Codeine

Actifed, Ambenyl, Bromanyl, Codrix, Empracet, Fioricet, Papeine, Phenaphen, Phenergan, Pherazine, Prometh, Proval, Soma, Tuxarin, Tylenol (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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Therapeutic Areas

Therapeutic Area	MeSH
respiratory tract diseases	D012140
signs and symptoms pathological conditions	D013568
psychological phenomena	D011579
musculoskeletal and neural physiological phenomena	D055687

Trade Name

FDA

EMA

Combinations

Fioricet, Tuxarin (generic drugs available since 1982-01-01, discontinued: Actifed, Ambenyl, Bromanyl, Codrix, Empracet, Papeine, Phenaphen, Phenergan, Pherazine, Prometh, Proval, Soma, Tylenol)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Acetaminophen

Butalbital

Caffeine

Codeine phosphate

Tradename	Company	Number	Date	Products
FIORICET W/ CODEINE	Allergan	N-020232 RX	1992-07-30	1 products, RLD, RS

Aspirin

Butalbital

Caffeine

Codeine phosphate

Tradename	Company	Number	Date	Products
FIORINAL W/CODEINE	Allergan	N-019429 DISCN	1990-10-26	1 products, RLD

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Aspirin

Carisoprodol

Codeine phosphate

Tradename	Company	Number	Date	Products
SOMA COMPOUND W/ CODEINE	Meda AB	N-012366 DISCN	1983-07-11	1 products

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Bromodiphenhydramine hydrochloride

Codeine phosphate

Tradename	Company	Number	Date	Products
AMBENYL	Forest Laboratories	N-009319 DISCN	1984-01-10	1 products

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Chlorpheniramine maleate

Codeine phosphate

Tradename	Company	Number	Date	Products
TUXARIN ER	MainPointe Pharmaceuticals	N-206323 RX	2015-06-22	1 products

Codeine phosphate

Phenylephrine hydrochloride

Promethazine hydrochloride

Tradename	Company	Number	Date	Products
PHENERGAN VC W/ CODEINE	ANI PHARMS	N-008306 DISCN	1984-04-02	1 products, RLD

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Codeine phosphate

Promethazine hydrochloride

Tradename	Company	Number	Date	Products
PHENERGAN W/ CODEINE	ANI PHARMS	N-008306 DISCN	1984-04-02	1 products, RLD

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Codeine phosphate

Pseudoephedrine hydrochloride

Triprolidine hydrochloride

Tradename	Company	Number	Date	Products
ACTIFED W/ CODEINE	GSK	N-012575 DISCN	1984-04-04	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

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Labels

FDA

EMA

Brand Name	Status	Last Update
acetaminophen and codeine	ANDA	2023-06-07
codrix		2008-05-16
extra strength tylenol severe cough plus sore throat night	OTC monograph final	2023-04-07
fioricet	ANDA	2021-01-01
phenergan	ANDA	2022-12-01
promethazine hydrochloride	ANDA	2023-06-08
triacin-c	ANDA	2015-07-28
tuxarin	New Drug Application	2021-11-04

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
cough	HP_0012735	D003371	R05
pain	EFO_0003843	D010146	R52

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Chlorpheniramine Maleate / Codeine Phosphate, Tuxarin Er, Mainpointe
9066942	2032-01-03		U-1716
9107921	2032-01-03	DP

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

1255 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	5	18	38	70	35	164
Pain	D010146	EFO_0003843	R52	19	25	29	53	31	152
Healthy volunteers/patients	—			39	—	2	5	9	55
Fever	D005334	HP_0001945	R50.9	3	5	10	12	5	33
Acute pain	D059787		R52	2	2	10	13	5	32
Analgesia	D000698			3	3	8	10	6	29
Migraine disorders	D008881	EFO_0003821	G43	—	6	6	10	3	24
Low back pain	D017116	HP_0003419	M54.5	1	2	7	9	5	24
Patent ductus arteriosus	D004374	HP_0001643	Q25.0	2	10	7	3	6	24
Osteoarthritis	D010003	EFO_0002506	M15-M19	1	2	5	9	4	21

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Multiple myeloma	D009101		C90.0	2	4	1	—	—	7
Dental pins	D003772			—	5	1	—	—	6
Covid-19	D000086382		U07.1	—	2	3	—	1	5
Lupus nephritis	D008181	EFO_0005761		—	2	3	—	—	5
Systemic lupus erythematosus	D008180	EFO_0002690	M32	—	2	4	—	—	5
Head and neck neoplasms	D006258			—	1	2	—	1	4
Pregnancy	D011247	EFO_0002950	Z33.1	—	—	1	—	2	3
Respiratory insufficiency	D012131	HP_0002093	J96.9	—	1	1	—	1	3
Hiv infections	D015658	EFO_0000764	B20	—	—	1	—	2	3
Lymphoma	D008223		C85.9	—	2	1	—	—	3

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pulpitis	D011671	EFO_1001139	K04.0	—	3	—	—	3	6
Precursor cell lymphoblastic leukemia-lymphoma	D054198		C91.0	3	2	—	—	—	4
Non-hodgkin lymphoma	D008228		C85.9	2	3	—	—	—	4
Cleft palate	D002972		Q35	—	2	—	—	1	3
Male breast neoplasms	D018567			—	1	—	—	2	3
Bcr-abl positive chronic myelogenous leukemia	D015464	EFO_0000340		3	1	—	—	—	3
Type 1 diabetes mellitus	D003922	EFO_0001359	E10	—	1	—	—	2	3
Atopic dermatitis	D003876	EFO_0000274	L20	1	1	—	—	1	3
Anxiety	D001007	EFO_0005230	F41.1	—	1	—	—	2	3
Alzheimer disease	D000544	EFO_0000249	F03	—	2	—	—	1	3

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pharmacokinetics	D010599			1	—	—	—	2	3
Overweight	D050177		E66.3	2	—	—	—	1	3
Therapeutic equivalency	D013810			2	—	—	—	—	2
Ankle fractures	D064386		S82.5	1	—	—	—	1	2
Intervertebral disc degeneration	D055959	HP_0008419		1	—	—	—	1	2
Alpha 1-antitrypsin deficiency	D019896		E88.01	1	—	—	—	1	2
Major depressive disorder	D003865	EFO_0003761	F22	2	—	—	—	—	2
Magnetic resonance imaging	D008279			1	—	—	—	—	1
Oral administration	D000284			1	—	—	—	—	1
Pure autonomic failure	D054970			1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Vitreoretinal surgery	D057586			—	—	—	—	3	3
Congenital heart defects	D006330	HP_0001627	Q24.9	—	—	—	—	3	3
Thyroidectomy	D013965			—	—	—	—	2	2
Retinopathy of prematurity	D012178	EFO_1001158	H35.1	—	—	—	—	2	2
Intervertebral disc displacement	D007405	EFO_1001800		—	—	—	—	2	2
Feeding and eating disorders	D001068		F50	—	—	—	—	2	2
Female genital diseases	D005831	EFO_0009549	N85	—	—	—	—	2	2
Long-term memory	D057567			—	—	—	—	1	1
Short-term memory	D008570	EFO_0004335		—	—	—	—	1	1
Aspirin-induced asthma	D055963	HP_0012042		—	—	—	—	1	1

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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	—
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	1545976
ChEMBL ID	CHEMBL485
ChEBI ID	16714
PubChem CID	5284371
DrugBank	DB00318
UNII ID	362O9ITL9D (ChemIDplus, GSRS)

Target

Agency Approved

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 (P42866)

Alternate

No data

Variants

Clinical Variant

No data

Financial

No data

Trends

PubMed Central

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Safety

Black-box Warning

Black-box warning for: Acetaminophen and codeine, Fioricet, Promethazine hydrochloride, Triacin-c, Tuxarin

Adverse Events

Top Adverse Reactions

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1,635 adverse events reported

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