What side effects are possible with this medication?

A side effect is an unwanted response to a medication when it is taken in normal doses. A side effect may be mild or severe, temporary or permanent, but does not occur in everyone. The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away over time. If you develop any of these side effects (or any other side effects not listed here) or they change in intensity, speak to your doctor or pharmacist for advice on managing them and on the risks and benefits of the medication.

• abdominal pain
• constipation
• dizziness
• drowsiness
• itching
• lightheadedness
• nausea
• shortness of breath
• vomiting

At higher doses, codeine can cause respiratory depression. Respiratory depression is a decreased breathing rate, which prevents the body from getting enough oxygen.

Click here to learn about serious side effects that can potentially occur with any medication. These examples are provided for information purposes only and are not meant to be exhaustive. Always consult your doctor for sound medical advice specific to your particular medication and treatment.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Alcohol use: People who drink alcohol should talk to their doctor about the risk for liver damage related to acetaminophen and how to use this medication safely.

Dependence and withdrawal: Physical dependence, psychological dependence, and abuse have occurred with the use of this medication. People with a history of past or current substance use problems may be at greater risk of developing abuse or addiction while taking this medication. Abuse is not a problem with people who require this medication for pain relief. Withdrawal symptoms may occur if this medication is stopped suddenly. Talk to your doctor about the risks and benefits of taking this medication.

Drowsiness/reduced alertness: Codeine may impair mental or physical abilities. You should not drive a car or perform hazardous tasks until you determine that this medication does not impair your ability to perform these tasks safely.

Kidney and liver disease: People with kidney or liver disease should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Medical conditions: People with head injury, increased pressure in the head, acute abdominal conditions, low thyroid, urethral stricture, Addison's disease, or enlarged prostate, as well as seniors or debilitated people, should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Worsening symptoms: If redness or swelling occurs in the area of pain, if symptoms do not improve or worsen, or if new symptoms develop (e.g., high fever, rash, itching, persistent headache) while you are taking this medication, contact your doctor as soon as possible. These may be signs of other conditions that require medical attention.

Pregnancy and newborns: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately. Dependency and withdrawal signs have been reported in newborns whose mothers took opiates such as codeine regularly during pregnancy. These signs include irritability, excessive crying, tremors, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life.

Breast-feeding: Acetaminophen and codeine pass into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children under 12 years of age.

What other drugs could interact with this medication?

There may an interaction between acetaminophen - codeine and any of the following:

• alcohol
• antianxiety agents (e.g., clonazepam, lorazepam)
• anticoagulants (blood thinners, e.g., warfarin)
• antipsychotics (e.g., clozapine, haloperidol, risperidone)
• cholestyramine
• fluoxetine
• imatinib
• lopinavir
• narcotic analgesics (e.g., morphine, oxycodone)
• other products containing acetaminophen or codeine
• other sedating agents (e.g., barbiturates, sedatives, sleeping pills, anaesthetics)
• paroxetine
• ritonavir
• terbinafine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.