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NUCYNTA ER

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Nucynta Er Adverse Events Reported to the FDA Over Time

How are Nucynta Er adverse event reports trending over time?

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

Most Common Nucynta Er Adverse Events Reported to the FDA

What are the most common Nucynta Er adverse events reported to the FDA?

Serotonin Syndrome
40 (4.43%)
Drug Ineffective
37 (4.1%)
Loss Of Consciousness
26 (2.88%)
Chest Pain
23 (2.55%)
Confusional State
23 (2.55%)
Withdrawal Syndrome
21 (2.33%)
Dizziness
20 (2.21%)
Hypertension
20 (2.21%)
Dyspnoea
19 (2.1%)
Feeling Hot
19 (2.1%)
Hallucination
18 (1.99%)
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Tremor
18 (1.99%)
Agitation
16 (1.77%)
Palpitations
15 (1.66%)
Poor Quality Sleep
14 (1.55%)
Drug Administration Error
12 (1.33%)
Gait Disturbance
12 (1.33%)
Adverse Event
11 (1.22%)
Anxiety
11 (1.22%)
Depression
11 (1.22%)
Heart Rate Increased
11 (1.22%)
Somnolence
11 (1.22%)
Delusion
9 (1%)
Drug Effect Decreased
9 (1%)
Insomnia
9 (1%)
Arthralgia
8 (.89%)
Feeling Abnormal
8 (.89%)
Incorrect Dose Administered
8 (.89%)
Intentional Overdose
8 (.89%)
Myalgia
8 (.89%)
Pneumonia Aspiration
8 (.89%)
Anaphylactic Reaction
7 (.78%)
Blood Pressure Increased
7 (.78%)
Dyskinesia
7 (.78%)
Malaise
7 (.78%)
Migraine
7 (.78%)
Renal Failure
7 (.78%)
Convulsion
6 (.66%)
Death
6 (.66%)
Feeling Jittery
6 (.66%)
Haemoglobin Decreased
6 (.66%)
Headache
6 (.66%)
Hyperhidrosis
6 (.66%)
Inadequate Analgesia
6 (.66%)
Oedema Peripheral
6 (.66%)
Renal Failure Acute
6 (.66%)
Rhabdomyolysis
6 (.66%)
Syncope
6 (.66%)
Abnormal Loss Of Weight
5 (.55%)
Amnesia
5 (.55%)
Blood Pressure Systolic Increased
5 (.55%)
Depressed Level Of Consciousness
5 (.55%)
Drug Interaction
5 (.55%)
Homicidal Ideation
5 (.55%)
Pain
5 (.55%)
Psychotic Disorder
5 (.55%)
Unevaluable Event
5 (.55%)
Urinary Retention
5 (.55%)
Adverse Drug Reaction
4 (.44%)
Body Height Decreased
4 (.44%)
Cardiac Flutter
4 (.44%)
Cognitive Disorder
4 (.44%)
Constipation
4 (.44%)
Disorientation
4 (.44%)
Drug Abuse
4 (.44%)
Drug Dose Omission
4 (.44%)
Drug Prescribing Error
4 (.44%)
Hot Flush
4 (.44%)
Hypersomnia
4 (.44%)
Laryngitis
4 (.44%)
Nausea
4 (.44%)
Nervousness
4 (.44%)
Overdose
4 (.44%)
Product Quality Issue
4 (.44%)
Tachycardia
4 (.44%)
Therapeutic Response Decreased
4 (.44%)
Abdominal Discomfort
3 (.33%)
Chest Discomfort
3 (.33%)
Consciousness Fluctuating
3 (.33%)
Delirium
3 (.33%)
Dysarthria
3 (.33%)
Eating Disorder
3 (.33%)
Fatigue
3 (.33%)
Feeling Cold
3 (.33%)
Hypoaesthesia
3 (.33%)
Mania
3 (.33%)
Mood Swings
3 (.33%)
Multiple Drug Overdose
3 (.33%)
Paraesthesia
3 (.33%)
Psychomotor Hyperactivity
3 (.33%)
Rectal Haemorrhage
3 (.33%)
Respiratory Arrest
3 (.33%)
Sensory Disturbance
3 (.33%)
Tinnitus
3 (.33%)
Unresponsive To Stimuli
3 (.33%)
Visual Impairment
3 (.33%)
Accident
2 (.22%)
Anger
2 (.22%)
Aphasia
2 (.22%)
Asthma
2 (.22%)
Back Pain
2 (.22%)

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

What are the most common Nucynta Er adverse events reported to the FDA?

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

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

Pain
66
Product Used For Unknown Indication
42
Back Pain
30
Analgesic Therapy
12
Fibromyalgia
7
Arthralgia
7
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Intervertebral Disc Protrusion
5
Musculoskeletal Pain
5
Procedural Pain
5
Headache
3
Back Injury
2
Pain Management
2
Spinal Fusion Surgery
2
Cervicogenic Headache
1
Rotator Cuff Syndrome
1
Intervertebral Disc Degeneration
1
Breakthrough Pain
1
Neck Pain
1
Arthritis
1
Spinal Column Injury
1
Spinal Osteoarthritis
1
Orthopedic Procedure
1
Pelvic Pain
1
Sciatica
1
Post Herpetic Neuralgia
1
Abdominal Pain
1
Neuropathy Peripheral
1

Drug Labels

LabelLabelerEffective
Nucynta ErJanssen Pharmaceuticals, Inc.31-AUG-12
Nucynta ErLake Erie Medical DBA Quality Care Products LLC04-OCT-12
Nucynta ErLake Erie Medical DBA Quality Care Products LLC12-FEB-13

Nucynta Er Case Reports

What Nucynta Er 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 Nucynta Er. 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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