CODEINE - EVERYTHING YOU NEED TO KNOW

Codeine

What is codeine?

Codeine is an opioid pain medication. An opioid is sometimes called a narcotic.

Codeine is used to treat mild to moderately severe pain.

Codeine may also be used for purposes not listed in this medication guide.

Important information

You should not use codeine if you are allergic to it, or if you have an uncontrolled breathing disorder, a bowel obstruction called paralytic ileus, or frequent asthma attacks or hyperventilation.

Codeine can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Codeine may also be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medicine in a place where others cannot get to it.

MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Medicines that contain codeine should not be given to a child just after surgery to remove the tonsils or adenoids.

Get emergency medical help if a child taking this medication has breathing problems, blue lips, or severe drowsiness, or if you cannot wake the child up from sleep.

Before taking this medicine

You should not use codeine if you are allergic to it, or if you have:

• untreated or uncontrolled asthma or other breathing disorder;
• a bowel obstruction called paralytic ileus; or
• frequent asthma attacks or hyperventilation.

Medicines that contain codeine should not be given to a child just after surgery to remove the tonsils or adenoids.

In some people, codeine breaks down rapidly in the liver and reaches higher than normal levels in the body. This can cause dangerously slow breathing and may cause death, especially in a child.

To make sure this medicine is safe for you, tell your doctor if you have:

• liver disease;
• asthma, COPD, sleep apnea, or other breathing disorders;
• curvature of the spine that affects breathing;
• kidney disease;
• a history of head injury or brain tumor;
• low blood pressure;
• blockage in your digestive tract (stomach or intestines);
• a gallbladder or pancreas disorder;
• underactive thyroid;
• Addison's disease or other adrenal gland disorder;
• enlarged prostate, urination problems;
• mental illness; or
• a history of drug or alcohol addiction.

FDA pregnancy category C. It is not known whether this medicine will harm an unborn baby.Codeine may cause breathing problems, behavior changes, or life-threatening addiction and withdrawal symptoms in your newborn if you use the medication during pregnancy. Tell your doctor if you are pregnant.

See also: Pregnancy and breastfeeding warnings (in more detail)

Codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not breast-feed while taking this medicine.

Older adults may be more sensitive to the effects of this medicine.

How should I take codeine?

Follow all directions on your prescription label. Codeine can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Codeine may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away codeine is against the law.

Take codeine with food or milk if it upsets your stomach.

Measure liquid medicine with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking codeine. Do not use a stool softener (laxative) without first asking your doctor.

Do not stop using codeine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using this medicine.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

After you have stopped using this medication, flush any unused pills down the toilet. Disposal of medicines by flushing is recommended to reduce the danger of accidental overdose causing death. This advice applies to a very small number of medicines only. The FDA, working with the manufacturer, has determined this method to be the most appropriate route of disposal and presents the least risk to human safety.

What happens if I miss a dose?

Since codeine is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A codeine overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

What should I avoid while taking codeine?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with codeine. Check your food and medicine labels to be sure these products do not contain alcohol.

Codeine may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Codeine side effects

Get emergency medical help if you have any of these signs of an allergic reaction to codeine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Seek emergency medical attention if a child taking this medication has any of the following life-threatening side effects: noisy breathing, sighing, slow breathing with long pauses between breaths; being unusually sleepy or hard to wake up; blue colored lips.

Call your doctor at once if you have:

• slow heart rate, weak pulse, fainting, shallow breathing;
• feeling like you might pass out;
• confusion, agitation, hallucinations, unusual thoughts or behavior;
• feelings of extreme happiness or sadness;
• seizure (convulsions); or
• problems with urination.

Common codeine side effects include:

• feeling dizzy or drowsy;
• nausea, vomiting, stomach pain;
• constipation;
• sweating; or
• mild itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Codeine Side Effects

For the Consumer

Applies to codeine: oral solution, oral syrup, oral tablet, oral tablet extended release

In addition to its needed effects, some unwanted effects may be caused by codeine. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking codeine:

Incidence not known

• Bloating
• blurred vision
• chills
• cold, clammy skin
• confusion
• constipation
• darkened urine
• difficult or troubled breathing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast, irregular, pounding, or racing heartbeat or pulse
• fast, weak pulse
• feeling of warmth
• fever
• indigestion
• irregular, fast or slow, or shallow breathing
• lightheadedness
• loss of appetite
• nausea
• no blood pressure or pulse
• no breathing
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale or blue lips, fingernails, or skin
• redness of the face, neck, arms, and occasionally, upper chest
• shortness of breath
• stopping of the heart
• sweating
• unconsciousness
• unusual tiredness or weakness
• vomiting
• wheezing
• yellow eyes or skin

If any of the following symptoms of overdose occur while taking codeine, get emergency help immediately:

Symptoms of overdose

• Bluish lips or skin
• change in consciousness
• chest pain or discomfort
• constricted, pinpoint, or small pupils (black part of the eye)
• decreased awareness or responsiveness
• extreme sleepiness or unusual drowsiness
• loss of consciousness
• no blood pressure or pulse
• severe sleepiness
• slow or irregular heartbeat

Some of the side effects that can occur with codeine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common

• Drowsiness
• relaxed and calm

Incidence not known

• Abdominal or stomach pain or cramps
• blurred or loss of vision
• diarrhea
• disturbed color perception
• double vision
• dry mouth
• false or unusual sense of well-being
• fear or nervousness
• feeling of constant movement of self or surroundings
• halos around lights
• headache
• hives or welts
• itching skin
• night blindness
• overbright appearance of lights
• redness of the skin
• sensation of spinning
• shakiness
• skin rash
• sleeplessness
• trouble sleeping
• tunnel vision
• unable to sleep
• weight loss

For Healthcare Professionals

Applies to codeine: compounding powder, injectable solution, oral solution, oral tablet

General

The side effects have been more likely and more severe in patients with liver and/or renal disease.

Nervous system

Nervous system side effects have included mental and respiratory depression, stupor, delirium, somnolence, and dysphoria. An increased risk of falls and hip fractures has also been associated with codeine therapy, particularly in the elderly. A case of seizures has been reported with the use of intravenous codeine phosphate.

Opioids may result in psychotic symptoms in some patients.

One retrospective study of elderly patients who sustained a hip fracture suggested that the relative risk of hip fracture was 1.6 in patients using codeine compared to age matched nonusers.

Other

Other side effects including withdrawal symptoms after either abrupt cessation or fast tapering of narcotic analgesics have been reported. These withdrawal symptoms have included agitation, restlessness, anxiety, insomnia, tremor, abdominal cramps, blurred vision, vomiting, and sweating.

Cardiovascular

Hypotension is rare and has been reported most frequently with high doses.

Cardiovascular side effects have included hypotension and dizziness.

Gastrointestinal

Gastrointestinal side effects including nausea, vomiting, and constipation have been reported frequently. Severe constipation and ileus resulting in colonic perforation have also been reported. Four cases of acute pancreatitis have been reported.

Genitourinary

Genitourinary side effects including urinary retention have been reported.

Dermatologic

Dermatologic side effects including rashes, severe scarlatiniform eruptions, and generalized dermatitis have been reported rarely.

Codeine induced rashes may be related to direct stimulation of histamine release.

Renal

Renal side effects including acute renal failure (which may respond to naloxone therapy) have been reported in association with codeine therapy.

Immunologic

Immunologic side effects have included one study of a patient with exercise induced anaphylaxis and three control subjects which found a correlation between codeine wheal size and recent exercise.

Hypersensitivity

Hypersensitivity side effects including a case of codeine phosphate induced hypersensitivity syndrome have been reported.

Ocular

Ocular side effects including a temporary 26% decrease in pupil diameter following the administration of intravenous codeine have been reported.

Respiratory

Respiratory side effects have included respiratory depression.