Soma (Carisoprodol) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Central Nervous System --Drowsiness and other CNS effects may require dosage reduction. Also observed: dizziness, vertigo, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, and insomnia. (See also Idiosyncratic Reactions under " Warnings.")

Allergic or Idiosyncratic --Allergic or idiosyncratic reactions occasionally develop. They are usually seen within the period of the first to fourth dose in patients having had no previous contact with the drug. Skin rash, erythema multiforme, pruritus, eosinophilia, and fixed drug eruption with cross reaction to meprobamate have been reported with carisoprodol. Severe reactions have been manifested by asthmatic episodes, fever, weakness, dizziness, angioneurotic edema, smarting eyes, hypotension, and anaphylactoid shock. (See also Idiosyncratic Reactions under " Warnings.")

In case of allergic or idiosyncratic reactions to carisoprodol, discontinue the drug and initiate appropriate symptomatic therapy, which may include epinephrine, antihistamines, and in severe cases corticosteroids. In evaluating possible allergic reactions, also consider allergy to excipients (information on excipients is available to physicians on request).

Cardiovascular --Tachycardia, postural hypotension, and facial flushing.

Gastrointestinal --Nausea, vomiting, hiccup, and epigastric distress.

Hematologic --Leukopenia, in which other drugs or viral infection may have been responsible, and pancytopenia, attributed to phenylbutazone, have been reported. No serious blood dyscrasias have been attributed to carisoprodol.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO SOMA

Possible Soma side effects / adverse reactions in 39 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2007-04-04

Patient: 39 year old female weighing 80.7 kg (177.5 pounds)

Reactions: Confusional State, Contusion, Subcutaneous Abscess, Pleural Adhesion, Fall, Drug Toxicity, Panniculitis, Cerebral Infarction, Dehydration, Hepatic Congestion, Thyroiditis Chronic, Myocardial Fibrosis, Gastroenteritis Viral

Adverse event resulted in: death

Suspect drug(s):
Ativan
    Indication: Drug USE FOR Unknown Indication

Benadryl
    Indication: Drug USE FOR Unknown Indication

Klonopin
    Indication: Drug USE FOR Unknown Indication

Noctec
    Administration route: Oral
    Indication: Insomnia

Robaxin
    Indication: Drug USE FOR Unknown Indication

Soma
    Indication: Drug USE FOR Unknown Indication

Tamiflu
    Administration route: Oral
    Start date: 2007-02-05

Valium
    Indication: Drug USE FOR Unknown Indication

Other drugs received by patient: Methadone HCL; Nutropin; Vitamin B-12; Immunoglobulin Injectable; Cipro; Topamax; Acetaminophen

Possible Soma side effects / adverse reactions in 39 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2007-05-24

Patient: 39 year old female weighing 80.7 kg (177.5 pounds)

Reactions: Refusal of Treatment by Patient, Contusion, Subcutaneous Abscess, Accidental Death, Pleural Adhesion, Fall, Autoimmune Thyroiditis, Drug Toxicity, Cardio-Respiratory Arrest, Hepatomegaly, Cerebral Infarction, Panniculitis, Dehydration, Gastroenteritis Viral, Myocardial Fibrosis

Adverse event resulted in: death

Suspect drug(s):
Chloral Hydrate
    Indication: Insomnia

Clonazepam
    Indication: Ill-Defined Disorder

Diazepam
    Indication: Ill-Defined Disorder

Diphenhydramine HCL
    Indication: Ill-Defined Disorder

Lorazepam
    Indication: Ill-Defined Disorder

Methocarbamol
    Indication: Ill-Defined Disorder

Soma
    Dosage: oral
    Administration route: Oral
    Indication: Back Pain

Tamiflu
    Indication: Influenza

Other drugs received by patient: Methadone HCL; Nutropin; Vitamin B-12; Immunoglobulin Injectable; Cipro; Topamax; Acetaminophen; Atropine

Possible Soma side effects / adverse reactions in 49 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2007-06-11

Patient: 49 year old male

Reactions: Unresponsive TO Stimuli, Multiple Drug Overdose Intentional

Adverse event resulted in: death

Suspect drug(s):
Oxycodone HCL
    Indication: Drug USE FOR Unknown Indication

Soma
    Indication: Drug USE FOR Unknown Indication

Possible Soma side effects / adverse reactions in 57 year old female

Reported by a lawyer from United States on 2007-06-21

Patient: 57 year old female

Reactions: Respiratory Failure, Pneumonia Streptococcal, Mitral Valve Incompetence, Troponin Increased, Sputum Culture Positive, Multiple Drug Overdose, Tricuspid Valve Incompetence

Adverse event resulted in: hospitalization

Suspect drug(s):
Buspar
    Administration route: Oral
    Start date: 2003-06-01
    End date: 2003-06-01

Lorazepam
    Administration route: Oral
    Start date: 2003-06-01
    End date: 2003-06-01

Motrin
    Administration route: Oral
    Start date: 2003-06-01
    End date: 2003-06-01

Soma
    Administration route: Oral
    Start date: 2003-06-01
    End date: 2003-06-01

Ultram
    Administration route: Oral
    Start date: 2003-06-01
    End date: 2003-06-01

Other drugs received by patient: Claritin; Neurontin; Celexa; Phenazopyridine HCL TAB; Dalmane; Potassium Chloride

Possible Soma side effects / adverse reactions in 36 year old male

Reported by a consumer/non-health professional from United States on 2007-07-02

Patient: 36 year old male weighing 63.5 kg (139.7 pounds)

Reactions: Weight Decreased, Dyspnoea, Drug Ineffective, Head Injury, Hypoaesthesia, Fall, Hyperhidrosis, Dysarthria, Visual Disturbance, Gait Disturbance

Adverse event resulted in: hospitalization

Suspect drug(s):
Hydrocodone/acetaminophen(hydrocodone Bitartrate, Acetaminophen) Table
    Dosage: 1-2 tabs every 4 hours, oral
    Administration route: Oral
    Indication: Back Pain
    Start date: 1992-01-01
    End date: 2003-01-01

Soma
    Dosage: 1-2 every 4 hours, oral
    Administration route: Oral
    Indication: Muscle Spasms
    Start date: 1999-01-01
    End date: 2003-01-01

Other drugs received by patient: Atenolol; Fentanyl; Norco

Possible Soma side effects / adverse reactions in 45 year old male

Reported by a physician from United States on 2007-07-27

Patient: 45 year old male weighing 94.3 kg (207.6 pounds)

Reactions: Drug Ineffective, Pharmaceutical Product Complaint

Suspect drug(s):
Dilantin
    Dosage: attached

Soma

Possible Soma side effects / adverse reactions in 49 year old female

Reported by a individual with unspecified qualification from United States on 2007-07-30

Patient: 49 year old female

Reactions: Restless Legs Syndrome, Conduction Disorder, Arrhythmia, Anxiety, Panic Attack, Overdose, Insomnia, Irritable Bowel Syndrome, Depressed Mood

Adverse event resulted in: hospitalization

Suspect drug(s):
Soma

Vicodin
    Administration route: Oral

Zelnorm
    Dosage: 6 mg, bid
    Administration route: Oral
    Indication: Irritable Bowel Syndrome
    Start date: 2004-01-01
    End date: 2007-05-03

Zelnorm

Other drugs received by patient: Buspar; Effexor /usa/; Protonix; Klonopin; Cenestin; Ativan; Magnesium Sulfate; Allegra; Trazodone HCL; Requip; Ambien; Combivent /jor/