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OXYBUTYNIN CHLORIDE

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Oxybutynin Chloride Adverse Events Reported to the FDA Over Time

How are Oxybutynin Chloride adverse event reports trending over time?

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

Most Common Oxybutynin Chloride Adverse Events Reported to the FDA

What are the most common Oxybutynin Chloride adverse events reported to the FDA?

Dry Mouth
86 (2.74%)
Drug Ineffective
81 (2.59%)
Confusional State
47 (1.5%)
Dizziness
44 (1.4%)
Constipation
41 (1.31%)
Fall
35 (1.12%)
Nausea
34 (1.09%)
Somnolence
31 (.99%)
Vomiting
31 (.99%)
Vision Blurred
30 (.96%)
Drug Interaction
29 (.93%)
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Asthenia
26 (.83%)
Pollakiuria
26 (.83%)
Hypertension
25 (.8%)
Urinary Tract Infection
25 (.8%)
Chest Pain
24 (.77%)
Death
24 (.77%)
Pruritus
24 (.77%)
Dyspnoea
23 (.73%)
Drug Exposure During Pregnancy
22 (.7%)
Fatigue
22 (.7%)
Malaise
22 (.7%)
Pain
22 (.7%)
Completed Suicide
21 (.67%)
Urinary Incontinence
21 (.67%)
Abdominal Pain
20 (.64%)
Talipes
20 (.64%)
Insomnia
19 (.61%)
Hallucination
18 (.57%)
Headache
18 (.57%)
Chest Discomfort
17 (.54%)
Diarrhoea
16 (.51%)
Loss Of Consciousness
16 (.51%)
Anxiety
15 (.48%)
Mental Status Changes
15 (.48%)
Oedema Peripheral
15 (.48%)
Pyrexia
15 (.48%)
Aggression
14 (.45%)
Agitation
14 (.45%)
Amnesia
14 (.45%)
Back Pain
14 (.45%)
Cognitive Disorder
14 (.45%)
Congenital Musculoskeletal Anomaly
14 (.45%)
Dehydration
14 (.45%)
Disorientation
14 (.45%)
Alanine Aminotransferase Increased
13 (.41%)
Aspartate Aminotransferase Increase...
13 (.41%)
Dyspepsia
13 (.41%)
Medication Error
13 (.41%)
Rib Hypoplasia
13 (.41%)
Spine Malformation
13 (.41%)
Blood Alkaline Phosphatase Increase...
12 (.38%)
Cerebrovascular Accident
12 (.38%)
Condition Aggravated
12 (.38%)
Convulsion
12 (.38%)
Delirium
12 (.38%)
Gait Disturbance
12 (.38%)
Hyponatraemia
12 (.38%)
Rash
12 (.38%)
Suicidal Ideation
12 (.38%)
Tremor
12 (.38%)
Abdominal Pain Upper
11 (.35%)
Blood Pressure Increased
11 (.35%)
Dry Eye
11 (.35%)
Dysuria
11 (.35%)
Memory Impairment
11 (.35%)
Pulmonary Hypoplasia
11 (.35%)
Renal Failure
11 (.35%)
Urticaria
11 (.35%)
Weight Decreased
11 (.35%)
Anorexia
10 (.32%)
Dry Throat
10 (.32%)
Dyskinesia
10 (.32%)
Gastrooesophageal Reflux Disease
10 (.32%)
Limb Malformation
10 (.32%)
Lung Disorder
10 (.32%)
Nocturia
10 (.32%)
Overdose
10 (.32%)
Tachycardia
10 (.32%)
Weight Increased
10 (.32%)
Balance Disorder
9 (.29%)
Bradycardia
9 (.29%)
Caesarean Section
9 (.29%)
Congenital Anomaly
9 (.29%)
Decreased Appetite
9 (.29%)
Drug Effect Decreased
9 (.29%)
Intestinal Obstruction
9 (.29%)
Pulmonary Malformation
9 (.29%)
Renal Failure Acute
9 (.29%)
Speech Disorder
9 (.29%)
Unevaluable Event
9 (.29%)
Urinary Retention
9 (.29%)
Cyanosis Neonatal
8 (.26%)
Feeling Abnormal
8 (.26%)
Hallucination, Visual
8 (.26%)
Hypersensitivity
8 (.26%)
Muscle Spasms
8 (.26%)
Muscular Weakness
8 (.26%)
Myalgia
8 (.26%)
Pain In Extremity
8 (.26%)
Product Quality Issue
8 (.26%)

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

What are the most common Oxybutynin Chloride adverse events reported to the FDA?

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

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

Drug Use For Unknown Indication
236
Urinary Incontinence
189
Hypertonic Bladder
180
Product Used For Unknown Indication
154
Bladder Disorder
138
Incontinence
100
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Pollakiuria
90
Bladder Spasm
46
Micturition Urgency
42
Neurogenic Bladder
24
Urinary Tract Disorder
19
Micturition Disorder
19
Enuresis
19
Ill-defined Disorder
18
Cystitis
18
Multiple Sclerosis
13
Benign Prostatic Hyperplasia
12
Urge Incontinence
11
Urinary Tract Infection
11
Urinary Retention
11
Automatic Bladder
10
Cystitis Interstitial
8
Stress Urinary Incontinence
7
Nocturia
6
Dysuria
6
Bladder Dysfunction
5
Prostatomegaly
5
Stress Incontinence
5
Drug Exposure During Pregnancy
4
Renal Failure
4
Prostatism
3
Urine Abnormality
3
Pyramidal Tract Syndrome
3
Salivary Hypersecretion
3
Convulsion
2
Trigonitis
2
Renal Disorder
2
Prophylaxis
2
Prostate Cancer
2
Cardiac Disorder
2
Pain
2
Hyperhidrosis
2
Drug Abuse
2
Abdominal Discomfort
2
Suicide Attempt
2
Back Pain
1
Anxiety
1
Therapeutic Skin Care Topical
1
Glaucoma
1
Urine Flow Decreased
1
Aortic Valve Replacement
1

Drug Labels

LabelLabelerEffective
Oxybutynin ChlorideBryant Ranch Prepack31-OCT-97
GelniquePhysicians Total Care, Inc.15-JAN-09
Oxybutynin ChlorideRebel Distributors Corp.04-SEP-09
Oxybutynin ChloridePhysicians Total Care, Inc.21-JAN-10
Oxybutynin ChloridePhysicians Total Care, Inc.21-JAN-10
Oxybutynin ChlorideUDL Laboratories, Inc.09-APR-10
Oxybutynin ChlorideState of Florida DOH Central Pharmacy07-JUN-10
Oxybutynin ChlorideState of Florida DOH Central Pharmacy07-JUN-10
Oxybutynin ChlorideUDL Laboratories, Inc.19-NOV-10
Oxybutynin ChlorideCardinal Health18-MAY-11
Oxybutynin ChlorideCardinal Health18-MAY-11
Oxybutynin ChlorideQualitest Pharmaceuticals08-JUN-11
Oxybutynin ChloridePD-Rx Pharmaceuticals, Inc.29-AUG-11
Oxybutynin ChlorideREMEDYREPACK INC. 29-SEP-11
Oxybutynin ChlorideMcKesson Contract Packaging09-NOV-11
Oxybutynin ChlorideMorton Grove Pharmaceuticals, Inc.24-JAN-12
Oxybutynin ChlorideMylan Pharmaceuticals Inc.30-JAN-12
DitropanxlPhysicians Total Care, Inc.16-FEB-12
Oxybutynin ChlorideMcKesson Contract Packaging19-MAR-12
Oxybutynin ChlorideAphena Pharma Solutions - Tennessee, Inc.26-MAR-12
Oxybutynin ChlorideCardinal Health08-MAY-12
Oxybutynin Chlorideextended ReleaseAvPAK17-MAY-12
Oxybutynin ChlorideQualitest Pharmaceuticals17-MAY-12
Oxybutynin Chlorideextended ReleaseMcKesson Packaging Services a business unit of McKesson Corporation18-MAY-12
Oxybutynin ChlorideUpsher-Smith Laboratories, Inc.08-JUN-12
Oxybutynin ChlorideMajor Pharmaceuticals11-JUL-12
Oxybutynin ChloridePharmaceutical Associates, Inc.03-AUG-12
Oxybutynin ChloridePliva Inc.28-SEP-12
Oxybutynin ChlorideAmerican Health Packaging03-OCT-12
GelniqueWatson Pharma, Inc.31-OCT-12
Oxybutynin ChlorideNCS HealthCare of KY, Inc dba Vangard Labs08-NOV-12
DitropanxlJanssen Pharmaceuticals, Inc.26-NOV-12
Oxybutynin ChlorideSilarx Pharmaceuticals, Inc21-DEC-12
Oxybutynin ChlorideMylan Pharmaceuticals Inc.30-JAN-13
Oxybutynin Chlorideextended ReleaseKremers Urban Pharmaceuticals Inc.05-FEB-13
Oxybutynin ChlorideTEVA Pharmaceuticals USA Inc14-FEB-13
Oxybutynin ChlorideNCS HealthCare of KY, Inc dba Vangard Labs20-FEB-13
Oxybutynin ChlorideREMEDYREPACK INC. 25-FEB-13
Oxybutynin ChlorideNCS HealthCare of KY, Inc dba Vangard Labs07-MAR-13
Oxybutynin ChloridePhysicians Total Care, Inc.18-MAR-13
Oxybutynin ChlorideCardinal Health25-MAR-13
Oxybutynin ChlorideAmerican Health Packaging26-MAR-13
Oxybutynin ChlorideREMEDYREPACK INC. 05-APR-13

Oxybutynin Chloride Case Reports

What Oxybutynin Chloride 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 Oxybutynin Chloride. 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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