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ROXICODONE

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Roxicodone Adverse Events Reported to the FDA Over Time

How are Roxicodone adverse event reports trending over time?

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

Most Common Roxicodone Adverse Events Reported to the FDA

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

Completed Suicide
1516 (3.67%)
Respiratory Arrest
1262 (3.06%)
Cardiac Arrest
1219 (2.95%)
Cardio-respiratory Arrest
802 (1.94%)
Death
692 (1.68%)
Drug Toxicity
646 (1.57%)
Drug Ineffective
568 (1.38%)
Drug Abuse
557 (1.35%)
Somnolence
557 (1.35%)
Nausea
532 (1.29%)
Vomiting
461 (1.12%)
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Multiple Drug Overdose
448 (1.09%)
Overdose
446 (1.08%)
Pain
418 (1.01%)
Confusional State
405 (.98%)
Poisoning
389 (.94%)
Constipation
347 (.84%)
Intentional Drug Misuse
334 (.81%)
Drug Dependence
310 (.75%)
Headache
269 (.65%)
Drug Abuser
262 (.63%)
Drug Withdrawal Syndrome
257 (.62%)
Dyspnoea
245 (.59%)
Drug Interaction
234 (.57%)
Loss Of Consciousness
224 (.54%)
Anxiety
210 (.51%)
Agitation
208 (.5%)
Insomnia
208 (.5%)
Malaise
207 (.5%)
Accidental Overdose
205 (.5%)
Diarrhoea
202 (.49%)
Substance Abuse
199 (.48%)
Fatigue
192 (.47%)
Pyrexia
192 (.47%)
Coma
190 (.46%)
Delirium
190 (.46%)
Dizziness
190 (.46%)
Hyperhidrosis
190 (.46%)
Medication Error
190 (.46%)
Hypotension
183 (.44%)
Depressed Level Of Consciousness
181 (.44%)
Fall
180 (.44%)
Depression
179 (.43%)
Mental Status Changes
177 (.43%)
Unresponsive To Stimuli
176 (.43%)
Feeling Abnormal
175 (.42%)
Lethargy
171 (.41%)
Drug Effect Decreased
164 (.4%)
Back Pain
163 (.39%)
Multiple Drug Overdose Intentional
160 (.39%)
Hallucination
155 (.38%)
Asthenia
150 (.36%)
Road Traffic Accident
149 (.36%)
Tremor
148 (.36%)
Suicidal Ideation
146 (.35%)
Weight Decreased
143 (.35%)
Abdominal Pain
137 (.33%)
Convulsion
136 (.33%)
Pneumonia
136 (.33%)
Heart Rate Increased
134 (.32%)
Multiple Drug Overdose Accidental
134 (.32%)
Respiratory Depression
128 (.31%)
Pruritus
123 (.3%)
Blood Creatine Phosphokinase Increa...
120 (.29%)
Dysarthria
120 (.29%)
Inadequate Analgesia
119 (.29%)
Miosis
116 (.28%)
Withdrawal Syndrome
116 (.28%)
Rash
114 (.28%)
Pulmonary Oedema
113 (.27%)
Sedation
112 (.27%)
Blood Glucose Increased
111 (.27%)
Gait Disturbance
107 (.26%)
Condition Aggravated
105 (.25%)
Dehydration
105 (.25%)
Abdominal Pain Upper
104 (.25%)
Blood Pressure Increased
104 (.25%)
Decreased Appetite
104 (.25%)
Incorrect Dose Administered
103 (.25%)
Suicide Attempt
103 (.25%)
Urinary Tract Infection
102 (.25%)
Drug Screen Positive
98 (.24%)
General Physical Health Deteriorati...
98 (.24%)
Accidental Death
97 (.24%)
Pain In Extremity
97 (.24%)
Aggression
96 (.23%)
Drug Hypersensitivity
96 (.23%)
Renal Failure Acute
95 (.23%)
Chest Pain
94 (.23%)
Tachycardia
94 (.23%)
Hypertension
91 (.22%)
Alanine Aminotransferase Increased
90 (.22%)
Abnormal Behaviour
89 (.22%)
Arthralgia
89 (.22%)
Intentional Overdose
89 (.22%)
Amnesia
88 (.21%)
Oedema Peripheral
87 (.21%)
Serotonin Syndrome
87 (.21%)
Aspartate Aminotransferase Increase...
86 (.21%)
Disturbance In Attention
83 (.2%)
Memory Impairment
82 (.2%)

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

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

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

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

Pain
5495
Drug Use For Unknown Indication
2336
Product Used For Unknown Indication
1884
Back Pain
941
Breakthrough Pain
729
Cancer Pain
572
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Arthralgia
199
Analgesic Therapy
149
Pain Management
132
Abdominal Pain
119
Drug Abuse
106
Pain In Extremity
105
Fibromyalgia
104
Procedural Pain
95
Ill-defined Disorder
88
Drug Abuser
85
Bone Pain
83
Neck Pain
82
Rheumatoid Arthritis
72
Musculoskeletal Pain
71
Neuralgia
62
Osteoarthritis
60
Headache
58
Suicide Attempt
54
Arthritis
54
Intervertebral Disc Degeneration
45
Migraine
40
Analgesia
38
Back Disorder
37
Surgery
35
Chest Pain
34
Neuropathy Peripheral
33
Intervertebral Disc Protrusion
33
Abdominal Pain Upper
28
Analgesic Effect
25
Intervertebral Disc Disorder
22
Sciatica
21
Postoperative Analgesia
20
Intentional Drug Misuse
20
Complex Regional Pain Syndrome
19
Back Injury
18
Maternal Exposure During Pregnancy
18
Musculoskeletal Chest Pain
17
Pain Prophylaxis
16
Accidental Drug Intake By Child
16
Tumour Pain
16
Spinal Column Stenosis
15
Myalgia
14
Post Procedural Pain
14
Herpes Zoster
14
Post Herpetic Neuralgia
13

Drug Labels

LabelLabelerEffective
RoxicodoneSTAT RX USA LLC12-OCT-10
RoxicodoneXanodyne Pharmaceuticals, Inc.23-MAR-11
RoxicodoneMallinckrodt, Inc01-AUG-12

Roxicodone Case Reports

What Roxicodone 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 Roxicodone. 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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