BESIVANCE

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Besivance Adverse Events Reported to the FDA Over Time

How are Besivance adverse event reports trending over time?

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

Most Common Besivance Adverse Events Reported to the FDA

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

Impaired Healing	55 (9.47%)
Eye Pain	29 (4.99%)
Ocular Hyperaemia	27 (4.65%)
Corneal Epithelium Defect	25 (4.3%)
Vision Blurred	23 (3.96%)
Endophthalmitis	22 (3.79%)
Corneal Disorder	21 (3.61%)
Eye Irritation	21 (3.61%)
Ulcerative Keratitis	21 (3.61%)
Corneal Opacity	20 (3.44%)
Visual Acuity Reduced	19 (3.27%)
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Corneal Infiltrates	18 (3.1%)
Corneal Oedema	15 (2.58%)
Inappropriate Schedule Of Drug Admi...	15 (2.58%)
Corneal Abrasion	13 (2.24%)
Hypersensitivity	12 (2.07%)
Iritis	12 (2.07%)
Condition Aggravated	10 (1.72%)
Drug Toxicity	10 (1.72%)
Eye Inflammation	9 (1.55%)
Chemical Eye Injury	8 (1.38%)
Intraocular Pressure Increased	8 (1.38%)
Keratitis	8 (1.38%)
Mydriasis	8 (1.38%)
Incorrect Drug Administration Durat...	7 (1.2%)
Corneal Pigmentation	6 (1.03%)
Dizziness	6 (1.03%)
Foreign Body Sensation In Eyes	6 (1.03%)
Keratitis Bacterial	6 (1.03%)
Nausea	6 (1.03%)
Wrong Technique In Drug Usage Proce...	6 (1.03%)
Punctate Keratitis	5 (.86%)
Corneal Erosion	4 (.69%)
Eye Discharge	4 (.69%)
Eye Swelling	4 (.69%)
Eyelid Oedema	4 (.69%)
Hypopyon	4 (.69%)
Keratopathy	4 (.69%)
Ocular Toxicity	4 (.69%)
Retinal Pigment Epitheliopathy	4 (.69%)
Toxic Anterior Segment Syndrome	4 (.69%)
Conjunctival Hyperaemia	3 (.52%)
Drug Hypersensitivity	3 (.52%)
Eyelid Margin Crusting	3 (.52%)
Feeling Jittery	3 (.52%)
Headache	3 (.52%)
Abdominal Discomfort	2 (.34%)
Abnormal Faeces	2 (.34%)
Abnormal Sensation In Eye	2 (.34%)
Asthenia	2 (.34%)
Back Pain	2 (.34%)
Blood Urine Present	2 (.34%)
Corneal Deposits	2 (.34%)
Corneal Epithelial Microcysts	2 (.34%)
Diplopia	2 (.34%)
Dry Eye	2 (.34%)
Dysgeusia	2 (.34%)
Erythema Of Eyelid	2 (.34%)
Faeces Discoloured	2 (.34%)
Insomnia	2 (.34%)
Lacrimation Increased	2 (.34%)
Ocular Discomfort	2 (.34%)
Pain	2 (.34%)
Pharyngeal Oedema	2 (.34%)
Pyrexia	2 (.34%)
Swollen Tongue	2 (.34%)
Vomiting	2 (.34%)
Abortion Spontaneous	1 (.17%)
Conjunctival Haemorrhage	1 (.17%)
Conjunctivitis	1 (.17%)
Convulsion	1 (.17%)
Drug Exposure During Pregnancy	1 (.17%)
Loss Of Consciousness	1 (.17%)
Medication Residue	1 (.17%)
Neoplasm Skin	1 (.17%)
Palpitations	1 (.17%)
Post Procedural Complication	1 (.17%)
Rhinorrhoea	1 (.17%)

Share/Embed Graph Export Data

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

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

Ocular Infections, Irritations And ...	135 (23.24%)
Eye	78 (13.43%)
Anterior Eye Structural Change, Dep...	63 (10.84%)
Tissue	55 (9.47%)
Vision	44 (7.57%)
Medication Errors	28 (4.82%)
Infections - Pathogen Unspecified	26 (4.48%)
Chemical Injury And Poisoning	19 (3.27%)
Allergic Conditions	15 (2.58%)
Gastrointestinal Signs	14 (2.41%)
Injuries	13 (2.24%)
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Neurological	9 (1.55%)
Neurological, Special Senses And Ps...	8 (1.38%)
Ocular Neuromuscular	8 (1.38%)
Ocular Sensory Symptoms	8 (1.38%)
Bacterial Infectious	6 (1.03%)
Procedural And Device Related Injur...	5 (.86%)
Ocular Injuries	4 (.69%)
Ocular Structural Change, Deposit A...	4 (.69%)
Headaches	3 (.52%)
Body Temperature Conditions	2 (.34%)
Musculoskeletal And Connective Tiss...	2 (.34%)
Renal And Urinary Tract Investigati...	2 (.34%)
Sleep Disorders	2 (.34%)
Tongue Conditions	2 (.34%)
Upper Respiratory Tract Disorders	2 (.34%)
Abortions And Stillbirth	1 (.17%)
Cardiac Disorder Signs	1 (.17%)
Ocular Hemorrhages And Vascular	1 (.17%)
Product Quality Issues	1 (.17%)
Respiratory	1 (.17%)
Seizures	1 (.17%)
Skin Neoplasms Malignant And Unspec...	1 (.17%)

Share/Embed Graph Export Data

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

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

Off Label Use	117
Postoperative Care	57
Antibiotic Prophylaxis	23
Preoperative Care	19
Ulcerative Keratitis	10
Prophylaxis	10
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Conjunctivitis Bacterial	9
Photorefractive Keratectomy	8
Eye Infection	8
Conjunctivitis	7
Product Used For Unknown Indication	7
Keratitis Bacterial	6
Drug Use For Unknown Indication	5
Corneal Abrasion	5
Superficial Injury Of Eye	4
Conjunctivitis Infective	2
Keratomileusis	2
Hordeolum	1
Conjunctivitis Allergic	1
Eye Infection Bacterial	1
Infection Prophylaxis	1
Removal Of Foreign Body From Eye	1
Meibomian Gland Dysfunction	1
Blepharitis	1
Cataract Operation	1
Therapeutic Procedure	1

Drug Labels

Label	Labeler	Effective
Besivance	Physicians Total Care, Inc.	01-APR-09
Besivance	Bausch & Lomb Incorporated	20-SEP-12

Besivance Case Reports

What Besivance safety concerns are being reported by doctors and researchers in the medical literature?

About Results

This report contains aggregated drug side effects and adverse events for Besivance. 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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