Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Eculizumab
Drug ID BADD_D00742
Description Eculizumab is a monoclonal antibody that targets complement protein C5.[L6919,A2245] Binding to this protein prevents the activation of a complement terminal complex, which is used to treat a number of autoimmune conditions.[L6919,A2245,A2246] Eculizumab was granted FDA approval on 16 March 2007.[L6919]
Indications and Usage Eculizumab is indicated to treat paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy[L6919,A2246], and neuromyelitis optica spectrum disorder (NMOSD).[L6916]
Marketing Status approved; investigational
ATC Code L04AA25
DrugBank ID DB01257
KEGG ID D03940
MeSH ID C481642
PubChem ID Not Available
TTD Drug ID D01RQV
NDC Product Code 69438-0001; 25682-001; 68225-042; 42098-0005
UNII A3ULP0F556
Synonyms eculizumab | 5G1.1 | H5G1.1VHC+H5G1.1VLC | H5G1.1 | H5G1-1 | H5G11 | Elizaria | Soliris | Alexion
Chemical Information
Molecular Formula Not Available
CAS Registry Number 219685-50-4
SMILES Not Available
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)
Abdominal pain07.01.05.002--
Anaemia01.03.02.001--
Back pain15.03.04.005--
Constipation07.02.02.001--
Cough22.02.03.001--
Diarrhoea07.02.01.001--
Fatigue08.01.01.002--
Headache17.14.01.001--
Herpes simplex23.11.05.004; 11.05.02.001--Not Available
Hypertension24.08.02.001--
Infection11.01.08.002--Not Available
Influenza like illness08.01.03.010--
Insomnia19.02.01.002; 17.15.03.002--
Laryngeal pain22.12.03.010--
Leukopenia01.02.02.001--Not Available
Meningitis meningococcal17.06.10.001; 11.02.14.004--Not Available
Meningococcal infection11.02.14.003--Not Available
Meningococcal sepsis11.02.14.002--Not Available
Myalgia15.05.02.001--
Nasal congestion22.04.04.001--
Nasopharyngitis11.01.13.002; 22.07.03.002--Not Available
Nausea07.01.07.001--
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Pain in extremity15.03.04.010--
Pyrexia08.05.02.003--
Sinusitis11.01.13.005; 22.07.03.007--
Tachycardia02.03.02.007--Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary tract infection20.08.02.001; 11.01.14.004--
Vertigo17.02.12.002; 04.04.01.003--
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