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PROPOXYPHENE AND ACETAMINOPHEN

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Propoxyphene And Acetaminophen Adverse Events Reported to the FDA Over Time

How are Propoxyphene And Acetaminophen adverse event reports trending over time?

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

Most Common Propoxyphene And Acetaminophen Adverse Events Reported to the FDA

What are the most common Propoxyphene And Acetaminophen adverse events reported to the FDA?

Cardio-respiratory Arrest
773 (9.27%)
Arrhythmia
726 (8.71%)
Cardiac Disorder
711 (8.53%)
Myocardial Infarction
711 (8.53%)
Cardiovascular Disorder
685 (8.22%)
Completed Suicide
426 (5.11%)
Sudden Cardiac Death
295 (3.54%)
Cardiac Arrest
156 (1.87%)
Respiratory Arrest
140 (1.68%)
Death
82 (.98%)
Dizziness
80 (.96%)
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Injury
79 (.95%)
Multiple Drug Overdose
75 (.9%)
Multiple Drug Overdose Intentional
65 (.78%)
Intentional Drug Misuse
60 (.72%)
Palpitations
59 (.71%)
Atrial Fibrillation
55 (.66%)
Chest Pain
52 (.62%)
Vomiting
49 (.59%)
Nausea
43 (.52%)
Dyspnoea
42 (.5%)
Poisoning
38 (.46%)
Pain
37 (.44%)
Somnolence
35 (.42%)
Cerebrovascular Accident
34 (.41%)
Drug Toxicity
34 (.41%)
Loss Of Consciousness
31 (.37%)
Heart Rate Irregular
30 (.36%)
Nervous System Disorder
30 (.36%)
Movement Disorder
29 (.35%)
Hypotension
28 (.34%)
Overdose
27 (.32%)
Heart Rate Increased
26 (.31%)
Diarrhoea
25 (.3%)
Drug Abuse
25 (.3%)
Bradycardia
24 (.29%)
Drug Ineffective
24 (.29%)
Fall
24 (.29%)
Confusional State
23 (.28%)
Tachycardia
23 (.28%)
Pruritus
22 (.26%)
Product Quality Issue
20 (.24%)
Tremor
20 (.24%)
Alanine Aminotransferase Increased
19 (.23%)
Blood Pressure Increased
19 (.23%)
Headache
19 (.23%)
Mitral Valve Incompetence
19 (.23%)
Weight Decreased
19 (.23%)
Abdominal Pain Upper
18 (.22%)
Anhedonia
18 (.22%)
Anxiety
18 (.22%)
Cholestasis
18 (.22%)
Disorientation
18 (.22%)
Emotional Distress
18 (.22%)
Gastrointestinal Disorder
18 (.22%)
Blood Alkaline Phosphatase Increase...
17 (.2%)
Duodenal Ulcer
17 (.2%)
Gastritis
17 (.2%)
Reflux Oesophagitis
17 (.2%)
Asthenia
16 (.19%)
Coma
16 (.19%)
Cytolytic Hepatitis
16 (.19%)
Deformity
16 (.19%)
Intentional Overdose
16 (.19%)
Aspartate Aminotransferase Increase...
15 (.18%)
Cardiac Failure
15 (.18%)
Cardiac Failure Congestive
15 (.18%)
Economic Problem
15 (.18%)
General Physical Health Deteriorati...
15 (.18%)
Malaise
15 (.18%)
Syncope
15 (.18%)
Depression
14 (.17%)
Hyponatraemia
14 (.17%)
Drug Interaction
13 (.16%)
Fear Of Death
13 (.16%)
Gamma-glutamyltransferase Increased
13 (.16%)
Hyperhidrosis
13 (.16%)
Pulmonary Arterial Hypertension
13 (.16%)
Rash Maculo-papular
13 (.16%)
Aortic Valve Incompetence
12 (.14%)
Constipation
12 (.14%)
Family Stress
12 (.14%)
Pulmonary Oedema
12 (.14%)
Pyrexia
12 (.14%)
Sudden Death
12 (.14%)
Ventricular Extrasystoles
12 (.14%)
Agitation
11 (.13%)
Fatigue
11 (.13%)
Hepatic Encephalopathy
11 (.13%)
Medication Error
11 (.13%)
Unresponsive To Stimuli
11 (.13%)
Acute Generalised Exanthematous Pus...
10 (.12%)
Cardiac Flutter
10 (.12%)
Feeling Abnormal
10 (.12%)
Lethargy
10 (.12%)
Skin Exfoliation
10 (.12%)
Toxic Skin Eruption
10 (.12%)
Transient Ischaemic Attack
10 (.12%)
Vertigo
10 (.12%)
Atrial Flutter
9 (.11%)
Drug Abuser
9 (.11%)

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This graph shows the top adverse events submitted to the FDA for Propoxyphene And Acetaminophen, 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 Propoxyphene And Acetaminophen 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 Propoxyphene And Acetaminophen

What are the most common Propoxyphene And Acetaminophen adverse events reported to the FDA?

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

Why are people taking Propoxyphene And Acetaminophen, according to those reporting adverse events to the FDA?

Pain
657
Product Used For Unknown Indication
647
Drug Use For Unknown Indication
452
Pain Management
98
Back Pain
82
Arthralgia
42
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Rheumatoid Arthritis
28
Osteoarthritis
22
Suicide Attempt
20
Arthritis
15
Pain In Extremity
15
Analgesic Therapy
15
Ill-defined Disorder
13
Abdominal Pain
11
Headache
10
Procedural Pain
10
Toothache
8
Migraine
7
Myalgia
7
Analgesic Effect
6
Crohns Disease
6
Bone Pain
6
Chest Pain
6
Sciatica
6
Neuralgia
5
Analgesia
5
Back Disorder
5
Medication Error
4
Fibromyalgia
4
Neck Pain
4
Intervertebral Disc Protrusion
4
Musculoskeletal Pain
4
Completed Suicide
3
Complex Regional Pain Syndrome
3
Narcolepsy
3
Intentional Overdose
3
Surgery
3
Localised Osteoarthritis
3
Pelvic Pain
2
Musculoskeletal Chest Pain
2
Umbilical Hernia Repair
2
Viral Infection
2
Drug Abuse
2
Chondrocalcinosis
2
Tinnitus
2
Dizziness
2
Pyrexia
2
Neuritis
2
Gout
2
Hernia Repair
2
Intentional Misuse
2

Drug Labels

LabelLabelerEffective
Propoxyphene Napsylate And AcetaminophenAmerican Health Packaging25-SEP-09
Propoxyphene Hydrochloride And AcetaminophenMylan Pharmaceuticals Inc.20-OCT-09
Propoxyphene Napsylate And AcetaminophenMylan Pharmaceuticals Inc.20-OCT-09
Propoxyphene Napsylate And AcetaminophenBryant Ranch Prepack20-OCT-09
Propoxyphene Napsylate And AcetaminophenRebel Distributors Corp.01-DEC-09
Propoxyphene Napsylate And AcetaminophenApotheca, Inc.11-MAR-10
Propoxyphene And AcetaminophenAltura Pharmaceuticals, Inc.28-APR-10
Propoxyphene And AcetaminophenPD-Rx Pharmaceuticals, Inc.10-MAY-10
Propoxyphene And AcetaminophenKeltman Pharmaceuticals Inc.03-AUG-10
Propoxyphene Napsylate And AcetaminophenBlenheim Pharmacal, Inc.23-AUG-10
Propoxyphene And AcetaminophenBlenheim Pharmacal, Inc.10-SEP-10
Propoxyphene Napsylate And AcetaminophenREMEDYREPACK INC. 15-FEB-11
Propoxyphene Napsylate And AcetaminophenRedPharm Drug Inc.25-MAY-11
Propoxyphene Napsylate And AcetaminophenRedPharm Drug Inc.20-JUN-11
Propoxyphene Napsylate And AcetaminophenRedPharm Drug Inc.20-JUN-11
Propoxyphene Napsylate And Acetaminophen Lake Erie Medical DBA Quality Care Products01-DEC-11

Propoxyphene And Acetaminophen Case Reports

What Propoxyphene And Acetaminophen 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 Propoxyphene And Acetaminophen. 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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