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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Commercial
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Trade Name
FDA
EMA
Conzip, Tramadol (discontinued: Conzip, Qdolo, Rybix, Ryzolt, Tramadol, Ultram)
CombinationsTramadol 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 |
|---|---|---|---|---|
| ULTRACET | Johnson & Johnson | N-021123 DISCN | 2001-08-15 | 1 products, RLD |
Hide discontinued
Tramadol hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CONZIP | Cipher Pharmaceuticals | N-022370 RX | 2010-05-07 | 3 products, RLD |
Show 6 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| banana boat kids ultramist tear free spf 30 | OTC monograph final | 2010-03-25 |
| banana boat ultramist baby tear free continuous spf 50 | OTC monograph final | 2010-03-18 |
| banana boat ultramist kids spf 50 factor de proteccion solar 50 | OTC monograph final | 2010-03-21 |
| banana boat ultramist kids tear free lotion spf 50 | OTC monograph final | 2010-03-21 |
| banana boat ultramist sport performance spf 50 | OTC monograph final | 2010-03-20 |
| conzip | New Drug Application | 2025-12-29 |
| direct rx | ANDA | 2015-09-09 |
| durela | Export only | 2024-12-06 |
| fulvicin p/g 165 | ANDA | 2025-02-10 |
| griseofulvin | ANDA | 2021-07-21 |
Show 22 more
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 |
| 11752103 | 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 | |
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
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Clinical
Clinical Trials
642 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 | 2 | 10 | 11 | 45 | 116 | 181 |
| Pain | D010146 | EFO_0003843 | R52 | 12 | 8 | 17 | 21 | 23 | 81 |
| Acute pain | D059787 | — | R52 | 1 | 5 | 9 | 7 | 15 | 37 |
| Agnosia | D000377 | EFO_0007136 | F88 | 1 | 3 | 3 | 9 | 19 | 34 |
| Chronic pain | D059350 | — | — | — | 5 | 11 | 4 | 13 | 32 |
| Healthy volunteers/patients | — | — | — | 19 | — | — | 4 | 1 | 24 |
| Low back pain | D017116 | — | M54.5 | 1 | 3 | 7 | 3 | 9 | 23 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 2 | 2 | 7 | 7 | 5 | 23 |
| Analgesia | D000698 | — | — | — | 1 | 2 | 7 | 11 | 20 |
| Anesthesia | D000758 | — | — | — | — | 1 | 5 | 11 | 17 |
Show 147 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | 3 | 7 | — | 10 | 20 |
| Pain management | D059408 | — | — | 1 | 2 | 4 | — | 11 | 17 |
| Pancreatitis | D010195 | EFO_0000278 | K85 | 1 | 1 | 2 | — | 1 | 4 |
| Spinal anesthesia | D000775 | — | — | — | — | 1 | — | 3 | 4 |
| Disease | D004194 | EFO_0000408 | R69 | 2 | — | 1 | — | — | 3 |
| Anterior cruciate ligament injuries | D000070598 | — | — | — | 1 | 2 | — | 1 | 3 |
| General anesthesia | D000768 | — | — | — | — | 1 | — | 2 | 3 |
| Procedural pain | D000073818 | — | — | — | — | 2 | — | 1 | 3 |
| Impacted tooth | D014095 | — | K01.1 | — | 2 | 1 | — | — | 3 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | — | 1 | — | 1 | 2 |
Show 15 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | 1 | — | — | 3 | 4 |
| Pruritus | D011537 | — | L29 | — | 1 | — | — | 1 | 2 |
| Covid-19 | D000086382 | — | U07.1 | 1 | 1 | — | — | 1 | 2 |
| Gastrointestinal diseases | D005767 | — | — | — | 2 | — | — | — | 2 |
| Intestinal diseases | D007410 | — | K63.9 | — | 2 | — | — | — | 2 |
| Opioid-induced constipation | D000079689 | — | — | — | 2 | — | — | — | 2 |
| Head and neck neoplasms | D006258 | — | — | — | 1 | — | — | — | 1 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | — | 1 | — | — | — | 1 |
| Mucositis | D052016 | EFO_1001898 | — | — | 1 | — | — | — | 1 |
| Vertigo | D014717 | — | H81.39 | — | 1 | — | — | — | 1 |
Show 13 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Therapeutic equivalency | D013810 | — | — | 2 | — | — | — | — | 2 |
| Brain injuries | D001930 | — | S06.9 | 1 | — | — | — | — | 1 |
| Consciousness disorders | D003244 | — | — | 1 | — | — | — | — | 1 |
| Persistent vegetative state | D018458 | — | R40.3 | 1 | — | — | — | — | 1 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 1 | — | — | — | — | 1 |
| Aging | D000375 | GO_0007568 | R41.81 | 1 | — | — | — | — | 1 |
| Biological availability | D001682 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 6 | 6 |
| Bariatric surgery | D050110 | — | — | — | — | — | — | 6 | 6 |
| Emergencies | D004630 | — | — | — | — | — | — | 5 | 5 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | — | — | — | 4 | 4 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | — | 4 | 4 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | — | — | 3 | 3 |
| Bites and stings | D001733 | — | — | — | — | — | — | 3 | 3 |
| Bronchiolitis obliterans syndrome | D000092122 | — | D89.811 | — | — | — | — | 2 | 2 |
| Ultrasonography | D014463 | — | — | — | — | — | — | 2 | 2 |
| Prolapse | D011391 | — | — | — | — | — | — | 2 | 2 |
Show 114 more
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 | — |
| ChEMBL ID | CHEMBL1237044 |
| ChEBI ID | 75722 |
| PubChem CID | 33741 |
| DrugBank | DB00193 |
| UNII ID | 39J1LGJ30J (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Estimated US medical usage
Tramadol
+
Acetaminophen
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Tramadol
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Trends
PubMed Central
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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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103,493 adverse events reported
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