Acetaminophen and Codeine

Designed to treat mild to moderate pain, acetaminophen and codeine is a painkiller often prescribed to adults to manage short term pain following surgeries or injuries.

Overview

Acetaminophen and codeine, often known as APAP and codeine, is a strong painkiller suitable for treating mild to moderate pain during short periods of time. It is available in tablet, capsule and liquid form and should be taken orally.

Acetaminophen is a painkiller and antipyretic, which means that it can reduce fever. It is not habit-forming, which means that when it is used alone it does not pose the risk of addiction. However, it can be harmful to the liver, particularly when taken for long periods of time. Codeine is a narcotic analgesic medicine and it can be habit-forming if taken for extended periods of time. If use of the drug is suddenly stopped, the patient may experience harmful withdrawal effects. Acetaminophen and codeine, when used together, should therefore only be prescribed to treat short-term pain to reduce the risk of both dependency and liver problems.

Respiratory depression – slow, labored breathing - is one of the most common harmful side effects associated with acetaminophen and codeine. The drug is therefore not recommended to people with a history of respiratory depression or preexisting respiratory problems. It’s also not recommended for children.

US brand names for acetaminophen and codeine include:

  • Capital & Codeine
  • Codrix
  • Empracet
  • Fioricet with Codeine
  • Papa-deine
  • Pehnaphen with Codeine
  • Phrenilin with Caffeine, Codeine
  • Proval
  • Tylenol with Codeine

Conditions treated?

  • Pain
  • Fever

Type of medicine?

  • Painkiller (mild to moderate pain)

Side Effects

Many people who take acetaminophen and codeine experience drowsiness or lightheadedness. They may feel sleepier or more lethargic than usual, or have an increased sense of calm and feel more relaxed. In relatively rare instances, individuals may experience constipation or have difficulty passing stools while taking acetaminophen and codeine. These side effects are not ones which require medical attention, but if they become a severe inconvenience it may be possible to discuss alternative medication options with your doctor, or ask for advice on how to minimize the severity of the side effects. In most cases, these side effects dissipate once the body adjusts to the medication.

One of the most common life-threatening side effects of acetaminophen and codeine is shortness of breath or difficulty breathing. Individuals are most at risk of this side effect when they first begin taking the medicine, or when they first take an increased dose of the medicine. If you notice any of the following symptoms when taking acetaminophen and codeine, consult your doctor immediately:

  • Shortness of breath
  • Labored breathing
  • Irregular breathing
  • Unusually fast, slow or shallow breathing
  • Blueness or paleness in the lips, skin or fingernails

Other potential side effects of acetaminophen and codeine occur so rarely that their incidence is not known, but individuals taking the medicine should familiarize themselves with them in order that they can seek medical treatment as soon as possible should they occur. It may be possible that patients experience bleeding gums, blood in the urine or black, tarry stools which indicate that blood is present in the stools. It’s also possible to experience unusual bleeding or bruising of the skin, and this should be reported to a doctor as soon as possible.

In rare instances, acetaminophen and codeine can cause a sore throat, a cough, hoarseness, difficulty swallowing or a tightness in the chest and this should be reported to a doctor immediately. It’s also known that the medicine can cause a rash, hives, itching or pinpoint red spots on the skin. There have been instances of the medicine causing ulcers, sores or white spots in the mouth or on the lips, and of puffiness of the lips, tongue, eyes or face in general. If you experience these side effects, consult your doctor immediately.

If you experience dizziness, a fast heartbeat or a fever (no matter if it is or is not accompanied by chills), consult your doctor immediately. You should also seek urgent medical care if you experience pain in the lower back or side, or if urinating becomes difficult or painful.

Overdose of acetaminophen and codeine is possible and patients taking the drug should familiarize themselves with symptoms of overdose and seek medical attention immediately if they believe they have overdosed. Overdose can cause stomach and abdominal pain, blood in the urine or unusually dark or cloudy urine, or an unusual decrease in the amount of urine produced. It may lead to chills, headache and increased sweating, nausea, loss of consciousness, convulsions and constricted or small pupils. It could also cause loss of appetite, bad breath and vomiting and there may be blood in vomit. Individuals who overdose could also experience yellowing of the eyes or skin.

In rare instances, some patients may experience other side effects not listed here. If you notice any other changes to your normal health while taking acetaminophen and codeine, report them to your doctor as soon as possible or report them to the FDA.

Dosage

The initial dose of acetaminophen and codeine for adults varies between 300 and 600 mg acetaminophen and between 15 and 60 mg codeine. Typically, the medication is administered every four hours or less, depending on the severity of the patient’s pain. The severity of pain, response to the drug, and prior experience with painkillers is considered when choosing an appropriate dose. Doctors also take into account the patient’s risk factor of misuse, abuse or addiction.

The maximum safe dose of acetaminophen and codeine is 4000 mg acetaminophen and 360 mg codeine every 24 hours. Codeine has been proven to be no more effective in relieving pain at doses over 60 mg, which means it is unnecessary to increase dosages beyond this level. Patients may develop a tolerance to codeine with continued use, which is why the medicine is usually only prescribed at the lowest dose necessary for short-term use.

Dosage for children, elderly and those with renal or hepatic failure

Acetaminophen and codeine is contraindicated for children under the age of 12. For children aged between 12 and 18, acetaminophen and codeine is only recommended if the benefits of the medicine far outweigh the risks associated with use in children of this age. In these instances, doses will be similar to those administered for adults. Particular care should be taken to consider risk factors that increase the chances of respiratory depression in children, such as:

  • Obesity
  • Sleep apnea
  • Neuromuscular disease
  • Postoperative status
  • Pulmonary disease
  • Use of other medications which can cause respiratory depression

Elderly patients may be prescribed acetaminophen and codeine but only with caution. Typically, doctors administer the drug at the lower end of the dosing range to begin with and monitor the success and impact on the health of the patient.

For people with severe renal (kidney) or hepatic (liver) impairment, the risk of harmful side effects may be heightened. In these instances, the drug should be administered with caution and frequent monitoring of liver or kidney health.

Dosage during dependency

Individuals who have become physically dependent on acetaminophen and codeine will need to gradually withdraw from the medicine. Ceasing the use of the drug immediately could cause adverse side effects. The recommended procedure is to reduce the dose by 25 to 50% every two to four days. During this time, the patient should be closely monitored, and, if withdrawal symptoms occur, the dose should be raised to the previous level before being reduced at a slower rate.

Once your doctor has prescribed your dose of acetaminophen and codeine, do not skip or change the dose or stop taking the medicine without consulting your doctor. Some people may experience withdrawal effects after taking the drug and doctors may therefore prefer to gradually reduce the dose over a few days, rather than stopping the medication at once.

Interactions

Acetaminophen and codeine is not recommended to be used with naltrexone. Naltrexone is designed to block the effects of narcotic medicines and alcohol and is often used to help individuals struggling with drug or alcohol addiction. It will, therefore, make the pain-relieving effects of codeine less effective and could trigger withdrawal effects. Acetaminophen also interacts with naltrexone to increase the risk of liver problems. For this reason, acetaminophen and codeine should never be used in combination with naltrexone.

Some medications are not recommended to be combined with acetaminophen and codeine, but they are combined in circumstances where alternative treatment options are simply not possible, and the benefits of both drugs far outweigh the potential risks. Doctors may be able to adjust the dosages of the drugs or the times at which they are taken to reduce the impact of interaction and negative side effects. If you are already taking any of the following medicines, be sure that your doctor knows before you begin taking acetaminophen and codeine:

  • Acepromazine
  • Alfentanil
  • Alprazolam
  • Amisulpride
  • Amobarbital
  • Anileridine
  • Aripiprazole
  • Asenapine
  • Baclofen
  • Benperidol
  • Bromazepam
  • Bromopride
  • Buprenorphine
  • Bupropion
  • Buspirone
  • Butabarbital
  • Butalbital
  • Butorphanol
  • Carbinoxamine
  • Cariprazine
  • Carisoprodol
  • Carphenazine
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorpromazine
  • Chlorzoxazone
  • Clobazam
  • Clonazepam
  • Clorazepate
  • Codeine
  • Conivaptan
  • Cyclobenzaprine
  • Dantrolene
  • Darunavir
  • Dezocine
  • Diacetylmorphine
  • Diazepam
  • Dichloralphenazone
  • Difenoxin
  • Dihydrocodeine
  • Diphenhydramine
  • Diphenoxylate
  • Donepezil
  • Doxylamine
  • Droperidol
  • Enflurane
  • Estazolam
  • Eszopiclone
  • Ethchlorvynol
  • Ethopropazine
  • Ethylmorphine
  • Fentanyl
  • Flibanserin
  • Flunitrazepam
  • Fluphenazine
  • Flurazepam
  • Fospropofol
  • Halazepam
  • Haloperidol
  • Halothane
  • Hexobarbital
  • Hydrocodone
  • Hydromorphone
  • Hydroxyzine
  • Iloperidone
  • Imatinib
  • Isoflurane
  • Isoniazid
  • Ketamine
  • Ketazolam
  • Ketobemidone
  • Levorphanol
  • Lorazepam
  • Lormetazepam
  • Lurasidone
  • Meclizine
  • Medazepam
  • Melperone
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Meptazinol
  • Mesoridazine
  • Metaxalone
  • Methadone
  • Methdilazine
  • Methocarbamol
  • Methohexital
  • Methotrimeprazine
  • Methylene Blue
  • Midazolam
  • Molindone
  • Moricizine
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Nicomorphine
  • Nitrazepam
  • Nitrous Oxide
  • Olanzapine
  • Opium
  • Opium Alkaloids
  • Orphenadrine
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Paliperidone
  • Papaveretum
  • Paregoric
  • Paroxetine
  • Pentazocine
  • Pentobarbital
  • Perampanel
  • Perazine
  • Periciazine
  • Perphenazine
  • Phenobarbital
  • Pimavanserin
  • Pimozide
  • Piperacetazine
  • Pipotiazine
  • Piritramide
  • Pixantrone
  • Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate
  • Prazepam
  • Primidone
  • Prochlorperazine
  • Promazine
  • Promethazine
  • Propofol
  • Propoxyphene
  • Quazepam
  • Quetiapine
  • Ramelteon
  • Remifentanil
  • Remoxipride
  • Risperidone
  • Secobarbital
  • Sertindole
  • Sodium Oxybate
  • Sufentanil
  • Sulpiride
  • Suvorexant
  • Tapentadol
  • Temazepam
  • Thiethylperazine
  • Thiopental
  • Thiopropazate
  • Thioridazine
  • Thiothixene
  • Tilidine
  • Tizanidine
  • Tolonium Chloride
  • Topiramate
  • Tramadol
  • Triazolam
  • Trifluoperazine
  • Trifluperidol
  • Triflupromazine
  • Trimeprazine
  • Zaleplon
  • Ziprasidone
  • Zolpidem
  • Zopiclone
  • Zotepine

Some medicines can interact with acetaminophen and codeine to increase the risk of certain side effects. However, the benefits of both drugs might outweigh the increased risk and doctors may continue to prescribe both. In other instances, they may adjust the dosage of one or both drugs. Examples of medicines which can increase the risk of side effects with acetaminophen and codeine include:

  • Acenocoumarol
  • Carbamazepine
  • Fosphenytoin
  • Lixisenatide
  • Phenytoin
  • Warfarin
  • Zidovudine

Warnings

Ultra-rapid metabolizers of codeine

Codeine is processed into morphine when it enters the body. For some people, this process happens much faster than for others. These people are known as “ultra-rapid metabolizers of codeine” and may experience extreme sleepiness and confusion or shallow breathing. If you have taken codeine in the past and know that you are an ultra-rapid metabolizer of codeine, let your doctor know as a prescription of acetaminophen and codeine may not be suitable for you.

Dizziness and drowsiness

Acetaminophen and codeine can cause dizziness and drowsiness. Do not drive or operate machinery while taking the drug until you know how it affects you. If you tend to feel these effects regularly when taking acetaminophen and codeine, do not drive, operate machinery or do anything else which requires you to be alert.

Due to the way that acetaminophen and codeine causes drowsiness, you should also avoid other substances or medications which have sedative effects. This includes:

  • Alcohol
  • Benzodiazepines (such as Valium and Xanax)
  • Sleep medications (such as Ambien and Lunesta)
  • Barbiturates (such as Mebaral and Nebutal)
  • Antihistamines
  • Muscle relaxants
  • Anesthetics

Alcohol and acetaminophen and codeine

Acetaminophen has been known to cause liver damage, which is another reason why it’s important to avoid alcohol when taking acetaminophen and codeine. If you consume three or more alcoholic drinks while taking acetaminophen, the chances of developing liver damage are significantly increased.

Risk of constipation

It’s possible to experience constipation when taking acetaminophen and codeine. Usually, this side effect does not require medical attention, but if you find that the problem persists for more than a few days, visit your doctor to avoid health complications. Drinking plenty of fluid can help to keep stools soft which will make them easier to pass. You should also take care to eat plenty of soluble fiber (found in oats, barley, nuts, seeds, lentils and beans) to reduce the risk of constipation. Your doctor may prescribe laxatives if the problem becomes particularly severe.

Using acetaminophen and codeine with preexisting medical problems

Individuals with a history of respiratory problems may be at an increased risk of respiratory depression when using acetaminophen and codeine. Example of such respiratory problems include:

  • Chronic obstructive pulmonary disease (COPD)
  • Cor pulmonale
  • Hypoxia
  • Sleep apnea

People with liver disease or kidney disease may also be at an increased risk of health complications when they take acetaminophen and codeine.

Acetaminophen and codeine is not a recommended pain relief solution for individuals who are recovering from nasopharyngeal surgery such as tonsil removal. This is because these surgeries might affect normal breathing, and respiration could be further worsened by acetaminophen and codeine.

People with asthma and allergies to sulfites may be at an increased risk of allergic reaction to Tylenol with codeine, which is a brand of acetaminophen and codeine in the US which contains sodium metabisulfite.

Individuals who are recovering from head injuries, have a brain tumor or have a condition which causes increased pressure in the head may be at a higher risk of medical problems when taking acetaminophen and codeine.

If any of the following medical conditions are present, patients may be at an increased risk of side effects or health complications when taking acetaminophen and codeine:

  • Addison's disease
  • CNS depression
  • Enlarged prostate
  • Underactive thyroid
  • Difficulty passing urine

Acetaminophen and codeine may not be suitable for patients with a history of alcohol or drug abuse or addiction. Consumption of alcohol can increase the severity of drowsiness caused by the drug and increase the risk of liver or kidney problems. Individuals who will struggle to abstain from alcohol use while taking acetaminophen and codeine should not be prescribed them. Since codeine can be addictive, it is not recommended for individuals with a history of drug abuse, no matter if the abuse was of street drugs or prescribed medicines.

Pregnancy, breastfeeding and fertility

Acetaminophen and codeine should be avoided during pregnancy where possible, but in some cases, it may be prescribed if the benefits of the drug outweigh the potential risk to the fetus. When used for long periods during pregnancy, the fetus may be born with a dependency to the drug and could therefore experience withdrawal effects. If codeine is administered to the mother during labor, respiratory depression may occur in the newborn baby. For this reason, acetaminophen and codeine are used with great caution when prescribing pain relief to pregnant women. If you become pregnant while taking acetaminophen and codeine, tell your doctor about the pregnancy immediately.

There hasn’t been enough research conducted to decipher the risk to infants nursing from mothers who are taking acetaminophen and codeine. Since it is not understood if breastfeeding infants will be affected by the drug, it tends not to be prescribed to nursing mothers unless the benefits far outweigh the potential risks.

The use of opioids such as codeine may lead to fertility problems. For this reason, acetaminophen and codeine should not be consumed for extended periods. Since extended use of the drug can also lead to addiction and liver problems, the medicine is only designed for short-term use.

Storage

Acetaminophen and codeine should be stored at room temperature in a closed container. It shouldn’t be exposed to heat, moisture or direct sunlight, and patients should avoid freezing the medicine. They shouldn’t be kept in the bathroom as they may become susceptible to the damp, humid environment.

As with all medicines, acetaminophen and codeine should be kept out of reach of children. This drug is very harmful to children, particularly those under the age of 12, and can be deadly. Keep medicine in containers with childproof safety caps, and up and away from the ground so that they cannot easily be reached by children.

If you have any acetaminophen and codeine left unused, consult your healthcare provider for advice on how to dispose of it. Since the drug can cause harmful effects to the respiratory system and the liver, it should never be consumed by anyone other than the patient it was first prescribed to. To reduce the risk of others taking the medicine, dispose safely of unused acetaminophen and codeine as soon as possible.

Summary

Acetaminophen and codeine is a painkiller most commonly known as Tylenol with Codeine in the US, although it is available under other brand names. It combines the pain-relieving effects of two medicines to provide relief from pain during short-term periods, such as in recovery from surgery or injury. It is most effective in treating mild to moderate pain, and it can also help to reduce fever.

Acetaminophen and codeine can be addictive, since it contains narcotic analgesic codeine which acts on the central nervous system. When used for long periods of time, patients may become physically and mentally dependent on codeine and could experience physical withdrawal effects when they stop taking the drug. To avoid this, acetaminophen and codeine should only be taken for short periods, and the dose should be gradually reduced rather than stopped all of a sudden. It’s also important to avoid suddenly changing the dosage of the drug without approval from a doctor.

Acetaminophen is not a habit-forming medication, but it’s also unsuitable for long term use. This is because it is known to cause liver problems, particularly when taken in high doses. For this reason, acetaminophen and codeine can also be risky for patients with preexisting liver or kidney problems.

It’s relatively common for acetaminophen and codeine to cause drowsiness, particularly when patients first begin taking it. For this reason, it shouldn’t be taken before driving or operating machinery until you know what affect it has on the body. Patients should also avoid alcohol when taking acetaminophen and codeine, not only because it will worsen the sedative effects of the drug, but because the risk of liver problems caused by the drug significantly increases when alcohol is consumed at the same time.

People taking acetaminophen and codeine should look out for signs of respiratory depression. The most common symptoms of this are slow, irregular, shallow or abnormally fast breathing, tightness in the chest, difficulty swallowing and blue lips, skin or fingertips. If any of these symptoms are present, seek medical advice immediately.

It’s also important to recognize signs of liver problems. Pain in the stomach, lower back or side, difficulty or painful urinating, blood in the urine or stools and cloudy or very dark urine are all serious symptoms which should be reported to a doctor immediately.

Acetaminophen and codeine is suitable for most adults and seems to be safe for the elderly, although lower doses tend to be given to elderly patients initially. It is not suitable for children under the age of 12, and only suitable for those between the ages of 12 and 18 if the benefits of the drug vastly outweigh the risks. It isn’t recommended for pregnant women since extended use could cause codeine dependency in the fetus when born, or it might lead to respiratory depression in the newborn if taken by the mother during labor. However, once again, if the benefits of the drug far outweigh the risks, doctors may prescribe it.

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Last Reviewed:
December 10, 2017
Last Updated:
December 22, 2017