Skip to main content

Soma Compound with Codeine Side Effects

Generic name: aspirin / carisoprodol / codeine

Medically reviewed by Last updated on Jun 28, 2023.

Note: This document contains side effect information about aspirin / carisoprodol / codeine. Some dosage forms listed on this page may not apply to the brand name Soma Compound with Codeine.

Applies to aspirin / carisoprodol / codeine: oral tablet.


Oral route (Tablet)

Addiction, Abuse and MisuseCarisoprodol, aspirin and codeine phosphate tablets expose patients and other users to the risks of opioid addiction, abuse and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing carisoprodol, aspirin and codeine phosphate tablets, and monitor all patients regularly for the development of these behaviors and conditions.Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic product must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to: complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of carisoprodol, aspirin and codeine phosphate tablets. Monitor for respiratory depression, especially during initiation of carisoprodol, aspirin and codeine phosphate tablets or following a dose increase.Accidental IngestionAccidental ingestion of even one dose of carisoprodol, aspirin and codeine phosphate tablets, especially by children, can result in a fatal overdose of carisoprodol, aspirin and codeine phosphate tablets.Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-threatening Respiratory Depression in ChildrenLife-threatening respiratory depression and death have occurred in children who received codeine. Most of the reported cases occurred following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism. Carisoprodol, aspirin and codeine phosphate tablets are contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of carisoprodol, aspirin and codeine phosphate tablets in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine.Neonatal Opioid Withdrawal SyndromeProlonged use of carisoprodol, aspirin and codeine phosphate tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Interactions with Drugs Affecting Cytochrome P450 IsoenzymesThe effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with carisoprodol, aspirin and codeine phosphate tablets requires careful consideration of the effects on codeine, and the active metabolite, morphine.Risks From Concomitant Use With Benzodiazepines Or Other CNS DepressantsConcomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of carisoprodol, aspirin and codeine phosphate tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.FDA is advising that the opioid addiction medications buprenorphine or methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). The combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction can outweigh these risks. Careful medication management by health care professionals can reduce these risks.

Serious side effects

Along with its needed effects, aspirin/carisoprodol/codeine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking aspirin / carisoprodol / codeine:

More common

Less common

Incidence not known

Get emergency help immediately if any of the following symptoms of overdose occur while taking aspirin / carisoprodol / codeine:

Symptoms of overdose

Other side effects

Some side effects of aspirin / carisoprodol / codeine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common


Incidence not known

For Healthcare Professionals

Applies to aspirin / carisoprodol / codeine: oral tablet.



Frequency not reported: Nausea, vomiting, epigastric discomfort


Frequency not reported: Bleeding, perforation, obstruction of stomach, small intestine or large intestine, epigastric discomfort, gastric and duodenal ulcers, gastritis, gastrointestinal erosions, abdominal pain, heartburn, vomiting, nausea, anorexia


Frequency not reported: Nausea, vomiting, constipation[Ref]

Nervous system


Frequency not reported: Sedation, drowsiness, dizziness, ataxia, tremor

Postmarketing reports: Motor vehicle accidents, seizures


Frequency not reported: Intracranial hemorrhage


Frequency not reported: Sedation, dizziness[Ref]


Tinnitus may be a symptom of high serum salicylate levels.[Ref]


Frequency not reported: Vertigo


Frequency not reported: Tinnitus[Ref]



Frequency not reported: Tachycardia, postural hypotension, facial flushing, syncope


Frequency not reported: Hypotension[Ref]



Frequency not reported: Rash pruritus, purpura



Frequency not reported: Interstitial nephritis, acute renal failure[Ref]



Frequency not reported: Anaphylaxis, anaphylactoid reactions[Ref]



Frequency not reported: Elevated liver enzymes[Ref]


The most commonly reported adverse reactions may include nausea, dizziness, drowsiness, and gastrointestinal discomfort.[Ref]



Frequency not reported: Miosis[Ref]


Withdrawal symptoms that have been reported following abrupt withdrawal after prolonged use have included: insomnia, vomiting, abdominal cramps, headache, tremors, muscle twitching, ataxia, hallucinations, and psychosis.[Ref]

Frequency not reported: Drug dependence, withdrawal, abuse, misuse, criminal diversion, agitation, irritability, depressive reactions, insomnia[Ref]

More about Soma Compound with Codeine (aspirin / carisoprodol / codeine)

Professional resources

Other formulations

Related treatment guides


1. Product Information. ASA/Carisoprodol/Codeine Phosphate (aspirin / carisoprodol / codeine). Sandoz Laboratories, Eon Division. 2022.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.