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Soma (Carisoprodol) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Soma (Carisoprodol) 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 (87)
Death (10)
Life Threatening Events (4)
Disability (3)

Reports by Reaction Type

Anxiety (17)Pain (15)Tremor (11)Drug Ineffective (9)Fatigue (9)Insomnia (9)Aggression (8)Blood Cholesterol Increased (7)Unevaluable Event (7)Muscle Spasms (7)Drug Hypersensitivity (7)Toxicity To Various Agents (7)

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

Possible Soma side effects in 40 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 40 year old male

Reactions: Depression, Drug Dependence, Drug Abuse, Suicidal Ideation

Drug(s) suspected as cause:
Soma
    Indication: Product Used FOR Unknown Indication

Vicodin
    Indication: Product Used FOR Unknown Indication

Oxycodone HCL
    Indication: Pain

Muscle Relaxants
    Indication: Product Used FOR Unknown Indication

Roxicodone
    Indication: Product Used FOR Unknown Indication

Flexeril
    Indication: Product Used FOR Unknown Indication



Possible Soma side effects in 76 year old

Reported by a physician from United States on 2012-08-23

Patient: 76 year old

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Doxycycline Hyclate
    Dosage: unk

Soma
    Dosage: unk

Morphine Sulfate
    Dosage: unk

Aspirin
    Dosage: unk

Penicillin



Possible Soma side effects in 76 year old

Reported by a physician from United States on 2012-08-23

Patient: 76 year old

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Morphine Sulfate
    Dosage: unk

Doxycycline Hyclate
    Dosage: unk

Aspirin
    Dosage: unk

Soma
    Dosage: unk

Penicillin



Possible Soma side effects in female

Reported by a physician from United States on 2012-08-13

Patient: female, weighing 54.5 kg (119.9 pounds)

Reactions: Toxic Encephalopathy, Accidental Overdose

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Seroquel
    Dosage: 300 mg
    Administration route: Oral
    Start date: 2003-03-12
    End date: 2011-09-20

Restoril
    Dosage: 60 mg
    Start date: 2000-09-27
    End date: 2011-04-19

Alprazolam
    Start date: 2004-09-22

Soma
    Dosage: 700 mg
    Start date: 2003-12-01

Midazolam

Other drugs received by patient: Trazodone Hydrochloride; Escitalopram; Morphine Sulfate; Gabapentin



Possible Soma side effects in 50 year old male

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

Patient: 50 year old male, weighing 81.0 kg (178.2 pounds)

Reactions: Weight Decreased, Eye Irritation, Hallucination, Auditory, Pain, Substance Abuse, Fatigue, Neck Pain, Unevaluable Event, Cold Sweat, Paranoia, Terminal Insomnia, Pain in Extremity, Musculoskeletal Pain, Lumbar Radiculopathy, Inadequate Analgesia, Drug Withdrawal Syndrome, Self Injurious Behaviour, Cervicobrachial Syndrome, Tremor, Aggression, Spinal Fusion Surgery, Major Depression, Drug Dependence, Neck Surgery

Drug(s) suspected as cause:
Oxycontin
    Dosage: 60 mg, q12h

Oxycontin
    Dosage: 80 mg, tid

Roxicodone
    Dosage: unk unk, see text
    Indication: Intervertebral Disc Degeneration

Oxycodone HCL
    Dosage: 30 mg, see text
    Administration route: Oral
    Indication: Intervertebral Disc Degeneration

Oxycontin
    Dosage: 60 mg, tid
    Administration route: Oral
    Indication: Intervertebral Disc Degeneration

Soma
    Indication: Intervertebral Disc Degeneration

Oxycontin
    Dosage: 40 mg, q6h
    Administration route: Oral
    Indication: Back Pain

Other drugs received by patient: Lexapro; Lyrica; Lexapro; Prozac; Klonopin; Requip; Depakote ER



Possible Soma side effects in 40 year old male

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: 40 year old male

Reactions: Depression, Drug Dependence, Suicidal Ideation

Drug(s) suspected as cause:
Flexeril

Oxycodone HCL
    Indication: Pain

Soma
    Indication: Product Used FOR Unknown Indication

Vicodin
    Indication: Product Used FOR Unknown Indication



Possible Soma side effects in 53 year old male

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

Patient: 53 year old male

Reactions: Dysphagia, Aphasia, Swollen Tongue, Muscle Spasms

Drug(s) suspected as cause:
Nucynta ER
    Dosage: 100 mg twice a day
    Administration route: Oral
    Indication: Pain
    Start date: 2012-07-16
    End date: 2012-07-18

Soma
    Dosage: 350 mg at bedtime
    Administration route: Oral
    Indication: Hypotonia
    Start date: 2012-07-16
    End date: 2012-07-18

Anaprox
    Dosage: 500 mg twice a day
    Administration route: Oral
    Indication: Inflammation
    Start date: 2012-07-16
    End date: 2012-07-18

Acetaminophen
    Dosage: 500 mg 4 times a day
    Administration route: Oral
    Indication: Pain
    Start date: 2012-07-16



Possible Soma side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: male

Reactions: Convulsion

Drug(s) suspected as cause:
Zyprexa

Soma
    Administration route: Oral
    Indication: Myalgia
    Start date: 2000-01-01
    End date: 2003-01-01

Soma
    Administration route: Oral
    Start date: 2011-01-01
    End date: 2011-08-03

Seroquel
    Administration route: Oral

Other drugs received by patient: Zyrtec; Naproxen; Prozac; Hydrocodone Bitartrate; Klonopin



Possible Soma side effects in 50 year old male

Reported by a physician from United States on 2012-07-26

Patient: 50 year old male, weighing 81.0 kg (178.2 pounds)

Reactions: Weight Decreased, Eye Irritation, Hallucination, Auditory, Pain, Substance Abuse, Fatigue, Surgery, Unevaluable Event, Cold Sweat, Drug Effect Decreased, Terminal Insomnia, Paranoia, Drug Withdrawal Syndrome, Self Injurious Behaviour, Aggression, Tremor, Major Depression, Drug Dependence

Drug(s) suspected as cause:
Roxicodone
    Dosage: unk unk, see text
    Indication: Intervertebral Disc Degeneration

Oxycontin
    Dosage: 60 mg, q12h

Oxycontin
    Dosage: 80 mg, tid

Soma
    Indication: Intervertebral Disc Degeneration

Oxycontin
    Dosage: 40 mg, q6h
    Administration route: Oral
    Indication: Back Pain

Oxycodone HCL
    Dosage: 30 mg, see text
    Administration route: Oral
    Indication: Intervertebral Disc Degeneration

Oxycontin
    Dosage: 60 mg, tid
    Administration route: Oral
    Indication: Intervertebral Disc Degeneration

Other drugs received by patient: Prozac; Depakote ER; Lexapro; Klonopin; Requip; Lexapro; Lyrica



Possible Soma side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19

Patient: male

Reactions: Panic Attack, Alcohol Abuse, Fibromyalgia, Intentional Overdose, Pain, Restless Legs Syndrome, Blood Cholesterol Increased, Accidental Overdose, Neck Surgery

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Soma
    Dosage: 80 mg, tid
    Indication: Product Used FOR Unknown Indication

Oxycontin
    Dosage: unk, see text
    Indication: Back Pain

Oxycodone HCL
    Dosage: unk, see text
    Indication: Breakthrough Pain

Klonopin
    Dosage: unk, see text
    Indication: Anxiety Disorder

Other drugs received by patient: Pravachol; Requip; Prozac



Possible Soma side effects in female

Reported by a physician from United States on 2012-07-17

Patient: female

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Potassium Penicillin G
    Dosage: unk

Soma
    Dosage: unk



Possible Soma side effects in female

Reported by a physician from United States on 2012-07-17

Patient: female

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Potassium Penicillin G
    Dosage: unk

Soma
    Dosage: unk



Possible Soma side effects in 50 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-16

Patient: 50 year old male, weighing 81.0 kg (178.2 pounds)

Reactions: Weight Decreased, Eye Irritation, Hallucination, Auditory, Pain, Substance Abuse, Fatigue, Surgery, Unevaluable Event, Cold Sweat, Paranoia, Terminal Insomnia, Drug Withdrawal Syndrome, Self Injurious Behaviour, Tremor, Aggression, Major Depression, Drug Dependence

Drug(s) suspected as cause:
Roxicodone
    Dosage: unk unk, see text
    Indication: Intervertebral Disc Degeneration

Soma
    Indication: Intervertebral Disc Degeneration

Oxycontin
    Indication: Intervertebral Disc Degeneration

Oxycontin
    Dosage: 80 mg, tid
    Indication: Back Pain

Oxycodone HCL
    Dosage: 30 mg, see text
    Indication: Intervertebral Disc Degeneration

Other drugs received by patient: Lyrica; Depakote ER; Lexapro; Lexapro; Requip



Possible Soma side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-16

Patient: male

Reactions: Alcohol Abuse, Pain, Restless Legs Syndrome, Accidental Overdose, Panic Attack, Fibromyalgia, Suicide Attempt, Blood Cholesterol Increased, Neck Surgery

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Soma
    Dosage: 80 mg, tid
    Indication: Product Used FOR Unknown Indication

Klonopin
    Dosage: unk, see text
    Indication: Anxiety Disorder

Oxycontin
    Dosage: unk, see text
    Indication: Back Pain

Oxycodone HCL
    Dosage: unk, see text
    Indication: Breakthrough Pain

Other drugs received by patient: Requip; Prozac; Pravachol



Possible Soma side effects in 46 year old female

Reported by a consumer/non-health professional from United States on 2012-07-13

Patient: 46 year old female

Reactions: Abdominal Pain, Dyspnoea, Vomiting, Nausea, Pain, Tremor, Delusion, Anxiety, Panic Attack, Palpitations, Insomnia, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xanax
    Dosage: unk
    End date: 2012-04-05

Soma
    Dosage: unk
    End date: 2012-04-05

Daliresp
    Dosage: 500 ug, unk
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-11-01
    End date: 2012-04-11

Oxycontin
    Dosage: unk
    End date: 2012-04-05

Other drugs received by patient: Estrace; Amlodipine; Patanol; Ventolin; Spiriva; Metoprolol; Nexium; Nasonex; Bentyl; Lidocaine; Norco



Possible Soma side effects in male

Reported by a lawyer from United States on 2012-07-12

Patient: male

Reactions: Cleft LIP and Palate, Cerebral Palsy, Torticollis, Craniosynostosis, Lacrimal Disorder, Developmental Delay, Plagiocephaly, Feeding Disorder, Hydrocele, Duane's Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetaminophen

Oxycodone / Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Nystatin
    Indication: Foetal Exposure During Pregnancy

Vicodin
    Indication: Foetal Exposure During Pregnancy

Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Topamax
    Indication: Foetal Exposure During Pregnancy

Oxycontin
    Indication: Foetal Exposure During Pregnancy

Ovcon-35
    Indication: Foetal Exposure During Pregnancy

Ultram
    Indication: Foetal Exposure During Pregnancy

Soma
    Indication: Foetal Exposure During Pregnancy

Feldene
    Indication: Foetal Exposure During Pregnancy

Crestor
    Indication: Foetal Exposure During Pregnancy

Effexor
    Indication: Foetal Exposure During Pregnancy

Selective Serotonin Reuptake Inhibitor
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP; Folic Acid; Fish OIL



Possible Soma side effects in 21 year old male

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

Patient: 21 year old male

Reactions: Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Soma
    Indication: Product Used FOR Unknown Indication

Methadose
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Oxycodone HCL
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Valium
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



Possible Soma side effects in

Reported by a physician from United States on 2012-07-10

Patient:

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Doxycycline Hyclate
    Dosage: unk

Penicillin

Aspirin
    Dosage: unk

Morphine Sulfate
    Dosage: unk

Soma
    Dosage: unk



Possible Soma side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-05

Patient: male

Reactions: Neoplasm Malignant

Drug(s) suspected as cause:
Soma



Possible Soma side effects in female

Reported by a physician from United States on 2012-06-28

Patient: female

Reactions: Drug Hypersensitivity

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

Potassium Penicillin G
    Dosage: unk



Possible Soma side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-27

Patient: female

Reactions: Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Soma



Possible Soma side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-18

Patient: 30 year old female

Reactions: Intentional Drug Misuse, Somnolence

Drug(s) suspected as cause:
Soma

Fentora



Possible Soma side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-15

Patient: male

Reactions: Cerebral Palsy, Cleft LIP and Palate, Maternal Drugs Affecting Foetus, Ear Infection, Torticollis, Craniosynostosis, Lacrimal Disorder, Developmental Delay, Plagiocephaly, Dacryostenosis Congenital, Hypermetropia, Feeding Disorder, Hydrocele, Duane's Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Oxycontin
    Indication: Foetal Exposure During Pregnancy

Effexor
    Indication: Foetal Exposure During Pregnancy

Vicodin
    Indication: Foetal Exposure During Pregnancy

Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Crestor
    Indication: Foetal Exposure During Pregnancy

Ovcon-35
    Indication: Foetal Exposure During Pregnancy

Nystatin
    Indication: Foetal Exposure During Pregnancy

Selective Serotonin Reuptake Inhibitor
    Indication: Foetal Exposure During Pregnancy

Topamax
    Indication: Foetal Exposure During Pregnancy

Soma
    Indication: Foetal Exposure During Pregnancy

Feldene
    Indication: Foetal Exposure During Pregnancy

Acetaminophen

Ultram
    Indication: Foetal Exposure During Pregnancy

Oxycodone / Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Leucovorin Calcium; Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP; Fish OIL



Possible Soma side effects in 46 year old female

Reported by a consumer/non-health professional from United States on 2012-06-14

Patient: 46 year old female

Reactions: Abdominal Pain, Dyspnoea, Vomiting, Nausea, Pain, Bruxism, Delusion, Tremor, Anxiety, Panic Attack, Palpitations, Mood Altered, Insomnia, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Daliresp
    Dosage: 500 mcg
    Administration route: Oral
    Start date: 2012-04-22

Daliresp
    Dosage: 500 mcg
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-11-01
    End date: 2012-04-11

Soma
    End date: 2012-04-05

Xanax
    End date: 2012-04-05

Oxycontin
    End date: 2012-04-05

Other drugs received by patient: Bentyl; Lidocaine; Norco; Patanol; Metoprolol Tartrate; Spiriva; Ventolin HFA; Nasonex; Nexium; Estrace; Amlodipine



Possible Soma side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-14

Patient: male

Reactions: Cleft LIP and Palate, Torticollis, Craniosynostosis, Lacrimal Disorder, Developmental Delay, Feeding Disorder, Duane's Syndrome, Hydrocele

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ovcon-35
    Indication: Foetal Exposure During Pregnancy

Soma
    Indication: Foetal Exposure During Pregnancy

Vicodin
    Indication: Foetal Exposure During Pregnancy

Effexor
    Indication: Foetal Exposure During Pregnancy

Acetaminophen

Feldene
    Indication: Foetal Exposure During Pregnancy

Selective Serotonin Reuptake Inhibitor
    Indication: Foetal Exposure During Pregnancy

Ultram
    Indication: Foetal Exposure During Pregnancy

Oxycontin
    Indication: Foetal Exposure During Pregnancy

Topamax
    Indication: Foetal Exposure During Pregnancy

Oxycodone / Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Crestor
    Indication: Foetal Exposure During Pregnancy

Nystatin
    Indication: Foetal Exposure During Pregnancy

Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Leucovorin Calcium; Fish OIL; Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP



Possible Soma side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-06

Patient: male

Reactions: Cleft LIP and Palate, Craniosynostosis, Developmental Delay, Torticollis, Feeding Disorder, Hydrocele, Duane's Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Crestor
    Indication: Foetal Exposure During Pregnancy

Feldene
    Indication: Foetal Exposure During Pregnancy

Topamax
    Indication: Foetal Exposure During Pregnancy

Oxycodone / Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Acetaminophen

Selective Serotonin Reuptake Inhibitor
    Indication: Foetal Exposure During Pregnancy

Ovcon-35
    Indication: Foetal Exposure During Pregnancy

Oxycontin
    Indication: Foetal Exposure During Pregnancy

Vicodin
    Indication: Foetal Exposure During Pregnancy

Ultram
    Indication: Foetal Exposure During Pregnancy

Soma
    Indication: Foetal Exposure During Pregnancy

Nystatin
    Indication: Foetal Exposure During Pregnancy

Effexor
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP; Folic Acid; Fish OIL



Possible Soma side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-31

Patient: female

Reactions: Intervertebral Disc Operation, Accident, Carpal Tunnel Decompression, Intervertebral Disc Protrusion, Surgery, Drug Ineffective, Tarsal Tunnel Decompression, Benign Neoplasm of Spinal Cord, Elbow Operation

Drug(s) suspected as cause:
Ibuprofen
    Indication: Inflammation

Oxycodone HCL
    Dosage: 5 mg, unk
    Indication: Neck Pain

Soma
    Indication: Muscle Relaxant Therapy

Oxycontin
    Indication: Inflammation

Oxycodone HCL
    Indication: Inflammation

Dilaudid
    Indication: Neck Pain

Diazepam
    Dosage: 5 mg, unk
    Indication: Muscle Relaxant Therapy

Ibuprofen
    Indication: Neck Pain

Oxycontin
    Dosage: 40 mg, unk
    Indication: Neck Pain

Dilaudid
    Dosage: 8 mg, unk
    Administration route: Oral
    Indication: Inflammation

Other drugs received by patient: Amitriptyline HCL; Promethazine; Chlordiazepoxide; Prilosec



Possible Soma side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-24

Patient: male, weighing 113.4 kg (249.5 pounds)

Reactions: Back Pain, Product Substitution Issue, Arthralgia, Paradoxical Drug Reaction, Condition Aggravated, Gait Disturbance

Drug(s) suspected as cause:
Soma



Possible Soma side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-23

Patient: female

Reactions: Intervertebral Disc Operation, Intervertebral Disc Protrusion, Drug Ineffective, Accident, Tarsal Tunnel Syndrome, Surgery, Arthropathy, Intervertebral Disc Disorder, Carpal Tunnel Syndrome, Benign Neoplasm

Drug(s) suspected as cause:
Oxycodone Hydrochloride
    Indication: Inflammation

Dilaudid
    Dosage: 8 mg, unk
    Administration route: Oral
    Indication: Neck Pain

Oxycodone Hydrochloride
    Dosage: 5 mg, unk
    Indication: Neck Pain

Soma
    Dosage: unk
    Indication: Muscle Relaxant Therapy

Oxycontin
    Dosage: 40 mg, unk
    Indication: Neck Pain

Diazepam
    Dosage: 5 mg, unk
    Indication: Muscle Relaxant Therapy

Ibuprofen
    Indication: Inflammation

Ibuprofen
    Dosage: unk
    Indication: Neck Pain

Oxycontin
    Indication: Inflammation

Dilaudid
    Indication: Inflammation

Other drugs received by patient: Promethazine; Amitriptyline; Chlordiazepoxide; Prilosec



Possible Soma side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-23

Patient: male, weighing 99.8 kg (219.5 pounds)

Reactions: DRY Mouth, Blood Cholesterol Increased, Toxicity To Various Agents

Drug(s) suspected as cause:
Lyrica
    Dosage: 300 mg, 2x/day
    Administration route: Oral
    Indication: Spinal Disorder
    Start date: 2005-01-01
    End date: 2012-03-01

MS Contin
    Dosage: 60 mg, 2x/day
    Indication: Product Used FOR Unknown Indication
    Start date: 2006-01-01

Elavil
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Valium
    Dosage: 10 mg, 3x/day
    Indication: Product Used FOR Unknown Indication

Soma
    Dosage: 350 mg, 3x/day
    Indication: Product Used FOR Unknown Indication

Percocet
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Lyrica
    Dosage: 300 mg, 2x/day
    Start date: 2012-04-01

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