Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tramadol hydrochloride
Drug ID BADD_D02255
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 D01355
MeSH ID D014147
PubChem ID 63013
TTD Drug ID D05GKD
NDC Product Code 76420-538; 29967-0002; 70859-010; 76420-950; 76420-951; 68025-072; 68071-2732; 70518-0942; 70518-1254; 70518-3397; 71093-119; 71205-468; 71205-708; 71335-1676; 76420-205; 38779-2781; 47621-002; 62350-0046; 29300-355; 52817-615; 55700-029; 55700-864; 61919-893; 68025-071; 70518-3418; 70518-3598; 71205-066; 71335-1319; 71610-006; 72888-080; 80425-0274; 80425-0276; 83008-009; 58624-0201; 61281-8500; 45865-115; 45865-976; 47335-531; 59651-441; 61919-073; 63187-615; 68071-2648; 70518-2795; 70518-3586; 71205-303; 71205-569; 71335-1675; 71610-398; 63187-063; 63629-8319; 63629-8324; 68025-073; 68134-402; 68180-698; 68180-699; 68788-7601; 71205-389; 71205-656; 71335-0521; 72888-008; 65372-1112; 65862-613; 13811-691; 45865-120; 50090-2215; 57664-377; 63187-597; 67296-1834; 68071-2923; 68071-2952; 68071-4119; 68071-5142; 68071-5204; 70518-0886; 71335-9658; 76420-244; 76420-537; 51927-4763; 76420-094; 13811-690; 35356-790; 47335-537; 50090-5789; 55700-996; 58118-0377; 61919-229; 63629-4899; 68071-5261; 70518-0118; 70518-0258; 70518-3386; 71205-463; 71335-9670; 47335-859; 53002-4322; 60760-772; 61919-597; 63629-8323; 68788-7321; 68788-8121; 69238-2348; 0615-8005; 83008-021; 49452-7875; 51552-1288; 13811-689; 45865-876; 45865-969; 47335-533; 60219-2348; 60760-377; 61919-892; 65162-627; 68084-808; 68382-319; 72189-311; 63275-9908; 16571-716; 0093-0058; 45865-709; 50090-5790; 50090-6033; 55700-016; 68180-697; 68788-7762; 68788-8367; 71511-301; 76420-127; 76420-245; 76420-246; 0395-8091; 0904-7179; 46438-1108; 51927-0123; 65085-0021; 71901-601; 45865-900; 47335-861; 50090-0806; 52817-195; 53002-4320; 60429-588; 65841-754; 68071-2945; 68788-7763; 70934-461; 72189-154; 76420-536; 62991-3079; 33342-201; 47335-860; 51655-152; 52817-196; 55700-997
UNII 9N7R477WCK
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 C16H26ClNO2
CAS Registry Number 36282-47-0
SMILES CN(C)CC1CCCCC1(C2=CC(=CC=C2)OC)O.Cl
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)
Flatulence07.01.04.002--
Flushing08.01.03.025; 23.06.05.003; 24.03.01.002--
Gait disturbance08.01.02.002; 15.03.05.013; 17.02.05.016--
Gamma-glutamyltransferase increased13.03.04.024--
Gastritis07.08.02.001--
Gastrooesophageal reflux disease07.02.02.003--
Gastrointestinal haemorrhage07.12.02.001; 24.07.02.009---
Haematochezia07.12.02.003; 24.07.02.012---
Haemoglobin decreased13.01.05.003---
Hallucination19.10.04.003--
Headache17.14.01.001--
Hepatic failure09.01.03.002--
Hepatic function abnormal09.01.02.001---
Hepatitis09.01.07.004---
Hyperhidrosis08.01.03.028; 23.02.03.004--
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Hypertonia15.05.04.007; 17.05.02.001---
Hypotension24.06.03.002--
Indifference19.05.01.004---
Injury12.01.08.004---
Insomnia17.15.03.002; 19.02.01.002--
Irritability08.01.03.011; 19.04.02.013--
Libido decreased19.08.03.001; 21.03.02.005--
Malaise08.01.01.003--
Melaena07.12.02.004; 24.07.02.013---
Menopausal symptoms21.02.02.002---
Menstrual disorder21.01.01.004---
Mental impairment17.03.03.002; 19.21.02.003---
Micturition disorder20.02.02.005---
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