Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Hydroxychloroquine sulfate
Drug ID BADD_D01104
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**The FDA emergency use authorization for hydroxychloroquine and [chloroquine] in the treatment of COVID-19 was revoked on 15 June 2020.[L14312]** Hydroxychloroquine was granted FDA approval on 18 April 1955.[L8072] A recent study reported a fatality in the group being treated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 D02114
MeSH ID D006886
PubChem ID 12947
TTD Drug ID D0OJ4L
NDC Product Code 51927-0279; 67835-0027; 16729-562; 43353-051; 50090-6280; 68071-2912; 68084-269; 71335-1771; 0615-8401; 0093-2401; 50268-412; 55154-3567; 71335-1523; 71610-506; 49452-3625; 70966-0022; 72640-020; 73309-106; 16571-687; 16714-110; 59212-562; 68382-096; 71610-473; 63739-777; 65841-633; 68071-4648; 71610-701; 0904-7046; 50095-002; 82231-108; 43598-133; 60219-1544; 71335-1949; 16729-561; 50090-5573; 57664-761; 67296-1780; 70954-172; 71205-448; 0781-5994; 57451-0198; 16729-485; 16729-563; 53808-1112; 69238-1544; 71335-0897; 57451-1118; 71796-031; 45542-1161; 42385-927; 43598-131; 59746-780; 67296-1781; 12780-2771; 65841-103; 68108-0336; 43598-721; 55154-2074; 68788-7747; 70954-171; 0615-8459; 76385-144; 82009-045; 67680-003; 71052-659; 73377-041; 16571-112; 43598-132
UNII 8Q2869CNVH
Synonyms Hydroxychloroquine | Oxychlorochin | Oxychloroquine | Hydroxychlorochin | Plaquenil | Hydroxychloroquine Sulfate | Hydroxychloroquine Sulfate (1:1) Salt
Chemical Information
Molecular Formula C18H28ClN3O5S
CAS Registry Number 747-36-4
SMILES CCN(CCCC(C)NC1=C2C=CC(=CC2=NC=C1)Cl)CCO.OS(=O)(=O)O
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)
Abdominal pain07.01.05.002--
Acute hepatic failure09.01.03.001--Not Available
Agranulocytosis01.02.03.001--Not Available
Alopecia23.02.02.001--
Anaemia01.03.02.001--
Angioedema23.04.01.001; 10.01.05.009; 22.04.02.008--Not Available
Aplastic anaemia01.03.03.002--Not Available
Ataxia17.02.02.001; 08.01.02.004--
Bronchospasm22.03.01.004; 10.01.03.012--
Chromatopsia06.02.05.001--Not Available
Corneal oedema06.04.02.001--Not Available
Corneal opacity06.06.03.005--Not Available
Deafness neurosensory17.04.07.001; 04.02.01.002--Not Available
Diarrhoea07.02.01.001--
Dizziness17.02.05.003; 02.11.04.006; 24.06.02.007--
Emotional disorder19.04.02.005--Not Available
Erythema annulare23.03.08.004--Not Available
Fatigue08.01.01.002--
Hair colour changes23.02.06.001--
Headache17.14.01.001--
Hepatic function abnormal09.01.02.001--Not Available
Hypoaesthesia eye17.02.06.019; 06.01.01.007--Not Available
Hyporeflexia17.02.01.003--
Irritability19.04.02.013; 08.01.03.011--
Leukopenia01.02.02.001--Not Available
Muscle atrophy17.05.03.004; 15.05.03.003--Not Available
Nausea07.01.07.001--
Nerve conduction studies abnormal13.07.03.002--Not Available
Nervousness19.06.02.003--Not Available
Nightmare19.02.03.003--Not Available
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