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OXYMORPHONE

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Oxymorphone Adverse Events Reported to the FDA Over Time

How are Oxymorphone adverse event reports trending over time?

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

Most Common Oxymorphone Adverse Events Reported to the FDA

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

Drug Abuse
331 (4.77%)
Drug Ineffective
273 (3.94%)
Intentional Drug Misuse
202 (2.91%)
Drug Toxicity
167 (2.41%)
Wrong Technique In Drug Usage Proce...
150 (2.16%)
Overdose
120 (1.73%)
Nausea
107 (1.54%)
Incorrect Route Of Drug Administrat...
99 (1.43%)
Vomiting
98 (1.41%)
Accidental Death
96 (1.38%)
Drug Effect Decreased
89 (1.28%)
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Inappropriate Schedule Of Drug Admi...
85 (1.23%)
Drug Dependence
82 (1.18%)
Withdrawal Syndrome
82 (1.18%)
Cardiac Arrest
77 (1.11%)
Death
77 (1.11%)
Unresponsive To Stimuli
75 (1.08%)
Completed Suicide
74 (1.07%)
Drug Diversion
74 (1.07%)
Respiratory Arrest
70 (1.01%)
Headache
60 (.87%)
Insomnia
58 (.84%)
Loss Of Consciousness
58 (.84%)
Pain
58 (.84%)
Feeling Abnormal
55 (.79%)
Drug Withdrawal Syndrome
54 (.78%)
Diarrhoea
52 (.75%)
Accidental Overdose
51 (.74%)
Malaise
51 (.74%)
Pulmonary Congestion
51 (.74%)
Constipation
50 (.72%)
Dizziness
49 (.71%)
Medication Residue
49 (.71%)
Pulmonary Oedema
49 (.71%)
Drug Screen Positive
43 (.62%)
Confusional State
39 (.56%)
Dyspnoea
39 (.56%)
Convulsion
38 (.55%)
Somnolence
35 (.5%)
Abdominal Pain Upper
34 (.49%)
Multiple Drug Overdose
33 (.48%)
Contusion
32 (.46%)
Abdominal Discomfort
31 (.45%)
Drug Dispensing Error
31 (.45%)
Inadequate Analgesia
31 (.45%)
Multiple Drug Overdose Accidental
31 (.45%)
Road Traffic Accident
31 (.45%)
Poisoning
30 (.43%)
Depression
29 (.42%)
Agitation
28 (.4%)
Chest Pain
28 (.4%)
Drug Screen Negative
28 (.4%)
Hallucination
26 (.37%)
Respiratory Depression
26 (.37%)
Tinnitus
25 (.36%)
Anxiety
24 (.35%)
Fatigue
24 (.35%)
Oedema Peripheral
24 (.35%)
Weight Decreased
24 (.35%)
Alcohol Poisoning
23 (.33%)
Hyperhidrosis
23 (.33%)
Pruritus
23 (.33%)
Dehydration
22 (.32%)
Substance Abuse
22 (.32%)
Fall
21 (.3%)
Incorrect Dose Administered
21 (.3%)
Cardio-respiratory Arrest
20 (.29%)
Cardiomegaly
20 (.29%)
Drug Interaction
20 (.29%)
Skin Laceration
20 (.29%)
Abdominal Pain
19 (.27%)
Cyanosis
19 (.27%)
Decreased Appetite
19 (.27%)
Dysphagia
19 (.27%)
Euphoric Mood
19 (.27%)
Hypotension
19 (.27%)
Tremor
19 (.27%)
Abnormal Behaviour
18 (.26%)
Brain Oedema
18 (.26%)
Migraine
18 (.26%)
Suicidal Ideation
18 (.26%)
Arteriosclerosis Coronary Artery
17 (.25%)
Facial Bones Fracture
17 (.25%)
Muscle Spasms
17 (.25%)
Periorbital Haematoma
17 (.25%)
Condition Aggravated
16 (.23%)
Drug Abuser
16 (.23%)
Hypersensitivity
16 (.23%)
Product Formulation Issue
16 (.23%)
Self-medication
16 (.23%)
Back Pain
15 (.22%)
Depressed Level Of Consciousness
15 (.22%)
Disorientation
15 (.22%)
Haemoptysis
15 (.22%)
Hepatic Congestion
15 (.22%)
Irritability
15 (.22%)
Nervousness
15 (.22%)
Palpitations
15 (.22%)
Pancreatitis
15 (.22%)
Pyrexia
15 (.22%)
Chest Discomfort
14 (.2%)

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

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

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

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

Pain
501
Product Used For Unknown Indication
349
Back Pain
213
Drug Use For Unknown Indication
170
Drug Abuse
110
Breakthrough Pain
84
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Arthralgia
30
Pain In Extremity
26
Rheumatoid Arthritis
25
Fibromyalgia
18
Intervertebral Disc Protrusion
17
Drug Diversion
16
Neck Pain
15
Intervertebral Disc Degeneration
10
Neuralgia
9
Drug Abuser
9
Musculoskeletal Pain
8
Bone Pain
8
Arthritis
8
Back Disorder
7
Headache
6
Myalgia
6
Multiple Sclerosis
6
Neuropathy Peripheral
5
Migraine
5
Pain Management
5
Back Injury
5
Osteoarthritis
4
Intentional Drug Misuse
4
Cancer Pain
4
Drug Dependence
4
Neck Injury
4
Abdominal Pain
3
Nerve Compression
3
Spinal Column Stenosis
3
Overdose
3
Completed Suicide
3
Substance Use
3
Accidental Exposure
3
Spinal Disorder
2
Depression
2
Scoliosis
2
Retinal Vasculitis
2
Road Traffic Accident
2
Victim Of Homicide
2
Spinal Fusion Surgery
2
Suicide Attempt
2
Joint Injury
2
Ill-defined Disorder
2
Radiculopathy
2
Intervertebral Disc Disorder
2

Drug Labels

LabelLabelerEffective
Oxymorphone HydrochlorideRoxane Laboratories, Inc27-SEP-10
Opana ErRebel Distributors Corp31-MAY-11
OpanaEndo Pharmaceuticals18-AUG-11
Oxymorphone HydrochlorideEndo Pharmaceuticals Inc.18-AUG-11
OpanaerLake Erie Medical & Surgical Supply DBA Quality Care Products LLC15-NOV-11
OpanaerEndo Pharmaceuticals Inc.14-DEC-11
OpanaSTAT Rx USA LLC13-JAN-12
OpanaerLake Erie Medical & Surgical Supply DBA Quality Care Products LLC14-FEB-12
OpanaLake Erie Medical & Surgical Supply DBA Quality Care Products LLC16-FEB-12
Oxymorphone HydrochlorideActavis Elizabeth LLC12-JUL-12
OpanaerEndo Pharmaceuticals16-JUL-12
Opana ErSt Marys Medical Park Pharmacy09-AUG-12
OpanaerEndo Pharmaceuticals Inc.15-AUG-12
Opana Er Bryant Ranch Prepack12-OCT-12
Opana ErBryant Ranch Prepack12-OCT-12
OpanaBryant Ranch Prepack12-OCT-12
Oxymorphone HydrochloridePhysicians Total Care, Inc.02-JAN-13
Oxymorphone HydrochlorideKVK-Tech, Inc.11-FEB-13
OpanaEndo Pharmaceuticals Inc.14-FEB-13
Oxymorphone HydrochlorideGlobal Pharmaceuticals, Division of Impax Laboratories, Inc.18-MAR-13
Oxymorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLC21-MAR-13
OpanaerLake Erie Medical DBA Quality Care Products LLC22-MAR-13
Oxymorphone HydrochlorideTeva Pharmaceuticals USA Inc08-APR-13
Oxymorphone HydrochlorideMallinckrodt, Inc.29-APR-13

Oxymorphone Case Reports

What Oxymorphone 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 Oxymorphone. 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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