Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Clarithromycin
Drug ID BADD_D00480
Description Clarithromycin, a semisynthetic macrolide antibiotic derived from erythromycin, inhibits bacterial protein synthesis by binding to the bacterial 50S ribosomal subunit. Binding inhibits peptidyl transferase activity and interferes with amino acid translocation during the translation and protein assembly process. Clarithromycin may be bacteriostatic or bactericidal depending on the organism and drug concentration.
Indications and Usage An alternative medication for the treatment of acute otitis media caused by H. influenzae, M. catarrhalis, or S. pneumoniae in patients with a history of type I penicillin hypersensitivity. Also for the treatment of pharyngitis and tonsillitis caused by susceptible Streptococcus pyogenes, as well as respiratory tract infections including acute maxillary sinusitis, acute bacterial exacerbations of chronic bronchitis, mild to moderate community-acquired pneuomia, Legionnaires' disease, and pertussis. Other indications include treatment of uncomplicated skin or skin structure infections, helicobacter pylori infection, duodenal ulcer disease, bartonella infections, early Lyme disease, and encephalitis caused by Toxoplasma gondii (in HIV infected patients in conjunction with pyrimethamine). Clarithromycin may also decrease the incidence of cryptosporidiosis, prevent the occurence of α-hemolytic (viridans group) streptococcal endocarditis, as well as serve as a primary prevention for Mycobacterium avium complex (MAC) bacteremia or disseminated infections (in adults, adolescents, and children with advanced HIV infection).
Marketing Status approved
ATC Code J01FA09
DrugBank ID DB01211
KEGG ID D00276
MeSH ID D017291
PubChem ID 84029
TTD Drug ID D0Z1ZM
NDC Product Code 49452-2112; 46708-344; 46708-345; 57237-044; 61919-643; 71335-1493; 0781-6023; 65096-0100; 53002-7561; 65862-226; 0527-1932; 76420-051; 27241-064; 43063-530; 68071-5045; 68788-8480; 0527-1930; 57237-045; 60687-435; 63187-376; 63187-625; 71335-1567; 38779-1937; 63415-0018; 43063-942; 53002-7562; 62332-345; 68788-7933; 0527-1931; 62991-2687; 51655-668; 65862-225; 0781-6022; 43666-0001; 60592-429; 50090-5285; 67296-1072; 67296-1360; 68071-3116; 70518-2773; 71335-0017; 72189-299; 0781-1961; 15894-0026; 27241-065; 62135-615; 62135-616; 62332-344; 0591-2805; 59566-0123; 50090-5282; 50268-178; 50268-179; 64380-906; 67296-0464; 68071-2869; 0781-1962; 43063-752; 43063-823; 64380-905; 68788-7125; 0904-6872; 43781-0403; 51552-1566; 50090-1830
UNII H1250JIK0A
Synonyms Clarithromycin | 6-O-Methylerythromycin | TE-031 | TE 031 | TE031 | A-56268 | A 56268 | A56268 | Biaxin
Chemical Information
Molecular Formula C38H69NO13
CAS Registry Number 81103-11-9
SMILES CCC1C(C(C(C(=O)C(CC(C(C(C(C(C(=O)O1)C)OC2CC(C(C(O2)C)O)(C)OC)C)OC3C(C(CC(O3)C)N( C)C)O)(C)OC)C)C)O)(C)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)
Generalised oedema14.05.06.007; 08.01.07.0040.000335%
Genital ulceration23.07.03.004; 21.10.05.0010.000447%Not Available
Gingival bleeding24.07.02.010; 07.09.07.0010.000335%Not Available
Gingival pain07.09.13.010--
Glossitis07.14.01.0010.000223%Not Available
Glossodynia07.14.02.0010.000759%Not Available
Haematemesis07.12.02.002; 24.07.02.0110.000558%Not Available
Haematochezia24.07.02.012; 07.12.02.0030.001005%Not Available
Haematoma24.07.01.0010.000893%
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.0060.000893%
Haemoglobin13.01.05.018--Not Available
Haemoglobin decreased13.01.05.003--Not Available
Haemolysis01.06.04.0020.000335%
Haemolytic anaemia01.06.03.0020.000223%Not Available
Haemoptysis24.07.01.006; 22.02.03.004; 02.11.04.0090.000558%Not Available
Haemorrhoids24.10.02.002; 07.15.03.001--
Hallucination19.10.04.0030.004020%
Hallucination, auditory19.10.04.0040.000335%Not Available
Hallucination, visual19.10.04.0070.000893%Not Available
Hallucinations, mixed19.10.04.0080.000447%Not Available
Head discomfort17.02.05.0270.000447%Not Available
Headache17.14.01.001--
Henoch-Schonlein purpura24.07.06.003; 23.06.01.002; 10.02.02.004; 01.01.04.0010.000335%Not Available
Hepatic cirrhosis09.01.04.0010.000223%Not Available
Hepatic encephalopathy17.13.01.003; 09.01.03.0060.000223%Not Available
Hepatic failure09.01.03.002--
Hepatic function abnormal09.01.02.0010.001452%Not Available
Hepatic necrosis09.01.07.0020.000447%
Hepatitis09.01.07.0040.000893%Not Available
Hepatitis cholestatic09.01.01.0020.000670%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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