Tramadol
Conzip, Qdolo, Seglentis, Ultracet (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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Trade Name
FDA
EMA
Conzip, Qdolo (generic drugs available since 2002-06-19, discontinued: Rybix, Ryzolt, Ultram)
CombinationsSeglentis (generic drugs available since 2002-06-19, discontinued: Ultracet)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| conzip | New Drug Application | 2022-01-20 |
| qdolo | New Drug Application | 2020-09-14 |
| ryzolt | New Drug Application | 2010-11-19 |
| seglentis | New Drug Application | 2021-10-25 |
| tramadol hydrochloride | ANDA | 2023-06-13 |
| ultracet | New Drug Application | 2022-01-31 |
| ultramicrosize griseofulvin | ANDA | 2023-04-19 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| pain | EFO_0003843 | D010146 | R52 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
CELECOXIB / TRAMADOL HYDROCHLORIDE, SEGLENTIS, KOWA PHARMS | |||
| 2024-10-15 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Tramadol Hydrochloride, Qdolo, Athena | |||
| 11103452 | 2040-09-01 | DP | U-3197 |
| Celecoxib / Tramadol Hydrochloride, Seglentis, Kowa Pharms | |||
| 8846744 | 2031-06-03 | DP | |
| 8598152 | 2030-04-19 | DS, DP | |
| 9012440 | 2030-04-19 | DS, DP | |
| 10238668 | 2030-04-19 | DS, DP | U-3244 |
| 10245276 | 2030-04-19 | DS, DP | |
| 10548909 | 2030-04-19 | U-3244 | |
| 11478488 | 2030-04-19 | U-3244 | |
| Tramadol Hydrochloride, Ryzolt, Purdue Pharma | |||
| 7988998 | 2023-10-27 | DP | |
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
274 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain | D010146 | EFO_0003843 | R52 | 9 | 5 | 14 | 16 | 4 | 48 |
| Postoperative pain | D010149 | G89.18 | — | 1 | 2 | 18 | 15 | 36 | |
| Healthy volunteers/patients | — | 13 | — | — | 3 | 1 | 17 | ||
| Acute pain | D059787 | R52 | — | 4 | 4 | 4 | 3 | 15 | |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 2 | 2 | 1 | 6 | 1 | 12 |
| Low back pain | D017116 | HP_0003419 | M54.5 | 1 | 2 | 5 | 3 | 1 | 12 |
| Hysteroscopy | D015907 | — | — | 4 | 1 | — | 5 | ||
| Neuralgia | D009437 | EFO_0009430 | — | 1 | 2 | 1 | 1 | 5 | |
| Pulpitis | D011671 | EFO_1001139 | K04.0 | 1 | 1 | — | 2 | 2 | 5 |
| Analgesia | D000698 | — | — | 1 | 1 | 2 | 4 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic pain | D059350 | HP_0012532 | — | 2 | 9 | — | 2 | 12 | |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 3 | 4 | 1 | — | — | 5 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | 1 | 4 | — | — | 5 |
| Pain management | D059408 | 1 | 1 | 3 | — | 1 | 5 | ||
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 2 | 1 | — | 1 | 3 |
| Procedural pain | D000073818 | — | — | 2 | — | 1 | 3 | ||
| Substance withdrawal syndrome | D013375 | EFO_0005800 | — | 1 | 1 | — | — | 1 | |
| Pancreatitis | D010195 | EFO_0000278 | K85 | — | — | 1 | — | — | 1 |
| Muscle weakness | D018908 | HP_0001324 | — | 1 | 1 | — | — | 1 | |
| Abdominal pain | D015746 | R10.9 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Squamous cell carcinoma of head and neck | D000077195 | — | 1 | — | — | — | 1 | ||
| Pruritus | D011537 | HP_0000989 | L29 | — | 1 | — | — | — | 1 |
| Nausea | D009325 | HP_0002018 | R11.0 | — | 1 | — | — | — | 1 |
| Vertigo | D014717 | H81.39 | — | 1 | — | — | — | 1 | |
| Laron syndrome | D046150 | Orphanet_633 | E34.321 | — | 1 | — | — | — | 1 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | 1 | — | — | — | 1 |
| Melanoma | D008545 | 1 | 1 | — | — | — | 1 | ||
| Eye neoplasms | D005134 | EFO_0003824 | C69.9 | 1 | 1 | — | — | — | 1 |
| Wounds and injuries | D014947 | T14.8 | — | 1 | — | — | — | 1 | |
| Shoulder fractures | D012784 | S42.9 | — | 1 | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Nerve block | D009407 | — | — | — | — | 4 | 4 | ||
| Cholecystectomy | D002763 | — | — | — | — | 2 | 2 | ||
| Intervertebral disc degeneration | D055959 | HP_0008419 | — | — | — | — | 1 | 1 | |
| Sleep deprivation | D012892 | F51.12 | — | — | — | — | 1 | 1 | |
| Burns | D002056 | T30.0 | — | — | — | — | 1 | 1 | |
| Pituitary neoplasms | D010911 | — | — | — | — | 1 | 1 | ||
| Nephrectomy | D009392 | — | — | — | — | 1 | 1 | ||
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | — | — | — | 1 | 1 |
| Intervertebral disc displacement | D007405 | EFO_1001800 | — | — | — | — | 1 | 1 | |
| Periapical abscess | D010482 | EFO_1001202 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | TRAMADOL |
| INN | tramadol |
| 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 class | analgesics (mixed opiate receptor agonists/antagonists) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | COc1cccc(C2(O)CCCCC2CN(C)C)c1 |
Identifiers
| PDB | — |
| CAS-ID | 2914-77-4 |
| RxCUI | 10689 |
| ChEMBL ID | CHEMBL1237044 |
| ChEBI ID | 75722 |
| PubChem CID | 33741 |
| DrugBank | DB00193 |
| UNII ID | 39J1LGJ30J (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
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Safety
Black-box Warning
Black-box warning for: Conzip, Qdolo, Seglentis, Tramadol hydrochloride, Ultracet
Adverse Events
Top Adverse Reactions
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62,466 adverse events reported
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