MedlinePlus Drug Information: Acetaminophen and Codeine

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Other drug names:	A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9

Acetaminophen and Codeine

(a set a mee' noe fen) (koe' deen)

Contents of this page:
Why is this medication prescribed? How should this medicine be used? What special precautions should I follow? What should I do if I forget a dose? What side effects can this medication cause?	What storage conditions are needed for this medicine? In case of emergency/overdose What other information should I know? Brand names Other names

IMPORTANT WARNING: Return to top

[Posted 08/17/2007] FDA issued a Public Health Advisory with important new information about a very rare, but serious, side effect in nursing infants whose mothers are taking codeine and are ultra-rapid metabolizers of codeine. When codeine enters the body and is metabolized, it changes to morphine, which relieves pain. Many factors affect codeine metabolism, including a person's genetic make-up. Some people have a variation in a liver enzyme and may change codeine to morphine more rapidly and completely than other people. Nursing mothers taking codeine may also have higher morphine levels in their breast milk. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer.

When prescribing codeine-containing drugs to nursing mothers, physicians should choose the lowest effective dose for the shortest period of time and should closely monitor mother-infant pairs. There is an FDA cleared test for determining a patient's CYP2D6 genotype. The test is not routinely used in clinical practice but is available through a number of different laboratories. The results of this test predict that a person can convert codeine to morphine at a faster rate than average, resulting in higher morphine levels in the blood. When levels of morphine are too high, patients have an increased risk of adverse events. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Codeine, http://www.fda.gov/cder/drug/advisory/codeine.htm and http://www.fda.gov/cder/drug/infopage/codeine/default.htm.

Why is this medication prescribed? Return to top

This combination of drugs is used to relieve mild to moderate pain.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used? Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

The combination of acetaminophen and codeine comes as a tablet, capsule, and liquid to take by mouth. It usually is taken every 6 hours as needed. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take acetaminophen and codeine exactly as directed.

Codeine can be habit-forming. Do not take a larger dose, take it more often, or for a longer period than your doctor tells you to.

What special precautions should I follow? Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Before taking acetaminophen and codeine,

tell your doctor and pharmacist if you are allergic to acetaminophen, codeine, sulfite or any other drugs.
tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially acetaminophen (Tylenol); antidepressants; medications for cough, cold, or allergies; other pain relievers; sedatives, sleeping pills, tranquilizers; and vitamins.
tell your doctor if you have or have ever had liver or kidney disease, a history of alcoholism, lung or thyroid disease, prostatic hypertrophy, or urinary retention.
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking acetaminophen and codeine, call your doctor.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking acetaminophen and codeine.
you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
remember that alcohol can add to the drowsiness caused by this drug.

What should I do if I forget a dose? Return to top

This medication usually is taken as needed. If your doctor has told you to take acetaminophen and codeine regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause? Return to top

Acetaminophen and codeine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

dizziness
lightheadedness
drowsiness
upset stomach
vomiting
constipation
stomach pain
rash
difficulty urinating

If you experience either of the following symptoms, call your doctor immediately:

difficulty breathing
mood changes

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine? Return to top

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose Return to top

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know? Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Keep all appointments with your doctor.

Too much acetaminophen may cause liver damage; do not take more than 4000 mg of acetaminophen per day.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names Return to top

Capital and Codeine®

Phenaphen with Codeine (No.3 and No.4)®

Tylenol with Codeine (No. 2, No. 3, No. 4)®

Other names Return to top

APAP and Codeine

Last Revised - 09/01/2007
Last Reviewed - 08/01/2007

American Society of Health-System Pharmacists, Inc. Disclaimer