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**The FDA emergency use authorization for hydroxychloroquine and [chloroquine] in the treatment of COVID-19 was revoked on 15 June 2020.[L14312]** Hydroxychloroquine was granted FDA approval on 18 April 1955.[L8072] A recent study reported a fatality in the group being treated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)
Sepsis11.01.11.0030.000264%
Sinus tachycardia02.03.03.0100.000810%
Sinusitis22.07.03.007; 11.01.13.0050.000405%
Sjogren's syndrome15.06.01.015; 10.04.04.009; 07.06.01.010; 06.08.02.0110.000405%Not Available
Skin discolouration23.03.03.0050.000607%Not Available
Skin disorder23.03.03.0070.000810%Not Available
Skin exfoliation23.03.07.0030.001215%Not Available
Skin ulcer24.04.03.007; 23.07.03.0030.000607%
Somnolence19.02.05.003; 17.02.04.0060.001620%
Speech disorder22.02.05.034; 19.19.02.002; 17.02.08.0030.000607%Not Available
Splenomegaly01.09.02.0010.000607%Not Available
Stevens-Johnson syndrome23.03.01.007; 12.03.01.014; 11.07.01.005; 10.01.03.0200.000405%
Stress19.06.02.0040.000405%Not Available
Suicidal ideation19.12.01.003--
Suicide attempt19.12.01.0040.001012%
Sunburn23.03.09.007; 12.05.02.0010.000405%Not Available
Swelling08.01.03.0150.001417%Not Available
Swelling face23.04.01.018; 10.01.05.0180.000810%Not Available
Syncope24.06.02.012; 17.02.04.008; 02.01.02.0080.001012%
Synovitis15.04.02.0010.000607%Not Available
Systemic lupus erythematosus10.04.03.004; 23.03.02.006; 15.06.02.0030.002025%Not Available
Systemic lupus erythematosus rash23.03.13.007; 15.06.02.005; 10.04.03.0050.000106%Not Available
Tachycardia02.03.02.0070.001012%Not Available
Tension19.06.02.005--Not Available
Thrombocytopenia01.08.01.002--Not Available
Thrombosis24.01.01.006--Not Available
Tinnitus17.04.07.004; 04.04.01.0020.002632%
Tongue oedema23.04.01.009; 10.01.05.008; 07.14.02.0070.000405%Not Available
Torsade de pointes02.03.04.0050.000405%Not Available
Toxic epidermal necrolysis23.03.01.008; 12.03.01.015; 11.07.01.006; 10.01.01.006--
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