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Azopt Adverse Events Reported to the FDA Over Time

How are Azopt adverse event reports trending over time?

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

Most Common Azopt Adverse Events Reported to the FDA

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

Dyspnoea
40 (3%)
Intraocular Pressure Increased
34 (2.55%)
Vision Blurred
24 (1.8%)
Eye Irritation
23 (1.73%)
Visual Impairment
22 (1.65%)
Drug Ineffective
21 (1.58%)
Dizziness
17 (1.28%)
Nausea
16 (1.2%)
Depression
15 (1.13%)
Headache
15 (1.13%)
Cataract
14 (1.05%)
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Eye Pain
14 (1.05%)
Alopecia
13 (.98%)
Vertigo
13 (.98%)
Cough
12 (.9%)
Ocular Hyperaemia
12 (.9%)
Palpitations
12 (.9%)
Dysgeusia
11 (.83%)
Fatigue
11 (.83%)
Arrhythmia
10 (.75%)
Asthenia
10 (.75%)
Asthma
10 (.75%)
Corneal Disorder
10 (.75%)
Drug Hypersensitivity
10 (.75%)
Visual Acuity Reduced
10 (.75%)
Bronchospasm
9 (.68%)
Condition Aggravated
9 (.68%)
Lacrimation Increased
9 (.68%)
Myalgia
9 (.68%)
Oedema Peripheral
9 (.68%)
Pain In Extremity
9 (.68%)
Vomiting
9 (.68%)
Deafness
8 (.6%)
Eye Pruritus
8 (.6%)
Eyelid Oedema
8 (.6%)
Pain
8 (.6%)
Skin Discolouration
8 (.6%)
Abdominal Pain
7 (.53%)
Alanine Aminotransferase Increased
7 (.53%)
Eye Swelling
7 (.53%)
Fear
7 (.53%)
Heart Rate Increased
7 (.53%)
Heart Rate Irregular
7 (.53%)
Insomnia
7 (.53%)
Keratitis
7 (.53%)
Night Blindness
7 (.53%)
Tachycardia
7 (.53%)
Anxiety
6 (.45%)
Confusional State
6 (.45%)
Corneal Erosion
6 (.45%)
Dry Mouth
6 (.45%)
Dyspepsia
6 (.45%)
Erythema
6 (.45%)
Eye Disorder
6 (.45%)
Hypersensitivity
6 (.45%)
Hypokalaemia
6 (.45%)
Hyponatraemia
6 (.45%)
Rash
6 (.45%)
Retinal Detachment
6 (.45%)
Spondylitis
6 (.45%)
Aspartate Aminotransferase Increase...
5 (.38%)
Bacterial Infection
5 (.38%)
Bradycardia
5 (.38%)
Bronchitis
5 (.38%)
Conjunctival Hyperaemia
5 (.38%)
Conjunctivitis Allergic
5 (.38%)
Corneal Epithelium Defect
5 (.38%)
Deafness Transitory
5 (.38%)
Dry Eye
5 (.38%)
Erythema Of Eyelid
5 (.38%)
Feeling Cold
5 (.38%)
Foreign Body Sensation In Eyes
5 (.38%)
Hypotension
5 (.38%)
Limb Injury
5 (.38%)
Medication Error
5 (.38%)
Optic Nerve Disorder
5 (.38%)
Oropharyngeal Pain
5 (.38%)
Punctate Keratitis
5 (.38%)
Pyrexia
5 (.38%)
Respiratory Distress
5 (.38%)
Sleep Disorder
5 (.38%)
Visual Field Defect
5 (.38%)
Abnormal Sensation In Eye
4 (.3%)
Agranulocytosis
4 (.3%)
Amnesia
4 (.3%)
Arthralgia
4 (.3%)
Blindness
4 (.3%)
Blindness Unilateral
4 (.3%)
Dehydration
4 (.3%)
Diplopia
4 (.3%)
Epistaxis
4 (.3%)
Flatulence
4 (.3%)
Glaucoma
4 (.3%)
Hepatic Steatosis
4 (.3%)
Loss Of Consciousness
4 (.3%)
Lower Respiratory Tract Infection
4 (.3%)
Malaise
4 (.3%)
Mental Disorder
4 (.3%)
Nasal Congestion
4 (.3%)
Scrotal Oedema
4 (.3%)
Sinusitis
4 (.3%)

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

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

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

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

Glaucoma
371
Product Used For Unknown Indication
48
Intraocular Pressure Increased
33
Drug Use For Unknown Indication
25
Ocular Hypertension
19
Open Angle Glaucoma
15
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Eye Disorder
10
Angle Closure Glaucoma
5
Normal Tension Glaucoma
5
Cataract
5
Macular Degeneration
4
Uveitis
4
Intraocular Pressure Test
4
Intraocular Pressure Test Abnormal
3
Behcets Syndrome
3
Myopia
2
Retinopathy
1
Cataract Congenital
1
Ill-defined Disorder
1
Eye Infection
1
Visual Acuity Reduced
1
Keratoconus
1
Eye Pain
1
Visual Impairment
1

Drug Labels

LabelLabelerEffective
Azopt Alcon Laboratories, Inc.08-MAR-12

Azopt Case Reports

What Azopt 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 Azopt. 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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