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Soma (Carisoprodol) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in practice.

The data described below are based on 1387 patients pooled from two double blind, randomized, multicenter, placebo controlled, one-week trials in adult patients with acute, mechanical, lower back pain [ see Clinical Studies ]. In these studies, patients were treated with 250 mg of SOMA, 350 mg of SOMA, or placebo three times a day and at bedtime for seven days. The mean age was about 41 years old with 54% females and 46% males and 74 % Caucasian, 16 % Black, 9% Asian, and 2% other.

There were no deaths and there were no serious adverse reactions in these two trials. In these two studies, 2.7%, 2%, and 5.4%, of patients treated with placebo, 250 mg of SOMA, and 350 mg of SOMA, respectively, discontinued due to adverse events; and 0.5%, 0.5%, and 1.8% of patients treated with placebo, 250 mg of SOMA, and 350 mg of SOMA, respectively, discontinued due to central nervous system adverse reactions.

Table 1 displays adverse reactions reported with frequencies greater than 2% and more frequently than placebo in patients treated with SOMA in the two trials described above.

Table 1. Patients with Adverse Reactions in Controlled Studies
Adverse Reaction

Placebo
(n=560)
n (%)

SOMA 250 mg
(n=548)
n (%)

SOMA 350 mg
(n=279)
n (%)

Drowsiness 31 (6) 73 (13) 47 (17)
Dizziness 11 (2) 43 (8) 19 (7)
Headache 11 (2) 26 (5) 9 (3)

Post-marketing Experience

The following events have been reported during postapproval use of SOMA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular: Tachycardia, postural hypotension, and facial flushing [ see Overdosage ].
Central Nervous System: Drowsiness, dizziness, vertigo, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, insomnia, and seizures [ see Overdosage ].
Gastrointestinal: Nausea, vomiting, and epigastric discomfort.
Hematologic: Leukopenia, pancytopenia



REPORTS OF SUSPECTED SOMA SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Soma. The information is not vetted and should not be considered as verified clinical evidence.

Possible Soma side effects / adverse reactions in 43 year old female

Reported by a consumer/non-health professional from United States on 2011-10-12

Patient: 43 year old female weighing 81.7 kg (179.8 pounds)

Reactions: Pain, Headache, Hypoaesthesia, H1n1 Influenza, Fall, Abdominal Discomfort, Blindness Unilateral, Feeling Abnormal, Transient Ischaemic Attack

Adverse event resulted in: hospitalization, disablity

Suspect drug(s):
Lyrica
    Indication: Fibromyalgia

Xanax
    Indication: Sleep Disorder

Motrin
    Indication: Pain

Celexa
    Dosage: unknown
    Indication: Depression

Vicodin
    Indication: Pain

Motrin
    Dosage: 3 to 4 times per day
    Indication: Fall

Vicodin
    Dosage: unknown
    Indication: Fall

Xanax
    Indication: Anxiolytic Therapy

Combination Pill OF Lisinopril and Some Fluid Pill
    Dosage: 10/12.5 mg unknow frequency
    Indication: Blood Pressure Abnormal

Xanax
    Indication: Pain

Soma
    Dosage: unknown
    Indication: Pain

Soma
    Indication: Fall

Aspirin
    Dosage: unknown
    Indication: Product Used FOR Unknown Indication



Possible Soma side effects / adverse reactions in 15 year old male

Reported by a individual with unspecified qualification from United States on 2011-11-14

Patient: 15 year old male

Reactions: Agitation, Breast Enlargement, Drug Ineffective, Pain, Adverse Drug Reaction, Rectal Haemorrhage, Deafness, Headache, Gastric Ulcer, Somnolence, Constipation, Suicidal Ideation, Weight Increased, Fatigue, Anger, Rapid Eye Movements Sleep Abnormal, Muscle Spasms, Hyperacusis, Condition Aggravated, Abnormal Behaviour, Rash, Aggression, Anxiety, Affective Disorder, Insomnia, Disturbance in Attention, Erection Increased, Memory Impairment, Feeling Abnormal, Influenza

Suspect drug(s):
Soma
    Indication: Product Used FOR Unknown Indication

Tegretol
    Indication: Product Used FOR Unknown Indication

Carbamazepine
    Indication: Product Used FOR Unknown Indication

Imitrex
    Indication: Product Used FOR Unknown Indication

Risperdal
    Indication: Product Used FOR Unknown Indication

Seroquel
    Indication: Product Used FOR Unknown Indication

Pamelor
    Indication: Product Used FOR Unknown Indication

Mirtazapine
    Indication: Product Used FOR Unknown Indication

Celebrex
    Indication: Product Used FOR Unknown Indication

Geodon
    Indication: Product Used FOR Unknown Indication

Lamictal
    Indication: Product Used FOR Unknown Indication

Valium
    Indication: Pain

Zomig
    Indication: Product Used FOR Unknown Indication

Trazodone HCL
    Indication: Depression

Lithium Carbonate
    Indication: Product Used FOR Unknown Indication

Lexapro
    Indication: Product Used FOR Unknown Indication

Metaxalone
    Indication: Product Used FOR Unknown Indication

Wellbutrin
    Indication: Product Used FOR Unknown Indication

Cymbalta
    Indication: Depression

Klonopin
    Indication: Product Used FOR Unknown Indication

Zoloft
    Indication: Product Used FOR Unknown Indication

Effexor XR
    Indication: Product Used FOR Unknown Indication

Buspar
    Indication: Product Used FOR Unknown Indication

Paxil
    Indication: Product Used FOR Unknown Indication

Effexor
    Dosage: (3.75 mg)
    Indication: Product Used FOR Unknown Indication

Depakote
    Indication: Headache

Zyprexa
    Indication: Product Used FOR Unknown Indication

Elavil
    Indication: Product Used FOR Unknown Indication

Ritalin
    Indication: Headache



Possible Soma side effects / adverse reactions in 15 year old male

Reported by a individual with unspecified qualification from United States on 2011-12-16

Patient: 15 year old male

Reactions: Agitation, Tinnitus, Drug Ineffective, Head Injury, Rectal Haemorrhage, Deafness, Headache, Constipation, Somnolence, Gastric Ulcer, Suicidal Ideation, Gynaecomastia, Weight Increased, Fatigue, Mood Altered, Anger, Muscle Spasms, Rash, Aggression, Insomnia, Disturbance in Attention, Memory Impairment, Erection Increased, Influenza

Suspect drug(s):
Geodon
    Indication: Product Used FOR Unknown Indication

Tegretol
    Indication: Product Used FOR Unknown Indication

Effexor XR
    Indication: Product Used FOR Unknown Indication

Soma
    Indication: Product Used FOR Unknown Indication

Celebrex
    Indication: Product Used FOR Unknown Indication

Lexapro
    Indication: Product Used FOR Unknown Indication

Zoloft
    Indication: Product Used FOR Unknown Indication

Imitrex
    Indication: Headache

Lithium Carbonate
    Indication: Product Used FOR Unknown Indication
    Start date: 2007-01-01

Risperdal
    Indication: Product Used FOR Unknown Indication
    Start date: 2007-01-01

Elavil
    Indication: Product Used FOR Unknown Indication

Ritalin
    Indication: Headache

Lamictal
    Indication: Product Used FOR Unknown Indication

Paxil
    Indication: Product Used FOR Unknown Indication

Klonopin
    Indication: Product Used FOR Unknown Indication

Pamelor
    Indication: Product Used FOR Unknown Indication

Zyprexa
    Indication: Product Used FOR Unknown Indication

Trazodone HCL
    Indication: Depression

Trazodone HCL
    Indication: Pain

Cymbalta
    Indication: Depression

Cymbalta
    Indication: Pain

Mirtazapine
    Indication: Product Used FOR Unknown Indication
    Start date: 2007-01-01

Skelaxin
    Indication: Product Used FOR Unknown Indication

Effexor
    Dosage: 3.75 mg
    Indication: Product Used FOR Unknown Indication

Depakote
    Indication: Headache

Wellbutrin
    Indication: Product Used FOR Unknown Indication

Buspar
    Indication: Product Used FOR Unknown Indication

Zomig
    Indication: Headache

Seroquel
    Indication: Product Used FOR Unknown Indication
    Start date: 2007-01-01

Valium
    Indication: Hypotonia

Valium
    Indication: Anxiety

Valium
    Indication: Pain



See index of all Soma side effect reports >>

Drug label data at the top of this Page last updated: 2012-05-31

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