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Tapentadol Adverse Events Reported to the FDA Over Time

How are Tapentadol adverse event reports trending over time?

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

Most Common Tapentadol Adverse Events Reported to the FDA

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

Dizziness
141 (2.49%)
Hallucination
141 (2.49%)
Confusional State
132 (2.33%)
Nausea
120 (2.12%)
Drug Ineffective
114 (2.01%)
Dyspnoea
103 (1.82%)
Depression
87 (1.53%)
Serotonin Syndrome
81 (1.43%)
Tremor
81 (1.43%)
Loss Of Consciousness
70 (1.23%)
Anxiety
65 (1.15%)
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Chest Pain
65 (1.15%)
Withdrawal Syndrome
64 (1.13%)
Death
62 (1.09%)
Palpitations
60 (1.06%)
Feeling Abnormal
58 (1.02%)
Hypertension
57 (1%)
Somnolence
54 (.95%)
Headache
52 (.92%)
Suicidal Ideation
52 (.92%)
Amnesia
50 (.88%)
Vomiting
49 (.86%)
Insomnia
47 (.83%)
Fatigue
43 (.76%)
Blood Pressure Increased
41 (.72%)
Delusion
41 (.72%)
Drug Interaction
41 (.72%)
Hyperhidrosis
41 (.72%)
Disorientation
40 (.71%)
Convulsion
38 (.67%)
Diarrhoea
38 (.67%)
Agitation
37 (.65%)
Overdose
37 (.65%)
Heart Rate Increased
36 (.63%)
Constipation
35 (.62%)
Abdominal Pain
34 (.6%)
Fall
34 (.6%)
Product Quality Issue
32 (.56%)
Tachycardia
31 (.55%)
Abnormal Behaviour
30 (.53%)
Malaise
29 (.51%)
Wrong Technique In Drug Usage Proce...
29 (.51%)
Chest Discomfort
28 (.49%)
Unresponsive To Stimuli
28 (.49%)
Decreased Appetite
27 (.48%)
Gait Disturbance
27 (.48%)
Hallucination, Visual
27 (.48%)
Asthma
26 (.46%)
Contusion
26 (.46%)
Hallucination, Auditory
26 (.46%)
Cardiac Arrest
25 (.44%)
Dehydration
25 (.44%)
Drug Abuse
25 (.44%)
Drug Screen Positive
25 (.44%)
Hospitalisation
25 (.44%)
Mental Impairment
25 (.44%)
Pyrexia
25 (.44%)
Speech Disorder
25 (.44%)
Hypersensitivity
24 (.42%)
Hypersomnia
24 (.42%)
Adverse Event
23 (.41%)
Asthenia
23 (.41%)
Oedema Peripheral
23 (.41%)
Pain
23 (.41%)
Pruritus
23 (.41%)
Abdominal Pain Upper
22 (.39%)
Dyskinesia
22 (.39%)
Feeling Hot
22 (.39%)
Restlessness
22 (.39%)
Anaphylactic Reaction
21 (.37%)
Back Pain
21 (.37%)
Swollen Tongue
21 (.37%)
Gastric Ulcer
20 (.35%)
Psychotic Disorder
20 (.35%)
Vision Blurred
20 (.35%)
Gastrointestinal Disorder
19 (.33%)
Pharyngeal Oedema
19 (.33%)
Angioedema
18 (.32%)
Balance Disorder
18 (.32%)
Disturbance In Attention
18 (.32%)
Electrocardiogram Change
18 (.32%)
Hypotension
18 (.32%)
Multiple Drug Overdose
18 (.32%)
Renal Failure
18 (.32%)
Suicide Attempt
18 (.32%)
Throat Tightness
18 (.32%)
Visual Impairment
18 (.32%)
Arthralgia
17 (.3%)
Cerebrovascular Accident
17 (.3%)
Intentional Overdose
17 (.3%)
Syncope
17 (.3%)
Urinary Retention
17 (.3%)
Urticaria
17 (.3%)
Drug Effect Decreased
16 (.28%)
Malignant Neoplasm Progression
16 (.28%)
Memory Impairment
16 (.28%)
Migraine
16 (.28%)
Depressed Level Of Consciousness
15 (.26%)
Hypoaesthesia
15 (.26%)
Mental Status Changes
15 (.26%)
Nervousness
15 (.26%)

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

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

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

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

Pain
443
Product Used For Unknown Indication
273
Back Pain
203
Procedural Pain
89
Analgesic Therapy
73
Arthralgia
53
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Drug Use For Unknown Indication
47
Cancer Pain
37
Diabetic Neuropathy
35
Breakthrough Pain
31
Fibromyalgia
27
Neuralgia
24
Neuropathy Peripheral
20
Musculoskeletal Pain
16
Complex Regional Pain Syndrome
14
Headache
13
Pain In Extremity
12
Pain Management
12
Ill-defined Disorder
9
Intervertebral Disc Protrusion
9
Spinal Column Stenosis
8
Neck Pain
8
Arthritis
8
Tumour Pain
7
Limb Injury
7
Trigeminal Neuralgia
6
Post Herpetic Neuralgia
6
Intervertebral Disc Degeneration
6
Surgery
5
Myalgia
5
Orthopedic Procedure
4
Rheumatoid Arthritis
4
Intentional Drug Misuse
4
Spinal Osteoarthritis
4
Post-traumatic Pain
4
Intervertebral Disc Disorder
4
Migraine
4
Spinal Fusion Surgery
4
Muscle Relaxant Therapy
3
Crohns Disease
3
Toe Amputation
3
Postoperative Analgesia
3
Peritonsillar Abscess
3
Sciatica
3
Laparoscopic Surgery
2
Radicular Pain
2
Pelvic Pain
2
Lumbar Radiculopathy
2
Wrist Fracture
2
Depression
2
Abdominal Pain
2

Drug Labels

LabelLabelerEffective
NucyntaBryant Ranch Prepack01-JUN-09
NucyntaStat Rx USA27-OCT-09
NucyntaPhysicians Total Care, Inc.24-MAR-10
NucyntaSTAT RX USA LLC09-JUL-10
NucyntaLake Erie Medical Surgical & Supply DBA Quality Care Products LLC13-JUL-11
NucyntaRebel Distributors Corp29-JUL-11
NucyntaOrtho-McNeil-Janssen Pharmaceuticals, Inc.29-JUL-11
Nucynta ErJanssen Pharmaceuticals, Inc.31-AUG-12
Nucynta ErLake Erie Medical DBA Quality Care Products LLC04-OCT-12
NucyntaBryant Ranch Prepack23-OCT-12
NucyntaJanssen Pharmaceuticals, Inc.25-OCT-12
Nucynta ErLake Erie Medical DBA Quality Care Products LLC12-FEB-13
NucyntaLake Erie Medical DBA Quality Care Products LLC12-FEB-13

Tapentadol Case Reports

What Tapentadol 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 Tapentadol. 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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