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Skelaxin (Metaxalone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Skelaxin (Metaxalone) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (91)
Death (4)

Reports by Reaction Type

Drug Ineffective (21)Headache (10)Abdominal Discomfort (10)Nausea (10)Insomnia (10)Cardiac Disorder (9)Dizziness (9)Drug Hypersensitivity (9)Rash (9)Pain (8)Hypersensitivity (7)Weight Increased (7)

Below are a few examples of reports where side effects / adverse reactions may be related to Skelaxin (Metaxalone). For a complete list or a specific selection of reports, please use the links above.

Possible Skelaxin side effects in 50 year old female

Reported by a physician from United States on 2012-08-27

Patient: 50 year old female

Reactions: Memory Impairment, Ankle Fracture, Feeling Abnormal, Loss of Consciousness

Drug(s) suspected as cause:
MS Contin
    Dosage: 30 mg, 2x/day

Flexeril
    Dosage: unk

Tramadol HCL
    Dosage: 50 mg, every 4 hrs

Avinza
    Dosage: 60 mg, 1x/day

Morphine
    Dosage: 15 mg, every 4 hrs

Skelaxin
    Dosage: unk



Possible Skelaxin side effects in 50 year old female

Reported by a physician from United States on 2012-08-24

Patient: 50 year old female

Reactions: Syncope, Hospitalisation, Sedation, Ankle Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avinza
    Dosage: 60 mg, am
    Indication: Product Used FOR Unknown Indication

MS Contin
    Dosage: 30 mg, q12h
    Indication: Product Used FOR Unknown Indication

Tramadol HCL
    Dosage: 50 mg, q4h
    Indication: Product Used FOR Unknown Indication

Morphine Sulfate
    Dosage: 15 mg, q4h
    Indication: Product Used FOR Unknown Indication

Skelaxin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Flexeril
    Indication: Product Used FOR Unknown Indication



Possible Skelaxin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female

Reactions: Spinal Disorder, Cardiac Disorder

Drug(s) suspected as cause:
Skelaxin
    Dosage: 800 mg, 3x/day
    Administration route: Oral
    Indication: Muscle Spasms

Neurontin
    Dosage: 600 mg, 3x/day
    Administration route: Oral
    Indication: Neuropathy Peripheral



Possible Skelaxin side effects in 52 year old male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 52 year old male, weighing 73.9 kg (162.6 pounds)

Reactions: Atrial Fibrillation

Drug(s) suspected as cause:
Skelaxin

Other drugs received by patient: Percocet; Diazepam



Possible Skelaxin side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: male

Reactions: Hypokinesia, Pain

Drug(s) suspected as cause:
Skelaxin



Possible Skelaxin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: female

Reactions: Confusional State, Agitation, Nightmare, Drug Ineffective, Hyperglycaemia, Rash, Toxicity To Various Agents, Convulsion, Tremor, Weight Increased, Bipolar Disorder, Chest Pain

Drug(s) suspected as cause:
Trileptal

Tizanidine Hydrochloride
    Indication: Migraine

Depakote

Darvocet-N 50

Skelaxin

Prozac

Paxil

Lunesta

Beta Blocking Agents

Topamax

Zonegran

Valium
    Indication: Agitation

Reglan

Abilify

Elavil

Zyprexa

Tegretol

Requip

MAO Inhibitors

Remeron

Buspar

Adderall

Erythromycin

Ritalin

Effexor

Sumatriptan

Wellbutrin

Tofranil

Zoloft

Daytrana

Antidepressants

Steroids NOS

Desyrel

Neurontin

Sinequan

Seroquel

Pamelor

Other drugs received by patient: Aspirin; Vitamin B-Complex, Other Combinations; Ensure; Caltrate +D; ONE A DAY



Possible Skelaxin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: female

Reactions: Spinal Disorder, Cardiac Disorder

Drug(s) suspected as cause:
Neurontin
    Dosage: 600 mg, 3x/day
    Administration route: Oral
    Indication: Neuropathy Peripheral

Skelaxin
    Dosage: 800 mg, 3x/day
    Administration route: Oral
    Indication: Muscle Spasms



Possible Skelaxin side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: male

Reactions: Drug Ineffective, Neuralgia

Drug(s) suspected as cause:
Skelaxin
    Dosage: 800mg
    Indication: Neuralgia
    Start date: 2009-10-05
    End date: 2009-10-01

Gabapentin
    Dosage: 300 mg, 2x/day
    Indication: Neuralgia
    Start date: 2009-11-18
    End date: 2009-12-18



Possible Skelaxin side effects in

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Skelaxin



Possible Skelaxin side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: female, weighing 83.9 kg (184.6 pounds)

Reactions: Procedural Pain, Hypersensitivity, Contusion, Fall

Drug(s) suspected as cause:
Skelaxin
    Administration route: Oral
    Indication: Muscle Relaxant Therapy
    Start date: 2012-06-11
    End date: 2012-06-01

Benadryl
    Administration route: Oral
    Indication: Urticaria
    Start date: 2012-06-20
    End date: 2012-06-01

Stelara
    Indication: Psoriasis
    Start date: 2012-03-01

Hydrocodone
    Administration route: Oral
    Indication: Procedural Pain
    Start date: 2012-06-11
    End date: 2012-06-01

Hydroxyzine HCL
    Administration route: Oral
    Indication: Urticaria
    Start date: 2012-06-01

Tramadol Hydrochloride
    Administration route: Oral
    Indication: Procedural Pain
    Start date: 2012-06-11

Corticosteroids
    Dosage: given once
    Indication: Urticaria
    Start date: 2012-06-01
    End date: 2012-06-01



Possible Skelaxin side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: female, weighing 86.2 kg (189.6 pounds)

Reactions: Malaise, Alopecia

Drug(s) suspected as cause:
Lyrica
    Dosage: 150 mg,daily
    Administration route: Oral
    Indication: Nervous System Disorder
    Start date: 2012-03-01
    End date: 2012-07-01

Lyrica
    Dosage: 150 mg/day
    Administration route: Oral
    Indication: Spinal Osteoarthritis
    Start date: 2012-07-25

Skelaxin
    Dosage: 800 mg, daily
    Indication: Spinal Osteoarthritis
    Start date: 2012-03-01



Possible Skelaxin side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: female, weighing 77.0 kg (169.4 pounds)

Reactions: Weight Decreased, Pain, Musculoskeletal Discomfort, Headache, Hypoaesthesia, Paraesthesia, Muscle Strain, Insomnia, Musculoskeletal Stiffness, Feeling Abnormal

Drug(s) suspected as cause:
Cyclobenzaprine
    Indication: Muscle Tightness

Cyclobenzaprine
    Dosage: 10 mg, 2x/day
    Indication: Brachial Plexopathy
    Start date: 2012-05-16
    End date: 2012-05-20

Cyclobenzaprine
    Indication: Nerve Compression

Lortab
    Dosage: unk
    Indication: Pain
    Start date: 2012-01-01

Skelaxin
    Dosage: 800 mg, 4x/day
    Indication: Brachial Plexopathy
    Start date: 2012-05-20
    End date: 2012-01-01

Skelaxin
    Indication: Nerve Compression

Skelaxin
    Indication: Muscle Tightness

Other drugs received by patient: Klonopin; Klonopin; Effexor XR



Possible Skelaxin side effects in female

Reported by a physician from United States on 2012-07-27

Patient: female

Reactions: Sexual Dysfunction

Drug(s) suspected as cause:
Tramadol Hydrochloride
    Dosage: unk

Lyrica
    Dosage: unk

Skelaxin
    Dosage: unk



Possible Skelaxin side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-23

Patient: male

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Skelaxin



Possible Skelaxin side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-20

Patient: female

Reactions: Burning Sensation, Breast Pain, Dyspnoea

Drug(s) suspected as cause:
Aldactone
    Dosage: unk

Lyrica
    Dosage: unk

Skelaxin
    Dosage: unk



Possible Skelaxin side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-12

Patient: female, weighing 80.0 kg (176.0 pounds)

Reactions: Intervertebral Disc Protrusion, Arthralgia, Oedema Peripheral

Drug(s) suspected as cause:
Skelaxin
    Dosage: 800 mg, 4x/day
    Administration route: Oral
    Indication: Fibromyalgia

Lyrica
    Dosage: 75 mg, 2x/day
    Administration route: Oral
    Indication: Fibromyalgia

Other drugs received by patient: Cymbalta; Xanax; Oxycontin; Naproxen



Possible Skelaxin side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-11

Patient: female

Reactions: Confusional State, Agitation, Nightmare, Drug Ineffective, Hyperglycaemia, Toxicity To Various Agents, Rash, Convulsion, Tremor, Weight Increased, Bipolar Disorder, Chest Pain

Drug(s) suspected as cause:
Tegretol

Requip

Neurontin

Darvocet-N 50

Remeron

Reglan

Depakote

Imitrex

Zonegran

Erythromycin

Ritalin

Sinequan

Elavil

Adderall 5

Wellbutrin

Pamelor

Prozac

Buspar

Lunesta

Trileptal

Topamax

Beta Blocking Agents

Abilify

Valium
    Indication: Agitation

Steroids NOS

Seroquel

MAO Inhibitors

Tofranil

Zoloft

Paxil

Daytrana

Effexor

Skelaxin

Antidepressants

Tizanidine Hydrochloride

Desyrel

Zyprexa

Other drugs received by patient: Vitamin B-Complex, Other Combinations; Caltrate +D; Ensure; ONE A DAY; Aspirin



Possible Skelaxin side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-11

Patient: female, weighing 83.9 kg (184.6 pounds)

Reactions: Procedural Pain, Contusion, Hypersensitivity, Fall

Drug(s) suspected as cause:
Benadryl
    Administration route: Oral
    Indication: Urticaria
    Start date: 2012-06-20
    End date: 2012-06-01

Stelara
    Indication: Psoriasis
    Start date: 2012-03-01

Hydrocodone Bitartrate
    Administration route: Oral
    Indication: Procedural Pain
    Start date: 2012-06-11
    End date: 2012-06-01

Hydroxyzine HCL
    Administration route: Oral
    Indication: Urticaria
    Start date: 2012-06-01

Tramadol HCL
    Administration route: Oral
    Indication: Procedural Pain
    Start date: 2012-06-11

Corticosteroids
    Dosage: given once
    Indication: Urticaria
    Start date: 2012-06-01
    End date: 2012-06-01

Skelaxin
    Administration route: Oral
    Indication: Muscle Relaxant Therapy
    Start date: 2012-06-11
    End date: 2012-06-01



Possible Skelaxin side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-22

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Zomig
    Dosage: unk

Keflex
    Dosage: unk

Skelaxin
    Dosage: unk

Clindamycin HCL
    Dosage: unk

Tramadol HCL
    Dosage: unk

Butorphanol
    Dosage: unk

Frova
    Dosage: unk

Lyrica
    Dosage: unk

Prochlorperazine
    Dosage: unk

Talwin
    Dosage: unk

Ciprofloxacin HCL
    Dosage: unk

Cyproheptadine HCL
    Dosage: unk

Benadryl
    Dosage: 2% spray

Scopolamine
    Dosage: unk

Naproxen
    Dosage: unk

Valium
    Dosage: unk

Reglan
    Dosage: unk

Ketorolac Tromethamine
    Dosage: unk

Lidocaine Hydrochloride
    Dosage: unk

Lovenox
    Dosage: unk

Augmentin '125'
    Dosage: unk

Dihydroergotamine Mesylate
    Dosage: unk

Celebrex
    Dosage: unk

Doxycycline Monohydrate
    Dosage: unk



Possible Skelaxin side effects in 66 year old female

Reported by a consumer/non-health professional from United States on 2012-06-11

Patient: 66 year old female

Reactions: Hypersensitivity

Adverse event resulted in: death

Drug(s) suspected as cause:
Skelaxin

Dilantin

Cytotec
    Dosage: unk



Possible Skelaxin side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-08

Patient: female

Reactions: Agitation, Confusional State, Nightmare, Drug Ineffective, Hyperglycaemia, Rash, Toxicity To Various Agents, Tremor, Convulsion, Weight Increased, Bipolar Disorder, Chest Pain

Drug(s) suspected as cause:
Skelaxin

Elavil

Prozac

Reglan

Tegretol

Depakote

Steroids NOS

Zonegran

MAO Inhibitors

Pamelor

Paxil

Requip

Sinequan

Abilify

Remeron

Tofranil

Buspar

Topamax

Imitrex

Darvocet-N 50

Seroquel

Tizanidine Hydrochloride

Adderall 5

Neurontin

Beta Blocking Agents

Desyrel

Zoloft

Ritalin

Trileptal

Valium
    Indication: Agitation

Lunesta

Daytrana

Erythromycin

Effexor

Antidepressants

Wellbutrin

Zyprexa

Other drugs received by patient: Aspirin; Caltrate +D; ONE A DAY; Vitamin B-Complex, Other Combinations; Ensure



Possible Skelaxin side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-07

Patient: female, weighing 80.0 kg (176.0 pounds)

Reactions: Intervertebral Disc Protrusion, Arthralgia, Oedema Peripheral

Drug(s) suspected as cause:
Skelaxin
    Dosage: 800 mg, 4x/day
    Administration route: Oral
    Indication: Fibromyalgia

Lyrica
    Dosage: 75 mg, 2x/day
    Administration route: Oral
    Indication: Fibromyalgia

Other drugs received by patient: Xanax; Cymbalta; Naproxen; Oxycontin



Possible Skelaxin side effects in 66 year old female

Reported by a consumer/non-health professional from United States on 2012-06-07

Patient: 66 year old female

Reactions: Hypersensitivity

Adverse event resulted in: death

Drug(s) suspected as cause:
Skelaxin

Dilantin



Possible Skelaxin side effects in female

Reported by a physician from United States on 2012-06-06

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Daypro
    Dosage: unk

Erythromycin
    Dosage: unk

Tetracycline Hydrochloride
    Dosage: unk

Chondroitin / Glucosamine
    Dosage: unk

Mobic
    Dosage: unk

Azithromycin
    Dosage: unk

Chloroquine
    Dosage: unk

Ceftin
    Dosage: unk

Claritin-D
    Dosage: unk

Plaquenil
    Dosage: unk

Sudafed 12 Hour
    Dosage: unk

Skelaxin
    Dosage: unk

Methotrexate Sodium
    Dosage: unk

Parafon Forte
    Dosage: unk

Ultram
    Dosage: unk

Prednisone TAB
    Dosage: unk

Lincocin
    Dosage: unk

Ciprofloxacin
    Dosage: unk

Benzylpenicillin Potassium
    Dosage: unk



Possible Skelaxin side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-05

Patient: female, weighing 78.9 kg (173.6 pounds)

Reactions: Vomiting, Nausea, Injection Site Haemorrhage, Pain, Musculoskeletal Chest Pain, Headache, Cardiac Disorder, Abdominal Discomfort, Fungal Oesophagitis, Gastrointestinal Fungal Infection, Dizziness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remicade
    Dosage: 1 in 8 week
    Indication: Rheumatoid Arthritis
    Start date: 2011-09-22
    End date: 2011-12-29

Skelaxin
    Dosage: 800 mg, qd
    Indication: Bone Disorder
    Start date: 2012-01-01

Other drugs received by patient: Calcium; Calcium Carbonate; Reclast; Citracal + D



Possible Skelaxin side effects in 59 year old female

Reported by a individual with unspecified qualification from United States on 2012-06-05

Patient: 59 year old female, weighing 65.3 kg (143.7 pounds)

Reactions: Pharyngeal Oedema, Swelling Face, Pruritus, Dyspnoea, Oedema Peripheral

Drug(s) suspected as cause:
Skelaxin
    Dosage: 1 tab 800 mg 1 at bedtime oral
    Administration route: Oral
    Start date: 2012-02-11
    End date: 2012-02-15

Medrol
    Dosage: dose pk on 3rd day reaction oral
    Administration route: Oral
    Indication: Accident
    Start date: 2012-02-10
    End date: 2012-02-12

Medrol
    Dosage: dose pk on 3rd day reaction oral
    Administration route: Oral
    Indication: Head Injury
    Start date: 2012-02-10
    End date: 2012-02-12



Possible Skelaxin side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-04

Patient: female, weighing 78.9 kg (173.6 pounds)

Reactions: Vomiting, Nausea, Injection Site Haemorrhage, Pain, Musculoskeletal Chest Pain, Headache, Cardiac Disorder, Abdominal Discomfort, Fungal Oesophagitis, Gastrointestinal Fungal Infection, Dizziness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Skelaxin
    Dosage: 800 mg, qd
    Indication: Bone Disorder
    Start date: 2012-01-01

Remicade
    Dosage: 1 in 8 week
    Indication: Rheumatoid Arthritis
    Start date: 2011-09-22
    End date: 2011-12-29

Other drugs received by patient: Citracal + D; Reclast; Calcium; Calcium Carbonate



Possible Skelaxin side effects in 66 year old female

Reported by a consumer/non-health professional from United States on 2012-06-01

Patient: 66 year old female

Reactions: Hypersensitivity

Adverse event resulted in: death

Drug(s) suspected as cause:
Skelaxin



Possible Skelaxin side effects in 46 year old female

Reported by a physician from United States on 2012-05-30

Patient: 46 year old female, weighing 54.4 kg (119.7 pounds)

Reactions: Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Nausea, Alanine Aminotransferase Increased, Blood Calcium Decreased, Anxiety, Alcohol Intolerance, Drug Tolerance Decreased, Malaise, Blood Potassium Decreased, Aspartate Aminotransferase Increased, Asthenia, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Skelaxin



Possible Skelaxin side effects in female

Reported by a physician from United States on 2012-05-29

Patient: female, weighing 71.7 kg (157.6 pounds)

Reactions: Dyspnoea, Drug Hypersensitivity

Drug(s) suspected as cause:
Lyrica
    Dosage: unk
    Indication: Fibromyalgia

Paxil
    Dosage: unk
    Indication: Mental Disorder

Codeine Sulfate
    Dosage: unk
    Indication: Gallbladder Pain

Aspirin
    Dosage: unk

Prozac
    Dosage: unk
    Indication: Mental Disorder

Skelaxin
    Dosage: unk
    Indication: Fibromyalgia

Potassium Penicillin G
    Dosage: unk
    Indication: Cholecystitis Infective

Ultram
    Dosage: unk
    Indication: Fibromyalgia

Other drugs received by patient: Seroquel; Buspar

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