Codeine
/ Butalbital / Caffeine / Codeine, Acetaminophen / Butalbital / Caffeine / Codeine, Acetaminophen / Codeine, Ambenyl, Bromanyl, Codeine, Codeine / / Promethazine, Codeine / Promethazine, Fioricet, Soma, Triacin-c, Tuxarin (codeine) is a small molecule pharmaceutical. Codeine was first approved as Codeine, aspirin, apap formula no. 4 on 1982-01-01. It is used to treat cough and pain in the USA. The pharmaceutical is active against mu-type opioid receptor.
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Commercial
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Codeine (discontinued: Codeine)
CombinationsAcetaminophen codeine, Butalbital, acetaminophen, caffeine codeine, Butalbital, aspirin, caffeine, codeine, Fioricet, Prometh hydrochloride,phenylephrine w/codeine, Promethazine codeine, Promethazine hydrochloride,phenylephrine w/codeine, Tuxarin (discontinued: Acetaminophen codeine, Actifed, Ambenyl, Bromanyl, Bromodiphenhydramine codeine, Butalbital, acetaminophen, caffeine codeine, Butalbital, aspirin, caffeine, codeine, Capital codeine, Carisoprodol, aspirin codeine, Codeine, aspirin, apap no., Codeprex, Codrix, Empracet, Fiorinal w/codeine, Penntuss, Phenaphen, Phenergan, Pherazine, Phrenilin with caffeine codeine, Prometh, Promethazine, Promethazine codeine, Promethazine hydrochloride, phenylephrine w/codeine, Promethazine with codeine, Proval, Soma, Triprolidine hydrochloride, pseudoephedrine codeine, Tuzistra, Tylenol)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Codeine phosphate
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Pseudoephedrine hydrochloride
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Triprolidine hydrochloride
Aspirin
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Butalbital
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Caffeine
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Codeine phosphate
Codeine phosphate
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Promethazine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PHENERGAN W/ CODEINE | ANI Pharmaceuticals | N-008306 DISCN | 1984-04-02 | 1 products, RLD |
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Codeine phosphate
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Phenylephrine hydrochloride
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Promethazine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PHENERGAN VC W/ CODEINE | ANI Pharmaceuticals | N-008306 DISCN | 1984-04-02 | 1 products, RLD |
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Bromodiphenhydramine hydrochloride
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Codeine phosphate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AMBENYL | Forest Laboratories | N-009319 DISCN | 1984-01-10 | 1 products |
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Codeine sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CODEINE SULFATE | Hikma Pharmaceuticals | N-022402 RX | 2009-07-16 | 3 products, RLD, RS |
Show 1 discontinued
Aspirin
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Carisoprodol
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Codeine phosphate
Chlorpheniramine maleate
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Codeine phosphate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TUXARIN ER | MainPointe Pharmaceuticals | N-206323 RX | 2015-06-22 | 1 products |
Acetaminophen
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Butalbital
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Caffeine
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Codeine phosphate
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| acetaminophen and codeine | ANDA | 2025-04-29 |
| acetaminophen and codeine phosphate | ANDA | 2025-06-17 |
| acetaminophen with codeine | ANDA | 2015-01-11 |
| ascomp with codeine | ANDA | 2024-07-01 |
| cheratussin ac | OTC monograph final | 2019-01-24 |
| codar | OTC monograph final | 2011-07-26 |
| codeine and chlorpheniramine maleate er | New Drug Application | 2017-01-20 |
| codeine guaifenesin | OTC monograph final | 2020-01-10 |
| codeine phosphate and guaifenesin | OTC monograph final | 2020-01-21 |
| codeine sulfate | ANDA | 2024-10-03 |
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Indications
FDA
EMA
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Agency Specific
FDA
EMA
No data
ATC Codes
N: Nervous system drugs
— N02: Analgesics
— N02A: Opioid analgesics
— N02AA: Natural opium alkaloid analgesics
— N02AA59: Codeine, combinations excl. psycholeptics
— N02AA79: Codeine, combinations with psycholeptics
— N02AJ: Opioids in combination with non-opioid analgesics
— N02AJ06: Codeine and paracetamol
— N02AJ07: Codeine and acetylsalicylic acid
— N02AJ08: Codeine and ibuprofen
— N02AJ09: Codeine and other non-opioid analgesics
R: Respiratory system drugs
— R05: Cough and cold preparations
— R05D: Cough suppressants, excl. combinations with expectorants
— R05DA: Opium alkaloids and derivatives, cough suppressants
— R05DA04: Codeine
HCPCS
Code | Description |
|---|---|
| J0745 | Injection, codeine phosphate, per 30 mg |
Clinical
Clinical Trials
121 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain | D010146 | EFO_0003843 | R52 | 4 | 1 | 5 | 5 | 8 | 23 |
| Postoperative pain | D010149 | — | G89.18 | — | — | 5 | 6 | 4 | 15 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 1 | 1 | 4 | 1 | 7 |
| Toothache | D014098 | — | K08.89 | 1 | 2 | 2 | 1 | — | 5 |
| Chronic pain | D059350 | — | — | — | 1 | — | 1 | 3 | 5 |
| Acute pain | D059787 | — | R52 | — | — | 2 | 1 | 2 | 5 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | 1 | 3 | 4 |
| Low back pain | D017116 | — | M54.5 | — | 1 | — | 1 | 2 | 4 |
| Impacted tooth | D014095 | — | K01.1 | — | — | 1 | 2 | 1 | 4 |
| Back pain | D001416 | — | M54 | — | 1 | — | 1 | 1 | 3 |
Show 34 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | 1 | 1 | — | 1 | 3 |
| Hernia | D006547 | — | K40-K46 | — | — | 1 | — | 1 | 2 |
| Intractable pain | D010148 | — | — | — | — | 1 | — | 1 | 2 |
| Myopia | D009216 | EFO_0003927 | H52.1 | — | 1 | 1 | — | — | 2 |
| Short bowel syndrome | D012778 | — | K90.82 | — | — | 2 | — | — | 2 |
| Syndrome | D013577 | — | — | — | — | 2 | — | — | 2 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | 1 | — | — | 1 |
| Pseudotumor cerebri | D011559 | EFO_1001132 | G93.2 | — | 1 | 1 | — | — | 1 |
| Intracranial hypertension | D019586 | EFO_1000992 | — | — | 1 | 1 | — | — | 1 |
| Phantom limb | D010591 | — | G54.6 | — | 1 | 1 | — | — | 1 |
Show 4 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Emergencies | D004630 | — | — | — | 1 | — | — | 2 | 3 |
| Cough | D003371 | — | R05 | 2 | 1 | — | — | — | 3 |
| Musculoskeletal pain | D059352 | — | — | — | 1 | — | — | — | 1 |
| Head and neck neoplasms | D006258 | — | — | — | 1 | — | — | — | 1 |
| Uterine cervical neoplasms | D002583 | — | — | — | 1 | — | — | — | 1 |
| Neck pain | D019547 | — | M54.2 | — | 1 | — | — | — | 1 |
| Hyperopia | D006956 | EFO_0006310 | H52.0 | — | 1 | — | — | — | 1 |
| Photorefractive keratectomy | D018903 | — | — | — | 1 | — | — | — | 1 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | 1 | — | — | — | 1 |
| Back injuries | D019567 | — | — | — | 1 | — | — | — | 1 |
Show 1 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | 2 | 5 |
| Corneal injuries | D065306 | — | — | 1 | — | — | — | — | 1 |
| Biotransformation | D001711 | — | — | 1 | — | — | — | — | 1 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | 1 | — | — | — | — | 1 |
| Hot flashes | D019584 | — | — | 1 | — | — | — | — | 1 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | — | — | — | — | 1 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | — | — | 2 | 2 |
| Vomiting | D014839 | — | R11.1 | — | — | — | — | 2 | 2 |
| Nausea | D009325 | — | R11.0 | — | — | — | — | 2 | 2 |
| Headache | D006261 | — | R51 | — | — | — | — | 2 | 2 |
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | — | — | — | 2 | 2 |
| Personality disorders | D010554 | — | F60.6 | — | — | — | — | 2 | 2 |
| Local anesthesia | D000772 | — | — | — | — | — | — | 1 | 1 |
| Drug interactions | D004347 | — | — | — | — | — | — | 1 | 1 |
| Edema | D004487 | — | R60.9 | — | — | — | — | 1 | 1 |
| Trismus | D014313 | — | — | — | — | — | — | 1 | 1 |
Show 26 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Codeine |
| INN | paracetamol |
| Description | Codeine is a morphinane alkaloid found in the opium poppy, Papaver somniferum var. album; has analgesic, anti-tussive and anti-diarrhoeal properties. It has a role as an opioid analgesic, an antitussive, an opioid receptor agonist, a prodrug, a xenobiotic, an environmental contaminant and a drug allergen. It is an organic heteropentacyclic compound and a morphinane alkaloid. It is functionally related to a morphine. It is a conjugate base of a codeine(1+). |
| Classification | Small molecule |
| Drug class | OpioidAntitussives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COc1ccc2c3c1O[C@H]1[C@@H](O)C=C[C@H]4[C@@H](C2)N(C)CC[C@]314 |
Identifiers
| PDB | — |
| CAS-ID | 76-57-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL485 |
| ChEBI ID | 16714 |
| PubChem CID | 5284371 |
| DrugBank | DB00318 |
| UNII ID | 362O9ITL9D (ChemIDplus, GSRS) |
Target
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Financial
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Estimated US medical usage
Codeine
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Acetaminophen
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Codeine
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Aspirin
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Carisoprodol
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Codeine
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Aspirin
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Codeine
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Bromodiphenhydramine
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Codeine
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Phenylephrine
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Brompheniramine
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Codeine
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Brompheniramine
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Phenylpropanolamine
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Codeine
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Phenylephrine
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Chlorpheniramine
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Codeine
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Codeine
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Phenylephrine
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Diphenhydramine
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Codeine
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Guaifenesin
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Codeine
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Guaifenesin
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Phenylpropanolamine
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Codeine
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Phenylephrine
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Promethazine
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Codeine
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Phenylephrine
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Triprolidine
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Codeine
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Promethazine
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Codeine
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Pseudoephedrine
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Safety
Black-box Warning
Black-box warning for: Acetaminophen and codeine, Acetaminophen and codeine phosphate, Acetaminophen with codeine, Ascomp with codeine, Codeine and chlorpheniramine maleate er, Codeine sulfate, Fioricet with codeine, Promethazine hci, Promethazine hcl, phenylephrine hcl, codeine phosphate, Promethazine hydrochloride and codeine phosphate, Promethazine hydrochloride and dextomethorphan hydrobromide, Promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate, Promethazine hydrochloride, phenylephrine hydrochloride, and codeine phosphate, Promethazine vc with codeine oral solution, Promethazine with codeine, Promethazine with codeine cough, Promethazine/codeine, Promethegan, Triacin-c, Tuxarin, Tylenol with codeine
Adverse Events
Top Adverse Reactions
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117,986 adverse events reported
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