Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tramadol
Drug ID BADD_D02254
Description Tramadol is a centrally acting synthetic opioid analgesic and SNRI (serotonin/norepinephrine reuptake-inhibitor) that is structurally related to [codeine] and [morphine]. Due to its good tolerability profile and multimodal mechanism of action, tramadol is generally considered a lower-risk opioid option for the treatment of moderate to severe pain. It is considered a Step 2 option on the World Health Organization's pain ladder and has about 1/10th of the potency of [morphine]. Tramadol differs from other traditional opioid medications in that it doesn't just act as a μ-opioid agonist, but also affects monoamines by modulating the effects of neurotransmitters involved in the modulation of pain such as serotonin and norepinpehrine which activate descending pain inhibitory pathways.[A182279] Tramadol's effects on serotonin and norepinephrine mimic the effects of other SNRI antidepressants such as [duloxetine] and [venlafaxine]. Tramadol exists as a racemic mixture consisting of two pharmacologically active enantiomers that both contribute to its analgesic property through different mechanisms and are also themselves metabolized into active metabolites: (+)-tramadol and its primary metabolite (+)-O-desmethyl-tramadol (M1) are agonists of the μ opioid receptor while (+)-tramadol inhibits serotonin reuptake and (-)-tramadol inhibits norepinephrine reuptake. These pathways are complementary and synergistic, improving tramadol's ability to modulate the perception of and response to pain.[A4269,A183842] Tramadol has also been shown to affect a number of other pain modulators within the central nervous system as well as non-neuronal inflammatory markers and immune mediators.[A183728,A183734,A183761,A17159,A182300] Due to the broad spectrum of targets involved in pain and inflammation, it's not surprising that the evidence has shown that tramadol is effective for a number of pain types including neuropathic pain, post-operative pain, lower back pain, as well as pain associated with labour, osteoarthritis, fibromyalgia, and cancer. Due to its SNRI activity, tramadol also has anxiolytic, antidepressant, and anti-shivering effects which are all frequently found as comorbidities with pain.[A182300] Similar to other opioid medications, tramadol poses a risk for development of tolerance, dependence and abuse. If used in higher doses, or with other opioids, there is a dose-related risk of overdose, respiratory depression, and death.[A183830,F4679] However, unlike other opioid medications, tramadol use also carries a risk of seizure and serotonin syndrome, particularly if used with other serotonergic medications.[A183836,A179926]
Indications and Usage Tramadol is approved for the management of moderate to severe pain in adults.[L9257,F4679] Tramadol is also used off-label in the treatment of premature ejaculation.[A173986]
Marketing Status approved; investigational
ATC Code N02AX02
DrugBank ID DB00193
KEGG ID D08623
MeSH ID D014147
PubChem ID 33741
TTD Drug ID D05GKD
NDC Product Code Not Available
UNII 39J1LGJ30J
Synonyms Tramadol | Tramundin | Biodalgic | Jutadol | K-315 | K 315 | K315 | MTW-Tramadol | MTW Tramadol | MTWTramadol | Nobligan | Prontofort | Zytram | Takadol | Theradol | Tiral | Tramadol Lindo | Topalgic | Tradol | Tradol-Puren | Tradol Puren | TradolPuren | Tradonal | Tralgiol | Trama AbZ | Trama KD | Trama-Dorsch | Trama Dorsch | TramaDorsch | Biokanol | Tramabeta | Tramadin | Tramadol-ratiopharm | Tramadolratiopharm | Tramadol Ratiopharm | Tramadoc | Tramadol PB | Tramadol acis | Tramadol AL | Tramadol Basics | Tramadol Bayvit | Tramadol Bexal | Tramadol 1A | Ranitidin 1A Pharma | Trama 1A Pharma | Tramadol Cinfa | Tramadol Edigen | Tramadol Hydrochloride | Trasedal | Ultram | Tramadol Heumann | Xymel 50 | Zamudol | Zumalgic | Zydol | Tramadol Kern | Tramadol Lichtenstein | Tramadol Mabo | Tramadol Normon | Tramadol Stada | Tramadol-Dolgit | Tramadol Dolgit | TramadolDolgit | Tramadol-Hameln | Tramadol Hameln | TramadolHameln | Tramadolor | Tramadura | Tramagetic | Tramagit | Tramake | Tramal | Tramex | Adolonta | Contramal | Amadol | Tramadol Asta Medica
Chemical Information
Molecular Formula C16H25NO2
CAS Registry Number 123154-38-1
SMILES CN(C)CC1CCCCC1(C2=CC(=CC=C2)OC)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.003--
Abdominal tenderness07.01.05.004--Not Available
Abnormal dreams17.15.02.001; 19.02.03.001--Not Available
Abnormal faeces07.01.03.001--Not Available
Acidosis14.01.03.0020.000058%
Acute hepatic failure09.01.03.0010.000014%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.001--Not Available
Acute pulmonary oedema22.01.03.005; 02.05.02.0040.000014%Not Available
Acute sinusitis22.07.03.013; 11.01.13.012--Not Available
Agitation19.06.02.001; 17.02.05.0120.000181%
Agranulocytosis01.02.03.0010.000022%Not Available
Alanine aminotransferase decreased13.03.04.004--Not Available
Alanine aminotransferase increased13.03.04.005--
Albuminuria20.02.01.001--Not Available
Alcohol abuse19.07.06.0010.000022%Not Available
Alopecia23.02.02.001--
Altered state of consciousness19.07.01.003; 17.02.04.0010.000130%Not Available
Amblyopia06.02.01.001--Not Available
Amnesia19.20.01.001; 17.03.02.0010.000051%
Amylase increased13.05.01.009--
Anaemia01.03.02.001--
Anaphylactic shock24.06.02.004; 10.01.07.0020.000043%Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.0030.000014%Not Available
Angina pectoris24.04.04.002; 02.02.02.002--
Angina unstable24.04.04.004; 02.02.02.004--Not Available
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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