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ROFECOXIB

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Rofecoxib Adverse Events Reported to the FDA Over Time

How are Rofecoxib adverse event reports trending over time?

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

Most Common Rofecoxib Adverse Events Reported to the FDA

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

Drug Ineffective
51 (2.6%)
Drug Interaction
29 (1.48%)
Retinal Haemorrhage
27 (1.38%)
Chest Pain
24 (1.23%)
Pain
24 (1.23%)
Cerebrovascular Accident
20 (1.02%)
Myocardial Infarction
19 (.97%)
Lactic Acidosis
18 (.92%)
Pain In Extremity
18 (.92%)
Renal Failure
18 (.92%)
Abdominal Pain
17 (.87%)
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Dizziness
17 (.87%)
Tremor
17 (.87%)
Dyspnoea
16 (.82%)
Somnolence
16 (.82%)
Blood Cholesterol Increased
15 (.77%)
Feeling Abnormal
15 (.77%)
Sleep Disorder
15 (.77%)
Gastrooesophageal Reflux Disease
14 (.72%)
Vomiting
14 (.72%)
Back Disorder
13 (.66%)
Erectile Dysfunction
13 (.66%)
Facial Pain
13 (.66%)
Feeling Cold
13 (.66%)
Gastrointestinal Haemorrhage
13 (.66%)
Glossodynia
13 (.66%)
Neck Pain
13 (.66%)
Tooth Abscess
13 (.66%)
Back Pain
12 (.61%)
Condition Aggravated
12 (.61%)
Nausea
12 (.61%)
Oesophageal Spasm
12 (.61%)
Pain In Jaw
12 (.61%)
Renal Failure Acute
12 (.61%)
Blood Pressure Increased
11 (.56%)
Haemoglobin Decreased
11 (.56%)
Arthralgia
10 (.51%)
Hypertension
10 (.51%)
Oedema Peripheral
10 (.51%)
Rash
10 (.51%)
Anxiety
9 (.46%)
Drug Level Increased
9 (.46%)
Haematemesis
9 (.46%)
Hypersomnia
9 (.46%)
Medication Error
9 (.46%)
Myalgia
9 (.46%)
Sedation
9 (.46%)
Angina Pectoris
8 (.41%)
Blood Potassium Decreased
8 (.41%)
Completed Suicide
8 (.41%)
Confusional State
8 (.41%)
Contusion
8 (.41%)
Disorientation
8 (.41%)
Drug Intolerance
8 (.41%)
Dyspepsia
8 (.41%)
Faeces Discoloured
8 (.41%)
Gastric Ulcer
8 (.41%)
Injury
8 (.41%)
Knee Operation
8 (.41%)
Metabolic Acidosis
8 (.41%)
Oedema
8 (.41%)
Overdose
8 (.41%)
Pulmonary Embolism
8 (.41%)
Arthritis Infective
7 (.36%)
Cardiac Disorder
7 (.36%)
Circulatory Collapse
7 (.36%)
Depressed Level Of Consciousness
7 (.36%)
Drug Effect Decreased
7 (.36%)
Gastric Disorder
7 (.36%)
Gastrointestinal Disorder
7 (.36%)
Haemodialysis
7 (.36%)
Insomnia
7 (.36%)
Irritability
7 (.36%)
Oesophagitis
7 (.36%)
Post Procedural Complication
7 (.36%)
Prothrombin Time Prolonged
7 (.36%)
Thrombocytopenia
7 (.36%)
Treatment Noncompliance
7 (.36%)
Accident
6 (.31%)
Arthritis
6 (.31%)
Blood Sodium Decreased
6 (.31%)
Diarrhoea
6 (.31%)
Duodenal Ulcer
6 (.31%)
Gait Disturbance
6 (.31%)
General Physical Health Deteriorati...
6 (.31%)
Haematoma
6 (.31%)
Haemorrhage
6 (.31%)
Headache
6 (.31%)
Heart Rate Increased
6 (.31%)
Hostility
6 (.31%)
Hyporeflexia
6 (.31%)
Impaired Healing
6 (.31%)
Mobility Decreased
6 (.31%)
Osteoarthritis
6 (.31%)
Vertigo
6 (.31%)
Abdominal Pain Upper
5 (.26%)
Anaemia
5 (.26%)
Blood Creatinine Increased
5 (.26%)
Coma
5 (.26%)
Convulsion
5 (.26%)
Drug Toxicity
5 (.26%)

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

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

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

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

Drug Use For Unknown Indication
138
Ill-defined Disorder
127
Rheumatoid Arthritis
64
Osteoarthritis
57
Arthritis
55
Pain
42
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Arthralgia
26
Back Pain
17
Pain In Jaw
13
Pain In Extremity
9
Facial Pain
7
Product Used For Unknown Indication
6
Psoriatic Arthropathy
5
Sarcoma
4
Polyarthritis
4
Osteoporosis
4
Allergy Test
4
Analgesic Effect
4
Spinal Osteoarthritis
3
Neuralgia
2
Arthropathy
2
Suicide Attempt
2
Musculoskeletal Pain
2
Antiinflammatory Therapy
2
Prophylaxis
2
Neuritis
2
Post Procedural Pain
2
Crohns Disease
2
Back Disorder
2
Systemic Lupus Erythematosus
2
Bone Pain
2
Joint Ankylosis
2
Migraine
2
Localised Osteoarthritis
2
Neoplasm Prophylaxis
2
Joint Dislocation
1
Hyperaesthesia
1
Osteomyelitis
1
Post Laminectomy Syndrome
1
Colorectal Cancer Recurrent
1
Back Injury
1
Intentional Misuse
1
Crushing Injury Of Trunk
1
Gout
1
Coronary Artery Disease
1
Analgesia
1
Abdominal Pain Upper
1
Scleritis
1
Spinal Cord Disorder
1
Joint Injury
1
Respiratory Tract Infection
1

Rofecoxib Case Reports

What Rofecoxib 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 Rofecoxib. 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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