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, Promethazine with 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, 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 |
Hide discontinued
Bromodiphenhydramine hydrochloride
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Codeine phosphate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AMBENYL | Forest Laboratories | N-009319 DISCN | 1984-01-10 | 1 products |
Hide discontinued
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 | 2024-07-25 |
| acetaminophen and codeine phosphate | ANDA | 2025-01-03 |
| acetaminophen with codeine | ANDA | 2015-01-11 |
| actifed | C200263 | 2024-10-04 |
| ascomp with codeine | ANDA | 2024-07-01 |
| butalbital, acetaminophen, caffeine and codeine phosphate | ANDA | 2024-04-05 |
| butalbital, acetaminophen, caffeine, and codeine phosphate | NDA authorized generic | 2024-02-29 |
| butalbital, aspirin, caffeine and codeine phosphate | ANDA | 2024-05-30 |
| capcof | C200263 | 2024-01-02 |
| carisoprodol | ANDA | 2024-10-14 |
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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
2197 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative pain | D010149 | — | G89.18 | 15 | 23 | 55 | 123 | 116 | 329 |
| Pain | D010146 | EFO_0003843 | R52 | 23 | 29 | 39 | 60 | 63 | 209 |
| Acute pain | D059787 | — | R52 | 6 | 13 | 17 | 22 | 23 | 80 |
| Healthy volunteers/patients | — | — | — | 54 | 1 | 2 | 5 | 14 | 75 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 5 | 7 | 15 | 20 | 23 | 68 |
| Low back pain | D017116 | HP_0003419 | M54.5 | 1 | 3 | 17 | 15 | 22 | 58 |
| Back pain | D001416 | HP_0003418 | M54 | 3 | 3 | 15 | 14 | 18 | 53 |
| Fever | D005334 | HP_0001945 | R50.9 | 6 | 7 | 10 | 15 | 11 | 47 |
| Headache | D006261 | HP_0002315 | R51 | 5 | 7 | 9 | 17 | 12 | 46 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | 2 | 9 | 16 | 12 | 7 | 44 |
Show 375 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 12 | 14 | 1 | — | 2 | 27 |
| Lymphoma | D008223 | — | C85.9 | 9 | 16 | 2 | — | 1 | 27 |
| Multiple myeloma | D009101 | — | C90.0 | 7 | 11 | 4 | — | 1 | 22 |
| Plasma cell neoplasms | D054219 | — | — | 5 | 10 | 3 | — | 1 | 18 |
| Premature birth | D047928 | EFO_0003917 | O60 | 1 | 5 | 4 | — | 7 | 15 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 4 | 9 | 1 | — | 1 | 14 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 5 | 7 | 1 | — | 1 | 12 |
| Lymphoid leukemia | D007945 | — | C91 | 4 | 7 | 1 | — | 1 | 12 |
| Sclerosis | D012598 | — | — | — | 3 | 6 | — | 3 | 11 |
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | 3 | 6 | — | — | 11 |
Show 132 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hematologic neoplasms | D019337 | — | — | 2 | 6 | — | — | 1 | 9 |
| Pulpitis | D011671 | EFO_1001139 | K04.0 | 1 | 3 | — | — | 5 | 9 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | 1 | 2 | — | — | 5 | 8 |
| Hepatitis b | D006509 | — | — | 1 | 5 | — | — | 2 | 8 |
| Myeloid leukemia | D007951 | — | C92 | 5 | 2 | — | — | — | 7 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 1 | 5 | — | — | 1 | 7 |
| B-cell lymphoma | D016393 | — | — | 4 | 3 | — | — | — | 7 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 4 | 3 | — | — | — | 6 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | 6 | — | — | — | 6 |
| Cardiac surgical procedures | D006348 | — | — | — | 1 | — | — | 4 | 5 |
Show 195 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Overweight | D050177 | — | E66.3 | 5 | — | — | — | 2 | 7 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | 4 | 5 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 3 | — | — | — | 2 | 5 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 2 | — | — | — | 2 | 4 |
| Facial pain | D005157 | — | R51.9 | 1 | — | — | — | 3 | 4 |
| Drug interactions | D004347 | — | — | 1 | — | — | — | 2 | 3 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | 1 | — | — | — | 2 | 3 |
| Spondylolisthesis | D013168 | EFO_0007493 | M43.1 | 1 | — | — | — | 2 | 3 |
| Fatigue | D005221 | HP_0012378 | R53.83 | 1 | — | — | — | 2 | 3 |
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | 1 | — | — | — | 2 | 3 |
Show 59 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep wake disorders | D012893 | — | G47 | — | — | — | — | 6 | 6 |
| Conduction anesthesia | D000765 | — | — | — | — | — | — | 4 | 4 |
| Dyssomnias | D020920 | — | — | — | — | — | — | 4 | 4 |
| Parasomnias | D020447 | — | G47.5 | — | — | — | — | 4 | 4 |
| Congenital heart defects | D006330 | HP_0001627 | Q24.9 | — | — | — | — | 4 | 4 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 4 | 4 |
| Shoulder injuries | D000070599 | — | — | — | — | — | — | 3 | 3 |
| Vitreoretinal surgery | D057586 | — | — | — | — | — | — | 3 | 3 |
| Elbow fractures | D000092482 | — | — | — | — | — | — | 3 | 3 |
| Retinal diseases | D012164 | HP_0000479 | H35.9 | — | — | — | — | 3 | 3 |
Show 203 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) |
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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, Butalbital, acetaminophen, caffeine and codeine phosphate, Butalbital, acetaminophen, caffeine, and codeine phosphate, Butalbital, aspirin, caffeine and codeine phosphate, Codeine and chlorpheniramine maleate er, Codeine sulfate, Fioricet, 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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108,728 adverse events reported
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