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---
Ill-defined disorder08.01.03.049---
Urinary tract obstruction20.08.01.0040.009352%
Obstructive airways disorder22.03.01.0110.006235%-
Haemophilia01.01.01.009; 03.15.01.006---
Renal impairment20.01.03.0100.018705%-
Bladder perforation12.02.10.001; 20.03.01.0050.003117%
Orthostatic intolerance02.11.01.019; 17.05.01.007; 24.06.01.0030.003117%-
Treatment failure08.06.01.0170.004676%-
Acute kidney injury20.01.03.0160.026499%
Posterior reversible encephalopathy syndrome17.13.02.0070.004676%
Drug-induced liver injury09.01.07.023; 12.03.01.0440.003117%-
Peripheral artery thrombosis24.01.02.0100.009352%-
Perforation08.01.03.0580.003117%-
Multiple organ dysfunction syndrome08.01.03.0570.006235%
Cerebral artery thrombosis17.08.01.026; 24.01.04.0080.004676%-
Urinary bladder haemorrhage20.03.01.023; 24.07.01.0860.004676%-
Atrial thrombosis02.11.01.002; 24.01.05.0050.006235%-
Palatal oedema07.05.04.0080.006235%-
Neurogenic shock17.02.10.025; 24.06.02.023---
Sopor17.02.04.021; 19.02.04.0020.003117%-
Stress cardiomyopathy02.04.01.012; 24.04.04.0260.010911%-
Spontaneous haemorrhage01.01.03.007; 24.07.01.0810.003117%-
Arterial intramural haematoma12.02.01.018; 24.02.01.0040.003117%-
Vascular stent stenosis08.07.05.007; 24.04.02.0280.003117%-
Cerebral venous sinus thrombosis17.08.03.006; 24.01.04.0210.003117%-
Drug ineffective for unapproved indication08.06.01.038; 12.09.02.0020.016211%-
Heavy menstrual bleeding21.01.03.0050.006235%-
Pharyngeal swelling22.04.05.0280.006235%-
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