Tramadol
Conzip, Qdolo, 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
Therapeutic Areas
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 | 2023-12-22 |
| direct rx | ANDA | 2015-09-09 |
| durela | Export only | 2022-12-19 |
| griseofulvin | ANDA | 2021-07-21 |
| qdolo | New Drug Application | 2023-12-21 |
Show 24 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
568 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 | 7 | 9 | 42 | 91 | 150 |
| Pain | D010146 | EFO_0003843 | R52 | 10 | 8 | 17 | 19 | 19 | 73 |
| Chronic pain | D059350 | HP_0012532 | — | — | 5 | 11 | 4 | 13 | 32 |
| Acute pain | D059787 | — | R52 | — | 5 | 9 | 6 | 12 | 32 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 2 | 3 | 9 | 8 | 8 | 30 |
| Healthy volunteers/patients | — | — | — | 17 | — | — | 4 | 1 | 22 |
| Low back pain | D017116 | HP_0003419 | M54.5 | 1 | 3 | 6 | 3 | 8 | 21 |
| Back pain | D001416 | HP_0003418 | M54 | 1 | 3 | 6 | 4 | 6 | 20 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | 3 | 6 | 1 | 10 | 20 |
| Analgesia | D000698 | — | — | — | 1 | 2 | 6 | 9 | 17 |
Show 148 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain management | D059408 | — | — | 1 | 1 | 4 | — | 6 | 11 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 2 | 1 | — | 4 | 6 |
| Pancreatitis | D010195 | HP_0001733 | 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 |
| Procedural pain | D000073818 | — | — | — | — | 2 | — | 1 | 3 |
| Impacted tooth | D014095 | HP_0011079 | K01.1 | — | 2 | 1 | — | — | 3 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | — | 1 | — | 1 | 2 |
| General anesthesia | D000768 | — | — | — | — | 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 | — | — | 2 | 3 |
| Covid-19 | D000086382 | — | — | 1 | 1 | — | — | 1 | 2 |
| Gastrointestinal diseases | D005767 | — | — | — | 2 | — | — | — | 2 |
| Intestinal diseases | D007410 | HP_0002242 | 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 |
| Pruritus | D011537 | HP_0000989 | L29 | — | 1 | — | — | — | 1 |
| Vertigo | D014717 | — | H81.39 | — | 1 | — | — | — | 1 |
Show 11 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 2 | — | — | — | — | 2 |
| 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 |
| 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 | — | — | — | — | — | — | 4 | 4 |
| Joint diseases | D007592 | HP_0003040 | M12.9 | — | — | — | — | 3 | 3 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | — | — | — | 3 | 3 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | — | 3 | 3 |
| Ultrasonography | D014463 | — | — | — | — | — | — | 2 | 2 |
| Emergencies | D004630 | — | — | — | — | — | — | 2 | 2 |
| Prolapse | D011391 | — | — | — | — | — | — | 2 | 2 |
| Radiculopathy | D011843 | — | M54.1 | — | — | — | — | 2 | 2 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | — | — | 2 | 2 |
Show 98 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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Additional graphs summarizing 92,864 documents
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Safety
Black-box Warning
Black-box warning for: Conzip, Direct rx, Qdolo, Seglentis, Tramadol acetaminophen, Tramadol hcl, Tramadol hcl and acetaminophen, Tramadol hcl er, Tramadol hcl tramadol hydrochloride, Tramadol hydrochloride, Tramadol hydrochloride and acetaminophen, Ultracet
Adverse Events
Top Adverse Reactions
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92,710 adverse events reported
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