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tramadol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
analgesics	2711	27203-92-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: tramadol (+/-)-Tramadol racemic tramadol tradolan tramadon tramadol hydrochloride tramadol HCl twotram	A narcotic analgesic proposed for severe pain. It may be habituating. Molecular weight: 263.38 Formula: C16H25NO2 CLOGP: 3.10 LIPINSKI: 0 HAC: 3 HDO: 1 TPSA: 32.70 ALOGS: -2.55 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

tramadol
(+/-)-Tramadol
racemic tramadol
tradolan
tramadon
tramadol hydrochloride
tramadol HCl
twotram

A narcotic analgesic proposed for severe pain. It may be habituating.

Molecular weight: 263.38
Formula: C16H25NO2
CLOGP: 3.10
LIPINSKI: 0
HAC: 3
HDO: 1
TPSA: 32.70
ALOGS: -2.55
ROTB: 4

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.30	g	O
0.30	g	P
0.30	g	R

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	72.50 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
CL (Clearance)	6.50 mL/min/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	5.80 hours	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	20 %	Benet LZ, Broccatelli F, Oprea TI
Vd (Volume of distribution)	2.80 L/kg	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	16.27 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
fu (Fraction unbound in plasma)	0.80 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
March 3, 1995	FDA	JANSSEN PHARMS
Sept. 25, 2020	PMDA	NIPPON ZOKI PHARMACEUTICAL CO., LTD.

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Serotonin syndrome	776.44	9.48	702	217167	27980	63243173
Drug dependence	697.88	9.48	617	217252	23866	63247287
Drug abuse	643.84	9.48	1002	216867	71516	63199637
Poisoning deliberate	605.83	9.48	413	217456	10805	63260348
Toxicity to various agents	601.39	9.48	2040	215829	245210	63025943
Pemphigus	427.75	9.48	61	217808	183665	63087488
Drug hypersensitivity	420.56	9.48	2141	215728	308546	62962607
Completed suicide	403.28	9.48	1257	216612	144416	63126737
Coma	323.09	9.48	695	217174	63669	63207484
Glossodynia	322.26	9.48	106	217763	178770	63092383

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug dependence	982.86	10.44	704	101968	23513	34830746
Drug abuse	953.71	10.44	1308	101364	97788	34756471
Toxicity to various agents	503.65	10.44	1508	101164	198854	34655405
Poisoning deliberate	442.69	10.44	280	102392	7564	34846695
Overdose	418.35	10.44	864	101808	90195	34764064
Prescription form tampering	418.27	10.44	120	102552	346	34853913
Serotonin syndrome	354.68	10.44	361	102311	19572	34834687
Intentional overdose	329.85	10.44	515	102157	43159	34811100
Intentional product misuse	321.31	10.44	521	102151	45090	34809169
Drug use disorder	318	10.44	181	102491	4010	34850249

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug abuse	1198.93	9.51	2060	270324	160631	79311373
Drug dependence	1181.78	9.51	1035	271349	39734	79432270
Serotonin syndrome	1066.82	9.51	1021	271363	44006	79427998
Poisoning deliberate	995.78	9.51	683	271701	18145	79453859
Toxicity to various agents	993.60	9.51	3429	268955	418111	79053893
Coma	631.46	9.51	1189	271195	99460	79372544
Intentional overdose	525.27	9.51	1135	271249	104825	79367179
Overdose	513.97	9.51	1589	270795	182617	79289387
Drug use disorder	431.97	9.51	303	272081	8348	79463656
Withdrawal syndrome	426.42	9.51	492	271892	26362	79445642

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	N02AJ13	NERVOUS SYSTEM ANALGESICS OPIOIDS Opioids in combination with non-opioid analgesics
ATC	N02AJ14	NERVOUS SYSTEM ANALGESICS OPIOIDS Opioids in combination with non-opioid analgesics
ATC	N02AJ15	NERVOUS SYSTEM ANALGESICS OPIOIDS Opioids in combination with non-opioid analgesics
ATC	N02AJ16	NERVOUS SYSTEM ANALGESICS OPIOIDS Opioids in combination with non-opioid analgesics
ATC	N02AX02	NERVOUS SYSTEM ANALGESICS OPIOIDS Other opioids
CHEBI has role	CHEBI:35482	narcotic analgesic
CHEBI has role	CHEBI:35640	adrenergic uptake inhibitors
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:48279	serotonin antagonists
CHEBI has role	CHEBI:48876	muscarinic antagonists

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Pain	indication	22253000
Chronic pain	indication	82423001
Osteoarthritis	indication	396275006
Fibromyalgia	off-label use	203082005	DOID:631
Neuropathic pain	off-label use	247398009
Suicidal thoughts	contraindication	6471006
Alcoholism	contraindication	7200002
Lowered convulsive threshold	contraindication	19260006
Cirrhosis of liver	contraindication	19943007	DOID:5082
Alcohol intoxication	contraindication	25702006

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.01	Basic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
56MG;44MG	SEGLENTIS	KOWA PHARMS	N213426	Oct. 15, 2021	RX	TABLET	ORAL	10238668	April 19, 2030	A METHOD FOR TREATMENT OF PAIN IN ADULTS USING TRAMADOL HYDROCHLORIDE AND CELECOXIB
56MG;44MG	SEGLENTIS	KOWA PHARMS	N213426	Oct. 15, 2021	RX	TABLET	ORAL	10548909	April 19, 2030	A METHOD FOR TREATMENT OF PAIN IN ADULTS USING TRAMADOL HYDROCHLORIDE AND CELECOXIB
56MG;44MG	SEGLENTIS	KOWA PHARMS	N213426	Oct. 15, 2021	RX	TABLET	ORAL	11478488	April 19, 2030	A METHOD FOR TREATMENT OF PAIN IN ADULTS USING TRAMADOL HYDROCHLORIDE AND CELECOXIB
5MG/ML	QDOLO	ATHENA	N214044	Sept. 1, 2020	RX	SOLUTION	ORAL	11103452	Sept. 1, 2040	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE AN OPIOID ANALGESIC AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
56MG;44MG	SEGLENTIS	KOWA PHARMS	N213426	Oct. 15, 2021	RX	TABLET	ORAL	Oct. 15, 2024	NEW PRODUCT

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Mu-type opioid receptor	GPCR	P35372	OPRM_HUMAN	AGONIST	Ki	5.80	CHEMBL	CHEMBL
Sodium-dependent serotonin transporter	Transporter	P31645	SC6A4_HUMAN		IC50	5.83	CHEMBL
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN		IC50	6.10	CHEMBL
Kappa-type opioid receptor	GPCR	P41145	OPRK_HUMAN		Ki	7.85	CHEMBL
Delta-type opioid receptor	GPCR	P41143	OPRD_HUMAN		Ki	8.03	CHEMBL
Solute carrier family 22 member 1	Transporter	O15245	S22A1_HUMAN		IC50	4.28	WOMBAT-PK
Mu-type opioid receptor	GPCR		OPRM_RAT		Ki	5.62	CHEMBL

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External reference:

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ID	Source
004180	NDDF
004181	NDDF
10689	RXNORM
108505002	SNOMEDCT_US
108507005	SNOMEDCT_US
2722	INN_ID
33741	PUBCHEM_CID
36282-47-0	SECONDARY_CAS_RN
386858008	SNOMEDCT_US
39J1LGJ30J	UNII

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
RYZOLT	HUMAN PRESCRIPTION DRUG LABEL	1	16590-244	TABLET, EXTENDED RELEASE	200 mg	ORAL	NDA	12 sections
RYZOLT	HUMAN PRESCRIPTION DRUG LABEL	1	16590-253	TABLET, EXTENDED RELEASE	100 mg	ORAL	NDA	12 sections
RYZOLT	HUMAN PRESCRIPTION DRUG LABEL	1	16590-255	TABLET, EXTENDED RELEASE	300 mg	ORAL	NDA	12 sections
Tramadol ER	HUMAN PRESCRIPTION DRUG LABEL	1	16590-893	TABLET, EXTENDED RELEASE	200 mg	ORAL	ANDA	13 sections
Tramadol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-0058	TABLET, FILM COATED	50 mg	ORAL	ANDA	29 sections
Tramadol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-0058	TABLET, FILM COATED	50 mg	ORAL	ANDA	29 sections
Tramadol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4151	TABLET, FILM COATED	50 mg	ORAL	ANDA	37 sections
Tramadol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4152	TABLET, EXTENDED RELEASE	100 mg	ORAL	ANDA	35 sections
Tramadol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4153	TABLET, EXTENDED RELEASE	200 mg	ORAL	ANDA	35 sections
Tramadol Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4154	TABLET, EXTENDED RELEASE	300 mg	ORAL	ANDA	35 sections

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