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**The FDA emergency use authorization for hydroxychloroquine and [chloroquine] in the treatment of COVID-19 was revoked on 15 June 2020.[L14312]** Hydroxychloroquine was granted FDA approval on 18 April 1955.[L8072] A recent study reported a fatality in the group being treated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 Hydroxychloroquine is indicated for the prophylaxis of malaria where chloroquine resistance is not reported, treatment of uncomplicated malaria (caused by _P. falciparum_, _P. malariae_, _P. ovale_, or _P. vivax_), chronic discoid lupus erythematosus, systemic lupus erythematosus, acute rheumatoid arthritis, and chronic rheumatoid arthritis.[L8072]
Marketing Status approved
ATC Code P01BA02
DrugBank ID DB01611
KEGG ID D08050
MeSH ID D006886
PubChem ID 3652
TTD Drug ID D0OJ4L
NDC Product Code Not Available
UNII 4QWG6N8QKH
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
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)
Hepatic encephalopathy09.01.03.006; 17.13.01.0030.002789%-
Hepatic failure09.01.03.0020.002789%
Hepatic function abnormal09.01.02.001---
Hepatic steatosis09.01.07.003; 14.08.04.0050.002789%-
Hepatitis09.01.07.0040.004648%-
Hepatitis acute09.01.07.0050.001859%-
Hepatitis fulminant09.01.07.007; 11.07.01.003---
Hepatocellular injury09.01.07.0080.013016%-
Hepatomegaly09.01.05.0010.005020%-
Hepatotoxicity09.01.07.009; 12.03.01.0080.002789%-
Hiatus hernia07.16.01.001; 22.09.02.004---
Hyperkeratosis23.01.01.0010.001859%
Hypersensitivity10.01.03.0030.122719%
Hypertensive crisis24.08.01.0010.001859%-
Hypoaesthesia17.02.06.023; 23.03.03.0810.010970%-
Hypoaesthesia eye06.01.01.007; 17.02.06.019---
Hypoglycaemia05.06.03.001; 14.06.03.0010.010598%
Hypokalaemia14.05.03.0020.015805%
Hypokinesia17.01.02.009---
Hypoxia22.02.02.0030.002789%
Impaired healing08.03.02.0010.002789%-
Influenza like illness08.01.03.0100.002789%
Initial insomnia17.15.03.005; 19.02.01.005---
Injection site bruising08.02.03.042; 12.07.03.042; 23.03.11.015; 24.07.06.0170.004091%-
Injection site pain08.02.03.010; 12.07.03.0110.007252%-
Interstitial lung disease10.02.01.033; 22.01.02.0030.002789%-
Irritability08.01.03.011; 19.04.02.013--
Jaundice01.06.04.004; 09.01.01.004; 23.03.03.0300.004091%-
Joint effusion15.01.02.0050.001859%
Joint stiffness15.01.02.003---
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ADReCS-Target
Drug Name ADR Term Target
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