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Nabumetone Adverse Events Reported to the FDA Over Time

How are Nabumetone adverse event reports trending over time?

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

Most Common Nabumetone Adverse Events Reported to the FDA

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

Drug Ineffective
46 (3.4%)
Completed Suicide
32 (2.36%)
Pain
31 (2.29%)
Diarrhoea
20 (1.48%)
Nausea
19 (1.4%)
Rash
19 (1.4%)
Fatigue
18 (1.33%)
Dyspnoea
17 (1.26%)
Pruritus
16 (1.18%)
Death
13 (.96%)
Dizziness
13 (.96%)
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Urticaria
12 (.89%)
Vomiting
12 (.89%)
Depression
11 (.81%)
Intentional Drug Misuse
11 (.81%)
Pain In Extremity
11 (.81%)
Abdominal Pain Upper
10 (.74%)
Cardiac Arrest
10 (.74%)
Drug Interaction
10 (.74%)
Pyrexia
10 (.74%)
Abdominal Pain
9 (.66%)
Angioedema
9 (.66%)
Blood Creatinine Increased
9 (.66%)
Coma
9 (.66%)
Drug Hypersensitivity
9 (.66%)
Rash Maculo-papular
9 (.66%)
Stevens-johnson Syndrome
9 (.66%)
Unresponsive To Stimuli
9 (.66%)
Arthralgia
8 (.59%)
Dysphagia
8 (.59%)
Erythema
8 (.59%)
Oedema
8 (.59%)
Respiratory Arrest
8 (.59%)
Anaemia
7 (.52%)
Anxiety
7 (.52%)
Asthenia
7 (.52%)
Blister
7 (.52%)
Cardio-respiratory Arrest
7 (.52%)
Headache
7 (.52%)
Hypertension
7 (.52%)
Hypotension
7 (.52%)
Insomnia
7 (.52%)
Loss Of Consciousness
7 (.52%)
Medication Error
7 (.52%)
Pneumonia
7 (.52%)
Rash Erythematous
7 (.52%)
Swelling
7 (.52%)
Alanine Aminotransferase Increased
6 (.44%)
Aspartate Aminotransferase Increase...
6 (.44%)
Blood Urea Increased
6 (.44%)
Chest Pain
6 (.44%)
Drug Dispensing Error
6 (.44%)
Dyspepsia
6 (.44%)
Gastrointestinal Haemorrhage
6 (.44%)
Hypersensitivity
6 (.44%)
Hypoaesthesia
6 (.44%)
Liver Function Test Abnormal
6 (.44%)
Malaise
6 (.44%)
Oedema Peripheral
6 (.44%)
Toxic Skin Eruption
6 (.44%)
Abdominal Discomfort
5 (.37%)
Back Pain
5 (.37%)
Eye Irritation
5 (.37%)
Gastrointestinal Disorder
5 (.37%)
Hypovolaemia
5 (.37%)
Memory Impairment
5 (.37%)
Oral Pain
5 (.37%)
Pruritus Generalised
5 (.37%)
Purpura
5 (.37%)
Swelling Face
5 (.37%)
Toxic Epidermal Necrolysis
5 (.37%)
Vision Blurred
5 (.37%)
Wound
5 (.37%)
Acidosis
4 (.3%)
Alopecia
4 (.3%)
Blood Glucose Increased
4 (.3%)
Blood Pressure Decreased
4 (.3%)
Cardiac Failure Congestive
4 (.3%)
Cerebral Infarction
4 (.3%)
Drug Eruption
4 (.3%)
Drug Screen Positive
4 (.3%)
Face Oedema
4 (.3%)
Gastric Haemorrhage
4 (.3%)
Incorrect Dose Administered
4 (.3%)
Lung Disorder
4 (.3%)
Nephrolithiasis
4 (.3%)
Paraesthesia
4 (.3%)
Pharyngeal Oedema
4 (.3%)
Photosensitivity Reaction
4 (.3%)
Pleural Effusion
4 (.3%)
Renal Failure Acute
4 (.3%)
Skin Exfoliation
4 (.3%)
Tinnitus
4 (.3%)
Upper Gastrointestinal Haemorrhage
4 (.3%)
Urinary Incontinence
4 (.3%)
Anaphylactic Shock
3 (.22%)
Asthma
3 (.22%)
Atrial Fibrillation
3 (.22%)
Blood Chloride Increased
3 (.22%)
Blood Parathyroid Hormone Increased
3 (.22%)
Blood Phosphorus Increased
3 (.22%)

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

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

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

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

Drug Use For Unknown Indication
208
Rheumatoid Arthritis
146
Arthritis
118
Product Used For Unknown Indication
94
Pain
70
Osteoarthritis
52
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Arthralgia
40
Inflammation
39
Back Pain
31
Antiinflammatory Therapy
23
Psoriatic Arthropathy
12
Myalgia
10
Fibromyalgia
8
Neck Pain
7
Pain In Extremity
6
Bursitis
6
Tendonitis
5
Ankylosing Spondylitis
5
Analgesic Therapy
5
Neuralgia
4
Spondylitis
4
Sciatica
4
Muscle Spasms
3
Ill-defined Disorder
3
Bone Pain
3
Muscle Relaxant Therapy
3
Torticollis
3
Osteoporosis
3
Lung Disorder
3
Plantar Fasciitis
2
Gingival Swelling
2
Juvenile Arthritis
2
Swelling
2
Gingival Pain
2
Intervertebral Disc Disorder
2
Temporomandibular Joint Syndrome
2
Gingival Erythema
2
Fall
2
Arthropathy
2
Hypertension
2
Crohns Disease
2
Infection
2
Musculoskeletal Chest Pain
2
Stevens-johnson Syndrome
2
Exostosis
2
Cervical Root Pain
2
Optic Neuritis
2
Muscle Disorder
1
Cancer Pain
1
Surgery
1
Cellulitis
1

Drug Labels

LabelLabelerEffective
NabumetoneBryant Ranch Prepack01-MAR-08
NabumetoneBryant Ranch Prepack01-MAR-08
NabumetoneGlenmark Generics Inc., USA15-SEP-09
NabumetoneUnit Dose Services15-SEP-09
NabumetoneUnit Dose Services15-SEP-09
NabumetoneBlenheim Pharmacal, Inc.21-APR-10
NabumetoneAltura Pharmaceuticals, Inc.28-APR-10
NabumetoneMajor Pharmaceuticals17-MAY-10
NabumetoneSTAT RX USA LLC19-JUL-10
NabumetoneUDL Laboratories, Inc.06-AUG-10
NabumetoneRebel Distributors Corp.08-OCT-10
NabumetonePar Pharmaceutical Inc.09-NOV-10
NabumetoneLake Erie Medical DBA Quality Care Products LLC23-NOV-10
NabumetoneNCS HealthCare of KY, Inc dba Vangard Labs23-MAY-11
NabumetoneREMEDYREPACK INC. 09-JUN-11
NabumetoneWatson Laboratories, Inc.15-JUN-11
NabumetonePD-Rx Pharmaceuticals, Inc.26-SEP-11
NabumetonePD-Rx Pharmaceuticals, Inc.26-SEP-11
NabumetoneLake Erie Medical DBA Quality Care Products LLC13-DEC-11
NabumetoneAmerican Health Packaging14-DEC-11
Nabumetone Lake Erie Medical DBA Quality Care Products LLC19-DEC-11
NabumetoneH.J. Harkins Company, Inc.20-DEC-11
NabumetonePreferred Pharmaceuticals, Inc30-JAN-12
Nabumetone Par Pharmaceutical Inc24-FEB-12
NabumetoneSTAT Rx USA LLC28-FEB-12
NabumetonePhysicians Total Care, Inc.02-APR-12
NabumetoneNCS HealthCare of KY, Inc dba Vangard Labs18-APR-12
NabumetoneSTAT Rx USA LLC24-APR-12
NabumetoneCardinal Health01-MAY-12
NabumetoneNCS HealthCare of KY, Inc dba Vangard Labs14-MAY-12
NabumetoneLake Erie Medical & Surgical Supply DBA Quality Care Products LLC02-JUL-12
NabumetoneLake Erie Medical & Surgical Supply DBA Quality Care Products LLC09-JUL-12
NabumetoneMylan Pharmaceuticals Inc.27-JUL-12
NabumetoneTeva Pharmaceuticals USA Inc31-JUL-12
NabumetoneLupin Pharmaceuticals, Inc.26-SEP-12
NabumetoneEon Labs, Inc.18-MAR-13
NabumetoneEon Labs, Inc.16-APR-13

Nabumetone Case Reports

What Nabumetone 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 Nabumetone. 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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