Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Hydroxychloroquine
Drug ID BADD_D01103
Description Hydroxychloroquine is a racemic mixture consisting of an R and S enantiomer.[A183047] Hydroxychloroquine is an aminoquinoline like [chloroquine].[L8072] It is a commonly prescribed medication in the treatment of uncomplicated malaria, rheumatoid arthritis, chronic discoid lupus erythematosus, and systemic lupus erythematosus.[L8072] Hydroxychloroquine is also used for the prophylaxis of malaria in regions where chloroquine resistance is unlikely.[L8072] It was developed during World War II as a derivative of [quinacrine] with less severe side effects.[A183092] Chloroquine and hydroxychloroquine are both being investigated for the treatment of SARS-CoV-2.[A192132] **The FDA emergency use authorization for hydroxychloroquine and [chloroquine] in the treatment of COVID-19 was revoked on 15 June 2020.[L14312]** Hydroxychloroquine was granted FDA approval on 18 April 1955.[L8072] A recent study reported a fatality in the group being treated with hydroxychloroquine for COVID-19.[A192546]
Indications and Usage For the suppressive treatment and treatment of acute attacks of malaria due to Plasmodium vivax, P. malariae, P. ovale, and susceptible strains of P. falciparum. It is also indicated for the treatment of discoid and systemic lupus erythematosus, and rheumatoid arthritis.
Marketing Status Prescription; Discontinued
ATC Code P01BA02
DrugBank ID DB01611
KEGG ID D08050
MeSH ID D006886
PubChem ID 3652
TTD Drug ID D0OJ4L
NDC Product Code Not Available
Synonyms Hydroxychloroquine | Oxychlorochin | Oxychloroquine | Hydroxychlorochin | Plaquenil | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate (1:1) Salt
Chemical Information
Molecular Formula C18H26ClN3O
CAS Registry Number 118-42-3
SMILES CCN(CCCC(C)NC1=C2C=CC(=CC2=NC=C1)Cl)CCO
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Blood bilirubin increased13.03.01.0080.000405%
Blood creatine phosphokinase increased13.04.01.0010.000158%
Blood pressure decreased13.14.03.0020.000405%Not Available
Blood pressure increased13.14.03.005--Not Available
Body temperature increased13.15.01.001--Not Available
Bone disorder15.02.04.0040.000405%Not Available
Bradycardia02.03.02.002--Not Available
Breast cancer21.05.01.003; 16.10.01.0010.000810%Not Available
Bronchospasm22.03.01.004; 10.01.03.012--
Bundle branch block left02.03.01.0070.000607%Not Available
Bundle branch block right02.03.01.0110.000810%Not Available
Burning sensation17.02.06.001; 08.01.09.0290.000810%Not Available
Cardiac arrest02.03.04.0010.000317%
Cardiac failure02.05.01.0010.000845%
Cardiac failure congestive02.05.01.0020.001417%Not Available
Cardiac hypertrophy02.04.02.0170.001417%Not Available
Cardio-respiratory arrest22.02.06.007; 02.03.04.0020.000158%Not Available
Cardiomegaly02.04.02.0010.000106%Not Available
Cardiomyopathy02.04.01.0010.003037%Not Available
Cardiovascular disorder24.03.02.009; 02.01.01.001--Not Available
Cataract06.06.01.0010.000810%
Cellulitis11.02.01.001; 23.09.01.0010.000810%Not Available
Cerebral haemorrhage24.07.04.001; 17.08.01.003--Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Chest discomfort22.02.08.001; 08.01.08.019; 02.02.02.0090.001012%Not Available
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.011--Not Available
Chills15.05.03.016; 08.01.09.0010.001012%
Cholestasis09.01.01.0010.000607%Not Available
Cleft lip07.05.08.002; 03.11.05.002; 15.11.05.0020.000106%Not Available
Conduction disorder02.03.01.0080.000405%
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