Applies to aspirin / carisoprodol / codeine: oral tablet.
Warning
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
- Burning feeling in the chest or stomach
- indigestion
- stomach upset
- tenderness in the stomach area
Less common
- 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
- 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
- inability to move the eyes
- increased blinking or spasms of the eyelid
- 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
- sticking out of the tongue
- sunken eyes
- sweating
- swelling in the legs and ankles
- thirst
- uncontrolled twisting movements of the neck, trunk, arms, or legs
- unusual drowsiness, dullness, or feeling of sluggishness
- unusual excitement, nervousness, or restlessness
- unusual facial expressions
- vomiting
- vomiting of blood or material that looks like coffee grounds
- weakness of the arms and legs
- wrinkled skin
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
- 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]
