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Soma Compound with Codeine Side Effects

Generic Name: aspirin / carisoprodol / codeine

Note: This page contains side effects data for the generic drug aspirin / carisoprodol / codeine. It is possible that some of the dosage forms included below may not apply to the brand name Soma Compound with Codeine.

For the Consumer

Applies to aspirin / carisoprodol / codeine: oral tablet

As well as its needed effects, aspirin / carisoprodol / codeine may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking aspirin / carisoprodol / codeine, check with your doctor immediately:

More common:
  • Burning feeling in the chest or stomach
  • indigestion
  • stomach upset
  • tenderness in the stomach area
Less common:
  • Cough
  • difficult or troubled breathing
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • noisy breathing
  • shakiness and unsteady walk
  • tightness in the chest
  • unsteadiness, trembling, or other problems with muscle control or coordination
Incidence not known:
  • Chills
  • cold sweats
  • confusion
  • continuing ringing or buzzing or other unexplained noise in the ears
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, pounding, or irregular heartbeat or pulse
  • flushing or redness of the skin
  • hearing loss
  • hives
  • itching
  • painful or difficult urination
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin rash
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusually warm skin

If any of the following symptoms of overdose occur while taking aspirin / carisoprodol / codeine, get emergency help immediately:

Symptoms of overdose:
  • Agitation or combativeness
  • anxiety
  • black, tarry stools
  • bloody stools
  • blue lips and fingernails
  • change in consciousness
  • cold, clammy skin
  • confusion
  • confusion as to time, place, or person
  • coughing that sometimes produces a pink frothy sputum
  • decreased awareness or responsiveness
  • decreased urination
  • depression
  • diarrhea
  • difficult, fast, or noisy breathing, sometimes with wheezing
  • difficulty with sleeping
  • disorientation
  • drowsiness to profound coma
  • dry mouth
  • expressed fear of impending death
  • extremely high fever or body temperature
  • fainting
  • fast or deep breathing
  • fast, weak pulse
  • hallucinations
  • headache
  • holding false beliefs that cannot be changed by fact
  • irregular, fast or slow, or shallow breathing
  • lethargy
  • loss of consciousness
  • loss of strength or energy
  • mood or other mental changes
  • muscle cramps
  • muscle pain or weakness
  • nausea
  • pale or blue lips, fingernails, or skin
  • pale, clammy skin
  • pinpoint pupils
  • severe sleepiness
  • sunken eyes
  • sweating
  • swelling in the legs and ankles
  • thirst
  • unusual excitement, nervousness, or restlessness
  • vomiting
  • vomiting of blood or material that looks like coffee grounds
  • wrinkled skin

Minor Side Effects

Some aspirin / carisoprodol / codeine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Drowsiness
Less common:
  • Feeling of constant movement of self or surroundings
  • sensation of spinning
Rare
  • Hyperventilation
  • irritability
  • shaking
  • trouble sleeping
Incidence not known:
  • Constipation
  • constricted, pinpoint, or small pupils (black part of the eye)
  • relaxed and calm

For Healthcare Professionals

Applies to aspirin / carisoprodol / codeine: oral tablet

Gastrointestinal

Gastrointestinal side effects are common and have included epigastric distress (in as many as 83% of patients treated with regular aspirin), abdominal discomfort or pain, endoscopically identifiable gastric mucosal lesions, nausea, and vomiting. More serious gastrointestinal effects include hemorrhage, peptic ulcers, perforation, and esophageal ulcerations.

Gastrointestinal side effects of carisoprodol have included nausea, vomiting, hiccups, and epigastric distress.

Nausea, vomiting, and constipation have been reported frequently with the use of codeine. Severe constipation and ileus resulting in colonic perforation have been also reported. Four cases of acute pancreatitis have been reported.[Ref]

Endoscopically identifiable gastric mucosal lesions occur in most patients who receive a single dose of aspirin. Clinically evident gastrointestinal bleeding has been reported in as many as 3% of treated elderly patients. Anorectal ulceration and rectal stenosis have been reported in patients who abuse aspirin-containing rectal suppositories. One case-controlled study has suggested that an association between aspirin (and other NSAID) consumption and appendicitis may exist.[Ref]

Nervous system

Regarding the use of aspirin, some investigators have suggested that tinnitus may be a less reliable indicator of salicylate toxicity than previously believed. Patients with high frequency hearing loss may have difficulty perceiving tinnitus. In a study of rheumatoid arthritis patients, those with tinnitus had no greater salicylate levels than those without tinnitus. Elderly patients may be less likely to perceive tinnitus than younger patients.

Central respiratory depression may occur with the use of carisoprodol, particularly at high doses.

Opioids may result in psychotic symptoms in some patients.

One retrospective study of elderly patients who sustained a hip fracture suggested that the relative risk of hip fracture was 1.6 in patients using codeine compared to age-matched non-users.[Ref]

Nervous system side effects in patients receiving aspirin have included agitation, cerebral edema, coma, confusion, dizziness, headache, cranial hemorrhage, lethargy, and seizures. Tinnitus and subjective hearing loss (or both) may occur. Some investigators have reported that modest doses may result in decreased frequency selectivity and may therefore impair hearing performance, particularly in the setting of background noise.

Nervous system side effects of carisoprodol have included drowsiness and sedation most often. There have been postmarketing reports of motor vehicle accidents associated with the use of carisoprodol. Dizziness, headache, tremor, agitation, insomnia, syncope, and ataxia have also been reported.

Nervous system side effects from codeine have included mental and respiratory depression, stupor, delirium, somnolence, and dysphoria. An increased risk of falls and hip fractures has been associated with codeine therapy, particularly in the elderly.[Ref]

Other

Other side effects of aspirin have included Reye's syndrome. Reye's syndrome has been reported rarely in children with an acute viral illness. Reye's syndrome has also been reported even more rarely in adults.

Withdrawal symptoms after abrupt cessation of carisoprodol have been reported and may be due to dependency on the meprobamate metabolite. Such symptoms include abdominal pain, agitation, tremor, restlessness, anxiety, depression, insomnia, nausea, and sweating. Seizures have been reported rarely.

Other side effects of codeine have included withdrawal symptoms. Withdrawal symptoms have been reported after either abrupt cessation or fast tapering of narcotic analgesics, and have included agitation, restlessness, anxiety, insomnia, tremor, abdominal cramps, blurred vision, vomiting, and sweating.[Ref]

Reye's syndrome typically involves vomiting, neurologic dysfunction, and hepatic dysfunction during or shortly after an acute viral infection.

Psychologic dependence and abuse of carisoprodol (often in combination with alcohol and other CNS depressants) have been reported.[Ref]

Cardiovascular

Hypotension is rare with codeine use and has been reported most frequently with high doses.[Ref]

Cardiovascular side effects of aspirin have been reported rarely and include salicylate-induced variant angina, ventricular ectopy, conduction abnormalities, and hypotension, particularly during salicylate toxicity.

Cardiovascular effects of carisoprodol have included tachycardia and hypotension.

Cardiovascular side effects of codeine have included hypotension and dizziness.[Ref]

Dermatologic

Dermatologic side effects from the use of aspirin have been reported rarely and include Stevens-Johnson syndrome and a lichenoid eruption.

Codeine-induced rash have been reported rarely. Codeine-induced rashes may be related to direct stimulation of histamine release. Case reports of severe scarlatiniform eruptions have also been reported.[Ref]

Renal

The mechanism of an aspirin-induced decrease in renal function may be related to inhibition of renal prostaglandin synthesis with consequent decreases in renal blood flow. Vasodilating renal prostaglandins may be particularly important in patients who exhibit arterial underfilling (i.e. heart failure, cirrhosis). The administration of high doses of NSAIDs to such patients has produced acute renal failure in rare instances.[Ref]

Renal side effects of aspirin have included reduction in glomerular filtration rate (particularly in patients who are sodium restricted or who exhibit diminished effective arterial blood volume, such as patients with advanced heart failure or cirrhosis), interstitial nephritis, papillary necrosis, elevations in serum creatinine, elevations in blood urea nitrogen, proteinuria, hematuria, and renal failure.

Renal side effects which have included acute renal failure and urinary retention have been reported in association with codeine therapy.[Ref]

Hematologic

Hematologic side effects of aspirin (in addition to predictable antiplatelet effects which may result in hemorrhage) include increased blood fibrinolytic activity. In addition, hypoprothrombinemia, thrombocytopenia, thrombocyturia, megaloblastic anemia, and pancytopenia have been reported rarely. Aplastic anemia has also been reported.[Ref]

Hypersensitivity

Hypersensitivity side effects include bronchospasm, rhinitis, conjunctivitis, urticaria, angioedema, and anaphylaxis with the use of aspirin. Approximately 10% to 30% of asthmatics are aspirin-sensitive (with the clinical triad of aspirin sensitivity, bronchial asthma, and nasal polyps).

Hypersensitivity effects of carisoprodol have included rash, pruritus, and erythema multiforme. Asthma, fever, hypotension and anaphylaxis have been reported rarely.[Ref]

The mechanism of aspirin-induced hypersensitivity may be related to an up-regulation of the 5-lipoxygenase pathway of arachidonic acid metabolism with a resulting increase in the products of 5-lipoxygenase (such as leukotrienes).[Ref]

Hepatic

Hepatic side effects including cases of aspirin-induced hepatoxicity and cholestatic hepatitis, particularly at high doses, have been reported rarely.[Ref]

Metabolic

Metabolic side effects of aspirin have included dehydration and hyperkalemia. Respiratory alkalosis and metabolic acidosis, particularly during salicylate toxicity, have been reported. A case of hypoglycemia has been reported in a patient on hemodialysis. Salicylates have also been reported to displace triiodothyronine (T3) and thyroxine (T4) from protein binding sites. The initial effect is an increase in serum free T4 concentrations.[Ref]

Musculoskeletal

Musculoskeletal side effects including rhabdomyolysis have occurred in patients receiving aspirin.[Ref]

Respiratory

Respiratory side effects including hyperpnea, pulmonary edema, and tachypnea have occurred in patients receiving aspirin.[Ref]

Endocrine

Endocrine side effects of aspirin use have been reported to include hypoglycemia (children) and hyperglycemia.[Ref]

General

In general, many of the side effects noted with aspirin use have been dose-related.[Ref]

Ocular

Ocular side effects including cases of localized periorbital edema have been reported rarely in patients receiving aspirin.[Ref]

Oncologic

Oncologic side effects may be beneficial ones. Several epidemiologic studies have suggested that chronic aspirin use may decrease the risk of large bowel neoplasms. Other studies have not found such a beneficial effect.[Ref]

Immunologic

Immunologic side effects may occur. One study of a patient with exercise-induced anaphylaxis and three control subjects has found a correlation between codeine wheal size and recent exercise.[Ref]

References

1. Petty GW, Brown RD, Whisnant JP, Sicks JD, O'Fallon WM, Wiebers DO "Frequency of major complications of aspirin, warfarin, and intravenous heparin for secondary stroke prevention: a population study." Ann Intern Med 130 (1999): 14-22

2. Lanas A, Serrano P, Bajador E, Esteva F, Benito R, Sainz R "Evidence of aspirin use in both upper and lower gastrointestinal perforation." Gastroenterology 112 (1997): 683-9

3. "Product Information. Soma Compound (aspirin-carisoprodol)." Wallace Laboratories, Cranbury, NJ.

4. Boissel JP "Individualizing aspirin therapy for prevention of cardiovascular events." JAMA 280 (1998): 1949-50

5. He J, Whelton PK, Vu B, Klag MJ "Aspirin and risk of hemorrhagic stroke: a meta-analysis of randomized controlled trials." JAMA 280 (1998): 1930-35

6. Hastier P, Buckley MJM, Peten EP, Demuth N, Dumas R, Demarquay JF, CaroliBosc FX, Delmont JP "A new source of drug-induced acute pancreatitis: Codeine." Am J Gastroenterol 95 (2000): 3295-8

7. Dickinson JP, Prentice CRM "Aspirin: benefit and risk in thromboprophylaxis." Qjm Mon J Assoc Physician 91 (1998): 523-38

8. Miller AR "A comparative study of Parafon Forte tablets and soma compound in the treatment of painful skeletal muscle conditions." Curr Ther Res Clin Exp 19 (1976): 444-50

9. Elder NC "Abuse of skeletal muscle relaxants." Am Fam Physician 44 (1991): 1223-6

10. Heacock C, Bauer MS "Tolerance and dependence risk with the use of carisoprodol." Am Fam Physician 69 (2004): 1622-3

11. Morse RM, Chua L "Carisoprodol dependence: a case report." Am J Drug Alcohol Abuse 5 (1978): 527-30

12. Gonzalogarijo MA, Revengaarranz F "Fixed drug eruption due to codeine." Br J Dermatol 135 (1996): 498-9

13. "Product Information. Bayer aspirin (aspirin)." Bayer, West Haven, CT.

It is possible that some side effects of Soma Compound with Codeine may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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