Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Tranexamic acid
Drug ID BADD_D02261
Description Tranexamic acid is a synthetic derivative of [lysine] used as an antifibrinolytic in the treatment and prevention of major bleeding. It possesses a similar mechanism of action to [aminocaproic acid] but is approximately 10-fold more potent.[L31883] It was first patented in 1957[A230108] and received its initial US approval in 1986.[L31858]
Indications and Usage Taken orally, tranexamic acid is indicated for the treatment of hereditary angioedema,[L31883] cyclic heavy menstrual bleeding in premenopausal females,[L31858] and other instances of significant bleeding in the context of hyperfibrinolysis.[L31883] Given intravenously, tranexamic acid is indicated for short-term use (2-8 days) in patients with hemophilia to prevent or reduce bleeding following tooth extraction.[L31853]
Marketing Status approved
ATC Code B02AA02
DrugBank ID DB00302
KEGG ID D01136
MeSH ID D014148
PubChem ID 5526
TTD Drug ID D05HXX
NDC Product Code 51927-0022; 73309-178; 42571-189; 50268-772; 69918-301; 70771-1085; 0591-3720; 49452-7876; 51552-0513; 81999-0001; 82920-038; 70121-1398; 23155-524; 43066-008; 55150-188; 63629-8838; 67850-041; 68083-160; 71335-1981; 60505-6169; 65145-106; 0517-0960; 81284-611; 12079-2001; 62991-3131; 82920-045; 51662-1532; 63629-8599; 67457-197; 70860-400; 70860-407; 71335-1957; 81284-612; 14537-115; 65388-0156; 61990-0611; 67850-042; 38779-3211; 57218-951; 25021-415; 42571-314; 50090-5072; 63323-563; 68382-891; 72611-760; 12848-1004; 0013-1114; 69918-300; 49452-7877; 71052-166; 23155-166; 51754-0108; 62559-265; 72485-107; 38779-2794; 39822-1000
UNII 6T84R30KC1
Synonyms Tranexamic Acid | AMCHA | trans-4-(Aminomethyl)cyclohexanecarboxylic Acid | t-AMCHA | AMCA | Anvitoff | Cyklokapron | Ugurol | KABI 2161 | Spotof | Transamin | Amchafibrin | Exacyl
Chemical Information
Molecular Formula C8H15NO2
CAS Registry Number 701-54-2
SMILES C1CC(CCC1CN)C(=O)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)
Perineal pain21.10.01.0030.007794%
Poisoning12.03.01.004--Not Available
Ill-defined disorder08.01.03.049--Not Available
Urinary tract obstruction20.08.01.0040.009352%
Obstructive airways disorder22.03.01.0110.006235%Not Available
Haemophilia03.15.01.006; 01.01.01.009--Not Available
Renal impairment20.01.03.0100.018705%Not Available
Bladder perforation20.03.01.005; 12.02.10.0010.003117%
Orthostatic intolerance02.11.01.019; 24.06.01.003; 17.05.01.0070.003117%Not Available
Treatment failure08.06.01.0170.004676%Not Available
Acute kidney injury20.01.03.0160.026499%
Posterior reversible encephalopathy syndrome17.13.02.0070.004676%
Drug-induced liver injury12.03.01.044; 09.01.07.0230.003117%Not Available
Peripheral artery thrombosis24.01.02.0100.009352%Not Available
Perforation08.01.03.0580.003117%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.006235%
Cerebral artery thrombosis24.01.04.008; 17.08.01.0260.004676%Not Available
Urinary bladder haemorrhage24.07.01.086; 20.03.01.0230.004676%Not Available
Atrial thrombosis02.11.01.002; 24.01.05.0050.006235%Not Available
Palatal oedema07.05.04.0080.006235%Not Available
Neurogenic shock24.06.02.023; 17.02.10.025--Not Available
Sopor19.02.04.002; 17.02.04.0210.003117%Not Available
Stress cardiomyopathy02.04.01.012; 24.04.04.0260.010911%Not Available
Spontaneous haemorrhage24.07.01.081; 01.01.03.0070.003117%Not Available
Arterial intramural haematoma24.02.01.004; 12.02.01.0180.003117%Not Available
Vascular stent stenosis24.04.02.028; 08.07.05.0070.003117%Not Available
Cerebral venous sinus thrombosis24.01.04.021; 17.08.03.0060.003117%Not Available
Drug ineffective for unapproved indication12.09.02.002; 08.06.01.0380.016211%Not Available
Heavy menstrual bleeding21.01.03.0050.006235%Not Available
Pharyngeal swelling22.04.05.0280.006235%Not Available
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