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Drug ReportsCodeine
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
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
signs and symptoms pathological conditionsD013568
psychological phenomenaD011579
musculoskeletal and neural physiological phenomenaD055687
Trade Name
FDA
EMA
Codeine (discontinued: Codeine)
Combinations
Acetaminophen 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
+
Pseudoephedrine hydrochloride
+
Triprolidine hydrochloride
Tradename
Company
Number
Date
Products
ACTIFED W/ CODEINEGSKN-012575 DISCN1984-04-04
1 products
Hide discontinued
Aspirin
+
Butalbital
+
Caffeine
+
Codeine phosphate
Tradename
Company
Number
Date
Products
FIORINAL W/CODEINEAllerganN-019429 DISCN1990-10-26
1 products, RLD
Hide discontinued
Codeine phosphate
+
Promethazine hydrochloride
Tradename
Company
Number
Date
Products
PHENERGAN W/ CODEINEANI PharmaceuticalsN-008306 DISCN1984-04-02
1 products, RLD
Hide discontinued
Codeine phosphate
+
Phenylephrine hydrochloride
+
Promethazine hydrochloride
Tradename
Company
Number
Date
Products
PHENERGAN VC W/ CODEINEANI PharmaceuticalsN-008306 DISCN1984-04-02
1 products, RLD
Hide discontinued
Bromodiphenhydramine hydrochloride
+
Codeine phosphate
Tradename
Company
Number
Date
Products
AMBENYLForest LaboratoriesN-009319 DISCN1984-01-10
1 products
Hide discontinued
Codeine sulfate
Tradename
Company
Number
Date
Products
CODEINE SULFATEHikma PharmaceuticalsN-022402 RX2009-07-16
3 products, RLD, RS
Show 1 discontinued
Aspirin
+
Carisoprodol
+
Codeine phosphate
Tradename
Company
Number
Date
Products
SOMA COMPOUND W/ CODEINEMeda ABN-012366 DISCN1983-07-11
1 products
Hide discontinued
Chlorpheniramine maleate
+
Codeine phosphate
Tradename
Company
Number
Date
Products
TUXARIN ERMainPointe PharmaceuticalsN-206323 RX2015-06-22
1 products
Acetaminophen
+
Butalbital
+
Caffeine
+
Codeine phosphate
Tradename
Company
Number
Date
Products
FIORICET W/ CODEINEAllerganN-020232 RX1992-07-30
1 products, RLD, RS
Chlorpheniramine polistirex
+
Codeine polistirex
Tradename
Company
Number
Date
Products
PENNTUSSFisonsN-018928 DISCN1985-08-14
1 products
CODEPREXLannettN-021369 DISCN2004-06-21
1 products
TUZISTRA XRTris PharmaN-207768 DISCN2015-04-30
1 products, RLD
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
acetaminophen and codeineANDA2025-02-19
acetaminophen and codeine phosphateANDA2025-03-24
acetaminophen with codeineANDA2015-01-11
actifedC2002632024-10-04
ascomp with codeineANDA2024-11-19
butalbital, acetaminophen, caffeine and codeine phosphateANDA2025-03-14
butalbital, acetaminophen, caffeine, and codeine phosphateNDA authorized generic2024-02-29
butalbital, aspirin, caffeine and codeine phosphateANDA2024-07-19
carisoprodolANDA2025-02-05
carisoprodol and aspirinANDA2010-12-10
Show 137 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
painEFO_0003843D010146R52
fever—D005334R50.9
cough—D003371R05
myositisEFO_0000783D009220G72.49
rheumatoid arthritisEFO_0000685D001172M06.9
inflammationMP_0001845D007249—
osteoarthritisEFO_0002506D010003M15-M19
muscle spasticity—D009128—
muscle cramp—D009120—
spasm—D013035M62.83
Show 31 more
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Chlorpheniramine Maleate / Codeine Phosphate, Tuxarin Er, Mainpointe
90669422032-01-03U-1716
91079212032-01-03DP
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
2251 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PainD010146EFO_0003843R523—2117
Common coldD003139EFO_0007214J001112—5
OsteoarthritisD010003EFO_0002506M15-M191—1114
ToothacheD014098—K08.89—1—2—3
Streptococcal infectionsD013290EFO_1001476———11—2
Postoperative painD010149—G89.18———2—2
Bacterial infectionsD001424—A49———1—1
AnthraxD000881—A22———1—1
Human influenzaD007251EFO_0007328J11.1———1—1
Knee osteoarthritisD020370EFO_0004616M17———1—1
Show 2 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HeadacheD006261—R51212——4
Respiratory tract infectionsD012141—J06.9——2——2
InfectionsD007239EFO_0000544———2——2
Tension-type headacheD018781—G44.2111——2
PemphigusD010392EFO_1000749L10——1——1
Migraine disordersD008881EFO_0003821G43——1——1
Rotavirus infectionsD012400————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Critical illnessD016638———1———1
GastroparesisD018589EFO_1000948K31.84—1———1
LymphomaD008223—C85.9—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———6————6
Headache disordersD020773EFO_0009550G441————1
FeverD005334—R50.91————1
AnalgesiaD000698——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCodeine
INNparacetamol
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 classOpioidAntitussives
Image (chem structure or protein)Loading
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-ID76-57-3
RxCUI—
ChEMBL IDCHEMBL485
ChEBI ID16714
PubChem CID5284371
DrugBankDB00318
UNII ID362O9ITL9D (ChemIDplus, GSRS)
Target
Agency Approved
OPRM1
OPRM1
Organism
Homo sapiens
Gene name
OPRM1
Gene synonyms
MOR1
NCBI Gene ID
4988
Protein name
mu-type opioid receptor
Protein synonyms
hMOP, MOP, Mu opiate receptor, Mu opioid receptor, mu opioid receptor hMOR-1a
Uniprot ID
Q9UN57
Mouse ortholog
Oprm1 (18390)
mu-type opioid receptor (Q9R1M0)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Codeine
+
Acetaminophen
Total medical expenditures per year (USD, in millions)
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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
+
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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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 25,395 documents
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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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115,497 adverse events reported
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