Dermal Conditions	21 (1.7%)
Bladder And Bladder Neck Disorders	20 (1.62%)
Renal And Urinary Tract Neoplasms M...	20 (1.62%)
Cardiac Arrhythmias	19 (1.54%)
Gastrointestinal Signs	18 (1.46%)
Hepatobiliary	17 (1.38%)
Ocular Infections, Irritations And ...	17 (1.38%)
Bacterial Infectious	14 (1.14%)
Procedural And Device Related Injur...	14 (1.14%)
Renal Disorders	14 (1.14%)
Therapeutic And Nontherapeutic Effe...	14 (1.14%)
Allergic Conditions	12 (.97%)
Muscle	12 (.97%)
Renal And Urinary Tract Investigati...	12 (.97%)
Viral Infectious	12 (.97%)
Anemias Nonhemolytic And Marrow Dep...	11 (.89%)
Myocardial	9 (.73%)
Nephropathies	9 (.73%)
Physical Examination Topics	9 (.73%)
Vascular Hemorrhagic	9 (.73%)
Cardiac And Vascular Investigations	8 (.65%)
Male Reproductive Tract Infections ...	8 (.65%)
Microbiology And Serology	8 (.65%)
Miscellaneous And Site Unspecified ...	8 (.65%)
Aneurysms And Artery Dissections	7 (.57%)
Cardiac Disorder Signs	7 (.57%)
Decreased And Nonspecific Blood Pre...	7 (.57%)
Skin Appendage Conditions	7 (.57%)
Movement Disorders	6 (.49%)
Neonatal And Perinatal Conditions	6 (.49%)
Tissue	6 (.49%)
Bronchial Disorders	5 (.41%)
Deliria	5 (.41%)
Eye	5 (.41%)
Headaches	5 (.41%)
Central Nervous System Vascular	4 (.32%)
Chemical Injury And Poisoning	4 (.32%)
Coagulopathies And Bleeding Diathes...	4 (.32%)
Diverticular	4 (.32%)
Enzyme	4 (.32%)
Exocrine Pancreas Conditions	4 (.32%)
Fungal Infectious	4 (.32%)
Hematological	4 (.32%)
Ocular Neuromuscular	4 (.32%)
Ocular Structural Change, Deposit A...	4 (.32%)
Penile And Scrotal Disorders	4 (.32%)
Peritoneal And Retroperitoneal Cond...	4 (.32%)
Pleural	4 (.32%)
Ureteric	4 (.32%)
Anterior Eye Structural Change, Dep...	3 (.24%)
Central Nervous System Infections A...	3 (.24%)
Encephalopathies	3 (.24%)
Gastrointestinal Motility And Defec...	3 (.24%)
Heart Failures	3 (.24%)
Hematological And Lymphoid Tissue T...	3 (.24%)
Increased Intracranial Pressure And...	3 (.24%)
Injuries	3 (.24%)
Musculoskeletal And Connective Tiss...	3 (.24%)
Protein And Chemistry Analyses	3 (.24%)
Psychiatric	3 (.24%)
Pulmonary Vascular	3 (.24%)
Seizures	3 (.24%)
Skin And Subcutaneous Tissue	3 (.24%)
Tendon, Ligament And Cartilage	3 (.24%)
Vision	3 (.24%)
Appetite And General Nutritional	2 (.16%)
Autoimmune	2 (.16%)
Bone Disorders	2 (.16%)
Cranial Nerve Disorders	2 (.16%)
Depressed Mood Disorders	2 (.16%)
Hemolyses And Related Conditions	2 (.16%)
Immunology And Allergy	2 (.16%)
Prostatic Disorders	2 (.16%)
Skin Vascular Abnormalities	2 (.16%)
Structural Brain	2 (.16%)
Testicular And Epididymal	2 (.16%)
Therapeutic Procedures And Supporti...	2 (.16%)
Vascular Inflammations	2 (.16%)
Ancillary Infectious Topics	1 (.08%)
Cardiac Therapeutic Procedures	1 (.08%)
Connective Tissue Disorders	1 (.08%)
Coronary Artery	1 (.08%)
Electrolyte And Fluid Balance Condi...	1 (.08%)
Eye Disorders Congenital	1 (.08%)
Eye Therapeutic Procedures	1 (.08%)
Fatal Outcomes	1 (.08%)
Gastrointestinal Hemorrhages	1 (.08%)

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