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 Indicated in the treatment of moderate to severe pain. Consider for those prone to constipation or respiratory depression. Tramadol is used to treat postoperative, dental, cancer, and acute musculosketetal pain and as an adjuvant to NSAID therapy in patients with osteoarthritis.
Marketing Status Prescription; Discontinued
ATC Code N02AX02
DrugBank ID DB00193
KEGG ID D01355
MeSH ID D014147
PubChem ID 63013
TTD Drug ID D05GKD
NDC Product Code 68071-5142; 71335-1676; 76420-094; 68025-072; 71205-066; 50090-5094; 0904-7179; 47335-861; 50090-2215; 45865-969; 13811-690; 55154-5656; 71901-601; 45865-900; 70859-010; 38779-2781; 0378-4151; 71335-1675; 58118-0377; 68788-7762; 71335-1319; 50090-5106; 68084-808; 70518-3386; 0615-8005; 68180-698; 55700-412; 50090-5107; 70518-0258; 61919-597; 68071-4119; 71335-0521; 65841-754; 68071-5078; 47335-537; 0378-4153; 63629-8324; 52817-196; 63187-597; 61919-229; 61919-895; 70518-2005; 68134-402; 55700-029; 53002-4320; 71335-1498; 55700-864; 61281-8500; 47335-860; 53002-4321; 65085-0021; 63275-9908; 68071-2329; 50090-0807; 59651-441; 71610-398; 68788-8121; 65162-627; 51927-0123; 72888-008; 47335-533; 46438-1108; 0093-0058; 71205-569; 0378-4152; 53002-4322; 70518-0886; 72189-154; 57664-377; 68788-7321; 65372-1112; 45865-120; 50436-0698; 60429-588; 71610-006; 45865-115; 0378-4154; 68071-4070; 70518-3397; 68180-699; 70518-0118; 68071-4154; 52817-195; 61919-893; 72888-080; 45865-876; 71205-303; 50090-4717; 51927-4763; 68071-1671; 61919-892; 68071-2648; 68071-5204; 13811-689; 68025-073; 70518-0891; 71205-468; 60760-319; 63629-4394; 60760-377; 70518-0942; 68071-1978; 63187-615; 68071-5261; 16571-716; 0395-8091; 50090-4716; 68071-4802; 72189-311; 47335-531; 68382-319; 62991-3079; 51079-991; 67296-1649; 50090-0806; 68509-1059; 76420-950; 63629-8190; 35356-790; 62350-0046; 49452-7875; 65862-613; 50090-5789; 69543-136; 67296-1766; 63187-063; 61919-073; 71205-463; 45865-709; 13811-691; 70518-1254; 63629-8323; 68788-7601; 45865-976; 50458-659; 47335-859; 29300-355; 71610-392; 38779-2374; 50090-5790; 71511-301; 67296-1021; 68071-4165; 29967-0002; 63629-4899; 68025-071; 70518-2795; 0904-6365; 47621-002; 68071-2410; 68788-7763; 71093-119; 71205-389; 76420-951; 71335-1003; 76420-127; 51552-1288; 53002-4323; 58624-0201; 68071-4282; 63629-8319; 55700-016; 68180-697
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Seizures (incl subtypes)Cytochrome P450 2D6P10635T57392Not Available
ADRs Induced by Drug
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
Adrenal insufficiency14.11.01.004; 05.01.02.001--
Agitation19.06.02.001; 17.02.05.012--
Alanine aminotransferase decreased13.03.01.002--Not Available
Alanine aminotransferase increased13.03.01.003--
Albuminuria20.02.01.001--Not Available
Amnesia19.20.01.001; 17.03.02.001--
Amylase increased13.05.01.009--
Anaemia01.03.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Androgen deficiency21.16.02.001; 05.05.02.008--
Anxiety19.06.02.002--
Arrhythmia02.03.02.001--Not Available
Arthralgia15.01.02.001--
Aspartate aminotransferase decreased13.03.01.005--Not Available
Aspartate aminotransferase increased13.03.01.006--
Asthenia08.01.01.001--Not Available
Ataxia17.02.02.001; 08.01.02.004--
Blister23.03.01.001; 12.01.06.002--Not Available
Blood creatinine increased13.13.01.004--
Blood potassium abnormal13.11.01.024--Not Available
Blood pressure increased13.14.03.005--Not Available
Bradycardia02.03.02.002--Not Available
Cataract06.06.01.001--
Change of bowel habit07.02.03.002--Not Available
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