BETADINE

Betadine Adverse Events Reported to the FDA Over Time

How are Betadine adverse event reports trending over time?

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

Most Common Betadine Adverse Events Reported to the FDA

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

Renal Failure Acute	71 (7.83%)
Oliguria	50 (5.51%)
Haematuria	46 (5.07%)
Toxic Anterior Segment Syndrome	40 (4.41%)
Lymphopenia	37 (4.08%)
Endophthalmitis	27 (2.98%)
Medication Error	22 (2.43%)
Product Quality Issue	20 (2.21%)
Blood Creatinine Increased	13 (1.43%)
Post Procedural Complication	13 (1.43%)
Pruritus	13 (1.43%)
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Rash	13 (1.43%)
Drug Hypersensitivity	12 (1.32%)
Poor Quality Drug Administered	11 (1.21%)
Toxic Skin Eruption	10 (1.1%)
Urticaria	10 (1.1%)
Rash Erythematous	9 (.99%)
Rash Maculo-papular	9 (.99%)
Culture Positive	7 (.77%)
Haemolysis	7 (.77%)
Metabolic Acidosis	7 (.77%)
Visual Acuity Reduced	7 (.77%)
Wrong Technique In Drug Usage Proce...	7 (.77%)
Anaphylactic Shock	6 (.66%)
Angioedema	6 (.66%)
Eye Pain	6 (.66%)
Idiopathic Urticaria	6 (.66%)
Malaise	6 (.66%)
Post Procedural Haematuria	6 (.66%)
Shock	6 (.66%)
Skin Irritation	6 (.66%)
Acute Pulmonary Oedema	5 (.55%)
Altered State Of Consciousness	5 (.55%)
Application Site Reaction	5 (.55%)
Chills	5 (.55%)
Dyspnoea	5 (.55%)
Rash Pruritic	5 (.55%)
Staphylococcal Infection	5 (.55%)
Vomiting	5 (.55%)
Burning Sensation	4 (.44%)
Burns Third Degree	4 (.44%)
Condition Aggravated	4 (.44%)
Dehydration	4 (.44%)
Erythema	4 (.44%)
Laryngeal Oedema	4 (.44%)
Pyrexia	4 (.44%)
Thrombocytopenia	4 (.44%)
Ulcerative Keratitis	4 (.44%)
Appendicitis	3 (.33%)
Application Site Irritation	3 (.33%)
Caustic Injury	3 (.33%)
Crystal Urine	3 (.33%)
Drug Interaction	3 (.33%)
Epiduritis	3 (.33%)
Eye Irritation	3 (.33%)
Eyelid Oedema	3 (.33%)
Face Oedema	3 (.33%)
Fatigue	3 (.33%)
Hypoxia	3 (.33%)
Influenza Like Illness	3 (.33%)
Iodine Allergy	3 (.33%)
Oral Discomfort	3 (.33%)
Oropharyngeal Discomfort	3 (.33%)
Pain	3 (.33%)
Puncture Site Reaction	3 (.33%)
Purpura	3 (.33%)
Rash Macular	3 (.33%)
Renal Tubular Necrosis	3 (.33%)
Skin Lesion	3 (.33%)
Anorectal Disorder	2 (.22%)
Back Pain	2 (.22%)
Bedridden	2 (.22%)
Blister	2 (.22%)
Blood Culture Positive	2 (.22%)
Burn Oesophageal	2 (.22%)
Burns Second Degree	2 (.22%)
Candidiasis	2 (.22%)
Cardiac Arrest	2 (.22%)
Cholestasis	2 (.22%)
Circumstance Or Information Capable...	2 (.22%)
Corneal Abrasion	2 (.22%)
Cough	2 (.22%)
Dermatitis	2 (.22%)
Dermatitis Bullous	2 (.22%)
Dermatitis Contact	2 (.22%)
Dermatitis Exfoliative	2 (.22%)
Drug Ineffective	2 (.22%)
Eczema	2 (.22%)
Eosinophilia	2 (.22%)
Epstein-barr Virus Antibody Positiv...	2 (.22%)
Epstein-barr Virus Antigen Positive	2 (.22%)
Eye Infection Bacterial	2 (.22%)
Foreign Body Sensation In Eyes	2 (.22%)
Herpes Zoster	2 (.22%)
Hyperkalaemia	2 (.22%)
Hyperthermia	2 (.22%)
Hypoaesthesia	2 (.22%)
Hypocapnia	2 (.22%)
Hypotension	2 (.22%)
Injury Corneal	2 (.22%)
Intraocular Pressure Increased	2 (.22%)

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

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

Renal Disorders	128 (14.11%)
Epidermal And Dermal Conditions	102 (11.25%)
Procedural And Device Related Injur...	66 (7.28%)
Urinary Tract Signs	48 (5.29%)
Medication Errors	43 (4.74%)
White Blood Cell	40 (4.41%)
Infections - Pathogen Unspecified	37 (4.08%)
Respiratory	29 (3.2%)
Allergic Conditions	25 (2.76%)
Angiedema And Urticaria	22 (2.43%)
Product Quality Issues	22 (2.43%)
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Neurological	21 (2.32%)
Microbiology And Serology	17 (1.87%)
Renal And Urinary Tract Investigati...	17 (1.87%)
Administration Site Reactions	16 (1.76%)
Ocular Infections, Irritations And ...	16 (1.76%)
Bacterial Infectious	10 (1.1%)
Eye	9 (.99%)
Injuries	9 (.99%)
Decreased And Nonspecific Blood Pre...	8 (.88%)
Injuries By Physical Agents	8 (.88%)
Vision	8 (.88%)
Acid-base	7 (.77%)
Gastrointestinal Signs	7 (.77%)
Hemolyses And Related Conditions	7 (.77%)
Body Temperature Conditions	6 (.66%)
Electrolyte And Fluid Balance Condi...	6 (.66%)
Chemical Injury And Poisoning	5 (.55%)
Fungal Infectious	5 (.55%)
Lifestyle Issues	5 (.55%)
Lower Respiratory Tract Disorders	5 (.55%)
Therapeutic And Nontherapeutic Effe...	5 (.55%)
Upper Respiratory Tract Disorders	5 (.55%)
Viral Infectious	5 (.55%)
Cardiac Arrhythmias	4 (.44%)
Oral Soft Tissue Conditions	4 (.44%)
Platelet	4 (.44%)
Therapeutic Procedures And Supporti...	4 (.44%)
Anterior Eye Structural Change, Dep...	3 (.33%)
Central Nervous System Infections A...	3 (.33%)
Dental And Gingival Conditions	3 (.33%)
Hematology Investigations	3 (.33%)
Metabolic, Nutritional And Blood Ga...	3 (.33%)
Musculoskeletal And Connective Tiss...	3 (.33%)
Neurological, Special Senses And Ps...	3 (.33%)
Psychiatric	3 (.33%)
Skin Vascular Abnormalities	3 (.33%)
Anal And Rectal Conditions	2 (.22%)
Ancillary Infectious Topics	2 (.22%)
Hepatic And Hepatobiliary	2 (.22%)
Investigations, Imaging And Histopa...	2 (.22%)
Joint	2 (.22%)
Muscle	2 (.22%)
Ocular Sensory Symptoms	2 (.22%)
Ocular Structural Change, Deposit A...	2 (.22%)
Physical Examination Topics	2 (.22%)
Pleural	2 (.22%)
Respiratory And Pulmonary Investiga...	2 (.22%)
Spleen, Lymphatic And Reticulendoth...	2 (.22%)
Thyroid Gland	2 (.22%)
Urolithiases	2 (.22%)
Anxiety Disorders	1 (.11%)
Bone And Joint Therapeutic Procedur...	1 (.11%)
Central Nervous System Vascular	1 (.11%)
Cornification And Dystrophic Skin	1 (.11%)
Depressed Mood Disorders	1 (.11%)
Encephalopathies	1 (.11%)
Enzyme	1 (.11%)
Fatal Outcomes	1 (.11%)
Gastrointestinal Conditions	1 (.11%)
Gastrointestinal Hemorrhages	1 (.11%)
Gastrointestinal Motility And Defec...	1 (.11%)
Headaches	1 (.11%)
Hematological And Lymphoid Tissue T...	1 (.11%)
Hepatobiliary	1 (.11%)
Increased Intracranial Pressure And...	1 (.11%)
Miscellaneous And Site Unspecified ...	1 (.11%)
Musculoskeletal And Connective Tiss...	1 (.11%)
Neuromuscular	1 (.11%)
Ocular Injuries	1 (.11%)
Protein And Chemistry Analyses	1 (.11%)
Retina, Choroid And Vitreous Hemorr...	1 (.11%)
Seizures	1 (.11%)
Skin And Subcutaneous Tissue	1 (.11%)
Skin And Subcutaneous Tissue Therap...	1 (.11%)
Sleep Disturbances	1 (.11%)
Structural Brain	1 (.11%)
Tissue	1 (.11%)
Vascular Hemorrhagic	1 (.11%)
Vascular Hypertensive	1 (.11%)
Vulvovaginal Disorders	1 (.11%)

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