Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Doripenem
Drug ID BADD_D00710
Description Doripenem is a broad-spectrum, carbapenem antibiotic marketed under the brand name Doribax by Janssen. Doripenem injection was approved by the FDA in 2007 to treat complicated urinary tract and intra-abdominal infections. In a clinical trial of doripenem treatment in ventilator associated pneumonia (vs. imipenem and cilastatin), it was found that doripenem carried an increased risk of death and lower clinical cure rates, resulting in a premature termination of the trial. The FDA revised the doripenem label in 2014 to include a warning against use in ventilator-associated pneumonia and to reiterate its safety and efficacy for its approved indications.
Indications and Usage Doripenem is indicated in the treatment of complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis, caused by designated susceptible bacteria.
Marketing Status approved; investigational
ATC Code J01DH04
DrugBank ID DB06211
KEGG ID D03895
MeSH ID D000077726
PubChem ID 73303
TTD Drug ID D03QWT
NDC Product Code Not Available
UNII BHV525JOBH
Synonyms Doripenem | 2-(5-sulfamoylaminomethylpyrrolidin-3-ylthio)-6-(1-hydroxyethyl)-1-methylcarbapen-2-em-3-carboxylic acid | S 4661 | S-4661 | S4661
Chemical Information
Molecular Formula C15H24N4O6S2
CAS Registry Number 148016-81-3
SMILES CC1C2C(C(=O)N2C(=C1SC3CC(NC3)CNS(=O)(=O)N)C(=O)O)C(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)
Anaemia01.03.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Clostridium difficile colitis11.02.02.004; 07.19.01.004--Not Available
Colitis07.08.01.001--
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Drug interaction08.06.03.001--Not Available
Erythema multiforme23.03.01.003; 10.01.03.015--
Gastrointestinal disorder07.11.01.001--Not Available
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Immune system disorder10.02.01.001--Not Available
Infection11.01.08.002--Not Available
Interstitial lung disease10.02.01.033; 22.01.02.003--Not Available
Leukopenia01.02.02.001--Not Available
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Neutropenia01.02.03.004--Not Available
Oral candidiasis11.03.03.004; 07.05.07.001--Not Available
Phlebitis24.12.03.004; 12.02.01.002--
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Renal failure20.01.03.005--Not Available
Seizure17.12.03.001--
Skin disorder23.03.03.007--Not Available
Stevens-Johnson syndrome11.07.01.005; 10.01.01.045; 23.03.01.007; 12.03.01.014--
Thrombocytopenia01.08.01.002--Not Available
Toxic epidermal necrolysis23.03.01.008; 12.03.01.015; 11.07.01.006; 10.01.01.006--
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