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**The FDA emergency use authorization for hydroxychloroquine and [chloroquine] in the treatment of COVID-19 was revoked on 15 June 2020.[L14312]** Hydroxychloroquine was granted FDA approval on 18 April 1955.[L8072] A recent study reported a fatality in the group being treated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)
Nystagmus17.02.02.006; 06.05.02.006--
Paralysis17.01.04.004--Not Available
Photosensitivity reaction23.03.09.003--
Porphyria14.14.01.001; 03.08.01.001--Not Available
Pruritus23.03.12.001--
Psoriasis23.03.14.002; 10.02.01.036--Not Available
Purpura24.07.06.005; 23.06.01.004; 01.01.04.003--
Rash23.03.13.001--Not Available
Rash maculo-papular23.03.13.004--
Rash morbilliform23.03.13.005--Not Available
Retinal degeneration06.09.03.002--Not Available
Retinal disorder06.08.03.005--Not Available
Retinal oedema24.03.07.006; 06.04.06.007--Not Available
Retinal pigmentation06.09.03.008--Not Available
Seizure17.12.03.001--
Stevens-Johnson syndrome11.07.01.005; 10.01.01.045; 23.03.01.007; 12.03.01.014--
Thrombocytopenia01.08.01.002--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Urticaria23.04.02.001; 10.01.06.001--
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred17.17.01.010; 06.02.06.007--
Visual acuity reduced06.02.10.012; 17.17.01.011--
Visual field defect17.17.01.001; 06.02.07.003--Not Available
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Decreased appetite14.03.01.005; 08.01.09.028--
Blood disorder01.05.01.004--Not Available
Psychotic disorder19.03.01.002--
Pigmentation disorder23.05.03.001--Not Available
Lichenoid keratosis23.01.01.004--Not Available
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