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FENTANYL TRANSDERMAL SYSTEM

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Fentanyl Transdermal System Adverse Events Reported to the FDA Over Time

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

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

Most Common Fentanyl Transdermal System Adverse Events Reported to the FDA

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

Wrong Technique In Drug Usage Proce...
1488 (6.59%)
Drug Ineffective
595 (2.64%)
Inappropriate Schedule Of Drug Admi...
497 (2.2%)
Pain
473 (2.1%)
Nausea
398 (1.76%)
Product Quality Issue
388 (1.72%)
Drug Administered At Inappropriate ...
350 (1.55%)
Hyperhidrosis
333 (1.48%)
Withdrawal Syndrome
300 (1.33%)
Vomiting
288 (1.28%)
Incorrect Drug Administration Durat...
279 (1.24%)
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Overdose
269 (1.19%)
Dizziness
267 (1.18%)
Weight Decreased
250 (1.11%)
Inadequate Analgesia
248 (1.1%)
Treatment Noncompliance
246 (1.09%)
Fall
217 (.96%)
Dyspnoea
215 (.95%)
Somnolence
208 (.92%)
Drug Withdrawal Syndrome
207 (.92%)
Drug Effect Decreased
187 (.83%)
Insomnia
183 (.81%)
Application Site Erythema
178 (.79%)
Malaise
178 (.79%)
Back Pain
173 (.77%)
Feeling Abnormal
166 (.74%)
Application Site Pruritus
162 (.72%)
Depression
161 (.71%)
Loss Of Consciousness
158 (.7%)
Drug Dose Omission
156 (.69%)
Application Site Rash
154 (.68%)
Confusional State
143 (.63%)
Fatigue
143 (.63%)
Hypertension
142 (.63%)
Drug Toxicity
141 (.62%)
Headache
134 (.59%)
Application Site Irritation
126 (.56%)
Death
126 (.56%)
Anxiety
124 (.55%)
Tremor
124 (.55%)
Intentional Drug Misuse
120 (.53%)
Therapeutic Response Decreased
116 (.51%)
Incorrect Dose Administered
114 (.5%)
Device Leakage
113 (.5%)
Asthenia
107 (.47%)
Muscle Spasms
107 (.47%)
Constipation
99 (.44%)
Convulsion
99 (.44%)
Gait Disturbance
93 (.41%)
Pneumonia
89 (.39%)
Blood Cholesterol Increased
87 (.39%)
Chest Pain
86 (.38%)
Respiratory Arrest
84 (.37%)
Oedema Peripheral
83 (.37%)
Weight Increased
82 (.36%)
Diabetes Mellitus
80 (.35%)
Arthralgia
78 (.35%)
Dehydration
77 (.34%)
Diarrhoea
77 (.34%)
Blood Pressure Increased
76 (.34%)
Application Site Reaction
75 (.33%)
Anorexia
71 (.31%)
Drug Prescribing Error
71 (.31%)
Drug Effect Increased
69 (.31%)
Nervousness
69 (.31%)
Hallucination
68 (.3%)
Hypersomnia
68 (.3%)
Unresponsive To Stimuli
67 (.3%)
Pain In Extremity
65 (.29%)
Device Adhesion Issue
63 (.28%)
Lethargy
62 (.27%)
Chills
59 (.26%)
Vision Blurred
58 (.26%)
Application Site Vesicles
56 (.25%)
Hypotension
56 (.25%)
Intervertebral Disc Protrusion
56 (.25%)
Agitation
55 (.24%)
Amnesia
55 (.24%)
Memory Impairment
54 (.24%)
Myocardial Infarction
54 (.24%)
Abdominal Pain
53 (.23%)
Hospitalisation
52 (.23%)
Rash
51 (.23%)
Decreased Appetite
50 (.22%)
Heart Rate Increased
50 (.22%)
Incorrect Route Of Drug Administrat...
50 (.22%)
Unevaluable Event
50 (.22%)
Road Traffic Accident
49 (.22%)
Sedation
49 (.22%)
Coma
48 (.21%)
Pruritus
48 (.21%)
Suicidal Ideation
48 (.21%)
Drug Administration Error
47 (.21%)
Cerebrovascular Accident
46 (.2%)
Device Failure
45 (.2%)
Gastric Disorder
44 (.19%)
Narcotic Intoxication
44 (.19%)
Off Label Use
43 (.19%)
Abasia
42 (.19%)
Abdominal Pain Upper
42 (.19%)
Dermatitis Contact
42 (.19%)

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

What are the most common 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 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 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 Fentanyl Transdermal System According to Those Reporting Adverse Events

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

Pain
1305
Back Pain
951
Drug Use For Unknown Indication
448
Arthralgia
195
Fibromyalgia
156
Cancer Pain
137
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Pain In Extremity
133
Neck Pain
128
Arthritis
80
Osteoarthritis
52
Abdominal Pain
49
Neuralgia
45
Intervertebral Disc Degeneration
45
Rheumatoid Arthritis
43
Neuropathy Peripheral
42
Intervertebral Disc Protrusion
38
Procedural Pain
38
Musculoskeletal Pain
37
Pain Management
32
Complex Regional Pain Syndrome
31
Spinal Column Stenosis
30
Headache
27
Osteoporosis
27
Bone Pain
26
Migraine
23
Product Used For Unknown Indication
21
Abdominal Pain Upper
21
Sciatica
21
Systemic Lupus Erythematosus
21
Intentional Drug Misuse
19
Back Injury
16
Anaesthesia
15
Spinal Fracture
14
Intervertebral Disc Disorder
14
Scoliosis
13
Myalgia
12
Diabetic Neuropathy
11
Radicular Pain
11
Multiple Sclerosis
11
Pancreatitis Chronic
11
Surgery
10
Back Disorder
10
Spinal Fusion Surgery
10
Spinal Disorder
10
Neoplasm Malignant
9
Accidental Exposure
9
Analgesia
8
Lung Neoplasm Malignant
8
General Anaesthesia
8
Nerve Injury
7
Muscle Spasms
7

Drug Labels

LabelLabelerEffective
FentanylDispensing Solutions Inc.03-MAR-10
FentanylDAVA Pharmaceuticals, Inc.29-DEC-10
FentanylDispensing Solutions, Inc.01-SEP-11
Fentanyl Transdermal SystemRebel Distributors Corp07-SEP-11
Fentanyl Transdermal SystemRebel Distributors Corp.04-OCT-11
Fentanyl Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC03-JAN-12
Fentanyl Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC03-JAN-12
FentanylSTAT Rx USA LLC30-JAN-12
Fentanyltransdermal SystemActavis South Atlantic LLC09-JUL-12
FentanylMylan Pharmaceuticals Inc.18-JUL-12
DuragesicJanssen Pharmaceuticals, Inc.19-JUL-12
FentanylTeva Pharmaceuticals USA Inc23-JUL-12
Fentanyl - NovaplusWatson Laboratories, Inc.31-JUL-12
FentanylSandoz,Inc.18-SEP-12
FentanylWatson Laboratories, Inc.01-OCT-12
FentanylApotex Corp.19-NOV-12
Fentanyl Transdermal SystemLake Erie Medical DBA Quality Care Products LLC31-JAN-13
FentanylUpsher-Smith Laboratories, Inc.28-FEB-13
FentanylLake Erie Medical DBA Quality Care Products LLC15-MAR-13
Fentanyl Transdermal SystemMallinckrodt, Inc.01-APR-13
FentanylBryant Ranch Prepack17-APR-13
FentanylBryant Ranch Prepack17-APR-13
Fentanyl Transdermal SystemBryant Ranch Prepack23-APR-13
Fentanyl Transdermal SystemBryant Ranch Prepack23-APR-13
Fentanyl Transdermal SystemBryant Ranch Prepack23-APR-13
FentanylBryant Ranch Prepack25-APR-13

Fentanyl Transdermal System Case Reports

What 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 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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