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CYCLOPENTOLATE

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Cyclopentolate Adverse Events Reported to the FDA Over Time

How are Cyclopentolate adverse event reports trending over time?

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

Most Common Cyclopentolate Adverse Events Reported to the FDA

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

Toxic Anterior Segment Syndrome
70 (7.48%)
Endophthalmitis
31 (3.31%)
Vomiting
19 (2.03%)
Visual Acuity Reduced
18 (1.92%)
Mydriasis
17 (1.82%)
Eye Pain
16 (1.71%)
Intraocular Pressure Increased
16 (1.71%)
Nausea
16 (1.71%)
Disorientation
15 (1.6%)
Dizziness
15 (1.6%)
Headache
15 (1.6%)
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Iridocyclitis
15 (1.6%)
Corneal Deposits
14 (1.5%)
Confusional State
13 (1.39%)
Drug Interaction
13 (1.39%)
Corneal Abrasion
12 (1.28%)
Eye Irritation
12 (1.28%)
Inflammation
12 (1.28%)
Angle Closure Glaucoma
11 (1.18%)
Eye Disorder
11 (1.18%)
Photophobia
11 (1.18%)
Somnolence
11 (1.18%)
Blindness
10 (1.07%)
Medication Error
10 (1.07%)
Vision Blurred
10 (1.07%)
Speech Disorder
9 (.96%)
Drug Effect Prolonged
8 (.85%)
Hallucination
8 (.85%)
Post Procedural Complication
8 (.85%)
Apnoea
7 (.75%)
Drug Toxicity
7 (.75%)
Grand Mal Convulsion
7 (.75%)
Hemiparesis
7 (.75%)
Malaise
7 (.75%)
Pyrexia
7 (.75%)
Amnesia
6 (.64%)
Bradycardia
6 (.64%)
Coordination Abnormal
6 (.64%)
Disturbance In Attention
6 (.64%)
Erythema
6 (.64%)
Gait Disturbance
6 (.64%)
Abdominal Pain Upper
5 (.53%)
Agitation
5 (.53%)
Circulatory Collapse
5 (.53%)
Cyanosis
5 (.53%)
Hallucination, Visual
5 (.53%)
Pupil Fixed
5 (.53%)
Abdominal Distension
4 (.43%)
Abnormal Behaviour
4 (.43%)
Adverse Event
4 (.43%)
Anxiety
4 (.43%)
Balance Disorder
4 (.43%)
Blood Glucose Increased
4 (.43%)
Convulsion
4 (.43%)
Drug Ineffective
4 (.43%)
Drug Label Confusion
4 (.43%)
Dyspnoea
4 (.43%)
Fatigue
4 (.43%)
Flushing
4 (.43%)
Heart Rate Increased
4 (.43%)
Hemianopia
4 (.43%)
Hypotension
4 (.43%)
Necrotising Colitis
4 (.43%)
Oxygen Saturation Decreased
4 (.43%)
Product Quality Issue
4 (.43%)
Rash
4 (.43%)
Restlessness
4 (.43%)
Aphasia
3 (.32%)
Dermatitis Allergic
3 (.32%)
Dry Mouth
3 (.32%)
Dysstasia
3 (.32%)
Feeling Abnormal
3 (.32%)
Floppy Iris Syndrome
3 (.32%)
Hypoglycaemia
3 (.32%)
Incorrect Route Of Drug Administrat...
3 (.32%)
Lacrimal Disorder
3 (.32%)
Memory Impairment
3 (.32%)
No Reaction On Previous Exposure To...
3 (.32%)
Obsessive-compulsive Disorder
3 (.32%)
Ocular Toxicity
3 (.32%)
Off Label Use
3 (.32%)
Ph Body Fluid Abnormal
3 (.32%)
Psychomotor Hyperactivity
3 (.32%)
Pupillary Reflex Impaired
3 (.32%)
Retrograde Amnesia
3 (.32%)
Sensory Disturbance
3 (.32%)
Syncope
3 (.32%)
Abasia
2 (.21%)
Abdominal Discomfort
2 (.21%)
Abdominal Pain
2 (.21%)
Aggression
2 (.21%)
Ataxia
2 (.21%)
Autism
2 (.21%)
Blood Chloride Decreased
2 (.21%)
Blood Potassium Increased
2 (.21%)
Blood Pressure Decreased
2 (.21%)
Blood Sodium Decreased
2 (.21%)
Body Temperature Increased
2 (.21%)
Brain Stem Haemorrhage
2 (.21%)
C-reactive Protein Increased
2 (.21%)
Cardiac Failure
2 (.21%)

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

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

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

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

Preoperative Care
81
Mydriasis
37
Ophthalmological Examination
34
Cycloplegia
27
Product Used For Unknown Indication
24
Drug Use For Unknown Indication
19
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Cataract Operation
17
Ulcerative Keratitis
12
Cycloplegic Refraction
10
Fundoscopy
8
Uveitis
6
Intraocular Lens Implant
5
Eye Laser Surgery
5
Iridocyclitis
4
Prophylaxis
4
Premedication
4
Retinopathy Of Prematurity
3
Corneal Abrasion
3
Iritis
3
Cataract Congenital
2
Retinal Detachment
2
Surgery
2
Drug Therapy
2
Postoperative Care
2
Post Procedural Complication
2
Investigation
2
Diagnostic Procedure
2
Eye Operation
1
Contact Lens Therapy
1
Eye Infection
1
Necrotising Retinitis
1
Angle Closure Glaucoma
1
Amblyopia
1
Off Label Use
1
Vitreous Adhesions
1
Corneal Transplant
1
Retinal Haemorrhage
1
Vitritis
1
Eye Pain
1
Glaucoma
1
Ocular Hyperaemia
1

Drug Labels

LabelLabelerEffective
Ak-pentolateRebel Distributors Corp.01-SEP-10
Cyclopentolate HydrochlorideBausch & Lomb Incorporated01-JUN-11
CyclogylAlcon Laboratories, Inc.03-AUG-11
CyclomydrilAlcon Laboratories, Inc.03-AUG-11
Cyclopentolate HydrochlorideFalcon Pharmaceuticals, Ltd.05-AUG-11
Cyclopentolate HydrochlorideAkorn, Inc.30-SEP-11
Cyclopentolate HydrochlorideRebel Distributors Corp25-OCT-11
Cyclopentolate HydrochloridePhysicians Total Care, Inc.06-FEB-13

Cyclopentolate Case Reports

What Cyclopentolate 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 Cyclopentolate. 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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