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Drug ReportsTramadol
Tramadol
Conzip, Seglentis, Tramadol (tramadol) is a small molecule pharmaceutical. Tramadol was first approved as Ultram on 1995-03-03. It is used to treat pain in the USA.
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Events Timeline
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3M
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
signs and symptoms pathological conditionsD013568
psychological phenomenaD011579
musculoskeletal and neural physiological phenomenaD055687
Trade Name
FDA
EMA
Conzip, Tramadol (discontinued: Conzip, Qdolo, Rybix, Ryzolt, Tramadol, Ultram)
Combinations
Tramadol acetaminophen (discontinued: Seglentis, Tramadol acetaminophen, Ultracet)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Acetaminophen
+
Tramadol hydrochloride
Tradename
Company
Number
Date
Products
ULTRACETJohnson & JohnsonN-021123 DISCN2001-08-15
1 products, RLD
Hide discontinued
Tramadol hydrochloride
Tradename
Company
Number
Date
Products
CONZIPCipher PharmaceuticalsN-022370 RX2010-05-07
3 products, RLD
Show 6 discontinued
Celecoxib
+
Tramadol hydrochloride
Tradename
Company
Number
Date
Products
SEGLENTISKowaN-213426 DISCN2021-10-15
1 products, RLD
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
banana boat kids ultramist tear free spf 30OTC monograph final2010-03-25
banana boat ultramist baby tear free continuous spf 50OTC monograph final2010-03-18
banana boat ultramist kids spf 50 factor de proteccion solar 50OTC monograph final2010-03-21
banana boat ultramist kids tear free lotion spf 50OTC monograph final2010-03-21
banana boat ultramist sport performance spf 50OTC monograph final2010-03-20
conzipNew Drug Application2023-12-22
direct rxANDA2015-09-09
durelaExport only2024-12-06
fulvicin p/g 165ANDA2025-02-10
griseofulvinANDA2021-07-21
Show 21 more
Agency Specific
FDA
EMA
Expiration
Code
CELECOXIB / TRAMADOL HYDROCHLORIDE, SEGLENTIS, KOWA PHARMS
2024-10-15NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Tramadol Hydrochloride, Qdolo, Athena
111034522040-09-01DPU-3197
117521032040-09-01DPU-3197
Celecoxib / Tramadol Hydrochloride, Seglentis, Kowa Pharms
88467442031-06-03DP
85981522030-04-19DS, DP
90124402030-04-19DS, DP
102386682030-04-19DS, DPU-3244
102452762030-04-19DS, DP
105489092030-04-19U-3244
114784882030-04-19U-3244
ATC Codes
N: Nervous system drugs
N02: Analgesics
N02A: Opioid analgesics
N02AJ: Opioids in combination with non-opioid analgesics
N02AJ13: Tramadol and paracetamol
N02AJ14: Tramadol and dexketoprofen
N02AJ15: Tramadol and other non-opioid analgesics
N02AJ16: Tramadol and celecoxib
N02AX: Other opioids in atc
N02AX02: Tramadol
HCPCS
No data
Clinical
Clinical Trials
592 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 painD010149G89.1828104398159
PainD010146EFO_0003843R5210817191973
Chronic painD05935051141332
Acute painD059787R525961232
OsteoarthritisD010003EFO_0002506M15-M192398830
Healthy volunteers/patients174122
Low back painD017116M54.51363821
Back painD001416M541364620
AnalgesiaD0006981271120
Knee osteoarthritisD020370EFO_0004616M173611020
Show 149 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pain managementD059408124915
Breast neoplasmsD001943EFO_0003869C502157
PancreatitisD010195EFO_0000278K8511214
Spinal anesthesiaD000775134
DiseaseD004194EFO_0000408R69213
Anterior cruciate ligament injuriesD0000705981213
General anesthesiaD000768123
Procedural painD000073818213
Impacted toothD014095K01.1213
Stomach neoplasmsD013274EFO_0003897C16112
Show 15 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Substance-related disordersD019966EFO_0003890F131123
Covid-19D000086382U07.11112
SyndromeD013577112
Gastrointestinal diseasesD00576722
Intestinal diseasesD007410K63.922
Opioid-induced constipationD00007968922
Head and neck neoplasmsD00625811
Squamous cell carcinoma of head and neckD00007719511
MucositisD052016EFO_100189811
PruritusD011537L2911
Show 14 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MalnutritionD044342EFO_0008572E40-E4622
Therapeutic equivalencyD01381022
Brain injuriesD001930S06.911
Consciousness disordersD00324411
Persistent vegetative stateD018458R40.311
AgingD000375GO_0007568R41.8111
Biological availabilityD00168211
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ObesityD009765EFO_0001073E66.966
Bariatric surgeryD05011044
AnxietyD001007EFO_0005230F41.144
Joint diseasesD007592M12.933
EmergenciesD00463033
Anxiety disordersD001008EFO_0006788F41.133
Morbid obesityD009767EFO_000107433
UltrasonographyD01446322
ProlapseD01139122
RadiculopathyD011843M54.122
Show 101 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTramadol
INNtramadol
Description
(R,R)-tramadol is a 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol in which both stereocentres have R-configuration; the (R,R)-enantiomer of the racemic opioid analgesic tramadol, it exhibits ten-fold higher analgesic potency than the (S,S)-enantiomer. It has a role as a delta-opioid receptor agonist, a kappa-opioid receptor agonist, a mu-opioid receptor agonist, an adrenergic uptake inhibitor, an antitussive, a capsaicin receptor antagonist, a muscarinic antagonist, a nicotinic antagonist, a NMDA receptor antagonist, an opioid analgesic, a serotonergic antagonist, a serotonin uptake inhibitor and a metabolite. It is a conjugate base of a (R,R)-tramadol(1+). It is an enantiomer of a (S,S)-tramadol.
Classification
Small molecule
Drug classanalgesics (mixed opiate receptor agonists/antagonists)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COc1cccc(C2(O)CCCCC2CN(C)C)c1
Identifiers
PDB
CAS-ID2914-77-4
RxCUI
ChEMBL IDCHEMBL1237044
ChEBI ID75722
PubChem CID33741
DrugBankDB00193
UNII ID39J1LGJ30J (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
No data
Estimated US medical usage
Tramadol
+
Acetaminophen
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Tramadol
Total medical expenditures per year (USD, in millions)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 98,637 documents
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Safety
Black-box Warning
Black-box warning for: Conzip, Direct rx, Tramadol acetaminophen, Tramadol hcl, Tramadol hcl and acetaminophen, Tramadol hcl er, Tramadol hcl tramadol hydrochloride, Tramadol hydrochloride, Ultracet
Adverse Events
Top Adverse Reactions
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98,271 adverse events reported
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