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DURAGESIC

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Duragesic Adverse Events Reported to the FDA Over Time

How are Duragesic adverse event reports trending over time?

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

Most Common Duragesic Adverse Events Reported to the FDA

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

Wrong Technique In Drug Usage Proce...
9692 (5.39%)
Product Quality Issue
5219 (2.9%)
Drug Ineffective
4604 (2.56%)
Pain
3536 (1.97%)
Inappropriate Schedule Of Drug Admi...
3175 (1.77%)
Nausea
2830 (1.57%)
Vomiting
2269 (1.26%)
Overdose
2191 (1.22%)
Withdrawal Syndrome
2188 (1.22%)
Somnolence
2142 (1.19%)
Hyperhidrosis
2120 (1.18%)
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Drug Administered At Inappropriate ...
1944 (1.08%)
Dizziness
1650 (.92%)
Drug Effect Decreased
1548 (.86%)
Dyspnoea
1533 (.85%)
Inadequate Analgesia
1513 (.84%)
Drug Prescribing Error
1383 (.77%)
Fall
1379 (.77%)
Feeling Abnormal
1351 (.75%)
Death
1337 (.74%)
Malaise
1313 (.73%)
Insomnia
1293 (.72%)
Drug Withdrawal Syndrome
1285 (.71%)
Drug Dose Omission
1276 (.71%)
Drug Toxicity
1268 (.71%)
Confusional State
1241 (.69%)
Weight Decreased
1223 (.68%)
Incorrect Drug Administration Durat...
1175 (.65%)
Headache
1158 (.64%)
Loss Of Consciousness
1153 (.64%)
Treatment Noncompliance
1113 (.62%)
Therapeutic Response Decreased
1074 (.6%)
Depression
1070 (.6%)
Anxiety
1023 (.57%)
Constipation
988 (.55%)
Back Pain
985 (.55%)
Fatigue
967 (.54%)
Hypertension
900 (.5%)
Tremor
895 (.5%)
Application Site Erythema
894 (.5%)
Drug Interaction
892 (.5%)
Application Site Pruritus
837 (.47%)
Intentional Drug Misuse
810 (.45%)
Application Site Rash
807 (.45%)
Asthenia
804 (.45%)
Convulsion
772 (.43%)
Respiratory Arrest
738 (.41%)
Pneumonia
720 (.4%)
Hypotension
718 (.4%)
Drug Administration Error
688 (.38%)
Muscle Spasms
669 (.37%)
Medication Error
659 (.37%)
Cardiac Arrest
646 (.36%)
Coma
646 (.36%)
Diarrhoea
626 (.35%)
Respiratory Depression
620 (.34%)
Pain In Extremity
599 (.33%)
Incorrect Dose Administered
598 (.33%)
Pruritus
586 (.33%)
Breakthrough Pain
579 (.32%)
Chest Pain
566 (.31%)
Pyrexia
561 (.31%)
Application Site Irritation
559 (.31%)
Hallucination
554 (.31%)
Dehydration
538 (.3%)
Application Site Reaction
523 (.29%)
Amnesia
493 (.27%)
Depressed Level Of Consciousness
472 (.26%)
Agitation
467 (.26%)
Drug Effect Increased
461 (.26%)
Cardio-respiratory Arrest
456 (.25%)
Oedema Peripheral
456 (.25%)
Weight Increased
454 (.25%)
Delirium
451 (.25%)
Disorientation
449 (.25%)
Rash
434 (.24%)
Unresponsive To Stimuli
432 (.24%)
Dermatitis Contact
431 (.24%)
Arthralgia
425 (.24%)
Decreased Appetite
425 (.24%)
Completed Suicide
423 (.24%)
Sedation
420 (.23%)
Chills
417 (.23%)
Abdominal Pain
415 (.23%)
Lethargy
408 (.23%)
Blood Pressure Increased
405 (.23%)
Off Label Use
402 (.22%)
Cerebrovascular Accident
397 (.22%)
Device Leakage
397 (.22%)
Hospitalisation
396 (.22%)
Myocardial Infarction
395 (.22%)
Accidental Overdose
387 (.22%)
Condition Aggravated
387 (.22%)
Hypersomnia
382 (.21%)
Gait Disturbance
376 (.21%)
Road Traffic Accident
367 (.2%)
Suicidal Ideation
367 (.2%)
Nervousness
362 (.2%)
Narcotic Intoxication
361 (.2%)
Blood Cholesterol Increased
357 (.2%)
Drug Abuse
350 (.19%)

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

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

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

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

Pain
13351
Back Pain
5204
Drug Use For Unknown Indication
4620
Product Used For Unknown Indication
3681
Cancer Pain
2099
Fibromyalgia
942
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Arthralgia
824
Anaesthesia
771
Pain Management
650
Pain In Extremity
620
Neck Pain
564
Induction Of Anaesthesia
449
Analgesic Therapy
416
Arthritis
412
General Anaesthesia
355
Sedation
342
Neuralgia
340
Bone Pain
319
Neuropathy Peripheral
310
Osteoarthritis
302
Intervertebral Disc Degeneration
294
Rheumatoid Arthritis
278
Ill-defined Disorder
273
Abdominal Pain
271
Intervertebral Disc Protrusion
262
Procedural Pain
249
Musculoskeletal Pain
245
Spinal Column Stenosis
179
Headache
172
Breakthrough Pain
170
Complex Regional Pain Syndrome
168
Migraine
152
Surgery
146
Intentional Misuse
141
Analgesia
140
Intentional Drug Misuse
136
Sciatica
126
Analgesic Effect
121
Back Disorder
116
Osteoporosis
113
Maintenance Of Anaesthesia
99
Systemic Lupus Erythematosus
98
Nerve Injury
94
Epidural Anaesthesia
89
Abdominal Pain Upper
86
Multiple Sclerosis
85
Anaesthesia Procedure
83
Sedative Therapy
80
Radicular Pain
78
Intervertebral Disc Disorder
77
Postoperative Analgesia
73

Drug Labels

LabelLabelerEffective
DuragesicJanssen Pharmaceuticals, Inc.19-JUL-12

Duragesic Case Reports

What Duragesic 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 Duragesic. 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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