Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Quetiapine
Drug ID BADD_D01888
Description Initially approved by the FDA in 1997, quetiapine is a second-generation atypical antipsychotic used in schizophrenia, major depression, and bipolar disorder.[L8546] Quetiapine demonstrates a high level of therapeutic efficacy and low risk of adverse effects during long-term treatment. It is well-tolerated and a suitable option for some patients with high sensitivity to other drugs, such as [Clozapine] and [Olanzapine].[A2189]
Indications and Usage Quetiapine is used in the symptomatic treatment of schizophrenia. In addition, it may be used for the management of acute manic or mixed episodes in patients with bipolar I disorder, as a monotherapy or combined with other drugs. It may be used to manage depressive episodes in bipolar disorder. In addition to the above indications, quetiapine is used in combination with antidepressant drugs for the treatment of major depression.[L8546] Some off-label uses for this drug include the management of post-traumatic stress disorder (PTSD), generalized anxiety disorder, and psychosis associated with Parkinson's disease.[A185438,A185447,T685]
Marketing Status approved
ATC Code N05AH04
DrugBank ID DB01224
KEGG ID D08456
MeSH ID D000069348
PubChem ID 5002
TTD Drug ID D0H7KF
NDC Product Code 0310-0530; 16729-145; 16729-149; 16714-453; 16714-454; 0093-8163; 50228-380; 0310-0280; 0310-0283; 60687-327; 65862-877; 68001-182; 68001-183; 68001-185; 80425-0107; 16729-146; 16729-150; 0310-0282; 60687-338; 63629-2479; 63629-2481; 65862-875; 70518-0752; 71093-136; 71205-402; 16729-147; 16714-455; 16714-457; 0093-8162; 42291-695; 42291-698; 42291-700; 43547-020; 0310-0272; 0310-0274; 0310-0278; 0310-0284; 68001-181; 70518-0239; 0310-0279; 60687-382; 65862-874; 71093-137; 0615-7987; 0310-0505; 43547-019; 50090-2830; 60687-349; 60687-371; 63629-2478; 63629-2480; 63629-2482; 63629-7116; 71093-138; 0615-7986; 0615-8119; 16714-452; 16714-456; 0093-8166; 33342-135; 43547-519; 71093-135; 72789-255; 80425-0143; 0093-2063; 0093-8164; 42291-699; 43547-520; 43547-522; 43547-523; 50090-2338; 50228-382; 50228-383; 0310-0271; 68001-184; 70518-0289; 71093-139; 16729-148; 29300-309; 50090-4788; 53002-1516; 0310-0275; 0310-0281; 60687-360; 65862-876; 70518-0570; 71205-026; 71610-702; 0310-0515; 0093-8165; 29300-308; 29300-310; 29300-311; 29300-312; 33342-136; 42291-696; 43547-021; 68001-180; 68788-7186; 70518-2828; 0615-7988; 0310-0520; 0310-0540; 33342-137; 42291-697; 43547-518; 43547-521; 50228-384; 65862-873; 71205-401; 0615-8118; 33342-134; 43547-022; 50228-381; 53002-1529
UNII BGL0JSY5SI
Synonyms Quetiapine Fumarate | Ethanol, 2-(2-(4-dibenzo(b,f)(1,4)thiazepin-11-yl-1-piperazinyl)ethoxy)-, (E)-2-butenedioate (2:1) (salt) | Seroquel | ICI 204,636 | ICI-204636 | ICI204636 | ICI 204636 | Quetiapine | 2-(2-(4-dibenzo(b,f)(1,4)thiazepine-11-yl-1-piperazinyl)ethoxy)ethanol
Chemical Information
Molecular Formula C21H25N3O2S
CAS Registry Number 111974-69-7
SMILES C1CN(CCN1CCOCCO)C2=NC3=CC=CC=C3SC4=CC=CC=C42
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)
Sensory loss17.02.07.0070.000055%Not Available
Serotonin syndrome17.05.02.004; 15.05.04.016; 12.03.01.0410.000174%Not Available
Sexual dysfunction21.03.02.003; 19.08.05.002--Not Available
Shock24.06.02.002--Not Available
Sinus arrhythmia02.03.03.0080.000120%Not Available
Sinus congestion22.04.06.001--Not Available
Sinus headache22.12.03.022; 17.14.01.002--
Sinus tachycardia02.03.03.0100.000709%
Sinusitis22.07.03.007; 11.01.13.005--
Skin discolouration23.03.03.005--Not Available
Skin disorder23.03.03.007--Not Available
Skin ulcer24.04.03.007; 23.07.03.003--
Sleep apnoea syndrome22.02.01.013; 19.02.05.002; 17.15.05.0010.000120%
Sleep disorder19.02.04.0010.001003%Not Available
Sleep terror19.02.03.008; 17.15.02.006--Not Available
Sluggishness08.01.01.004--Not Available
Snoring22.12.03.0250.000120%Not Available
Somnambulism19.02.03.006; 17.15.02.0040.000387%Not Available
Somnolence17.02.04.006; 19.02.05.0030.006987%
Speech disorder22.12.03.027; 19.19.02.002; 17.02.08.0030.000719%Not Available
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.0050.000136%
Stomatitis07.05.06.005--
Stress19.06.02.0040.000387%Not Available
Stupor19.02.05.004; 17.02.04.0070.000136%Not Available
Subdural haematoma24.07.04.005; 17.08.05.002; 12.01.10.003--Not Available
Sudden death08.04.01.003; 02.03.04.0130.000055%
Suicidal ideation19.12.01.0030.001226%
Suicide attempt19.12.01.0040.005886%
Supraventricular tachycardia02.03.03.0120.000164%
Syncope24.06.02.012; 17.02.04.008; 02.11.04.0150.001085%
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