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OPANA ER

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Opana Er Adverse Events Reported to the FDA Over Time

How are Opana Er adverse event reports trending over time?

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

Most Common Opana Er Adverse Events Reported to the FDA

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

Drug Abuse
223 (6.14%)
Drug Ineffective
211 (5.81%)
Intentional Drug Misuse
158 (4.35%)
Wrong Technique In Drug Usage Proce...
122 (3.36%)
Drug Effect Decreased
76 (2.09%)
Incorrect Route Of Drug Administrat...
74 (2.04%)
Inappropriate Schedule Of Drug Admi...
73 (2.01%)
Nausea
70 (1.93%)
Overdose
68 (1.87%)
Withdrawal Syndrome
66 (1.82%)
Drug Toxicity
53 (1.46%)
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Vomiting
53 (1.46%)
Drug Diversion
51 (1.4%)
Drug Dependence
46 (1.27%)
Medication Residue
46 (1.27%)
Death
42 (1.16%)
Headache
40 (1.1%)
Malaise
35 (.96%)
Unresponsive To Stimuli
34 (.94%)
Diarrhoea
33 (.91%)
Drug Screen Positive
30 (.83%)
Drug Withdrawal Syndrome
30 (.83%)
Constipation
28 (.77%)
Dizziness
27 (.74%)
Drug Dispensing Error
27 (.74%)
Feeling Abnormal
27 (.74%)
Loss Of Consciousness
27 (.74%)
Abdominal Discomfort
26 (.72%)
Abdominal Pain Upper
26 (.72%)
Accidental Death
26 (.72%)
Confusional State
25 (.69%)
Pain
25 (.69%)
Drug Screen Negative
24 (.66%)
Insomnia
22 (.61%)
Accidental Overdose
21 (.58%)
Convulsion
21 (.58%)
Inadequate Analgesia
20 (.55%)
Dyspnoea
19 (.52%)
Chest Pain
17 (.47%)
Dysphagia
17 (.47%)
Road Traffic Accident
17 (.47%)
Somnolence
16 (.44%)
Contusion
15 (.41%)
Hyperhidrosis
15 (.41%)
Abdominal Pain
14 (.39%)
Depression
14 (.39%)
Incorrect Dose Administered
14 (.39%)
Pulmonary Congestion
14 (.39%)
Pulmonary Oedema
14 (.39%)
Euphoric Mood
13 (.36%)
Drug Effect Delayed
12 (.33%)
Drug Interaction
12 (.33%)
Oedema Peripheral
12 (.33%)
Agitation
11 (.3%)
Anxiety
11 (.3%)
Cardiac Arrest
11 (.3%)
Facial Bones Fracture
11 (.3%)
Hypoaesthesia
11 (.3%)
Intestinal Obstruction
11 (.3%)
Periorbital Haematoma
11 (.3%)
Urticaria
11 (.3%)
Asthenia
10 (.28%)
Disorientation
10 (.28%)
Fall
10 (.28%)
Fatigue
10 (.28%)
Hallucination
10 (.28%)
Medication Error
10 (.28%)
Product Formulation Issue
10 (.28%)
Pruritus
10 (.28%)
Self-medication
10 (.28%)
Skin Laceration
10 (.28%)
Suicidal Ideation
10 (.28%)
Chest Discomfort
9 (.25%)
Completed Suicide
9 (.25%)
Condition Aggravated
9 (.25%)
Dehydration
9 (.25%)
Haemoptysis
9 (.25%)
Migraine
9 (.25%)
Multiple Drug Overdose
9 (.25%)
Pain In Extremity
9 (.25%)
Palpitations
9 (.25%)
Tremor
9 (.25%)
Abnormal Behaviour
8 (.22%)
Blood Pressure Increased
8 (.22%)
Cardiac Failure Congestive
8 (.22%)
Hepatic Congestion
8 (.22%)
Hypersensitivity
8 (.22%)
Prescription Form Tampering
8 (.22%)
Therapeutic Response Decreased
8 (.22%)
Tinnitus
8 (.22%)
Treatment Noncompliance
8 (.22%)
Alcohol Poisoning
7 (.19%)
Anger
7 (.19%)
Breakthrough Pain
7 (.19%)
Drug Abuser
7 (.19%)
Dyspepsia
7 (.19%)
Epistaxis
7 (.19%)
Hepatic Steatosis
7 (.19%)
Nervousness
7 (.19%)
No Therapeutic Response
7 (.19%)
Pneumonia
7 (.19%)

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

What are the most common Opana 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 Opana 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 Opana 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 Opana Er According to Those Reporting Adverse Events

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

Pain
336
Product Used For Unknown Indication
177
Back Pain
156
Drug Abuse
81
Drug Use For Unknown Indication
58
Arthralgia
19
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Fibromyalgia
14
Pain In Extremity
14
Neck Pain
13
Intervertebral Disc Protrusion
11
Drug Diversion
8
Neuralgia
7
Intervertebral Disc Degeneration
7
Rheumatoid Arthritis
7
Musculoskeletal Pain
6
Arthritis
6
Multiple Sclerosis
6
Headache
5
Neck Injury
4
Back Injury
4
Drug Abuser
4
Myalgia
3
Nerve Compression
3
Cancer Pain
3
Migraine
3
Pain Management
3
Abdominal Pain
2
Bone Pain
2
Road Traffic Accident
2
Spinal Fusion Surgery
2
Intentional Drug Misuse
2
Drug Dependence
2
Back Disorder
2
Neuropathy Peripheral
2
Radiculopathy
2
Intervertebral Disc Disorder
2
Cervical Vertebral Fracture
2
Accidental Exposure
2
Crush Injury
2
Spinal Disorder
1
Lyme Disease
1
Bladder Pain
1
Benign Intracranial Hypertension
1
Surgery
1
Osteoarthritis
1
Leg Amputation
1
Scoliosis
1
Systemic Lupus Erythematosus
1
Off Label Use
1
Post Herpetic Neuralgia
1
Spinal Column Stenosis
1

Drug Labels

LabelLabelerEffective
Opana ErRebel Distributors Corp31-MAY-11
OpanaerLake Erie Medical & Surgical Supply DBA Quality Care Products LLC15-NOV-11
OpanaerEndo Pharmaceuticals Inc.14-DEC-11
OpanaerLake Erie Medical & Surgical Supply DBA Quality Care Products LLC14-FEB-12
OpanaerEndo Pharmaceuticals16-JUL-12
Opana ErSt Marys Medical Park Pharmacy09-AUG-12
OpanaerEndo Pharmaceuticals Inc.15-AUG-12
Opana ErBryant Ranch Prepack12-OCT-12
Opana Er Bryant Ranch Prepack12-OCT-12
OpanaerLake Erie Medical DBA Quality Care Products LLC22-MAR-13

Opana Er Case Reports

What Opana 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 Opana 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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