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Codeine

Codeine is an opioid pain reliever used to manage mild to moderate pain when other treatments are not enough.

Drug classes Full Opioid Agonists
Rx Schedule CII Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Codeine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Codeine is an older opioid pain reliever, on the market since about 1952 and available as a generic, that acts on the brain’s opioid receptors, mostly after the body converts it to morphine. It is reserved for mild to moderate pain when non-opioid options fall short. Short courses are often manageable, but drowsiness, dizziness, nausea and constipation are common. Its boxed warning covers addiction, misuse and overdose death, plus slowed or stopped breathing that is riskiest at the start or after a dose increase, so call 911 if breathing turns very slow or shallow.

Clinical pearls

  • Never combine it with alcohol, benzodiazepines like Xanax or Valium, or other sedatives, because together they can stop breathing.
  • Paroxetine, fluoxetine and bupropion can block codeine’s conversion to morphine, so pain relief fades; tell every prescriber you take it.
  • Plan a laxative from the first dose, because opioid constipation rarely eases the longer you take it.
  • Lock it away, since one tablet can kill a child, and it is off-limits under 12 and after tonsil or adenoid surgery before 18.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Codeine Sulfate tablets carry the FDA's most serious warning label. Here is what it means for you:

  • Risk of addiction and overdose death: Codeine can be addictive even when used as directed. Overdose — which can be fatal — is a real risk at any dose.
  • Breathing can stop: Codeine can cause breathing to slow dangerously or stop altogether, especially when first starting or after a dose increase. This is a medical emergency — call 911.
  • One dose can kill a child: Accidental ingestion of even one tablet by a child can be fatal. Keep this medication locked away and out of reach.
  • Deadly with sedatives or alcohol: Combining codeine with benzodiazepines (like Xanax or Valium), other sedatives, or alcohol can cause coma or death. These combinations should be avoided unless absolutely necessary and closely monitored.
  • Pregnancy risk: Using codeine regularly during pregnancy can cause the newborn to go through dangerous opioid withdrawal after birth.
  • Children's special risk: Codeine is contraindicated (must not be used) in children under 12 and in anyone under 18 after tonsil or adenoid surgery. Some children convert codeine to morphine much faster than normal, making even a standard dose potentially lethal.
  • Drug interaction complexity: Many common medications (including some antidepressants and antifungals) can dramatically change how much morphine codeine produces in your body, raising the risk of overdose or reducing pain relief.
Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet
Earliest FDA record1952
Companies listing it with the FDA2
FDA label last updatedDec 22, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Codeine, written from its FDA label.

What Codeine is used for

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Codeine is an opioid used to treat pain when non-opioid alternatives are not enough.

  • Codeine Sulfate tablets (oral) are indicated for the management of mild to moderate pain in adults where an opioid is appropriate and other treatments have been inadequate or are not tolerated
  • Codeine Sulfate tablets are not a first-line treatment — they are specifically reserved for situations where other pain management options have failed
  • Codeine Sulfate tablets are not approved for use in children under 12 years of age, or in anyone under 18 following tonsillectomy or adenoidectomy

How Codeine works

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Codeine works by binding to mu-opioid receptors in the brain and nervous system — the same receptors that respond to the body's natural pain-relieving chemicals. Most of its pain-relieving effect is believed to come from the body converting codeine into morphine through a liver enzyme called CYP2D6. Higher codeine levels lead to more morphine, stronger pain relief, and a greater risk of side effects like slowed breathing.

How much morphine a person produces from codeine varies widely based on genetics. People who are "ultra-rapid metabolizers" convert codeine to morphine very quickly, reaching dangerously high morphine levels even at normal doses. "Poor metabolizers" may get little to no pain relief because they produce very little morphine from codeine.

Codeine dosage

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Codeine Sulfate tablets are taken by mouth, typically every 4 hours as needed for pain. They can be taken with or without food — even a large fatty meal does not meaningfully change how the body absorbs the medication. Your prescriber will set the dose based on your pain level, previous opioid use, and personal risk factors.

  • Always use the lowest dose that controls your pain
  • Do not increase your dose on your own
  • Do not stop taking it suddenly if you've been using it regularly — ask your doctor how to taper safely
  • Talk to your pharmacist about getting a naloxone overdose reversal kit, especially if others in your home are at risk

Dosing details from the FDA-approved label

From the Codeine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Initial dosage (pain severe enough to require an opioid analgesic)
    • Initiate treatment in a dosing range of 15 to 60 mg every 4 hours as needed for pain, and at the lowest dose necessary to achieve adequate analgesia
    • Titrate the dose based upon the individual patient's response to their initial dose
    • Maximum: The maximum 24-hour dose is 360 mg. Adult doses higher than 60 mg provide no further efficacy but are associated with greater adverse reactions.
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION • Codeine Sulfate Tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. ( 2.1 ) • Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of Codeine Sulfate Tablets for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. ( 2.1 , 5 ) • Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. ( 2.1 ) • Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse. ( 2.1 , 5.1 ) • Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with Codeine Sulfate Tablets. Consider this risk when selecting an initial dose and when making dose adjustments. ( 2.1 , 5.2 ) • Discuss opioid overdose reversal agents and options for acquiring them with the patient and/or caregiver, both when initiating and renewing treatment with Codeine Sulfate Tablets, especially if the patient has additional risk factors for overdose, or close contacts at risk for exposure and overdose. ( 2.2 , 5.1 , 5.2 , 5.3 ) • Initiate treatment with 15 to 60 mg every 4 hours as needed for pain, and at the lowest dose necessary to achieve adequate analgesia. Titrate the dose based upon the individual patient’s response to their initial dose of Codeine Sulfate Tablets. ( 2.3 ) • Periodically reassess patients receiving Codeine Sulfate Tablets to evaluate the continued need for opioid analgesics to maintain pain control, for the signs or symptoms of adverse reactions, and for the development of addiction, abuse, or misuse.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Codeine side effects

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The most common side effects of codeine include:

Common side effects

  • Drowsiness or sedation
  • Dizziness or lightheadedness
  • Nausea or vomiting
  • Constipation
  • Sweating
  • Shortness of breath
  • Headache
  • Itching (pruritus)
  • Itching (pruritus) or flushing

When to get medical help

  • Call 911 immediately if breathing slows, becomes very shallow, or stops
  • Seek emergency help if you feel extreme sleepiness and cannot be woken
  • Go to the ER if you have signs of an allergic reaction: hives, swelling of the face or throat, trouble breathing
  • Call your doctor if you feel severe dizziness or faint when standing up
  • Tell your doctor right away if you develop confusion, agitation, rapid heart rate, or muscle twitching — these can be signs of serotonin syndrome
  • Contact your doctor if you notice signs of low adrenal function: unusual tiredness, weakness, or stomach pain
  • Call your doctor if pain seems to get worse rather than better while on codeine (a sign of opioid-induced hyperalgesia)

Serious reactions that require immediate medical attention include dangerously slow or shallow breathing, extreme sleepiness you can't shake, signs of a severe allergic reaction (hives, throat swelling), serotonin syndrome (agitation, muscle twitching, rapid heart rate), and signs of adrenal insufficiency (severe fatigue, weakness, stomach pain). Call 911 or go to an emergency room right away if breathing problems occur.

Codeine warnings and precautions

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  • Breathing can slow or stop (respiratory depression): This is the most dangerous risk. It can happen at any dose but is most likely when starting codeine or after a dose increase. Accidental ingestion of even one tablet by a child can be fatal.
  • Addiction and misuse: Codeine is a Schedule II controlled substance. Addiction can develop even when used as prescribed, particularly in people with a personal or family history of substance use disorders.
  • Deadly interactions with sedatives and alcohol: Combining codeine with benzodiazepines, other sedatives, or alcohol sharply raises the risk of coma and death.
  • Children's risk: Contraindicated in children under 12. Fatal breathing problems — sometimes related to a genetic trait that causes ultra-rapid conversion to morphine — have been reported in children given codeine after tonsil surgery.
  • Pregnancy and breastfeeding: Extended use during pregnancy can cause newborn opioid withdrawal. Codeine and morphine pass into breast milk and can cause fatal breathing problems in nursing infants — breastfeeding is not recommended.
  • Withdrawal on stopping: Abruptly stopping codeine after regular use can trigger serious withdrawal. Always taper under medical supervision.
  • Opioid-induced hyperalgesia: In some cases, codeine can paradoxically make pain feel worse rather than better. Tell your doctor if your pain increases while on this medication.

Codeine interactions

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Codeine interacts with many common medications and substances — some combinations can be life-threatening.

  • Benzodiazepines and sedatives (e.g., Xanax, Valium, sleep aids): Combined use can cause fatal respiratory depression, coma, or death
  • Alcohol: Increases sedation and breathing risk dramatically — avoid completely
  • MAO inhibitors (e.g., phenelzine, tranylcypromine, linezolid): Can cause serotonin syndrome or severe opioid toxicity; do not combine or use within 14 days of each other
  • CYP3A4 inhibitors (e.g., erythromycin, ketoconazole, ritonavir): Raise morphine levels and increase overdose risk
  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): Reduce codeine's effectiveness and can trigger opioid withdrawal
  • CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, bupropion, quinidine): Reduce conversion to morphine, decreasing pain relief; stopping them later can spike morphine levels dangerously
  • Serotonergic drugs (SSRIs, SNRIs, triptans, tramadol, trazodone, mirtazapine): Risk of serotonin syndrome — a potentially life-threatening reaction
  • Muscle relaxants (e.g., cyclobenzaprine): Increase the degree of respiratory depression
  • Anticholinergic drugs: Increase risk of severe constipation or urinary retention when used with codeine
  • Diuretics: Codeine can reduce how well diuretics (water pills) work

Interactions listed in the FDA-approved label

From the Codeine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Inhibitors of CYP3A4 (e.g., erythromycin, ketoconazole, ritonavir): May increase codeine plasma concentrations and morphine levels, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression; stopping the inhibitor may result in decreased opioid efficacy or a withdrawal syndrome. If concomitant use is necessary, consider dosage reduction until stable drug effects are achieved and evaluate patients at frequent intervals for respiratory depression and sedation. If the inhibitor is discontinued, consider increasing the dosage and assess for signs of opioid withdrawal.
  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): Can result in lower codeine and morphine levels, decreased efficacy or onset of a withdrawal syndrome; after stopping the inducer, codeine and morphine levels may increase and may cause serious respiratory depression. If concomitant use is necessary, evaluate patients at frequent intervals for reduced efficacy and signs of opioid withdrawal and consider increasing the dosage as needed. If the inducer is discontinued, consider dosage reduction and evaluate for respiratory depression and sedation.
  • Inhibitors of CYP2D6 (e.g., paroxetine, fluoxetine, bupropion, quinidine): Can increase codeine concentration but decrease active metabolite morphine, which could result in reduced analgesic efficacy or opioid withdrawal symptoms; after stopping the inhibitor, morphine levels will increase and may cause potentially fatal respiratory depression. Consider dosage adjustment and evaluate patients at frequent intervals; consider increasing the dosage if efficacy is reduced or withdrawal occurs, and consider reducing the dosage after stopping the inhibitor.
  • Benzodiazepines and other CNS depressants (including alcohol): Additive pharmacologic effect can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. Reserve concomitant prescribing for patients for whom alternative options are inadequate; limit dosages and durations to the minimum required; inform patients and caregivers of the signs of respiratory depression; consider recommending or prescribing an opioid overdose reversal agent.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, trazodone, tramadol, linezolid): Concomitant use with opioids has resulted in serotonin syndrome. If concomitant use is warranted, frequently evaluate the patient, particularly during treatment initiation and dose adjustment. Discontinue codeine if serotonin syndrome is suspected.
  • Monoamine oxidase inhibitors (MAOIs) (e.g., phenelzine, tranylcypromine, linezolid): Interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma). Do not use in patients taking MAOIs or within 14 days of stopping such treatment.
  • Mixed agonist/antagonist and partial agonist opioid analgesics (butorphanol, nalbuphine, pentazocine, buprenorphine): May reduce the analgesic effect of codeine and/or precipitate withdrawal symptoms. Avoid concomitant use.
  • Muscle relaxants (e.g., cyclobenzaprine, metaxalone): Codeine may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. Decrease the dosage of codeine and/or the muscle relaxant as necessary; consider recommending or prescribing an opioid overdose reversal agent.
  • Diuretics: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Evaluate patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.
  • Anticholinergic drugs: May increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Evaluate patients for signs of urinary retention or reduced gastric motility when used concomitantly.
Read the label’s full interactions text

7 DRUG INTERACTIONS Table 1 includes clinically significant drug interactions with codeine sulfate tablets. Table 1: Clinically Significant Drug Interactions with Codeine Sulfate Tablets Inhibitors of CYP3A4 C li n i cal Impact: The concomitant use of codeine sulfate tablets with CYP3A4 inhibitors, may result in an increase in codeine plasma concentrations with subsequently greater metabolism by cytochrome CYP2D6, resulting in greater morphine levels, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of codeine sulfate tablets is achieved [see Warnings and Precautions ( 5.7 ) ] . After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, it may result in lower codeine levels, greater norcodeine levels, and less metabolism via CYP2D6 with resultant lower morphine levels [see Clinical Pharmacology ( 12.3 ) ] , resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to codeine. Intervention: If concomitant use of CYP3A4 inhibitor is necessary, consider dosage reduction of codeine sulfate tablets until stable drug effects are achieved. Evaluate patients at frequent intervals for respiratory depression and sedation. If a CYP3A4 inhibitor is discontinued, consider increasing the codeine sulfate tablets dosage until stable drug effects are achieved. Assess for signs of opioid withdrawal. E xamples: Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), protease inhibitors (e.g., ritonavir).

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿144 supplements and herbs with documented Codeine interactions, ranked by severity Check Codeine against a supplement or herb →

Before taking Codeine

▾
  • You have a history of addiction, substance use disorder, or a mental health condition such as major depression
  • You have significant breathing problems, severe or uncontrolled asthma, or chronic lung disease
  • You have a known or suspected bowel obstruction or paralytic ileus (bowel that has stopped moving)
  • You are currently taking or have recently taken MAO inhibitors
  • You are pregnant or planning to become pregnant — extended use can cause dangerous withdrawal in the newborn
  • You are breastfeeding — codeine and morphine pass into breast milk and can be fatal to infants; breastfeeding is not recommended
  • You are 65 or older — older adults are more sensitive to codeine's effects, especially breathing problems
  • You have kidney or liver impairment — the drug may build up to higher-than-expected levels
  • You are a known ultra-rapid metabolizer of codeine (a genetic trait) — you are at higher risk of morphine toxicity
  • You have a child, or anyone at risk, in your household — accidental ingestion of even one tablet can be fatal to a child

Codeine overdose

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Signs of a codeine overdose include dangerously slow or stopped breathing, extreme sleepiness progressing to unconsciousness or coma, limpness, cold and clammy skin, and very small (pinpoint) pupils. Bluish lips or fingertips can also occur as oxygen levels drop. Call 911 immediately — an opioid overdose reversal agent such as naloxone can reverse the overdose but its effects may not last as long as codeine's, so emergency medical care is still essential even after giving naloxone.

What Codeine does in the body

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Codeine slows breathing by acting directly on the brain's respiratory control centers, making them less responsive to rising carbon dioxide levels — this is the most dangerous of its effects. It also slows the movement of food through the stomach and intestines (causing constipation), causes the pupils to constrict (pinpoint pupils), and relaxes blood vessels (which can cause a drop in blood pressure, especially on standing). With long-term use, codeine can suppress hormones related to stress response and reproductive function, potentially causing reduced libido, erectile dysfunction, or menstrual irregularities.

How your body processes Codeine

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When taken by mouth, codeine is absorbed through the gastrointestinal tract and reaches peak blood levels in about 60 minutes. Food — even a high-fat meal — does not significantly affect absorption. The drug spreads widely into body tissues and is processed mainly by the liver: the majority is converted to an inactive compound (codeine-6-glucuronide), about 5–10% becomes morphine (the active pain-relieving metabolite), and about 10% becomes norcodeine. Roughly 90% of codeine and its breakdown products are eliminated through the kidneys. The half-life — the time for the body to clear half the drug — is about 3 hours for codeine and its metabolites. People with kidney or liver problems clear the drug more slowly, raising the risk of buildup and side effects.

How to store Codeine

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Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP/NF.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

144

Supplements & herbs that interact with Codeine

144 supplements and herbal products have documented interactions with Codeine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 7
  • Moderate · 114
  • Minor · 23
1,4-BUTANEDIOL Major ACTIVATED CHARCOAL Major BEER Major GAMMA-HYDROXYBUTYRATE (GHB) Major KAVA Major L-TRYPTOPHAN Major WINE Major 1,3-DMAA Moderate +136 more
Every supplement checked against Codeine — ranked by severity The full interaction hub: 7 major · 114 moderate · 23 minor · every one linked to its full report. Check Codeine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Codeine: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Codeine — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is codeine used for?

▾
Codeine Sulfate tablets are used to treat mild to moderate pain when other pain relievers — like ibuprofen or acetaminophen — haven't worked well enough. It's an opioid, so it's only prescribed when your doctor has decided the benefit truly outweighs the risks. It's not something you'd typically get for a minor headache — it's reserved for pain that really needs an opioid to manage it.

Can I take codeine with my other medications or have a drink?

▾
This is really important: do not drink alcohol while taking codeine — the combination can dangerously slow or stop your breathing. The same goes for sleep aids, anxiety medications like Xanax or Valium, or any other sedatives. A lot of common medications — including some antidepressants and antifungals — can also interact with codeine and either boost its effects to dangerous levels or make it stop working. Always give your pharmacist or doctor a full list of everything you take, including supplements.

What side effects should I expect, and which ones mean I need to call for help?

▾
The most common things people notice are drowsiness, dizziness, nausea, constipation, and sweating — those are expected and usually manageable. What you need to watch out for are signs of a serious problem: breathing that feels very slow or labored, feeling so sleepy you can barely stay awake, or bluish lips. Those are emergencies — call 911 right away. Also let your doctor know if your pain actually gets worse while you're on codeine, which can occasionally happen with opioids.

Is it safe for children to take codeine?

▾
No — codeine is not safe for children under 12, and it must never be used in anyone under 18 after tonsil or adenoid surgery. There have been cases of children dying from codeine, partly because some kids convert it to morphine much faster than expected due to their genetics. If a child in your home accidentally swallows even one tablet, treat it as an emergency and call 911 immediately.

Can I take codeine if I'm pregnant or breastfeeding?

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Codeine is not recommended during breastfeeding — it passes into breast milk, and infants can develop dangerous breathing problems from exposure. If you've been using codeine regularly during pregnancy, your newborn may go through opioid withdrawal after birth, which can be life-threatening without proper medical care. If you're pregnant or planning to be, have an honest conversation with your doctor so they can help you weigh the risks and find the safest plan for you and your baby.

Can I become dependent on codeine, and what happens if I stop taking it suddenly?

▾
Yes — physical dependence can develop with regular use of codeine, even when taken exactly as prescribed. If you've been taking it for a while and stop suddenly, you may experience withdrawal symptoms like restlessness, muscle aches, and anxiety. That's why it's important never to stop abruptly — your doctor will guide you through a gradual taper to reduce those symptoms safely. Addiction (a pattern of compulsive use despite harm) is also a real risk, especially if you or a family member has a history of substance use problems.

Is Codeine available over the counter?

▾
No. Codeine is a prescription medicine: every Codeine product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

Is Codeine a controlled substance?

▾
Yes — Codeine is a federally controlled substance (Schedule II) in the United States, so how it is prescribed, refilled and dispensed is regulated by the DEA.

When was Codeine first available?

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The earliest FDA record we hold for Codeine is from 1952: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Codeine was first used.

Who makes Codeine?

▾
2 companies currently list Codeine products in the FDA's NDC Directory, including Hikma Pharmaceuticals USA Inc., Lannett Company, Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Codeine on HelloPharmacist

📊Codeine supplement interactions144 checked — ranked by severity 🌿Drug & Supplement CheckerCodeine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Codeine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Codeine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Codeine forms and strengths (how it comes)

Codeine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
How this form is used
What it may be used for
  • Codeine Sulfate tablets are used to manage mild to moderate pain in adults when an opioid is appropriate and other treatments are not adequate
  • Codeine Sulfate tablets are reserved for patients whose pain cannot be controlled by non-opioid options
Important instructions
  • Codeine Sulfate tablets are taken by mouth every 4 hours as needed for pain — follow your prescriber's exact instructions
  • Codeine Sulfate tablets can be taken with or without food; a high-fat meal does not significantly affect absorption
  • Codeine Sulfate tablets should be used at the lowest effective dose for the shortest possible time
  • Do not stop Codeine Sulfate tablets suddenly if you have been taking them regularly — talk to your doctor about tapering
Available strengths 3 strengths
15 mg 30 mg 60 mg
14 FDA-listed product records ⓘ

Codeine on the U.S. market: products, makers and brands

How Codeine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

2 companies list 6 Codeine product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 1952.

1
Dose forms ⓘ
2
Labelers (makers, repackagers, distributors)
1
Brand names
6
FDA-listed product records ⓘ
1952
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (10) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Hikma Pharmaceuticals USA Inc.50%
Lannett Company, Inc.50%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Codeine is used (Medicaid data)

A general measure of how commonly Codeine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Codeine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

849
Medicaid prescriptions filled (Q1–Q4 2025)
$41,517 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Codeine prescribed? Of the 1,601 medications we measure, Codeine ranks #1,307 by Medicaid prescriptions — more than 18% of them.

Where Codeine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,307 of 1,601
#1,302 Carbidopa / Entacapone... 868 Rx #1,303 Cysteamine 867 Rx #1,304 Etomidate 858 Rx #1,305 Salsalate 856 Rx #1,306 Bosentan 852 Rx #1,307 Nepafenac Ophthalmic 849 Rx #1,308 Codeine 849 Rx #1,309 Mesna 848 Rx #1,310 Lorlatinib 846 Rx #1,311 Aluminum Hydroxide 844 Rx #1,312 Remifentanil 842 Rx

Utilization by Codeine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 30 mg oral tablet is the most-dispensed Codeine product — about 88% of these Medicaid prescriptions.

codeine sulfate 30 MG Oral Tablet Most dispensed

743 Medicaid prescriptions (Q1–Q4 2025) 88% of Codeine prescriptions shown $37,064 gross reimbursement (before rebates) ≈ $50 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 997287

codeine sulfate 15 MG Oral Tablet

70 Medicaid prescriptions (Q1–Q4 2025) 8% of Codeine prescriptions shown $2,195 gross reimbursement (before rebates) ≈ $31 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 997170

codeine sulfate 60 MG Oral Tablet

36 Medicaid prescriptions (Q1–Q4 2025) 4% of Codeine prescriptions shown $2,258 gross reimbursement (before rebates) ≈ $63 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 997296

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Codeine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 4 of 8 listed Codeine NDCs with Medicaid activity.

Compare Codeine products

A representative set of FDA-listed product records for Codeine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Tablet
15 mg Oral Hikma Pharmaceuticals USA Inc. NDA View NDC →
30 mg Oral Hikma Pharmaceuticals USA Inc. NDA View NDC →
60 mg Oral Hikma Pharmaceuticals USA Inc. NDA View NDC →
15 mg Oral Lannett Company, Inc. ANDA View NDC →
30 mg Oral Lannett Company, Inc. ANDA View NDC →
60 mg Oral Lannett Company, Inc. ANDA View NDC →

Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Codeine NDCs →

Codeine recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Codeine recalls since July 2021.

✅No Codeine recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Codeine RxCUI 2670 3 dose forms · 9 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 371609 No current FDA listing
    Clinical drug / strength (SCD) phosphate 60 MG/ML RxCUI 997303
  2. Dose form (SCDF) Oral Solution RxCUI 371610 No current FDA listing
    Clinical drug / strength (SCD) phosphate 3 MG/ML RxCUI 997284 phosphate 5 MG/ML RxCUI 996734
  3. Dose form (SCDF) Oral Tablet RxCUI 371613 In current FDA listings
    Clinical drug / strength (SCD) phosphate 15 MG RxCUI 997169 phosphate 30 MG RxCUI 997285 phosphate 60 MG RxCUI 997301 sulfate 15 MG RxCUI 997170 sulfate 30 MG RxCUI 997287 sulfate 60 MG RxCUI 997296

Look up RxCUI 2670 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Codeine costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet · Oral 30 mg $0.726 per tablet NDC details & price history
Tablet · Oral 60 mg $1.28 per tablet NDC details & price history
Tablet · Oral 15 mg $0.677 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Who makes Codeine: manufacturers and labelers

2 companies list Codeine products with the FDA. By number of product records, the largest are Hikma Pharmaceuticals USA Inc., Lannett Company, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Hikma Pharmaceuticals USA Inc. 3 Lannett Company, Inc. 3

Codeine drug class (RxNorm)

Codeine belongs to the Opioid Agonist class.

Pharmacologic class Opioid Agonist
Drug family (ATC) Opium alkaloids and derivatives
How it works Full Opioid Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Codeine page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Dec 22, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Codeine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Codeine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
Finished products in the current FDA directory
6
Companies listing them (makers, repackagers, distributors)
2
FDA labeler codes behind them ⓘ
2
Linked representative label ⓘ
West-Ward Pharmaceuticals Corp.
Linked label effective
Dec 22, 2025
Composite sections available
24
Linked SPL Set ID
010905f9-3bcb-4b50-9fe8-a3ad0010f14c
Linked SPL Document ID
b04f74f8-d960-4b7a-988a-372d9a1e1406
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. West-Ward Pharmaceuticals Corp. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →