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Bss Adverse Events Reported to the FDA Over Time

How are Bss adverse event reports trending over time?

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

Most Common Bss Adverse Events Reported to the FDA

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

Toxic Anterior Segment Syndrome
349 (27.7%)
Endophthalmitis
102 (8.1%)
Post Procedural Complication
85 (6.75%)
Medication Error
50 (3.97%)
Visual Acuity Reduced
36 (2.86%)
Off Label Use
29 (2.3%)
Corneal Oedema
27 (2.14%)
Corneal Opacity
25 (1.98%)
Cataract Operation Complication
21 (1.67%)
Corneal Disorder
21 (1.67%)
Eye Pain
20 (1.59%)
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Ocular Hyperaemia
17 (1.35%)
Keratopathy
16 (1.27%)
Wrong Technique In Drug Usage Proce...
16 (1.27%)
Anterior Chamber Fibrin
15 (1.19%)
Hypopyon
14 (1.11%)
Post Procedural Infection
14 (1.11%)
Eyelid Oedema
13 (1.03%)
Medical Device Complication
13 (1.03%)
Eye Inflammation
12 (.95%)
Poor Quality Drug Administered
12 (.95%)
Anterior Chamber Disorder
11 (.87%)
Corneal Abrasion
11 (.87%)
Eye Infection
11 (.87%)
Keratitis
11 (.87%)
Vision Blurred
10 (.79%)
Eye Irritation
9 (.71%)
Intraocular Pressure Increased
9 (.71%)
Eye Infection Intraocular
8 (.63%)
Eye Operation Complication
8 (.63%)
Eye Pruritus
8 (.63%)
Culture Positive
7 (.56%)
Iridocyclitis
7 (.56%)
Anterior Chamber Cell
6 (.48%)
Flat Anterior Chamber Of Eye
6 (.48%)
Inflammation
6 (.48%)
Product Sterility Lacking
6 (.48%)
Retinal Detachment
6 (.48%)
Treatment Noncompliance
6 (.48%)
Uveitis
6 (.48%)
Eye Infection Bacterial
5 (.4%)
Eye Infection Staphylococcal
5 (.4%)
Hypotony Of Eye
5 (.4%)
Procedural Complication
5 (.4%)
Pupil Fixed
5 (.4%)
Streptococcal Infection
5 (.4%)
Vitreous Opacities
5 (.4%)
Anterior Chamber Inflammation
4 (.32%)
Bacterial Infection
4 (.32%)
Blood Glucose Increased
4 (.32%)
Cataract
4 (.32%)
Corneal Epithelium Defect
4 (.32%)
Corneal Scar
4 (.32%)
Fibrin
4 (.32%)
Iritis
4 (.32%)
Meibomian Gland Discharge
4 (.32%)
Pigment Dispersion Syndrome
4 (.32%)
Product Quality Issue
4 (.32%)
Retinal Tear
4 (.32%)
Staphylococcal Infection
4 (.32%)
Blindness
3 (.24%)
Chemical Eye Injury
3 (.24%)
Corneal Erosion
3 (.24%)
Eye Oedema
3 (.24%)
Iris Atrophy
3 (.24%)
Needle Issue
3 (.24%)
Retinal Haemorrhage
3 (.24%)
Syringe Issue
3 (.24%)
Vitreous Haemorrhage
3 (.24%)
Anterior Chamber Opacity
2 (.16%)
Blindness Unilateral
2 (.16%)
Ciliary Hyperaemia
2 (.16%)
Conjunctival Haemorrhage
2 (.16%)
Expired Drug Administered
2 (.16%)
Eye Disorder
2 (.16%)
Eye Injury
2 (.16%)
Fibrin Deposition On Lens Postopera...
2 (.16%)
Hypotonia
2 (.16%)
Injury
2 (.16%)
Iris Disorder
2 (.16%)
Nocardiosis
2 (.16%)
Pain
2 (.16%)
Pseudomonas Infection
2 (.16%)
Pupillary Deformity
2 (.16%)
Scleritis
2 (.16%)
Skin Laceration
2 (.16%)
Stenotrophomonas Infection
2 (.16%)
Visual Impairment
2 (.16%)
Accident At Work
1 (.08%)
Activities Of Daily Living Impaired
1 (.08%)
Allergy Test Positive
1 (.08%)
Amblyopia
1 (.08%)
Anterior Chamber Cleavage Syndrome
1 (.08%)
Anterior Chamber Pigmentation
1 (.08%)
Atrophy Of Globe
1 (.08%)
Burning Sensation
1 (.08%)
Choroidal Detachment
1 (.08%)
Choroidal Haemorrhage
1 (.08%)
Conjunctival Bleb
1 (.08%)
Conjunctival Hyperaemia
1 (.08%)
Conjunctival Oedema
1 (.08%)

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

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

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

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

Cataract Operation
142
Intraocular Lens Implant
87
Surgery
48
Eye Irrigation
43
Eye Laser Surgery
27
Postoperative Care
25
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Eye Operation
5
Cataract
4
Vitrectomy
3
Trabeculectomy
2
Cataract Operation Complication
2
Wound Treatment
1
Medication Dilution
1
Preoperative Care
1
Therapeutic Procedure
1
Keratoplasty
1

Drug Labels

LabelLabelerEffective
Bss Plus Alcon Laboratories, Inc.22-DEC-06
BssAlcon Laboratories, Inc.23-JUL-11
BssAlcon Laboratories, Inc.23-JUL-11
BssAlcon Laboratories, Inc.23-JUL-11
Bss Plus Alcon Laboratories, Inc.12-DEC-11

Bss Case Reports

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

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About Results

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