"Consumers and health care professionals will soon find updated labeling for extended-release and long-acting opioid pain relievers to help ensure their safe and appropriate use.
In addition to requiring new labeling on these prescript"...
- Clinician Information:
Codeine Phosphate Patient Information Including Side Effects
Generic Name: codeine (Pronunciation: KOE deen)
- What is codeine ?
- What are the possible side effects of codeine ?
- What is the most important information I should know about codeine ?
- What should I discuss with my healthcare provider before taking codeine ?
- How should I take codeine ?
- What happens if I miss a dose ?
- What happens if I overdose ?
- What should I avoid while taking codeine ?
- What other drugs will affect codeine ?
- Where can I get more information?
What is codeine ?
Codeine is in a group of drugs called narcotic pain medicines.
Codeine is used to treat mild to moderately severe pain.
Codeine may also be used for purposes not listed in this medication guide.
Codeine Phosphate 30 mg-RAN
Codeine Sulfate 15 mg-ROX
round, white, imprinted with 54 613
Codeine Sulfate 30 mg-ROX
round, white, imprinted with 54 783
Codeine Sulfate 60 mg-ROX
round, white, imprinted with 54 412
What are the possible side effects of codeine ?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- 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.
Less serious side effects include:
- feeling dizzy or drowsy;
- nausea, vomiting, stomach pain,;
- 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. You may report side effects to FDA at 1-800-FDA-1088.
Read the Codeine Phosphate (codeine phosphate) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about codeine ?
Codeine may be habit-forming and should be used only by the person it was prescribed for. Never share codeine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.
Never take codeine in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
Codeine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Do not stop using codeine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using codeine.
Additional Codeine Phosphate Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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