Skip to main content

Soma Compound With Codeine Side Effects

Generic name: aspirin / carisoprodol / codeine

Medically reviewed by Drugs.com. Last updated on Sep 1, 2024.

Note: This document provides detailed information about Soma Compound with Codeine Side Effects associated with aspirin / carisoprodol / codeine. Some dosage forms listed on this page may not apply specifically to the brand name Soma Compound with Codeine.

Applies to aspirin / carisoprodol / codeine: oral tablet.

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

Addiction, Abuse and Misuse. Carisoprodol, 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 Depression. Serious, 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 Ingestion. Accidental 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 Children. Life-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 Syndrome. Prolonged 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 Isoenzymes. The 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 Depressants. Concomitant 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.

Precautions

It is very important that your doctor check your progress at regular visits, especially within the first 24 to 72 hours of treatment to make sure this medicine is working properly and to check for unwanted effects. Blood tests may be needed to check for unwanted effects.

If your condition does not improve or becomes worse, check with your doctor. Do not use this medicine for more than 2 to 3 weeks (14 to 21 days) to treat pain unless your doctor told you to.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

Using this medicine during late pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Using this medicine while you are pregnant, especially during the later part of pregnancy may cause serious unwanted effects in your newborn baby, including neonatal withdrawal syndrome. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

This medicine may make you dizzy, drowsy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness. If this problem continues or gets worse, check with your doctor right away.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, or anesthetics, including some dental anesthetics. Also, there may be a greater risk of bleeding problems if you drink 3 or more alcoholic beverages per day while you are taking aspirin. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Your doctor may also give naloxone to treat an overdose. Signs of an overdose include: bigger, dilated, or enlarged pupils (black part of eye), blurred vision, change in consciousness, confusion, difficult or trouble breathing, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, false or unusual sense of well-being, increased sensitivity of the eyes to light, irregular, fast or slow, or shallow breathing, loss of consciousness, pale or blue lips, fingernails, or skin, sweating, uncontrolled eye movements, unusual tiredness or weakness.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. You may need to gradually reduce your dose before stopping it completely. This will decrease your chance of having withdrawal symptoms, including stomach cramps, hallucinations, headache, muscle twitching, tremors, trouble sleeping, or vomiting.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

This medicine may cause bleeding in your stomach or bowels. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (eg, blood thinner or NSAIDs).

This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

This medicine may also cause a serious allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

Check with your doctor right away if you have black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness. These may be symptoms of serious skin reaction including drug reaction with eosinophilia and systemic symptoms (DRESS).

Codeine is changed to morphine in the body. Some people change codeine to morphine more quickly than others. These individuals are called "ultra-rapid metabolizers of codeine". Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". As a result, there is too much morphine in the body and more side effects of morphine than usual. Children may be especially sensitive to this effect. Do not give this medicine to:

If a nursing mother is an ultra-rapid metabolizer of codeine, it could lead to a morphine overdose in the nursing baby and cause very serious side effects.

For nursing mothers taking this medicine:

Talk to your doctor if you have any questions about using codeine or about how this medicine may affect your baby.

Call your doctor if you become extremely tired and have difficulty caring for your baby.

Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.

Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.

Check with your doctor right away if you or your child have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using narcotics (eg, codeine) for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Do not give aspirin to a child or teenager who has chickenpox or flu symptoms, unless approved by a doctor. Aspirin can cause a life-threatening reaction called Reye syndrome.

Using too much of this medicine may cause infertility (unable to have children) or may cause a delay in ovulation for women and may affect their ability to have children. Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St John's wort) or vitamin supplements.

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 side effects

  • burning feeling in the chest or stomach
  • indigestion
  • stomach upset
  • tenderness in the stomach area

Less common side effects

  • chest tightness
  • cough
  • difficult or trouble breathing
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • noisy breathing
  • shakiness and unsteady walk
  • 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
  • darkening of the skin
  • diarrhea
  • 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, skin rash
  • loss of appetite
  • painful or difficult urination
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • 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

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 side effects

  • drowsiness

Less common side effects

  • feeling of constant movement of self or surroundings
  • sensation of spinning

Rare side effects

  • deep or fast breathing with dizziness
  • numbness of the feet, hands, and around the mouth
  • irritability
  • shaking
  • trouble sleeping

Incidence not known

  • constipation
  • constricted, pinpoint, or small pupils (black part of the eye)
  • relaxed and calm feeling

For healthcare professionals

Applies to aspirin / carisoprodol / codeine: oral tablet.

General adverse events

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

Nervous system

Carisoprodol:

Aspirin:

Codeine:

Other

Carisoprodol:

Aspirin:

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

Cardiovascular

Carisoprodol:

Codeine:

Dermatologic

Aspirin:

Renal

Aspirin:

Hypersensitivity

Aspirin

Hepatic

Aspirin:

Gastrointestinal

Carisoprodol:

Aspirin:

Codeine:

Ocular

Codeine:

Psychiatric

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]

See also:

References

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

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

Professional resources

Other formulations

Related treatment guides

Further information

Soma Compound with Codeine side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.