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SKELAXIN

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Skelaxin Adverse Events Reported to the FDA Over Time

How are Skelaxin adverse event reports trending over time?

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

Most Common Skelaxin Adverse Events Reported to the FDA

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

Drug Ineffective
133 (4.22%)
Nausea
114 (3.62%)
Headache
88 (2.79%)
Dizziness
74 (2.35%)
Somnolence
73 (2.32%)
Feeling Abnormal
70 (2.22%)
Insomnia
67 (2.13%)
Rash
66 (2.09%)
Vomiting
47 (1.49%)
Pruritus
43 (1.36%)
Fatigue
41 (1.3%)
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Abdominal Discomfort
38 (1.21%)
Muscle Spasms
36 (1.14%)
Dyspnoea
35 (1.11%)
Tremor
31 (.98%)
Urticaria
31 (.98%)
Pain
29 (.92%)
Hypersensitivity
27 (.86%)
Oedema Peripheral
27 (.86%)
Nervousness
26 (.83%)
Malaise
25 (.79%)
Burning Sensation
22 (.7%)
Constipation
21 (.67%)
Heart Rate Increased
20 (.63%)
Completed Suicide
18 (.57%)
Diarrhoea
18 (.57%)
Palpitations
18 (.57%)
Drug Effect Decreased
17 (.54%)
Irritability
17 (.54%)
Pyrexia
17 (.54%)
Coma
16 (.51%)
Drug Hypersensitivity
16 (.51%)
Erythema
16 (.51%)
Hypoaesthesia
16 (.51%)
Weight Decreased
16 (.51%)
Myalgia
15 (.48%)
Back Pain
14 (.44%)
Chest Discomfort
14 (.44%)
Deafness
14 (.44%)
Drug Interaction
14 (.44%)
Intervertebral Disc Protrusion
14 (.44%)
Lethargy
14 (.44%)
Memory Impairment
14 (.44%)
Pain In Extremity
14 (.44%)
Pharyngeal Oedema
14 (.44%)
Abdominal Pain Upper
13 (.41%)
Alopecia
13 (.41%)
Anaphylactic Reaction
13 (.41%)
Anxiety
13 (.41%)
Fall
13 (.41%)
Feeling Jittery
13 (.41%)
Arthralgia
12 (.38%)
Cardiac Disorder
12 (.38%)
Confusional State
12 (.38%)
Convulsion
12 (.38%)
Dysuria
12 (.38%)
Paraesthesia
12 (.38%)
Sleep Disorder
12 (.38%)
Swelling Face
12 (.38%)
Aggression
11 (.35%)
Gastric Ulcer
11 (.35%)
Influenza Like Illness
11 (.35%)
Loss Of Consciousness
11 (.35%)
Asthenia
10 (.32%)
Balance Disorder
10 (.32%)
Blister
10 (.32%)
Cardio-respiratory Arrest
10 (.32%)
Disorientation
10 (.32%)
Drug Toxicity
10 (.32%)
Dyspepsia
10 (.32%)
Gait Disturbance
10 (.32%)
Mood Altered
10 (.32%)
Multiple Sclerosis Relapse
10 (.32%)
Neck Pain
10 (.32%)
Overdose
10 (.32%)
Parosmia
10 (.32%)
Speech Disorder
10 (.32%)
Weight Increased
10 (.32%)
Abdominal Pain
9 (.29%)
Chest Pain
9 (.29%)
Dyskinesia
9 (.29%)
Dysphagia
9 (.29%)
Flushing
9 (.29%)
Hyperhidrosis
9 (.29%)
Psychomotor Hyperactivity
9 (.29%)
Rash Generalised
9 (.29%)
Stevens-johnson Syndrome
9 (.29%)
Syncope
9 (.29%)
Back Disorder
8 (.25%)
Blood Pressure Increased
8 (.25%)
Cardiac Arrest
8 (.25%)
Cerebrovascular Accident
8 (.25%)
Disturbance In Attention
8 (.25%)
Feeling Hot
8 (.25%)
Flatulence
8 (.25%)
Musculoskeletal Chest Pain
8 (.25%)
Pruritus Generalised
8 (.25%)
Suicidal Ideation
8 (.25%)
Anaemia
7 (.22%)
Apnoeic Attack
7 (.22%)
Blood Glucose Increased
7 (.22%)

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

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

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

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

Muscle Spasms
250
Back Pain
181
Muscle Relaxant Therapy
144
Pain
105
Drug Use For Unknown Indication
79
Product Used For Unknown Indication
67
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Fibromyalgia
52
Myalgia
36
Neck Pain
35
Intervertebral Disc Degeneration
28
Musculoskeletal Pain
21
Arthralgia
20
Back Injury
19
Muscle Strain
19
Muscle Disorder
16
Back Disorder
14
Arthritis
13
Sciatica
13
Neuralgia
11
Bone Disorder
10
Pain In Extremity
10
Headache
10
Spinal Column Stenosis
9
Muscle Tightness
9
Intervertebral Disc Protrusion
8
Osteoarthritis
7
Completed Suicide
7
Surgery
7
Musculoskeletal Discomfort
6
Musculoskeletal Stiffness
6
Neck Injury
6
Ill-defined Disorder
5
Inflammation
5
Rheumatoid Arthritis
5
Oesophageal Stenosis
5
Neuropathy Peripheral
5
Muscle Spasticity
5
Hyperkeratosis
4
Breakthrough Pain
4
Nerve Injury
4
Hypotonia
4
Nerve Compression
4
Musculoskeletal Disorder
3
Periarthritis
3
Joint Injury
3
Drug Abuse
3
Migraine
3
Analgesic Effect
3
Temporomandibular Joint Syndrome
3
Road Traffic Accident
3
Bone Pain
3

Drug Labels

LabelLabelerEffective
SkelaxinPhysicians Total Care, Inc.21-JUL-10
SkelaxinRebel Distributors Corp04-JAN-11
SkelaxinPreferred Pharmaceuticals, Inc03-MAY-11
SkelaxinCardinal Health04-AUG-11
SkelaxinKing Pharmaceuticals, Inc.06-SEP-11
SkelaxinPD-Rx Pharmaceuticals, Inc.06-SEP-11
SkelaxinLake Erie Medical & Surgical Supply DBA Quality Care Products LLC14-DEC-11
SkelaxinSTAT Rx USA LLC15-AUG-12

Skelaxin Case Reports

What Skelaxin 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 Skelaxin. 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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