Pronunciation: koe-deen
Generic name: codeine sulfate, codeine phosphate
Brand name: generic only
Dosage form: oral tablet (codeine sulfate: 15 mg, 30 mg, 60 mg), oral solution (discontinued)
Drug classes: Antitussives, Opioids

Medically reviewed by Carmen Pope, Senior Medical Editor, B. Pharm. Last updated on March 18, 2026.

What is Codeine?

Codeine is used to manage mild to moderate pain, where treatment with an opioid is appropriate, and when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them. Codeine is an opioid and considered a strong prescription pain medicine. It also has cough-suppressing (anti-tussive) properties.

Codeine is available as one of 2 salts: codeine or codeine phosphate:

• Codeine phosphate is highly water-soluble and used in oral liquids, tablets, and injections
• Codeine sulfate is less soluble and primarily used in tablet form
• Codeine sulfate tablets are the only single-ingredient codeine still available in the United States.

An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Codeine is available in combination with several other ingredients, including acetaminophen, guaifenesin, promethazine, and pseudoephedrine. In products containing guaifenesin, promethazine, or pseudoephedrine, codeine is included specifically for its cough-suppressing properties.

Codeine falls under three different Schedule classifications depending on the product and how much codeine it contains.

• Single-ingredient codeine sulfate tablets are Schedule II.
• Combination products that contain less than 90 mg of codeine per dosage unit (such as acetaminophen with codeine) are Schedule III
• Combination cough preparations containing not more than 200 milligrams of codeine per 100 milliliters, such as codeine and guaifenesin, are Schedule V (although some states have reclassified these as Schedule III).

Codeine has been used for over 100 years and has been classified as generally recognized as safe (GRAS) since 1950. On July 16, 2009, single-ingredient, prescription-only codeine tablets received FDA approval via a new drug application (NDA).

Important Information About Codeine

Get emergency help or call 911 right away if you take too much codeine (overdose). When you first start taking codeine, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose.

Taking codeine with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

Never give anyone else your codeine. They could die from taking it. Selling or giving away codeine is against the law.

Store codeine securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Important Information Guiding Use in Pediatric Patients

• Do not give codeine to a child younger than 12 years of age.
• Do not give codeine to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.
• Avoid giving codeine to children between 12 and 18 years of age who have risk factors for breathing problems, such as obstructive sleep apnea, obesity, or underlying lung problems.

Side Effects

The possible side effects of codeine are constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, and abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help or call 911 right away if you have:

• Trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion
• If you are a nursing mother taking codeine and your breastfeeding baby has increased sleepiness, confusion, difficulty breathing, shallow breathing, limpness, or difficulty breastfeeding.

These are not all the possible side effects of codeine. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. 

Related/similar drugs

Before Taking

Do not take codeine if you have:

• Severe asthma, trouble breathing, or other lung problems.
• A bowel blockage or a narrowing of the stomach or intestines.
• An allergy to codeine Tablets or any of the ingredients.

Before taking codeine, tell your healthcare provider if you have a history of:

• Head injury, seizures
• Problems urinating
• Abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.
• Liver, kidney, thyroid problems
• Pancreas or gallbladder problems
• Have been told by your healthcare provider that you are a “rapid metabolizer” of certain medicines.

Tell your healthcare provider if you are:

• Noticing your pain is getting worse. If your pain gets worse after you take codeine, do not take more codeine without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking codeine.
• Pregnant or planning to become pregnant. Use of codeine for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• Breastfeeding. Not recommended; may harm your baby.
• Living in a household where there are small children or someone who has abused street or prescription drugs.
• Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking codeine with certain other medicines can cause serious side effects that could lead to death.

How do I Take Codeine

Do not change your dose. Take codeine exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.

• For acute (short-term) pain, you may only need to take codeine for a few days. You may have some codeine left over that you did not use. See disposal information at the bottom of this section for directions on how to safely throw away (dispose of) your unused codeine.
• Take your prescribed dose every 4 hours as needed for pain.
• Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.

Call your healthcare provider if the dose you are taking does not control your pain.

If you have been taking codeine regularly, do not stop taking codeine without talking to your healthcare provider.

Dispose of expired, unwanted, or unused codeine by taking your drug to an authorized DEA-registered collector or drug take-back program. If one is not available, you can dispose of codeine by mixing the product with dirt, cat litter, or coffee grounds; placing the mixture in a sealed plastic bag, and throwing the bag in your trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

What Should I Avoid While Taking Codeine?

While taking codeine, DO NOT:

• Drive or operate heavy machinery until you know how codeine affects you. Codeine sulfate can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with codeine may cause you to overdose and die.

Dosing information

Adult Dose of Codeine for Pain

• Initial dose: 15 to 60 mg orally up to every 4 hours as needed
• Maximum dose: 360 mg in 24 hours

Comments:

• Initial doses should be individualized, taking into account the severity of pain, response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse.
• Doses higher than 60 mg have not been shown to improve pain relief and are associated with an increased incidence of adverse effects.
• Because of the risks of addiction, abuse, and misuse, the lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
• Monitor patients closely for respiratory depression within the first 24 to 72 hours after initiating therapy and after any dose increase.

How Does Codeine Work?

Codeine is a mu-opioid receptor agonist, though its affinity for this receptor is considerably weaker than morphine's. Its analgesic properties depend primarily on its conversion to morphine in the liver, which binds to the mu-opioid receptor with far greater affinity. When opioids bind to these receptors, a cascade of intracellular events occurs, leading to hyperpolarization of neuronal cells and inhibition of nociceptive neurotransmitter release, ultimately reducing the perception of pain. The exact mechanism, however, remains incompletely understood.

What Other Drugs Will Affect Codeine?

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");

• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

• other narcotic medications - opioid pain medicine or prescription cough medicine;

• a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;

• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or

• drugs that affect serotonin levels in your body- a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may interact with codeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Company

Codeine sulfate is distributed by Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922. For more information, please call Hikma Pharmaceuticals at 1-800-962-8364.

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