Prescription medicine
Codeine
Codeine is a prescription medicine with an FDA approval on record since 2009. FDA's NDC Directory lists it from 1 generic labeler, and pharmacies paid $0.726 per codeine sulfate 30 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the codeine FDA label on DailyMed (effective December 22, 2025, Hikma Pharmaceuticals USA Inc.); the NDA 22402 record on Drugs@FDA; every codeine label on DailyMed.
Highlights of the record
FDA label of December 22, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF CODEINE SULFATE TABLETS.
Addiction, Abuse, and Misuse Because the use of Codeine Sulfate Tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions ( 5.1 ), Dosage and Administration ( 2.1 )]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Codeine Sulfate Tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Codeine Sulfate Tablets are essential [see Warnings and Precautions ( 5.2 )]. Accidental Ingestion Accidental ingestion of even one dose of Codeine Sulfate Tablets, especially by children, can result in a fatal overdose of codeine [see Warnings and Precautions ( 5.2 )]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. […]
Used for
From the label: indications and usageCodeine Sulfate Tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate.
Forms and strengths
- 15 mg
- 30 mg
- 60 mg
Tablet.
On the market
- Earliest approval on file
- July 16, 2009 Codeine Sulfate, Hikma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first June 13, 2014; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 1 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.726 per tablet Codeine sulfate 30 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,295 through July 30, 2026
What is codeine used for?
From the label: indications and usageCodeine Sulfate Tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use:
Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions ( 5.1 )], reserve opioid analgesics, including Codeine Sulfate Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. […]
Conditions named in the indications of codeine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Opioid Agonist.
Source: FDA drug label (Codeine sulfate), Hikma Pharmaceuticals USA Inc., effective December 22, 2025 (SPL set 010905f9-3bcb-4b50-9fe8-a3ad0010f14c), via openFDA; the full label on DailyMed
Is there a generic for codeine?
The FDA approved the first generic codeine on June 13, 2014. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists codeine from 1 labeler under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2009 earliest approval on file
- 2014 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for codeine?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.726 per Codeine sulfate 30 mg tablet, up 8% from $0.672 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Codeine sulfate 30 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Codeine sulfate 15 mg tablet | Generic | $0.677 per tablet | $20.32 | -1% |
| Codeine sulfate 30 mg tablet | Generic | $0.726 per tablet | $21.79 | +8% |
| Codeine sulfate 60 mg tablet | Generic | $1.28 per tablet | $38.40 | +23% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the codeine label say about other medicines?
The codeine label names 31 other medicines in its interaction, contraindication or warning sections. The labels of 8 other medicines name codeine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | warnings and precautions | Risks of Concomitant Use or Discontinuation of Cytochrome P450 2D6 Inhibitors: The concomitant use of Codeine Sulfate Tablets with all cytochrome P450 2D6 inhibitors (e.g., amiodarone, quinidine) may result in an increase in codeine plasma concentrations and a decrease in active metabolite morphine plasma … |
| Buprenorphine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). … other opioids (such as oxycodone, hydrocodone, oxymorphone, hydrocodone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression. … |
| Bupropion | drug interactions | Rifampin, carbamazepine, phenytoin Inhibitors of CYP2D6 Clinical Impact: Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of Codeine Sulfate Tablets and CYP2D6 inhibitors can increase the plasma concentration of codeine, but can decrease the plasma concentration of active metabolite morphine … and symptoms of respiratory depression or sedation. Paroxetine, fluoxetine, bupropion, quinidine. |
| Butorphanol | drug interactions | Clinical Impact: May reduce the analgesic effect of Codeine Sulfate Tablets and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Butorphanol, nalbuphine, pentazocine, buprenorphine. |
| Carbamazepine | drug interactions | Rifampin, carbamazepine, phenytoin Inhibitors of CYP2D6 Clinical Impact: Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of Codeine Sulfate Tablets and CYP2D6 inhibitors can increase the plasma concentration of codeine, but can decrease the plasma concentration of active metabolite morphine … Intervention: If concomitant use with a CYP2D6 inhibitor is necessary, or if a CYP2D6 inhibitor is discontinued after concomitant use, consider dosage adjustment of Codeine Sulfate Tablets and evaluate patients at … |
| Cyclobenzaprine | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as … |
| Erythromycin | drug interactions | Clinical Impact: The concomitant use of Codeine Sulfate Tablets and CYP3A4 inducers can result in lower codeine levels, greater norcodeine levels, and less metabolism via 2D6 with resultant lower morphine levels, resulting in decreased efficacy or onset of a … Intervention: If concomitant use of a CYP3A4 inducer is necessary, evaluate patients at frequent intervals for reduced efficacy and signs of opioid withdrawal and consider increasing the Codeine Sulfate Tablets dosage … |
| Fluoxetine | drug interactions | Rifampin, carbamazepine, phenytoin Inhibitors of CYP2D6 Clinical Impact: Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of Codeine Sulfate Tablets and CYP2D6 inhibitors can increase the plasma concentration of codeine, but can decrease the plasma concentration of active metabolite morphine … for signs and symptoms of respiratory depression or sedation. Paroxetine, fluoxetine, bupropion, quinidine. |
| Gabapentin | drug interactions | Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. … anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. |
| Hydrocodone | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). … and frequent titration of small doses of other opioids (such as oxycodone, hydrocodone, oxymorphone, hydrocodone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and … |
| Ketoconazole | drug interactions | Clinical Impact: The concomitant use of Codeine Sulfate Tablets and CYP3A4 inducers can result in lower codeine levels, greater norcodeine levels, and less metabolism via 2D6 with resultant lower morphine levels, resulting in decreased efficacy or onset of a … Intervention: If concomitant use of a CYP3A4 inducer is necessary, evaluate patients at frequent intervals for reduced efficacy and signs of opioid withdrawal and consider increasing the Codeine Sulfate Tablets dosage … |
| Linezolid | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Metaxalone | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and … |
| Methylene blue | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
Every other medicine the codeine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Mirtazapine | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those … |
| Morphine | boxed warning | … the effects on the parent drug, codeine, and the active metabolite, morphine. [See Warnings and Precautions ( 5.7 ), Drug Interactions ( 7 )]. |
| Nalbuphine | drug interactions | Clinical Impact: May reduce the analgesic effect of Codeine Sulfate Tablets and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Butorphanol, nalbuphine, pentazocine, buprenorphine. |
| Nalmefene | warnings and precautions | Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). |
| Naloxone | warnings and precautions | Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). |
| Oxycodone | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). … test doses and frequent titration of small doses of other opioids (such as oxycodone, hydrocodone, oxymorphone, hydrocodone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms … |
| Oxymorphone | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). … titration of small doses of other opioids (such as oxycodone, hydrocodone, oxymorphone, hydrocodone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory … |
| Paroxetine | drug interactions | Rifampin, carbamazepine, phenytoin Inhibitors of CYP2D6 Clinical Impact: Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of Codeine Sulfate Tablets and CYP2D6 inhibitors can increase the plasma concentration of codeine, but can decrease the plasma concentration of active metabolite morphine … frequent intervals for signs and symptoms of respiratory depression or sedation. Paroxetine, fluoxetine, bupropion, quinidine. |
| Phenelzine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). … pressure and signs and symptoms of CNS and respiratory depression. Examples: Phenelzine, tranylcypromine, linezolid. |
| Phenytoin | warnings and precautions | … a cytochrome P450 3A4 inducer such as rifampin, carbamazepine, and phenytoin, may result in an increase in codeine plasma concentrations with subsequently greater metabolism by cytochrome P450 2D6 … |
| Pregabalin | drug interactions | Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. … relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. |
| Quinidine | drug interactions | Rifampin, carbamazepine, phenytoin Inhibitors of CYP2D6 Clinical Impact: Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of Codeine Sulfate Tablets and CYP2D6 inhibitors can increase the plasma concentration of codeine, but can decrease the plasma concentration of active metabolite morphine … of respiratory depression or sedation. Paroxetine, fluoxetine, bupropion, quinidine. |
| Rifampin | drug interactions | Rifampin, carbamazepine, phenytoin Inhibitors of CYP2D6 Clinical Impact: Codeine is metabolized by CYP2D6 to form morphine. The concomitant use of Codeine Sulfate Tablets and CYP2D6 inhibitors can increase the plasma concentration of codeine, but can decrease the plasma concentration of active metabolite morphine … Intervention: If concomitant use with a CYP2D6 inhibitor is necessary, or if a CYP2D6 inhibitor is discontinued after concomitant use, consider dosage adjustment of Codeine Sulfate Tablets and evaluate patients at … |
| Ritonavir | drug interactions | Clinical Impact: The concomitant use of Codeine Sulfate Tablets and CYP3A4 inducers can result in lower codeine levels, greater norcodeine levels, and less metabolism via 2D6 with resultant lower morphine levels, resulting in decreased efficacy or onset of a … Intervention: If concomitant use of a CYP3A4 inducer is necessary, evaluate patients at frequent intervals for reduced efficacy and signs of opioid withdrawal and consider increasing the Codeine Sulfate Tablets dosage … |
| Tramadol | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat … |
| Tranylcypromine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). … signs and symptoms of CNS and respiratory depression. Examples: Phenelzine, tranylcypromine, linezolid. |
| Trazodone | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat … |
Other labels that name codeine
Source: FDA drug label (Codeine sulfate), Hikma Pharmaceuticals USA Inc., effective December 22, 2025 (SPL set 010905f9-3bcb-4b50-9fe8-a3ad0010f14c), via openFDA; the full label on DailyMed
What do FAERS reports show for codeine?
The FDA Adverse Event Reporting System holds 3,295 reports that list codeine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 798 are coded as a death and 663 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as codeine?
33 other medicines are given the same way (oral) and in the same FDA class as codeine or labeled mainly for the same use (pain), the same class first. Pain lists all 80 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Acetaminophen and hydrocodone | Pain | 38 labelers | $0.152 per tablet 10-325 mg tablet | No current entry |
| Oxycodone | Pain | 34 labelers | $0.0884 per tablet 5 mg tablet | No current entry |
| Acetaminophen and oxycodone | Pain | 30 labelers | $0.183 per tablet 7.5-325 mg tablet | A presentation being discontinued |
| Tramadol | Pain | 40 labelers | $0.0248 per tablet 50 mg tablet | No current entry |
| Morphine | Pain | 17 labelers | $0.226 per tablet 15 mg tablet | In shortage |
| Hydromorphone | Pain | 11 labelers | $0.219 per tablet 4 mg tablet | In shortage |
| Methadone | Pain | 17 labelers | $0.177 per tablet 10 mg tablet | No current entry |
| Oxymorphone | Pain | 9 labelers | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does codeine compare with medicines for the same use?
2 side-by-side pages set codeine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to codeine
- 33 medicines for the same use
- Other opioids
- the pharmacologic class, with prices and generics
- Codeine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other