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Aspirin / carisoprodol / codeine Side Effects

For the Consumer

Applies to aspirin/carisoprodol/codeine: oral tablet

Warning

Oral route (Tablet)

Addiction, Abuse, and Misuse

Carisoprodol, aspirin, and codeine phosphate tablets exposes 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 or 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 products 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 codeine.

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 CYP3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex. Use of CYP3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with carisoprodol, aspirin, and codeine phosphate tablets requires careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine.

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other 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

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

  • Cough
  • difficult or troubled breathing
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • 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, skin rash
  • 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

  • Agitation or combativeness
  • anxiety
  • black, tarry stools
  • bloody stools
  • blue lips and fingernails
  • change in consciousness
  • cold, clammy skin
  • 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
  • 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
  • headache
  • holding false beliefs that cannot be changed by fact
  • irregular, fast or slow, or shallow breathing
  • loss of consciousness
  • loss of strength or energy
  • mood or other mental changes
  • muscle cramps, pain, or weakness
  • nausea
  • pale or blue lips, fingernails, or skin
  • pale, clammy skin
  • pinpoint pupils
  • seeing, hearing, or feeling things that are not there
  • severe sleepiness
  • sunken eyes
  • sweating
  • swelling in the legs and ankles
  • thirst
  • unusual drowsiness, dullness, or feeling of sluggishness
  • unusual excitement, nervousness, or restlessness
  • vomiting
  • vomiting of blood or material that looks like coffee grounds
  • wrinkled skin

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

  • Drowsiness

Less Common

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

Rare

  • 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

Gastrointestinal

Carisoprodol:

Frequency not reported: Nausea, vomiting, epigastric discomfort

Aspirin:

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

Codeine:

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

Nervous system

Carisoprodol:

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

Postmarketing reports: Motor vehicle accidents, seizures

Aspirin:

Frequency not reported: Intracranial hemorrhage

Codeine:

Frequency not reported: Sedation, dizziness[Ref]

Other

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

Carisoprodol:

Frequency not reported: Vertigo

Aspirin:

Frequency not reported: Tinnitus[Ref]

Cardiovascular

Carisoprodol:

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

Codeine:

Frequency not reported: Hypotension[Ref]

Dermatologic

Aspirin:

Frequency not reported: Rash pruritus, purpura

Renal

Aspirin:

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

Hypersensitivity

Aspirin

Frequency not reported: Anaphylaxis, anaphylactoid reactions[Ref]

Hepatic

Aspirin:

Frequency not reported: Elevated liver enzymes[Ref]

General

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

Ocular

Codeine:

Frequency not reported: Miosis[Ref]

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]

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

References

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

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.

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