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SANDOZ FENTANYL TRANSDERMAL SYSTEM

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Sandoz Fentanyl Transdermal System Adverse Events Reported to the FDA Over Time

How are Sandoz Fentanyl Transdermal System adverse event reports trending over time?

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

Most Common Sandoz Fentanyl Transdermal System Adverse Events Reported to the FDA

What are the most common Sandoz Fentanyl Transdermal System adverse events reported to the FDA?

Wrong Technique In Drug Usage Proce...
371 (13.7%)
Product Quality Issue
140 (5.17%)
Drug Ineffective
103 (3.8%)
Pain
91 (3.36%)
Drug Administered At Inappropriate ...
79 (2.92%)
Withdrawal Syndrome
61 (2.25%)
Inappropriate Schedule Of Drug Admi...
50 (1.85%)
Drug Dose Omission
49 (1.81%)
Treatment Noncompliance
47 (1.74%)
Therapeutic Response Decreased
39 (1.44%)
Nausea
38 (1.4%)
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Inadequate Analgesia
31 (1.14%)
Fall
30 (1.11%)
Application Site Erythema
29 (1.07%)
Feeling Abnormal
28 (1.03%)
Hyperhidrosis
28 (1.03%)
Weight Decreased
28 (1.03%)
Application Site Pruritus
27 (1%)
Malaise
26 (.96%)
Drug Effect Decreased
24 (.89%)
Headache
24 (.89%)
Vomiting
24 (.89%)
Dizziness
23 (.85%)
Insomnia
20 (.74%)
Application Site Pain
19 (.7%)
Back Pain
19 (.7%)
Depression
18 (.66%)
Dyspnoea
18 (.66%)
Somnolence
17 (.63%)
Abnormal Loss Of Weight
16 (.59%)
Body Height Decreased
16 (.59%)
Hypertension
16 (.59%)
Application Site Irritation
15 (.55%)
Anxiety
14 (.52%)
Application Site Rash
14 (.52%)
Hypersomnia
14 (.52%)
Tremor
14 (.52%)
Oedema Peripheral
13 (.48%)
Overdose
13 (.48%)
Diabetes Mellitus
12 (.44%)
Drug Toxicity
12 (.44%)
Intervertebral Disc Protrusion
12 (.44%)
Abdominal Discomfort
11 (.41%)
Application Site Reaction
11 (.41%)
Diarrhoea
11 (.41%)
Drug Prescribing Error
11 (.41%)
Fatigue
11 (.41%)
Gait Disturbance
11 (.41%)
Asthenia
10 (.37%)
Device Leakage
10 (.37%)
Irritability
10 (.37%)
Weight Increased
10 (.37%)
Arthralgia
9 (.33%)
Cardiac Disorder
9 (.33%)
Osteoarthritis
9 (.33%)
Application Site Urticaria
8 (.3%)
Arthropathy
8 (.3%)
Decreased Appetite
8 (.3%)
Eating Disorder
8 (.3%)
Intentional Drug Misuse
8 (.3%)
Loss Of Consciousness
8 (.3%)
Muscle Spasms
8 (.3%)
Pain In Extremity
8 (.3%)
Thrombosis
8 (.3%)
Adverse Event
7 (.26%)
Cold Sweat
7 (.26%)
Constipation
7 (.26%)
Expired Drug Administered
7 (.26%)
Incorrect Drug Administration Durat...
7 (.26%)
Infection
7 (.26%)
Memory Impairment
7 (.26%)
Migraine
7 (.26%)
Narcotic Intoxication
7 (.26%)
Pneumonia
7 (.26%)
Sedation
7 (.26%)
Abdominal Pain Upper
6 (.22%)
Application Site Burn
6 (.22%)
Bedridden
6 (.22%)
Blood Cholesterol Increased
6 (.22%)
Chest Pain
6 (.22%)
Chronic Obstructive Pulmonary Disea...
6 (.22%)
Dermal Cyst
6 (.22%)
Dysstasia
6 (.22%)
Foot Fracture
6 (.22%)
Hiccups
6 (.22%)
Hospitalisation
6 (.22%)
Hypothyroidism
6 (.22%)
Incorrect Dose Administered
6 (.22%)
Incorrect Drug Administration Rate
6 (.22%)
Influenza Like Illness
6 (.22%)
Multiple Sclerosis Relapse
6 (.22%)
Scar
6 (.22%)
Scoliosis
6 (.22%)
Thyroid Disorder
6 (.22%)
Abasia
5 (.18%)
Abnormal Dreams
5 (.18%)
Agitation
5 (.18%)
Application Site Dryness
5 (.18%)
Application Site Scar
5 (.18%)
Application Site Vesicles
5 (.18%)
Back Disorder
5 (.18%)

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This graph shows the top adverse events submitted to the FDA for Sandoz Fentanyl Transdermal System, 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 Sandoz Fentanyl Transdermal System 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 Sandoz Fentanyl Transdermal System

What are the most common Sandoz Fentanyl Transdermal System adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Sandoz Fentanyl Transdermal System, 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 Sandoz Fentanyl Transdermal System 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 Sandoz Fentanyl Transdermal System According to Those Reporting Adverse Events

Why are people taking Sandoz Fentanyl Transdermal System, according to those reporting adverse events to the FDA?

Pain
161
Back Pain
132
Fibromyalgia
31
Arthralgia
28
Product Used For Unknown Indication
19
Pain In Extremity
19
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Neck Pain
15
Drug Use For Unknown Indication
15
Arthritis
13
Rheumatoid Arthritis
12
Musculoskeletal Pain
10
Spinal Column Stenosis
7
Intervertebral Disc Degeneration
7
Cancer Pain
6
Neuralgia
6
Intervertebral Disc Protrusion
5
Abdominal Pain
4
Bone Pain
4
Systemic Lupus Erythematosus
4
Neuropathy Peripheral
3
Spinal Disorder
3
Radicular Pain
3
Abdominal Pain Upper
3
Ill-defined Disorder
3
Osteoarthritis
3
Procedural Pain
3
Headache
3
Pain Management
2
Migraine
2
Osteonecrosis
2
Osteoporosis
2
Complex Regional Pain Syndrome
2
Back Disorder
2
Sciatica
2
Perineurial Cyst
2
Multiple Sclerosis
2
Spinal Fracture
2
Cystitis Interstitial
2
Cluster Headache
2
Accidental Exposure
2
Sjogrens Syndrome
2
Gun Shot Wound
1
Facial Pain
1
Polyarthritis
1
Nerve Compression
1
Road Traffic Accident
1
Muscle Spasms
1
Lung Neoplasm Malignant
1
Scoliosis
1
Muscular Dystrophy
1
Bone Neoplasm
1

Sandoz Fentanyl Transdermal System Case Reports

What Sandoz Fentanyl Transdermal System 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 Sandoz Fentanyl Transdermal System. 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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