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**The FDA emergency use authorization for hydroxychloroquine and [chloroquine] in the treatment of COVID-19 was revoked on 15 June 2020.[L14312]** Hydroxychloroquine was granted FDA approval on 18 April 1955.[L8072] A recent study reported a fatality in the group being treated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)
Joint swelling15.01.02.0040.010598%Not Available
Keratopathy06.06.03.007--Not Available
Lacrimation increased06.08.02.004--
Left ventricular failure02.05.02.0010.002789%Not Available
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.0080.003719%
Leukoderma23.05.02.001--Not Available
Leukopenia01.02.02.0010.008367%Not Available
Lip oedema23.04.01.006; 10.01.05.004; 07.05.04.0040.001859%Not Available
Lip swelling07.05.04.005; 23.04.01.007; 10.01.05.0050.001859%Not Available
Liver disorder09.01.08.001--Not Available
Liver function test abnormal13.03.04.030--Not Available
Lividity23.06.05.009--Not Available
Long QT syndrome02.03.01.0170.005578%Not Available
Loss of consciousness17.02.04.0040.010227%Not Available
Lung disorder22.02.07.0010.002789%Not Available
Lymphadenopathy01.09.01.0020.003719%Not Available
Lymphopenia01.02.02.0020.003719%Not Available
Macular degeneration06.09.03.0010.002789%Not Available
Maculopathy06.09.03.0070.013388%Not Available
Malignant melanoma23.08.01.001; 16.03.01.0010.001859%Not Available
Memory impairment19.20.01.003; 17.03.02.003--
Methaemoglobinaemia01.05.01.0020.005578%
Migraine24.03.05.003; 17.14.02.001--Not Available
Mood swings19.04.03.001--Not Available
Mouth ulceration07.05.06.0040.008181%Not Available
Multiple sclerosis10.04.10.008; 17.16.01.0010.001859%Not Available
Muscle disorder15.05.03.0140.004091%Not Available
Muscular weakness15.05.06.001; 17.05.03.0050.009669%
Myasthenia gravis17.05.04.001; 15.05.08.001; 10.04.05.0010.007438%
Myocarditis02.04.03.0010.001859%
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ADReCS-Target
Drug Name ADR Term Target
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