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**The FDA emergency use authorization for hydroxychloroquine and [chloroquine] in the treatment of COVID-19 was revoked on 15 June 2020.[L14312]** Hydroxychloroquine was granted FDA approval on 18 April 1955.[L8072] A recent study reported a fatality in the group being treated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)
Sudden hearing loss04.02.01.0090.000405%Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Pseudomonas infection11.02.12.0010.000405%Not Available
Ill-defined disorder08.01.03.0490.000405%Not Available
Blood disorder01.05.01.004--Not Available
Autoimmune disorder10.04.04.0030.000405%
Disease progression08.01.03.038--
Drug intolerance08.06.01.0130.003847%Not Available
Psychotic disorder19.03.01.002--
Pulmonary toxicity12.03.01.013; 22.01.02.0070.000405%Not Available
Immunosuppression10.03.02.0010.000405%Not Available
Pigmentation disorder23.05.03.001--Not Available
Renal impairment20.01.03.010--Not Available
Respiratory tract infection22.07.07.001; 11.01.08.0170.000405%Not Available
Unevaluable event08.01.03.051--Not Available
Lichenoid keratosis23.01.01.0040.000607%Not Available
Osteonecrosis of jaw24.04.05.005; 15.02.04.0100.000607%
Bone marrow failure01.03.03.005--
Suicidal behaviour19.12.01.006--Not Available
Cytopenia01.03.03.0120.000405%Not Available
Treatment failure08.06.01.0170.000475%Not Available
Low birth weight baby18.04.02.0030.000405%Not Available
Mucosal pigmentation08.01.06.006--Not Available
Oropharyngeal discomfort22.02.05.027; 07.05.05.008--Not Available
Oropharyngeal pain07.05.05.004; 22.02.05.0220.000405%
Acute kidney injury20.01.03.016--
Foetal growth restriction18.03.01.0020.000405%
Macular pigmentation06.09.03.015--Not Available
Posterior reversible encephalopathy syndrome17.13.02.0070.000405%
Macular fibrosis06.09.03.0140.000405%Not Available
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